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West London Cancer Network
LUNG CANCER
Section by: Dr Peter Schmid, Dr Danielle Power, Dr Conrad Lewanski, Dr Stephen Mangar,
Professor Mark Bower and Professor Michael Seckl
Section last reviewed: 05 June 2009 Section last corrected: 10 June 2009
Approved by Oncology Lead Lung Clinician: Dr P Schmid Date
Agreed by WLCN Lung Tumour Group: Dr B Mann Date
Review date: June 2010
INDEX Page
Non Small Cell Lung Cancer
1. Neo-Adjuvant Chemotherapy according to current trial protocols
2. Adjuvant Chemotherapy
a. Cisplatin 80 - Vinorelbine 30 CTIS 768 3
b. Gemcitabine 1250/Carboplatin 5AUC CTIS 794 4
3. Locally Advanced/Palliative
a. Gemcitabine1250/ Carboplatin 5AUC CTIS 794 5
b. Cisplatin80 - Vinorelbine30 CTIS 768 6
c. Paclitaxel/Carboplatin CTIS 7
d. Paclitaxel/Cisplatin 8
e. Docetaxel/Cisplatin 8
4. Poor performance/Platinum intolerant
a. Vinorelbine 30 IV CTIS 759 9
b. Vinorelbine Oral CTIS 10
c. Gemcitabine D1+8 CTIS 12
5. Relapse regimens
a. Docetaxel-75 CTIS 793 12
b. Pemetrexed single agent (alimta) CTIS 13
c. Erlotinib-150 (tarceva) CTIS 15
6. Chemo-Radiation according to current trial protocols
7. Additional Private Care regimens
a. Paclitaxel/Carboplatin/Bevacizumab CTIS 16
b. Pemetrexed/Cisplatin CTIS 20
c. Erlotinib-150 (tarceva) CTIS 22
Small Cell Lung Cancer
8. First Line: Etoposide/Platinum combination
a. EP 80/440 oral CTIS 1388 24
b. E-Carbo CTIS 1146 25
9. Relapse regimens
a. CAV CTIS 791 26
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 1 of 30
Small Cell Lung Cancer (contd)
10. Additional Private Care regimens
a. Topotecan IV CTIS 27
11. Palliative Chemotherapy
a. Oral etoposide 14day CTIS 170 28
Mesothelioma
12. Pemetrexed/Cisplatin CTIS 1241 29
13. Vinorelbine 30 IV CTIS 759 30
14. Vinorelbine30/Cisplatin80 CTIS 768 30
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 2 of 30
West London Cancer Network
Non Small Cell Lung Cancer
Section by: Dr Peter Schmid, Dr Danielle Power, Dr Conrad Lewanski, Dr Stephen Mangar,
Professor Mark Bower and Professor Michael Seckl
Section last reviewed: 05 June 2009 Section last corrected: 10 June 2009
Approved by Oncology Lead Lung Clinician: June 2009
Agreed by WLCN Lung Tumour Group: June 2009
Review date: June 2010
1. Neo-Adjuvant Chemotherapy (prior to surgery)
Clinical Trials if available or at discretion of consultant after discussion at the MDT.
2. Adjuvant Chemotherapy
Preferred option based on available evidence is Cisplatin/Vinorelbine
2a. Cisplatin/Vinorelbine (CTIS: 768)
Vinorelbine 30mg/m2 IV minibag over 10 mins Day 1 and 8
Prehydrations Day 1
Cisplatin 80mg/m2 IV over 2-4 hours Day 1
Post hydrations Day 1
Interval between cycles: Repeat every 21 days
Number of cycles: 4 cycles
Tests before starting course of chemo: FBC, U&Es, LFTs, CrCl (calculated). Do
EDTA if <60ml/min.
Tests to ok/confirm each cycle of chemo: FBC, U&Es, LFTs, CrCl (calculated). Do
EDTA if serum creatinine is rising.
Supportive drugs with each cycle: 5HT3 and dexamethasone antiemetics as
per local protocol, laxatives
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information:
Vinorelbine is a vesicant and must be administered according to WLCN
administration policy. It should be administered as a slow IV bolus with 0.9% sodium
chloride and injected into a free-running saline drip. It should be flushed in with
250ml of 0.9% sodium chloride. At HHNT patients receiving vinorelbine should be
observed for 2 hours post injection.
Cisplatin Maintain fluid output over 100ml/hour during and for 6-8 hours after
cisplatin administration. Alternatively, weigh patient prior to and after cisplatin
infusion. If weight gain is greater than 1.5kg, or patient is symptomatic of fluid
retention, contact medical team for diuretic. Encourage patients to drink 2-3 litres of
fluid following cisplatin
Dose modifications: See table Lung/Cisp-Vinorel below
Reference: NEJM. 2005;352(25):2589-2597. Winton et al
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 3 of 30
Table: Lung/Cisp-Vinorel
NB. Palliative patients will require greater/earlier dose reductions than those stated below based
on individual patient parameters. Discuss with consultant.
Side-effect Cisp-Vinorel Radical Dose Modification (Schmid/Lewanski)
Haematology
Neutrophils Platelets
x109/L x109/L
Day 1
1.5 100 Full dose
<1.5 < 100 Delay until recovery then
Cisplatin full dose.
Vinorelbine 20% dose reduction
Day 8
1.0 50 Omit day 8 restart next cycle once recovered
Renal function (NLCN)
Crcl (EDTA) >60mls/min Full dose
50-59mls/min Cisplatin 25% dose reduction. Vinorelbine full dose
41-49mls/min Cisplatin 50% dose reduction. Vinorelbine full dose
<40mls/min Do not give cisplatin. Consider carboplatin 5AUC.
Vinorelbine full dose
Hepatic Impairment (NLCN)
Bilirubin 26micromols/L Full dose
27-50micromols/L Discuss with consultant. Consider vinorelbine 50%
dose reduction
>51micromols/L Do not give vinorelbine
Constipation
Grade 3 or 4
Severe, interfering with activities of daily Omit vinorelbine. Consider changing regimen.
living or ileus >96 hour
2b. Gemcitabine/Carboplatin (CTIS: 794)
Gemcitabine 1250mg/m2 IV over 30mins Day 1 and 8
Carboplatin 5 x (GFR+25)mg (max 750mg) IV over 1 hour Day 1
NB. Consider gemcitabine 1000mg/m2 in poor performance status
Interval between cycles: Repeat every 21 days
Number of cycles: 4 cycles
Tests before starting course of chemo: FBC, U&Es, LFTs, EDTA,
Tests to ok/confirm each cycle of chemo: FBC, U&Es, LFTs. Creatinine clearance
(calculated). Redo EDTA if serum
creatinine is rising
Supportive drugs with each cycle: 5HT3 and dexamethasone antiemetics as
per local protocol
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information:
Gemcitabine must be administered over 30 minutes. In the case of injection site
reaction (vein irritation) the infusion may be slowed down slightly after agreement
with the medical team but must not be infused over more than one hour. Prolonged
infusion increases the treatment toxicity and should be avoided. Peripheral venous
comfort may be increased with warming the arm with a heat pad.
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 4 of 30
Carboplatin may cause allergic reactions and can occur within minutes of
administration
Dose modifications: See table Gem/Carbo lung page 5
Reference:
3. Locally Advanced/Palliative Chemotherapy
Preferred Regimen for Good Performance Status is Gemcitabine/Carboplatin
3a. Gemcitabine/Carboplatin (CTIS: 794)
Gemcitabine 1250mg/m2 IV over 30mins Day 1 and 8
Carboplatin 5 x (GFR+25)mg (max 750mg) IV over 1 hour Day 1
Interval between cycles: Repeat every 21 days
Number of cycles: Up to 4 cycles unless evidence of continued benefit, then max 6
cycles.
Tests before starting course of chemo: FBC, U&Es, LFTs, EDTA,
Tests to ok/confirm each cycle of chemo: FBC, U&Es, LFTs. Creatinine clearance
(calculated). Redo EDTA if serum creatinine
is rising
Supportive drugs with each cycle: 5HT3 and dexamethasone antiemetics as
per local protocol
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information: See Gem-Carbo Lung page 4
Dose modifications: See table Gem/Carbo below
Reference: J. Chemother 2002;14(3):296-300 Tognoni A et al
J. Clin Oncol 2005;23(1):142-153 Rudd RM et al
Table Gem/Carbo (lung)
NB. Palliative patients will require greater/earlier dose reductions than those stated below based
on individual patient parameters. Discuss with consultant.
Side-effect Gem-Carbo Lung Dose Modification (Source LLG/SPC amended by P Schmid/C
Lewanski/, BTOG2 trial)
Haematology
Neutrophils x 109/L Platelets x109/L
Day 1
1.5 and 100 Full dose all drugs
<1.5 or <100 Delay until recovered then discuss with consultant
either give full dose or consider
gemcitabine 20% dose reduction
carboplatin 20% dose reduction
Day 8
1.0 100 Full dose gemcitabine
<1.0 or <100 Omit day 8 gemcitabine.
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 5 of 30
Side-effect: Gem-Carbo lung Dose Modification (Source LLG/SPC amended by P Schmid/C
Lewanski/, BTOG2 trial)
Renal function (Crcl) 50ml/min Full dose all drugs
40-49mls/min Carboplatin as per GFR
Gemcitabine 20% dose reduction
30-39mls/min Discuss suitability of platinum based chemotherapy with
consultant . If to go ahead
Carboplatin as per GFR
Gemcitabine 20% dose reduction
<30mls/min Do not give. Discuss with consultant
Neurotoxicity (BTOG2 Trial) Grade 0-1 Full dose all drugs
Grade 2 Carboplatin 50% dose reduction.
Gemcitabine full dose
Grade 3 Carboplatin DO NOT GIVE.
Gemcitabine full dose
Grade 4 Discontinue regimen discuss with consultant
3b. Cisplatin-80/Vinorelbine-30 (CTIS: 768)
Vinorelbine 30mg/m2 IV minibag over 10 mins Day 1 and 8
Prehydrations Day 1
Cisplatin 80mg/m2 IV over 2-4 hours Day 1
Post hydrations Day 1
Interval between cycles: Repeat every 21 days
Number of cycles: 2-4 cycles
Tests before starting course of chemo: FBC, U&Es, LFTs, CrCl (calculated) If
<60ml/min do EDTA.
Tests to ok/confirm each cycle of chemo: FBC, U&Es, LFTs. Creatinine clearance
(calculated). Do EDTA if serum creatinine is
rising
Supportive drugs with each cycle: 5HT3 and dexamethasone antiemetics as
per local protocol, laxatives
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information: See Cisp-Vinorel Lung page 3
Dose modifications: See table Cisp-Vinorel Lung page 4
Reference: J. Clin Oncol 2003;21:3025-3034 Gridelli et al
Side-effect Cisp-Vinorel Palliative Dose Modification (Schmid/Lewanski)
Haematology
Neutrophils Platelets
x109/L x109/L
Day 1
1.5 100 Full dose
<1.5 < 100 Delay until recovery then
Cisplatin full dose.
Vinorelbine 20% dose reduction
Day 8
1.0 50 Omit day 8 restart next cycle once recovered
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 6 of 30
Side-effect Cisp-Vinorel Palliative Dose Modification (Schmid/Lewanski)
Renal function (NLCN)
Crcl (EDTA) >60mls/min Full dose
50-59mls/min Cisplatin 25% dose reduction. Vinorelbine full dose
41-49mls/min Cisplatin 50% dose reduction. Vinorelbine full dose
<40mls/min Do not give cisplatin. Consider carboplatin 5AUC.
Vinorelbine full dose
Hepatic Impairment (NLCN)
Bilirubin 26micromols/L Full dose
27-50micromols/L Discuss with consultant. Consider vinorelbine 50%
dose reduction
>51micromols/L Do not give vinorelbine
Palliative chemotherapy
Extensive liver metastases (>75% liver Patients with extensive liver metastases (>75% of liver
volume replaced) volume replaced) suggest vinorelbine dose reduction by
a third and dose monitoring
Constipation
Grade 3 or 4
Severe, interfering with activities of daily Omit vinorelbine. Consider changing regimen.
living or ileus >96 hour
Taxane/Platinum Regimens
Preferred taxane/platinum regimen is paclitaxel/Carboplatin
3c Paclitaxel/Carboplatin
Dexamethasone 20mg PO 12 hours pre-paclitaxel
Dexamethasone 20mg PO 3-6 hours pre-paclitaxel
Ranitidine 50mg IV over 10 mins Day 1
Chlorphenamine 10mg IV bolus Day 1
Paclitaxel 175mg/m2 IV over 3 hours Day 1
Carboplatin 5(GFR+25)mg IV over 1 hour Day 1
Interval between cycles: Repeat every 21 days
Number of cycles: up to 6 cycles.
Tests before starting course of chemo: FBC, U&Es, LFTs, EDTA,
Tests to ok/confirm each cycle of chemo: FBC, U&Es, LFTs. Creatinine clearance
(calculated). Redo EDTA if serum creatinine
is rising
Supportive drugs with each cycle: 5HT3 and dexamethasone antiemetics as
per local protocol
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information:
Paclitaxel: Use administration set (polyethylene lined with inline filter < 0.22 microns)
provided by pharmacy only for paclitaxel. Paclitaxel should be administered prior to
carboplatin. Vital signs should be monitored every 15 minutes for 1st hour of
paclitaxel infusion on all cycles. If hypersensitivity reaction to paclitaxel occurs,
patient should not be rechallenged.
Carboplatin also may cause allergic reactions and can occur within minutes of
administration.
Dose modifications: See table Gem/Taxol below
Reference: J. Chemother 2002;14(3):296-300 Tognoni A et al
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 7 of 30
J. Clin Oncol 2005;23(1):142-153 Rudd RM et al
Table: Carbo/Taxol
Side-effect Dose Modification (SourceICON3)
Neutrophils Platelets Carboplatin Paclitaxel
x109/L x109/L
1.5 and 100 Full dose Full dose
1.0-1.4 and 75-99 Delay 1 week Delay 1 week then
Reduce to 4AUC Full dose
<1.0 and <75 Delay 1 week initially then Delay 1 week then
subsequently 20% dose 20% dose reduction
reduction
Neurotoxicity
Grade 2 Full dose 20% dose reduction.
If recurs after dose
reduction, omit paclitaxel
Hepatic function (NLCN)
Bilirubin 17 micromol/L Full dose Full dose
18-26 micromol/L Full dose Paclitaxel 135mg/m2
27-51 micromol/L Full dose Paclitaxel 75mg/m2
>51 micromol/L Discuss with consultant Omit paclitaxel
Severe liver impairment Omit paclitaxel
Renal function
Crcl: If cr increases by 25% Recalculate dose using
repeat EDTA standard formula
Crcl <20mls/min DO NOT give
3d Paclitaxel/Cisplatin: Preferred taxane/platinum regimnen is paclitaxel/carboplatin page 7
Dexamethasone 20mg PO 12 hours pre-paclitaxel
Dexamethasone 20mg PO 3-6 hours pre-paclitaxel
Ranitidine 50mg IV over 10 mins Day 1
Chlorphenamine 10mg IV bolus Day 1
Paclitaxel 175mg/m2 IV over 3 hours Day 1
Prehydrations Day 1
Cisplatin 80mg/m2 IV over 2 hours Day 1
Post hydrations Day 1
Interval between cycles: Repeat every 21 days
Number of cycles: 6 cycles
Reference: NEJM 2002;346(2):92-98 Schiller JH et al
3d. Docetaxel/Cisplatin: Preferred taxane/platinum regimnen is paclitaxel/carboplatin page 7
Dexamethasone 8mg PO twice a day for 3 days starting
1 day before docetaxel
Docetaxel 75mg/m2 IV over 1 hour Day 1
Prehydrations Day 1
Cisplatin 75mg/m2 IV over 1 hour Day 1
Post hydrations Day 1
Interval between cycles: Repeat every 21 days
Number of cycles: 6 cycles
Reference: NEJM 2002;346(2):92-98
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 8 of 30
4. Poor Performance Status/Unable to Tolerate Platinum
4a. Vinorelbine-30 IV Day 1 + 8 (CTIS: 759)
Vinorelbine 30mg/m2 IV minibag over 10 mins Days 1 and 8
Interval between cycles: Repeat every 21 days
Number of cycles: Usually 2-4 cycles (max 6 cycles)
Tests before starting course of chemo: FBC, U&Es, LFTs
Tests to ok/confirm each cycle of chemo: FBC, U&Es, LFTs
Supportive drugs with each cycle: Low risk antiemetics, consider prophylactic
laxatives
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information:
Vinorelbine is a vesicant and must be administered according to WLCN
administration policy. It should be administered as a slow IV bolus with 0.9% sodium
chloride and injected into a free-running saline drip. It should be flushed in with
250ml of 0.9% sodium chloride. At HHNT patients receiving vinorelbine should be
observed for 2 hours post injection.
Dose modifications: See table Vinorelbine-Lung below
Reference: The Oncologist 2001;6(suppl 1):4-7. Gridelli C et al (Elvis trial)
Table: Vinorelbine IV
Side effect: Vinorelbine IV Dose Modification
Haematology (St Mary’s)
Neutrophils Platelets
x10/9/L x109/L
1.5 100 Full dose
<1.5 <100 Delay until recovery then vinorelbine 20% dose
reduction
Renal function (Pierre Fabre/NLCN)
Serum creatinine
2.5 x ULN Full dose
2.6 x ULN Delay and reassess after 1 week.
If after 2 weeks, creatinine still elevated by 2.6 x ULN
discontinue treatment
Hepatic function (NLCN/Pierre Fabre/St Mary’s)
AST/ALT Bilirubin
5 x ULN or 26micromol/L Full dose
5.1-20 x ULN or 26-52micromol/L Delay and reassess 1 week later.
Consider vinorelbine 50% dose reduction.
If toxicity persists for more than 3 weeks discontinue
treatment
>20 x ULN or >52micromol/L Do not give
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 9 of 30
4b. Vinorelbine Oral Single Agent (CTIS ) (Subject to local approval)
First three administrations (week 1,2 and 3);
Vinorelbine 60mg/m2 (max 160mg/week) Oral once Day 1 (repeat every 7 days
for first 3 weeks)
Subsequent administrations (cycle 4 onwards)
Do NOT increase dose if neutrophils have dropped once below 0.5x109/L or have dropped
more than once between 0.5 to 1.0x 109/L
Vinorelbine 80mg/m2(max 160mg/week) Oral once Day 1 (repeat every 7 days)
Interval between cycles: Repeat every 7 days
Dose for first 3 administrations is 60mg/m2
Dose may be increased for cycle 4 onwards as outlined above
Number of cycles: Usually 2-4 cycles (max 6 cycles)
Subject to local approval of oral formulation
Tests before starting course of chemo: FBC, U&Es, LFTs
Tests to ok/confirm each cycle of chemo: FBC, U&Es, LFTs
Supportive drugs with each cycle: Low risk antiemetics, consider prophylactic
laxatives
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information:
Swallow whole with water, do not suck or chew as the contents of the capsule is irritant.
Recommended to take the capsule with some food
SPC: Based on clinical studies
Oral vinorelbine 80mg/m2 corresponds to IV vinorelbine 30mg/m2 and
Oral vinorelbine 60mg/m2 corresponds to IV vinorelbine 25mg/m2
Dose modifications: See table Vinorelbine-Lung below
Reference:
Vinorelbine dose table from SPC
Body Surface Area Dose for 60mg/m2 Dose for 80mg/m2
2
m mg mg
0.95 – 1.04 60 80
1.05 – 1.14 70 90
1.15 – 1.24 70 100
1.25 – 1.34 80 100
1.35 – 1.44 80 110
1.45 – 1.54 90 120
1.55 – 1.64 100 130
1.65 – 1.74 100 140
1.75 – 1.84 110 140
1.85 – 1.94 110 150
≥ 1.96 120 160
Even patients with BSA ≥ 2.0 m2 should not exceed 160mg/day
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 10 of 30
Table: Vinorelbine Oral Single Agent
Side effect: Vinorelbine Oral Dose Modification
Haematology (SPC)
Neutrophils Platelets
x10/9/L x109/L
1.5 100 Full dose
<1.5 <100 Delay until recovery then dose as below
Neutrophil count during first three Recommended dose for Dose for next administration
2
administrations of 60mg/m
>1.0 x10/9/L Vinorelbine 80mg/m2 Repeat every 7 days
0.5 and <1.0 x10/9/L (1 episode) Vinorelbine 80mg/m2 Repeat every 7 days
0.5 and <1.0 x10/9/L (2 episodes) Vinorelbine 60mg/m2 Repeat every 7 days
<0.5 x10/9/L Vinorelbine 60mg/m2 Repeat every 7 days
Neutrophil count beyond the 4th
administration of 60mg/m2
>1.0 x10/9/L Vinorelbine 80mg/m2 Repeat every 7 days
0.5 and <1.0 x10/9/L (1 episode) Vinorelbine 80mg/m2 Repeat every 7 days
0.5 and <1.0 x10/9/L (2 episodes) Vinorelbine 60mg/m2 Repeat every 7 days
2
<0.5 x10/9/L Vinorelbine 60mg/m Repeat every 7 days
It is possible to re-escalate the dose from 60mg/m2 to
80mg/m2 if the neutrophil count did not once drop
below 0.5 or more than once drop between 0.5 and 1.0
during previous three consecutive administrations
given at 60mg/m2
Renal function (Pierre Fabre/NLCN)
Serum creatinine
2.5 x ULN Full dose
2.6 x ULN Delay and reassess after 1 week.
If after 2 weeks, creatinine still elevated by 2.6 x ULN
discontinue treatment
Hepatic function (NLCN/Pierre Fabre/St Mary’s)
AST/ALT Bilirubin
5 x ULN or 26micromol/L Full dose
5.1-2.0 x ULN or 26-52micromol/L Delay and reassess 1 week later.
Consider vinorelbine 50% dose reduction.
If toxicity persists for more than 3 weeks discontinue
treatment
>2.0 x ULN or >52micromol/L Do not give
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 11 of 30
4c Gemcitabine D1 and 8 (CTIS….)
Gemcitabine 1000mg/m2 IV over 30 mins Day 1 and 8
Interval between cycles: Repeat every 21 days
Number of cycles: 4-6 cycles (used if patient unable to tolerate regimens above)
Tests before starting course of chemo: FBC, U&Es, LFTs
Tests to OK/Confirm each cycle of chemo: FBC, U&Es, LFTs
Supportive drugs with each cycle: Low risk antiemetics
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information:
Gemcitabine must be administered over 30 minutes. In the case of injection site
reaction (vein irritation) the infusion may be slowed down slightly after agreement
with the medical team but must not be infused over more than one hour. Prolonged
infusion increases the treatment toxicity and should be avoided. Peripheral venous
comfort may be increased with warming the arm with a heat pad.
Dose modifications: See table Gemcitabine-Lung below
Reference: Br J. Cancer 2000;83:447-453. Anderson H et al
Table: Gemcitabine-Lung
Side effect Dose Modification (Schmid/Lewanski)
Haematology (SPC)
Neutrophils Platelets
x10/9/L x109/L
Day 1
>1.5 and 100 Full dose
<1.5 or <100 Delay until recovered then discuss with consultant
either give full dose or consider
gemcitabine 20% dose reduction
Day 8
1.0 or 100 Full dose
<1.0 or <100 Omit day 8 dose
Hepatic function (NLCN)
Bilirubin 27micromol/L Full dose
>27micromol/L Discuss with consultant
Renal impairment (NLCN
Crcl >30mls/min Full dose
<30mls/min Discuss with consultant
Renal function (Crcl)
50ml/min Full dose
30-49mls/min Gemcitabine 20% dose reduction
<30mls/min Do not give. Discuss with consultant
5. Relapse Protocols
5a Docetaxel-75 (CTIS: 793)
Dexamethasone 8mg BD Oral Twice a day for 3 days starting
day before docetaxel
Docetaxel 75mg/m2 IV over 1 hour Day 1
Interval between cycles: Repeat every 21 days
Number of cycles: up to 6 cycles
Tests before starting course of chemo FBC, U&Es, LFTs,
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 12 of 30
Tests to OK/Confirm each cycle of chemo: FBC, U&Es, LFTs
Supportive drugs with each cycle: 5HT3 antiemetics as per local policy
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information:
Dexamethasone 8mg must be taken orally twice a day for 3 days (the day before,
the day of and the day after docetaxel) to prevent fluid retention and hypersensitivity
reactions; therefore, the patient must be discharged with enough dexamethasone to
take before their next cycle. Ensure patient understands how to take their steroids at
home. Diabetic patients will need to monitor blood sugar levels more regularly and
inform their doctor if they are having problems with the control of their blood sugar
levels. IV dexamethasone should not be given to replace oral doses. Observations
(temperature, BP, pulse and respiration) for acute hypersensitivity reactions should
be taken prior to administration, directly after infusion has commenced and then at
15 minute intervals for at least the first two cycles. Assess for any drug-induced
neuropathy.
Dose modifications: See table Docetaxel Lung below
Reference: Clin Lung Cancer. 2002;2(suppl 2):S23-8. Fosella FV et al.
Table: Docetaxel – Lung
Side effect Dose Modification (M Seckl/D Power)
Haematology
Neutrophils Platelets
x109/L x109/L
1.5 100 Full dose
<1.5 <100 Delay until recovery then consider docetaxel dose
reduction
Hepatic function (SPC/NLCN)
If Bilirubin >22micromol/ml }
and/or }
ALT/AST >3.5 x ULN } Do not give docetaxel
And }
ALP >6 x ULN }
Neurotoxicity:
Grade 0-2 Full dose
Grade 3+ Omit docetaxel
5b Pemetrexed Single agent
Dexamethasone 8mg BD Oral Twice a day for 3 days starting the
day before pemetrexed
Pemetrexed 500mg/m2 IV over 10-15 mins Day 1
Interval between cycles: Repeat every 21 days
Number of cycles: Non Squamous NSCLC up to 6 cycles
Second-line treatment of patients with locally advanced or
metastatic non small cell lung cancer other than predominantly
squamous cell histology. This will not be supported should the
current price arrangement with the manufacturer be changed in
the future
Tests before starting course of chemo FBC, U&Es, LFTs, CrCl calculated. Do
EDTA if <60ml/min
Tests to OK/Confirm each cycle of chemo: FBC, U&Es, LFTs, CrCl calculated.
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 13 of 30
Do EDTA if rising serum creatinine
Supportive drugs with each cycle:
5HT3 antiemetics as per local policy
Dexamethasone as above to reduce the incidence and severity
of skin reactions
Vitamin supplementation to reduce toxicity and incidence of
grade 3/4 haematological and non-haematological toxicities
Folic acid 1,000microgram oral daily, starting 7 days before 1st
pemetrexed dose and continuing for 21days after last
pemetrexed dose
Vitamin B12 1000micrograms IM. first dose must be given the
week before the 1st pemetrexed dose and then once every 3
cycles thereafter, (subsequent doses may be given on the same
day as pemetrexed.
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information: NB for non squamous cell only.
Do not use in squamous cell as fatal haemorrhage documented.
Refer to company for info on reimbursement plan
Dose modifications:
Reference: J Clin Oncol 2008; 26:3543-3551 Scagliotti GV et al
J Clin. Onco. 22:1589-1597 Hanna S et al
Side effect: Pemetrexed Dose Modification (SPC)
Haematology (SPC)
Neutrophils Platelets
x109/L x109/L
1.5 100 Full dose
<1.5 <100 Delay until recovery then dose should be based on
nadir blood counts below
Nadir Counts
Dose reductions based on nadir counts.
<0.5 and >50 Wait until full recovery then give
Pemetrexed 25% dose reduction
Any and <50 Wait until full recovery then give
Pemetrexed 25% dose reduction
Any and <50 Wait until full recovery then give
With bleeding Pemetrexed 50% dose reduction
Renal function (NLCN/SPC)
Crcl (EDTA) >60mls/min Full dose
45-59mls/min Pemetrexed full dose but avoid NSAID 2days before
and after pemetrexed dose
<45mls/min Do not give regimen. Discuss with consultant
Hepatic function (SPC)
Bilirubin 1.5xULN Full dose
> 1.5xULN Do not give pemetrexed
Contd….
Alk Phos, AST (or SGOT),
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 14 of 30
Side effect: Pemetrexed Dose Modification (SPC)
ALT (or SGPT)
3 xULN Full dose pemetrexed
3 to 5 xULN Do not give pemetrexed if there are no hepatic
metastases.
If liver does has tumour involvement, then full dose
pemetrexed is permitted.
>5 xULN Do not give pemetrexed
Neurotoxicity: NCICTC Grade
Grade 0-1 Full dose all drugs
Grade 2 Pemetrexed full dose
Grade 3 or 4 Discontinue regimen
Diarrhoea (SPC)
Grade 2 Full dose all drugs
Grade 3 or 4 Pemetrexed 25% dose reduction
Any diarrhoea requiring hospitalisation Pemetrexed 25% dose reduction
irrespective of grade
Mucositis (SPC)
Grade 2 Full dose all drugs
Grade 3 or 4 Withhold treatment until resolved to pre-treatment
levels, then give
Pemetrexed 50% dose reduction
Persistent grade 3 or 4 If toxicity persists at grade 3 or 4, despite two dose
reductions; discontinue pemetrexed
Other Non Haematological toxicities
Grade 2 Full dose all drugs
Grade 3 or 4 except mucositis Pemetrexed 25% dose reduction
5b Erloitinib
Erlotinib 150mg Oral once a day continuous treatment
Take at least 1 hour before or 2 hours after food
Interval between cycles: Repeat tests every 28 days
Number of cycles: In line with NICE as an alternative
to docetaxel as 2nd line treatment
of NSCLC using the Roche
reimbursement program up to 6 cycles
Tests before starting course of chemo FBC, U&Es, LFTs,
Tests to OK/Confirm each cycle of chemo: FBC, U&Es, LFTs, monitor for symptoms
and biochemical signs of dehydration
Supportive drugs with each cycle:
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information:
Plasma concentrations of erlotinib are reduced in patients who smoke.
High stomach pH can reduce bioavailability of erlotinib by up to 50%. Do not administer PPI
with erlotinib. Roche recommend ranitidine 150mg BD, Erlotinib should be taken 2 hours
before or 10 hours after ranitidine. See SPC for information about other drug interactions
NPSA Information on safety concern Summary (issued June 2009)
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 15 of 30
•Patients receiving tarceva/erlotinib are at increased risk of developing
gastrointestinal perforations.
• Patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs
and/or taxane based chemotherapy, or who have a prior history of peptic ulceration
or diverticular disease are at increased risk.
• Tarceva/erlotinib should be permanently discontinued in patients who develop
gastrointestinal perforation.
Dose modifications:
Reference:
Side effect: Erlotinib Dose Modification (SPC)
Haematology (SPC)
Neutrophils Platelets
x109/L x109/L
1.5 100 Full dose
<1.5 <100 Do not give discuss with
Renal function (SPC)
Approx 9% renal elimination
Crcl (EDTA) 30mls/min Full dose
<30mls/min Discuss with consultant. No data below 15mls/min
Hepatic function (SPC)
.90% excreted as metabolites via faeces
Severe hepatic impairment Do not give
Rash
Occurs in approx 75% of patients, (median time
to onset 8days).
Grade 1 or 2 Mostly grade 1 or 2 in severity and manageable
without intervention.
Grade 3 or 4 Grade 3 or 4 rash (9% of patients) may require dose
reduction or discontinuation
Diarrhoea (SPC)
Occursv in approx 50% of patients, median time
to onset 12days
Moderate/severe diarrhoea Treat with loperamide
In some cases dose reduction may be necessary.
Clinical studies reduced doses bin 50mg steps. Dose
reduction in 25mg steps has not been investigated
Severe or persistent diarrhoea, STOP erlotinib and take appropriate measures to treat
nausea, anorexia or vomiting dehydration. See SPC.
associated with dehydration
Gastrointestinal perforation Permanently Discontinue erlotinib
Other Non Haematological toxicities
Eg anorexia, fatigue
Grade 2
Grade 3 or 4
6. Chemo-Radiation
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 16 of 30
According to current clinical trials
7. Additional Private Care Regimens
7a PCB: Paclitaxel/Carboplatin/Bevacizumab (15)
Dexamethasone
Paclitaxel 175mg/m2 IV over 3 hours Day 1
Carboplatin 5(GFR+25)mg IV over 1 hour Day 1
Bevacizumab 15mg/Kg IV over 90minutes Day 1
*First infusion of bevacizumab should be infused over 90 minutes. If this first infusion is
well tolerated, the second infusion may be administered over 60 minutes. If the 60 minute
infusion is well tolerated, all subsequent infusions may be administered over 30 minutes.
Interval between cycles: Repeat every 21 days
Number of cycles: Non squamous cell NSCLC up to 6 cycles
Tests before starting course of chemo FBC, U&Es, LFTs,
Tests to OK/Confirm each cycle of chemo: FBC, U&Es, LFTs
Supportive drugs with each cycle: 5HT3 antiemetics as per local policy
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information:
Administration information; see Paclitaxel/carbo page 7
Only for NON squamous cell NSCLC. Fatal haemorrhage documented in squamous cell.
Dose modifications: For Paclitaxel/carbo see page 8
For bevacizumab see below
Reference:
Table: Bevacizumab
Side effect: Bevacizumab Dose modification (SPC)
All toxicities graded according to CTCAE v3.0 guidelines
Thrombosis/Embolism
Venous thromboembolic event
Grade 3 or incidentally discovered Hold bevacizumab for 2 weeks. Bevacizumab may be
pulmonary embolus (first occurrence) resumed after initiation of therapeutic-dose
anticoagulant therapy as soon as all of the following
criteria are met:
• The patient must be on a stable dose of
anticoagulant and, if on an oral coumarin-derivative,
have an INR within the target range (usually between
2 and 3) prior to restarting bevacizumab.
Symptomatic Grade 4 venous Permanently discontinue bevacizumab
thromboembolic event (first
occurrence)
Arterial thromboembolic event – any Permanently discontinue bevacizumab if patient
grade develops any grade of arterial thromboembolic event.
Haemorrhage
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 17 of 30
Side effect: Bevacizumab Dose modification (SPC)
Grade 1 and 2 No schedule modifications
Grade 3 or 4 (first occurrence) Discontinue bevacizumab and institute appropriate
treatment
Proteinuria
First occurrence of proteinuria:
1+ (dipstick) Administer bevacizumab as scheduled. NO additional
evaluation is required.
2+, 3+ and 4+ dipstick Administer bevacizumab as scheduled and collect 24-
hour urine to determine the total protein within 3 days
prior to the next scheduled dose.
If
• 24-hour proteinuria 2g:
Administer bevacizumab as scheduled
• 24-hour proteinuria >2g:
Bevacizumab treatment should be withheld pending
next 24 hour total protein.
If
• Repeat 24 hour urine protein 2g:
Administer bevacizumab as schedule. 24-hour
protein should be further monitored prior to each
administration of bevacizumab until it has
decreased to 1g/24 hour.
• Repeat 24-hour urine protein > 2g:
Bevacizumab dose should be withheld until 24-
hour protein has decreased to 2g. 24-hour
protein should be further monitored prior to each
administration of bevacizumab until it has
decreased to 1g/24 hour.
Second and subsequent occurrence of
2+ proteinuria (dipstick)
2+ (dipstick) Administer bevacizumab as scheduled. NO additional
evaluation is required.
3+ and 4+ (dipstick): Administer bevacizumab as scheduled and collect 24-
hour urine to determine the total protein within 3 days
prior to the next scheduled dose is required:
If
• 24-hour proteinuria 2g: Administer bevacizumab as
scheduled
• 24-hour proteinuria >2g: Bevacizumab treatment
should be withheld pending next 24 hour total
protein.
If
• Repeat 24 hour urine protein 2g:
Administer bevacizumab as schedule. 24-hour
protein should be further monitored prior to each
administration of bevacizumab until it has
decreased to 1g/24 hour.
• Repeat 24-hour urine protein > 2g:
Bevacizumab dose should be withheld until 24-
hour protein has decreased to 2g. 24-hour
protein should be further monitored prior to each
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 18 of 30
Side effect: Bevacizumab Dose modification (SPC)
administration of bevacizumab until it has
decreased to 1g/24 hour.
Nephrotic Syndrome (Grade 4) Discontinue bevacizumab treatment
Gastro-intestinal perforation
Gastro-intestinal perforation or Discontinue bevacizumab permanently and institute
dehiscence appropriate treatment
Wound healing complications
Prevention of wound healing Bevacizumab therapy should not be initiated for at least
complications 28 days following major surgery or until the surgical
wound is fully healed. Bevacizumab therapy should be
withheld for at least 28 days before elective surgery.
Wound healing complications In patients who experience wound healing complications
during bevacizumab treatment, bevacizumab should be
withheld until the wound is fully healed.
Fistula or intra-abdominal abscess
Fistula or intra-abdominal abscess Patients who develop a fistula or intra-abdominal
abscess should discontinue bevacizumab
Hypertension
Patients should be monitored for development of, or worsening hypertension by frequent blood
pressure measurement. BP measurement should be taken after the patient has been in a resting
position for 5 minutes. Repeated measurement of BP for verification should be taken of the initial
reading is 140mmHg systolic and/or 90mmHg diastolic blood pressure
Grade 1 Hypertension Continue with bevacizumab
Asymptomatic, transient (<24hr) increase
>20mmHg (diastolic) or to >150/100mmHg if
previously within normal limits.
Grade 2 Hypertension Monotherapy of antihypertensive may be indicated.
Recurrent or persistent (>24hrs) increase by Withhold bevacizumab. Once BP controlled to
20mmHg (diastolic) or to >150/100mmHg if <150/100mmHg patient may restart bevacizumab.
previously within normal limits
Grade 3 Hypertension
Requiring more than one anti-hypertensive or
Withhold bevacizumab for persistent or symptomatic
more intensive therapy than previously. hypertension, until BP controlled.
If hypertension is not controlled with medication
permanently discontinue bevacizumab.
Grade 4 Hypertension Stop bevacizumab permanently.
Life threatening consequence eg.
hypertensive crisis
Infusion-related or allergic reactions If infusion related reactions occur with any infusion:
Grade 2 Administer the next dose with premedication over the
Infusion related reactions same time period (ie. do not reduce infusion time for
eg. fever, chills, headaches, nausea.
Allergic reactions next dose).
eg. fever, rash, urticaria, bronchospasm
If next dose with premedication is well tolerated, then the
subsequent infusion time may be reduced by 30 minutes
(+/- 10mins) provided premedication is still used ie. 90
minute infusion reduced to 60 minutes.
contd
If infusion related reactions occur with the reduced
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 19 of 30
Side effect: Bevacizumab Dose modification (SPC)
infusion time with premedication then all subsequent
doses must be administered over the previous longer
infusion time with premedication.
eg. if infusion related reactions occur with a 60 minute infusion all
subsequent doses should be administered over 90 minutes (+/-
15mins) with premedication.
eg. if infusion related reactions occur with 30 minute infusion, all
subsequent doses should be administered over 60 minutes (+/-
10mins) with premedication
Stop bevacizumab infusion. DO NOT restart on that
Grade 3 day.
Discuss with consultant to decide if bevacizumab should
be permanently discontinued or reinstituted with
premedication over 90 minutes (+/- 15mins). If the
reaction occurred at the 90 minute rate, initially
challenge at a slower rate and gradually increase to 90
minutes. When bevacizumab reinstituted, the patient
should be monitored for a duration comparable to
duration of previous reaction,.
If suspected anaphylactic reactions during bevacizumab
Grade 4 infusion STOP bevacizumab infusion, institute usual
medical response to reaction, consider application of
tourniquet proximal to the injection site to slow systemic
absorption of bevacizumab (do not obstruct arterial flow
in the limb)
Reference:
7b Pemetrexed-500/Cisplatin-75 (CTIS; )
Dexamethasone 8mg BD Oral Twice a day for 3 days starting the
day before pemetrexed
Sodium chloride 0.9% 1000mls IV over 2 hours Day 1 to run before,
during and after
pemetrexed
75 Minutes after start of sodium chloride
Pemetrexed 500mg/m2 IV over 10-15 mins Day 1
30 Minutes after end of pemetrexed
Cisplatin 75mg/m2 IV over 2hours Day 1
Sodium chloride 0.9% 1000mls IV over 2 hours Day 1
Plus MgSO4 and KCl according to local policy
Interval between cycles: Repeat every 21 days
Number of cycles: Licensed as 1st line treatment
for non squamous locally
advanced or metastatic NSCLC up to 6 cycles
Tests before starting course of chemo FBC, U&Es, LFTs, CrCl calculated. Do
EDTA if <60ml/min
Tests to OK/Confirm each cycle of chemo: FBC, U&Es, LFTs, CrCl calculated.
Do EDTA if rising serum creatinine
Supportive drugs with each cycle:
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 20 of 30
5HT3 antiemetics as per local policy
Dexamethasone as above to reduce the incidence and severity
of skin reactions.
Vitamin supplementation to reduce toxicity and incidence of
grade 3/4 haematological and non-haematological toxicities
Folic acid 1,000microgram oral daily, starting 7 days before 1st
pemetrexed dose and continuing for 21days after last
pemetrexed dose
Vitamin B12 1000micrograms IM. first dose must be given the
week before the 1st pemetrexed dose and then once every 3
cycles thereafter, (subsequent doses may be given on the same
day as pemetrexed.
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information:
Sodium chloride is the pre-hydration for cisplatin. It should start approx. 75 minutes before
pemetrexed and runs before, during and for 30minutes after the pemetrexed. Cisplatin must
not start until 30minutes after the pemetrexed and the sodium chloride will keep the line
patent whilst during this delay.
Dose modifications:
Reference:
Side effect: Pemetrexed/Cisplat Dose Modification (SPC)
Haematology (SPC)
Neutrophils Platelets
x109/L x109/L Full dose
1.5 100 Delay until recovery then dose should be based on
<1.5 <100 nadir blood counts below
Nadir Counts
Dose reductions should be based on
nadir counts. Wait for full recovery then
dose as below Wait until full recovery then give
<0.5 and >50 Pemetrexed 25% dose reduction
Wait until full recovery then give
Any and <50 Pemetrexed 25% dose reduction
Wait until full recovery then give
Any and <50 Pemetrexed 50% dose reduction
With bleeding
Renal function (NLCN/SPC)
Crcl (EDTA) >60mls/min Full dose
50-59mls/min Cisplatin 25% dose reduction. Pemetrexed full dose
but avoid NSAID 2days before and after pemetrexed
dose
45-49mls/min Cisplatin 50% dose reduction. Pemetrexed full dose
<45mls/min Do not give regimen. Discuss with consultant
Hepatic function (SPC)
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 21 of 30
Side effect: Pemetrexed/Cisplat Dose Modification (SPC)
Bilirubin 1.5xULN Full dose
> 1.5xULN Do not give pemetrexed
Alk Phos, AST (or SGOT),
ALT (or SGPT)
3 xULN Full dose pemetrexed
3 to 5 xULN Do not give pemetrexed if there are no hepatic
metastases.
If liver does has tumour involvement, then full dose
pemetrexed is permitted.
>5 xULN Do not give pemetrexed
Neurotoxicity: NCICTC Grade
Grade 0-1 Full dose all drugs
Grade 2 Cisplatin 50% dose reduction
Pemetrexed full dose
Grade 3 or 4 Discontinue regimen
Diarrhoea (SPC)
Grade 2 Full dose all drugs
Grade 3 or 4 Cisplatin 25% dose reduction
Pemetrexed 25% dose reduction
Any diarrhoea requiring hospitalisation Cisplatin 25% dose reduction
irrespective of grade Pemetrexed 25% dose reduction
Mucositis (SPC)
Grade 2 Full dose all drugs
Grade 3 or 4 Withhold treatment until resolved to pre-treatment
levels, then give
Cisplatin full dose
Pemetrexed 50% dose reduction
Persistent grade 3 or 4 If toxicity persists at grade 3 or 4, despite two dose
reductions; discontinue pemetrexed
Other Non Haematological toxicities
Grade 2 Full dose all drugs
Grade 3 or 4 except mucositis Cisplatin 25% dose reduction
Pemetrexed 25% dose reduction
7c Erlotinib
Erlotinib 150mg Oral once a day continuous treatment
Take at least 1 hour before or 2 hours after food
Interval between cycles: Repeat tests every 28 days
Number of cycles: Mutated EGFR receptor positive patients
Poor performance, life long non smoker
1st line NSCLC up to 6 cycles
Tests before starting course of chemo FBC, U&Es, LFTs,
Tests to OK/Confirm each cycle of chemo: FBC, U&Es, LFTs, monitor for symptoms
and biochemical signs of dehydration
Supportive drugs with each cycle:
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information:
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 22 of 30
Plasma concentrations of erlotinib are reduced in patients who smoke.
High stomach pH can reduce bioavailability of erlotinib by up to 50%. Do not administer PPI
with erlotinib. Roche recommend ranitidine 150mg BD, Erlotinib should be taken 2 hours
before or 10 hours after ranitidine. See SPC for information about other drug interactions
NPSA Information on safety concern Summary (issued June 2009)
• Patients receiving tarceva/erlotinib are at increased risk of developing
gastrointestinal perforations.
• Patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs
and/or taxane based chemotherapy, or who have a prior history of peptic ulceration
or diverticular disease are at increased risk.
• Tarceva/erlotinib should be permanently discontinued in patients who develop
gastrointestinal perforation
Dose modifications: See table page 16
Reference:
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 23 of 30
West London Cancer Network
Small Cell Lung Cancer
Section by: Dr Peter Schmid, Dr Danielle Power, Dr Conrad Lewanski, Dr Stephen Mangar,
Professor Mark Bower and Professor Michael Seckl
Section last reviewed: 05 June 2009 Section last corrected: 05 June 2009
Approved by Oncology Lead Lung Clinician: June 2009
Agreed by WLCN Lung Tumour Group: June 2009
Review date: June 2010
8. First Line Regimens: Etoposide/Platinum (EP) Combinations
8a. EP-80/440 Oral (CTIS: 1388 )
Etoposide 120mg/m2 IV over 1 hour Day 1 and 2
Cisplatin *80mg/m2 IV over 1 hour Day 1
Post hydration Day 1
Etoposide 100mg Oral Twice a day Day 3 only
* Cisplatin dose may be split and given as 40mg/m2 day 1 and 2.
Interval between cycles: Repeat every 21 days
Number of cycles: 6 cycles
Tests before starting course of chemo: FBC, U&Es, LFTs, CrCl calculated. If
<60ml/min do EDTA
Tests to ok/confirm each cycle of chemo: FBC, U&Es, LFTs, Crcl calculated. Do
EDTA if serum creatinine is rising,
Supportive drugs with each cycle: 5HT3 and dexamethasone antiemetics as
per local protocol
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information:
Dose modifications: See table EP-SCLC below
Reference: J. Nat Can Inst. 1997;89(8);577-80. Souhami et al
Table: EP-SCLC
Side-Effect Dose Modification (Source Schmid/Lewanski)
Haematology
Neutrophils Platelets
x109/L x109/L
1.5 and 100 Full dose
<1.5 <100 Delay until recovery then omit day 3 on subsequent
cycles.
If problem persists, discuss with consultant.
Radical patients only
1.0-1.5 and 100 Discuss with consultant and consider treatment with
GCSF support.
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 24 of 30
Side-Effect Dose Modification (Source Schmid/Lewanski)
Renal Function (NLCN)
Creatinine Clearance (EDTA)
60mls/min Full dose
50-59mls/min Cisplatin25% dose reduction.
Etoposide Full dose
40-49mls/min Cisplatin 50% dose reduction.
Etoposide 20% dose reduction or omit day 3 dose
<40ml/min Do not give cisplatin. Consider E-Carb below
Hepatic function (NLCN)
Arguments for and against dose
reduction
Bilirubin AST
Micromol/L Units
<26 or <60 Full dose
26-51 or 60-180 Discuss with consultant. Consider etoposide 50% dose
reduction
>51 or >180 Do not give etoposide
8b. E-Carbo (CTIS:1146)
Etoposide 120mg/m2 IV over 1 hour Days 1 and 2*
Carboplatin 5(GFR+25)mg* (max 750mg) IV over 30 mins Day 1
Etoposide 100mg Oral Twice a day Day 3 only
* Etoposide day 2 may be given orally 100mg BD if IV not possible
Interval between cycles: Repeat every 21 days
Number of cycles: 6 cycles
Tests before starting course of chemo: FBC, U&Es, LFTs, EDTA,
Tests to ok/confirm each cycle of chemo: FBC, U&Es, LFTs, redo EDTA if serum
creatinine is rising
Supportive drugs with each cycle: 5HT3 and dexamethasone antiemetics as
per local protocol. Consider prophylactic
ciprofloxacin Day 8 to 15 (publication
pending)
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information:
Dose modifications: See Table E-Carb Lung below
Reference: Ann Oncol 1994;5:601-7. Skarlos DV et al.
Table E-Carbo Lung
Side-Effect Dose Modification (Source/M Seckl )
Haematology
Neutrophils Platelets
x 109/L x 109/L
1.5 and 100 Full dose
< 1.5 and < 100 Delay until recovery then omit day 3 in subsequent cycles
and/or carboplatin dose reduction
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 25 of 30
Renal Function (NLCN)
Creatinine Clearance (EDTA) Full dose
60mls/min Carboplatin dose as GFR.
50-59mls/min Etoposide Full dose
Carboplatin dose as GFR.
40-49mls/min Etoposide 20% dose reduction or omit day 3 dose
Do not give, Discuss with consultant
<40ml/min
9. Relapse Regimens
Late Relapse (beyond 3 months), Consider retreatment with original first line chemotherapy.
9a. CAV (CTIS: 791)
Vincristine 2mg IV minibag over 10 mins Day 1
Doxorubicin 50mg/m2 IV bolus Day 1
Cyclophosphamide 750mg/m2 IV over 30 mins Day 1
Interval between cycles: Repeat every 21 days
Number of cycles: 6 cycles
Tests before starting course of chemo: FBC, U&Es, LFTs, cardiac assessment/
ECG
Tests to OK/Confirm each cycle of chemo: FBC, U&Es, LFTs
Supportive drugs with each cycle: 5HT3 antiemetics as per local protocol
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information:
Dose modifications: Table CAV-SCLC Lung below
Reference:
Table: CAV-SCLC
Side-Effect Dose Modification (Source LLG8 trial/Prof Seckl)
Haematology
Neutrophils Platelets
x109/L x109/L
1.5 and 100 Full dose
<1.5 or <100 Delay until recovery. Consider dose reduction in
subsequent cycles. Discuss with consultant
Hepatic Function: (NLCN/SPC)
Bilirubin
<20 micromol/L Full Dose
20-51 micromol/L Doxorubicin 50% dose reduction, omit cyclophosphamide,
vincristine 50% dose reduction
52-85 micromol/L Doxorubicin 75% dose reduction, omit cyclophosphamide,
vincristine 50% dose reduction
>85 micromol/L Do not give regimen
Transaminases or ALP >2-3 x ULN Do not give cyclophosphamide
Bilirubin >51micromol/L and Do not give vincristine
AST/ALT > 180 units
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 26 of 30
Side-Effect Dose Modification (Source LLG8 trial/Prof Seckl)
Renal Function (SPC)
Serum creatinine >120micromol/L Do not give cyclophosphamide
10. Additional Private Care Regimens
10b Topotecan IV
Topotecan 1.5mg/m2 IV over 30mins Days 1 to 5
Interval between cycles: Repeat every 21days
Number of cycles: Relapsed SCLC for whom re-treatment
with the 1st line regimen is not appropriate
Subject to Local approval up to 6 cycles
Tests before starting course of chemo: FBC, U&Es, LFTs
Tests to OK/Confirm each cycle of chemo: FBC, U&Es, LFTs
Supportive drugs with each cycle: Low risk antiemetics
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information:
Dose Modifications:
Side-Effect Dose Modification (SPC)
Haematology
Neutrophils Platelets Haemoglobin
x109/L x109/L g/dl
1.5 and 100 and 9.0 Full dose
<1.5 and/or <100 and/or <9.0 Do not treat below these levels. Delay and
discuss with consultant
Dose reductions for subsequent cycles
Neutropenia (N<0.5) for 7 days or more }
Or }
Severe neutropenia associated } Wait until full recovery 2
with fever or infection } then dose reduce by 0.25mg/m /day
Orr }
Platelet count falls below 25x 10 /L }
9
Hepatic Function: (SPC)
Insufficient data in hepatic impairment
Renal Function (SPC single agent)
CrCl
≥40ml/min Full dose
20-39mls/min Discuss with consultant. If treatment to go
ahead give 0.75mg/m2/day for 5 days.
<20mls/min Do not give
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 27 of 30
11. Palliative Chemotherapy for Poor Performance Status
11a. Oral Etoposide
Etop – oral 14Day (CTIS: 170)
Etoposide 50mg Oral Twice a day Days 1 to 14
(28 doses)
Reduce dose/duration in poor performance status.
Interval between cycles: Repeat every 3-4 weeks
Number of cycles: 2-6 cycles
Tests before starting course of chemo: FBC, U&Es, LFTs,
Tests to OK/Confirm each cycle of chemo: FBC, U&Es, LFTs
Supportive drugs with each cycle: Low risk antiemetics
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information:
Dose Modifications: Discuss with consultant
Reference: MRC 2001 Stenning Comparison IV vs Oral Etoposide
J. Nat Cancer Inst 1997;89(8):577-80
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 28 of 30
West London Cancer Network
Mesothelioma
Section by: Dr Peter Schmid, Dr Danielle Power, Dr Conrad Lewanski, Dr Stephen Mangar,
Professor Mark Bower and Professor Michael Seckl
Section last reviewed: 05 June 2009 Section last corrected: 05 June 2009
Approved by Oncology Lead Lung Clinician: June 2009
Agreed by WLCN Lung Tumour Group: June 2009
Review date: June 2010
12. Pemetrexed-500/Cisplatin-75 (CTIS; )
Dexamethasone 8mg BD Oral Twice a day for 3 days starting the
day before pemetrexed
Sodium chloride 0.9% 1000mls IV over 2 hours Day 1 to run before,
during and after
pemetrexed
75 Minutes after start of sodium chloride
Pemetrexed 500mg/m2 IV over 10-15 mins Day 1
30 Minutes after end of pemetrexed
Cisplatin 75mg/m2 IV over 2hours Day 1
Sodium chloride 0.9% 1000mls IV over 2 hours Day 1
Plus MgSO4 and KCl according to local policy
Interval between cycles: Repeat every 21 days
Number of cycles: Chemo naïve patients with unresectable
Malignant pleural mesothelioma up to 6 cycles
Tests before starting course of chemo FBC, U&Es, LFTs, CrCl calculated. If
<60ml/min do EDTA.
Tests to OK/Confirm each cycle of chemo: FBC, U&Es, LFTs, CrCl calculated.
Do EDTA if rising serum creatinine
Supportive drugs with each cycle:
5HT3 antiemetics as per local policy
Dexamethasone as above to reduce the incidence and severity
of skin reactions.
Vitamin supplementation to reduce toxicity and incidence of
grade 3/4 haematological and non-haematological toxicities
Folic acid 1,000microgram oral daily, starting 7 days before 1st
pemetrexed dose and continuing for 21days after last
pemetrexed dose
Vitamin B12 1000micrograms IM. first dose must be given the
week before the 1st pemetrexed dose and then once every 3
cycles thereafter, (subsequent doses may be given on the same
day as pemetrexed.
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information:
Sodium chloride is the pre-hydration for cisplatin. It should start approx. 75 minutes before
pemetrexed and runs before, during and for 30minutes after the pemetrexed. Cisplatin must
not start until 30minutes after the pemetrexed and the sodium chloride will keep the line
patent whilst during this delay.
Dose modifications: See table page 14
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 29 of 30
13. Vinorelbine-30
Vinorelbine 30mg/m2 IV minibag over 10 mins Day 1 and 8
Interval between cycles: Repeat every 21 days
Number of cycles: 6 cycles
Tests before starting course of chemo: FBC, U&Es, LFTs
Tests to OK/Confirm each cycle of chemo: FBC, U&Es, LFTs
Supportive drugs with each cycle: Low risk antiemetics. Consider prophylactic
laxatives
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information:
Dose modifications: See table Lung Vinorelbine Mesothelioma on Lung page 9
Reference: J. Clin Oncol 2000;18:3912-17 Steele JPC et al
14. Vinorelbine plus Cisplatin
Vinorelbine 30mg/m2 IV minibag over 10 mins Day 1 and 8
Prehydrations Day 1
Cisplatin 80mg/m2 IV over 2-4 hours Day 1
Post hydrations Day 1
Interval between cycles: Repeat every 21 days
Number of cycles: 6 cycles
Tests before starting course of chemo: FBC, U&Es, LFTs, CrCL calculated, if
<60ml/min do EDTA.
Tests to ok/confirm each cycle of chemo: FBC, U&Es, LFTs, CrCL calculated. Do
EDTA if serum creatinine is rising
Supportive drugs with each cycle: 5HT3 and dexamethasone antiemetics as
per local protocol, laxatives
Patient information: Chemotherapy treatment booklet (local information)
Your chemotherapy record (WLCN red book)
BACUP information sheet(s)
Additional information:
Dose modifications: See table Lung/Cisp-Vinorel Lung page 6
Reference:
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Lung Regimens v2.3 WLCN June 5 2009 Lung page 30 of 30
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