What is advanced NSCLC, and how is it treated?
NSCLC that has spread from the lung to other organs in the body, or that has caused a build-up of fluid
around the lung or heart, is called advanced NSCLC. It includes stages IIIb and IV. While surgery to
remove the cancer is not an option in these stages, other forms of treatment are available and can
prolong survival, relieve symptoms and improve quality of life. The following is a description of first-
line treatment, or the first treatment that a patient receives after being diagnosed with advanced
Chemotherapy has been a standard component of treatment for advanced NSCLC since 1995, when an
analysis of several clinical trials demonstrated for the first time that chemotherapy offered better survival
than best supportive care (BSC). That finding was confirmed in 2008 when reviewers published updated
results in the Journal of Clinical Oncology. Their updated analysis continued to show that chemotherapy
offered improved survival, without compromising quality of life. They noted that this was true for elderly
patients as well.
Depending upon the type of NSCLC cancer and other patient characteristics, current standards
recommend that some patients receive treatment with chemotherapy only, while others receive a
combination of chemotherapy plus a category of drugs called targeted therapy.
What is chemotherapy?
Chemotherapy refers to a group of medications that damage or destroy cancer cells and, to a lesser
extent, some normal cells. Because it enters the bloodstream and is distributed throughout the body,
chemotherapy can be used when cancer has spread (metastasized). This is in contrast to surgery and
radiation therapy, which affect only a limited area of the body.
Chemotherapy is usually given as a series of regularly scheduled treatments, often called cycles. For
example, a patient's chemotherapy might consist of 4 cycles, one beginning every 3 weeks, comprising
12 total weeks of treatment. The spacing between treatment cycles is designed to allow adequate
recovery of healthy cells or tissue before the next cycle.
Potential side effects of chemotherapy vary and can be mild to severe, depending on the specific drugs,
the dose of the drugs, and the patient's overall health. Simultaneous or prior radiation therapy can
increase severity of effects from certain drugs. In many cases side effects can be prevented or reduced,
but long term effects are possible.
What chemotherapy drugs are available? Is there a "best" combination?
Several drugs are active against advanced NSCLC. Studies have shown that a 2-drug combination is
more effective than a single drug. At this time, a "platinum-based" combination is considered standard,
meaning that one of the drugs is a platinum drug, either cisplatin or carboplatin.
Several 2-drug combinations have been compared in clinical trials and found to be similar in response
rate and survival benefit. Overall, no "best" combination has been identified. One possible exception is
the combination of pemetrexed (Alimta®) and cisplatin for patients whose histologic type is
adenocarcinoma or large cell carcinoma. Recent clinical trials have confirmed that pemetrexed is an
active drug against adenocarcinoma and large cell carcinoma and may be more effective than other
options. The combination of pemetrexed and cisplatin has been approved for those histologic types.
Patients who receive pemetrexed must take vitamin supplementation with folic acid and vitamin B12.
Taking folic acid and vitamin B12 during pemetrexed treatment has been shown to reduce the degree of
side effects including bone marrow suppression and infection. The corticosteroid drug dexamethasone is
also prescribed to be taken before each pemetrexed treatment because it reduces the incidence and
severity of skin rash.
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While the 2-drug combinations are similar in survival benefit, they differ somewhat in their side effects.
Some cause peripheral neuropathy, while others have a greater effect on blood counts. These
differences may be important to you if you are at risk because of overall health or a co-existing illness.
Your oncologist can talk with you about choosing a combination that might be better for you as an
How long is chemotherapy continued?
There are 2 questions to be considered. First, when cancer responds to chemotherapy, how long should
that same chemotherapy be continued? The current recommendation is to give 4-6 cycles. This standard
is supported by a phase III clinical trial conducted by researchers at the University of North Carolina and
Northwestern University. They compared 2 groups, one that received 4 cycles of chemotherapy and one
that received ongoing cycles of the same chemotherapy drugs beyond 4 cycles until worsening of
cancer. In this trial they found no benefit to continuing the same chemotherapy until cancer worsened.
The second question concerns whether to begin maintenance chemotherapy promptly after completion
of first-line chemotherapy, in an effort to delay cancer progression and improve length of survival.
Maintenance chemotherapy refers to giving treatment while the cancer is in remission from first-line
chemotherapy, instead of waiting until cancer progresses. The drug given as maintenance therapy may
be different from drugs received during first-line chemotherapy and in general is less likely to cause
severe side effects. The U.S. Food and Drug Administration (FDA) has approved the use of pemetrexed
as maintenance therapy for the following patients: those with nonsquamous non-small cell lung cancer
whose cancer has not progressed after four cycles of platinum-based first-line chemotherapy. It is not
approved for squamous carcinoma of the lung. Researchers continue to study this question in clinical
trials. Until more clinical trial results are available the answers remain uncertain. Your oncologist can
discuss advantages and disadvantages in your individual situation.
What is targeted therapy, and when is it combined with chemotherapy?
Because more effective therapy is clearly needed for advanced NSCLC, researchers have looked at new
treatment strategies that differ from chemotherapy. A newer class of drugs called targeted therapy attack
the steps that enable cancer cells to reproduce and spread. Unlike chemotherapy drugs, their effects are
more damaging to cancer cells than to normal cells. At this time one such drug, bevacizumab (Avastin®),
is approved in combination with paclitaxel and carboplatin for first-line treatment in advanced non-
squamous NSCLC. Another targeted therapy drug, erlotinib, is approved for second and third line
treatment. Others are being evaluated in clinical trials.
Bevacizumab (Avastin®) is approved to be given in combination with paclitaxel/carboplatin
chemotherapy. It is not given alone because it offers little benefit by itself. The approval of bevacizumab
for the treatment of NSCLC was based on evidence from a phase III clinical trial showing that combining
a targeted therapy drug with standard chemotherapy can improve survival in advanced non-small cell
lung cancer. The median survival of patients who received paclitaxel and carboplatin plus the targeted
therapy drug bevacizumab (PCB) was 12.5 months, compared with 10.2 months for the group who
received only the chemotherapy drugs paclitaxel plus carboplatin (PC). Although this seems like a small
difference it was significant when analyzed statistically. Patients receiving PCB had a 27% response
rate, compared with 10% for patients receiving PC, a difference that was also statistically significant.
The PCB combination did, however have more toxicity that the PC combination. The most serious
toxicity was severe bleeding or hemorrhage from the lung. Further analysis showed that the risk of
bleeding is greater for patients whose cancer is the type of NSCLC called squamous cell. Because of the
risk of hemorrhage, bevacizumab is currently not used for patients who have squamous lung cancer,
brain metastasis, or a history of bleeding from the lung.
How is the targeted therapy drug bevacizumab (Avastin®) different from chemotherapy?
Bevacizumab (bev-uh-SIZ-uh-mab) is a specific type of targeted therapy known as an anti-angiogenic
drug. It interferes with the function of a protein that the cancer needs in order to grow new blood vessels.
The protein is named VEGF (pronounced vej - F), and the formation of new blood vessels is called
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angiogenesis (AN-gee-oh-JEN-eh-sis). Cancer cannot grow without creating new blood vessels to supply
nutrients and oxygen, so angiogenesis is essential in order for cancer to grow and spread.
The most common side effects of bevacizumab are nosebleed, headache, hypertension (high blood
pressure), protein in the urine, dry skin, eye irritation, taste changes, and rectal bleeding. Perforation of
the gastrointestinal tract has also occurred, as have myocardial infarction (heart attack), stroke, and
infection. Bevacizumab can cause surgical and wound-healing complications and should not be given
within 28 days of surgery or until a surgical wound is completely healed. Side effects are discussed
further in the Side Effects section below.
While targeted therapy drugs are encouraging, much remains to be learned about how best to use them,
including how to identify patients who are most likely to benefit. At this time there is not a great deal of
long-term follow up or survival information, but clinical trials are underway to answer these and other
What if I am in poor health overall or have other medical problems?
For people who have other medical problems in addition to lung cancer, treatment with a combination of
drugs can be difficult to withstand. Treatment with one drug alone is likely to have fewer side effects than
a combination of drugs. The drug vinorelbine is one option in this situation, and some physicians
recommend the drug gemcitabine. Discuss with your physician whether a chemotherapy drug or a
combination of drugs would be appropriate based on your individual situation.
Alternatively, some patients with inoperable or advanced non-small cell lung carcinoma choose not to
receive chemotherapy because it will not cure their illness and may have side effects that could increase
their discomfort. Instead they receive best supportive care. Return to the treatment options report page to
review the Best Supportive Care Treatment Option. These are individual decisions that should be
discussed with your physician.
Intensive research is ongoing to develop improved therapies for advanced NSCLC. A 2-drug platinum-
based chemotherapy combination is the current standard first-line treatment for patients who are in
otherwise good health. Several options are available to serve as the 2-drug combination. The available
2-drug chemotherapy combinations are similar in benefit but differ in the nature of potential side effects,
and one may be better for you as an individual. The targeted therapy drug bevacizumab (Avastin®)
combined with chemotherapy can improve survival for patients with non-squamous cancer who do not
have brain metastasis or increased risk for bleeding. Side effects of treatment can be managed in most
cases. Remember that you and your physician are in partnership. Discuss with your physician the risks
and benefits of various treatments, their impact on quality of life, and the possibility of participating in
Side Effects Information
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Possible side effects for Chemotherapy and Targeted Therapies for Advanced Disease
Common side effects of chemotherapy - The side effects of chemotherapy vary from person to
person in incidence, severity, frequency, and duration. They will also vary depending on the specific
type of chemotherapy used. Common side effects include fatigue, full or partial hair loss (alopecia), loss
of appetite (anorexia), nausea and vomiting, diarrhea, mouth sores (stomatitis) and low blood counts.
Cisplatin can cause abnormal kidney function. Paclitaxel may cause numbness and tingling in the
hands and feet (peripheral neuropathy), which is generally mild initially but can become worse with
repeated doses, an effect known as cumulative toxicity. Not all chemotherapy agents cause all of these
There are many medications and other approaches that can prevent or reduce the side effects of
chemotherapy. If one approach doesn't work well, there are others to try. The timing of the approaches
may also make a difference, such as giving anti-nausea medications before, during, or after the actual
Discuss with your doctor:
1. What are the side effects that are related to the specific chemotherapy medications that I will
2. When do the side effects generally begin, and how long should I expect them to last?
3. How will I be monitored for potential organ damage, such as to my kidneys, during my therapy?
4. Will any of the side effects be permanent?
Bone marrow depression (myelosuppression) - Bone marrow depression (also referred to as bone
marrow suppression), is a decrease in the cells produced in the bone marrow. This commonly occurs
with many chemotherapy drugs and radiation therapy. The cells affected may vary, depending on the
specific treatment, though generally they include red blood cells (RBCs), white blood cells (WBCs), and
RBCs carry oxygen and help increase energy. When production of RBCs is depressed, anemia can
occur, resulting in decreased energy and shortness of breath (in severe cases of anemia).
WBCs fight infection, so the risk of infection is increased when the WBC count is low. Paclitaxel
commonly causes low WBC count.
Platelets help blood clot normally, so easy bruising or bleeding may occur when the platelet count is
low. Carboplatin is one of the chemotherapy drugs that can cause low platelet counts.
Your physician will perform a blood test called a CBC (complete blood count) to monitor the levels of
these important cells. If they are decreased, special precautions may need to be followed until the body
makes new cells and the blood levels return to normal. This will occur as you recover from the
treatment. Recovery must occur before the next cycle of treatment is given. Subsequent treatments
may even be delayed until recovery occurs.
In some cases, your physician may order a medication known as a growth factor to help the body
produce blood cells. Examples of growth factors that help the body produce RBCs to reduce the
occurrence of anemia during chemotherapy are epoetin alfa (Epogen® or Procrit®) and darbepoetin
alfa (Aranesp®). A different growth factor helps the body to produce WBCs. Growth factors are
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administered by subcutaneous injection, much like injecting insulin.
Discuss with your doctor:
1. How low should I expect my blood counts to drop, and when should I anticipate it?
2. Are there symptoms that I should watch for, such as bruising, bleeding, or fevers? Should I
notify my physician and how do I contact the appropriate person?
3. Are there special precautions that I should take when my blood counts are low?
4. Are there any medications that I can take to increase my blood counts?
Fatigue - Fatigue is a feeling of being tired, exhausted, weary, or energy depleted. Patients may also
feel weak and dizzy. It is associated with a desire for rest or sleep. Some patients report difficulty
thinking, forgetfulness, and an inability to concentrate. There are no medical tests to measure fatigue.
Fatigue can be a common side effect of cancer, cancer therapy (surgery, chemotherapy, radiation
therapy), and anemia. No one knows the exact cause of cancer-related fatigue, but causes are usually
multiple. Any physical or emotional change can deplete energy. Varying levels of fatigue may be
experienced, depending on the individual patient situation and treatment(s). Patients experiencing
persistent and more severe fatigue may have a diminished quality of life because they are just too tired
to participate in the activities of daily living or work. Fatigue related to cancer treatment is usually
temporary and the energy level improves over time when treatment is completed.
Some patients find that they have the most energy at a certain time of day, such as in the morning. If
so, arrange your day accordingly. Plan for rest periods after periods of activity. You may find it helpful
to take a nap. Some people feel that they benefit from regular activity such as walking. Discuss with
your physician what is reasonable and appropriate for your situation.
Talk with your doctor or oncology nurse about your fatigue. Ask whether there are things you can do to
help you feel better. Your fatigue is often related to your treatment. Understanding more about your
fatigue can help you better plan your activity and rest periods. This can help you feel more in control of
Discuss with your doctor:
1. Should I expect to feel fatigued, and if so, at what point in the treatment?
2. Is there anything that I can do to improve my energy level?
3. How will regular exercise or activity affect my level of energy?
Kidney dysfunction - Cisplatin and carboplatin (platinum drugs), chemotherapy drugs used to treat
non-small cell lung cancer, can cause temporary or permanent kidney damage resulting in abnormal
kidney function tests and changes in the kidney's ability to filter body wastes and regulate important
blood chemicals such as sodium, potassium, calcium, and magnesium. Cisplatin more commonly
causes kidney changes than carboplatin. There are usually no symptoms. Kidney function is evaluated
by blood tests. The doctor will order these tests before therapy begins and will periodically recheck
them to monitor for changes in kidney function.
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To help prevent kidney damage, intravenous (IV) fluids are given before and after cisplatin therapy,
along with special medication if necessary. For some patients who have kidney problems, adjustments
in the dosage are made or the drug may need to be discontinued. Because carboplatin is much less
toxic to the kidney, it does not require additional IV fluids or special medication.
Discuss with your doctor:
1. Will I be receiving cisplatin or carboplatin chemotherapy? If so, how frequently will you monitor
my kidney function?
2. If kidney changes occur, is this reversible and how is it treated?
Fluid retention (edema) - Some chemotherapy can cause fluid retention. Fluid retention is a condition
in which the body retains fluids. The individual will notice swelling or puffiness in the face, hands, feet,
or abdomen as well as weight gain (called "peripheral edema"). Patients may experience tight-feeling
rings or shoes or ankle swelling as the day progresses that may not be relieved by elevating the feet. In
some cases, it may become generalized and, less frequently, lead to fluid in the lining of the lung, heart
or abdomen. This can result in shortness of breath and difficulty breathing, even at rest. Salt and foods
high in sodium content may need to be restricted or avoided, as they can contribute to fluid retention. If
the problem is severe, your doctor may prescribe a diuretic (a "water pill"), a medicine to help your
body get rid of the excess fluid.
Docetaxel (Taxotere®) is a chemotherapy drug sometimes used to treat lung cancer that can cause a
cumulative fluid retention problem. Fluid retention develops over time in relation to the docetaxel dose,
typically after three to five cycles. It is not life threatening, but it can result in treatment delay or
discontinuation. Once docetaxel is discontinued, the fluid retention resolves and body weight slowly
returns to normal. To help minimize or prevent this complication, pre-medication with dexamethasone
(a steroid) is given before treatment.
Discuss with your doctor:
1. Will I be at risk for fluid retention? What should I expect?
2. Will my chemotherapy cause this? Does this require treatment?
Nerve damage to hands/feet (peripheral neuropathy) - This is a condition in which the nerves in the
body are irritated or damaged by some chemotherapy drugs. This is experienced as numbness, tingling
("pins and needles"), burning and/or weakness in the hands, soles of feet or both, and called "stocking-
and-glove distribution." It may feel like your hands or feet are asleep. You may have difficulty picking up
a coin or buttoning your shirt or blouse. Other types of problems from nerve damage can be
constipation or other changes in your bowel or bladder function, ringing in your ears, difficulty hearing
or changes in your vision.
Symptoms usually begin after multiple treatments over several months, although symptoms can occur
after a single dose. Symptoms can range from mild to severe, and the severity is related to the
individual dose, total dose received over time, and schedule of doses. These symptoms typically last 3
to 6 months following completion of therapy but may last longer. In rare cases, symptoms may continue
or worsen after therapy has been stopped. Early recognition and sometimes a delay or reduction in the
dose can improve symptoms in most cases. If you experience any of these symptoms, consult your
doctor or oncology nurse so they can advise you on management. Physical therapy is necessary for
some individuals. In some cases treatment may be changed due to this problem.
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Discuss with your doctor:
1. Will I be receiving any drugs that cause this complication? If so, what should I expect?
2. How long will peripheral neuropathy last? Will it interfere with my activities?
Hearing loss - Cisplatin or carboplatin (platinum drugs), chemotherapy drugs used to treat head and
neck cancer, can cause damage to the nerves that supply the inner ear. This can result in ringing in the
ears (called tinnitus), loss of balance and possible hearing loss that involves the high frequency range
of sounds. Usually, normal conversation tones are not affected. The risk for hearing loss is cumulative,
meaning that the risk of experiencing this complication increases over time as more drug is received. In
rare cases, hearing changes can occur after the first dose of cisplatin. Hearing loss may be temporary
or permanent and may affect one or both ears. Cisplatin is more likely to cause hearing changes than
carboplatin. You should report any ringing or decreased ability to hear normal conversation to your
Discuss with your doctor:
1. What is my risk for hearing loss? Can hearing loss be treated?
2. Will I be receiving cisplatin or carboplatin?
Nausea and vomiting - Major progress has been made in preventing and treating nausea and
vomiting related to chemotherapy. Extensive studies have identified appropriate drugs, dose strength,
and timing of doses to counteract nausea and vomiting. Anti-nausea medications are commonly called
anti-emetics. Oncology standards of practice specify which anti-emetics are most appropriate with
which chemotherapy combinations, since the different chemotherapy drugs vary in their likelihood to
produce nausea or vomiting. Cisplatin can cause a great deal of nausea and vomiting unless treated
appropriately with antiemetics, while any nausea related to vinorelbine is likely to be mild.
Nausea and vomiting can begin 30 minutes to a few hours after chemotherapy and last for
approximately 24 hours. In some cases, it begins or persists later than 24 hours, an effect known as
delayed nausea/vomiting. Anti-nausea medications can be prescribed prior to chemotherapy and then
every few hours until no longer needed. For chemotherapy drugs known to cause delayed nausea and
vomiting, antiemetics will be continued for an appropriate period of time. You will receive medications
chosen specifically for you based on your characteristics and the emetogenic potential of your
chemotherapy, and your physician or oncology nurse will review your medications carefully with you.
In addition to anti-emetics, non-medicinal measures such as relaxation exercises, diversion, and
hypnosis can be helpful.
In some cases nausea/vomiting develops or persists in spite of antiemetics. There are always other
medications and combinations of medications to try until a better solution is found, so be sure to let
your physician know if your symptoms are not effectively controlled. Also, be sure to contact your
physician if you are so nauseated that you are unable to drink fluids.
Discuss with your doctor:
1. Is my chemotherapy treatment likely to cause nausea or vomiting?
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2. What anti-emetics will be prescribed to control this effect? How do I take them?
3. Are there any side effects to the anti-emetics?
4. Are there signs or symptoms for which I should contact my physician or oncology nurse, and if
so, how do I contact the appropriate person?
Allergic reaction to chemotherapy - Some chemotherapy medications can cause allergic reactions
such as itching of the skin, rash, hives, shortness of breath, wheezing, fevers, chills, blood pressure
changes, or an abnormal heart rate. This is not always predictable and usually, though not always,
occurs within the first 15 to 30 minutes of the drug administration. During the infusion of the medication,
you will be monitored closely for any signs or symptoms of an allergic reaction. Should a reaction
occur, the chemotherapy drug will be stopped and medication given to effectively relieve the symptoms
and reverse the reaction.
Some chemotherapy medications, including docetaxel and paclitaxel, require premedications that are
given before the chemotherapy to reduce or prevent an allergic reaction. If these premedications are
prescribed for you to take at home before going in for your treatment, it is very important that you take
each dose and take it on time. Your nurse or other health care person will give you a schedule for
taking the premedication. Review the schedule to be certain that you and/or your caregiver understand
it, and ask to have it reviewed again if it is not clear to you.
Discuss with your doctor:
1. What are the risks of an allergic reaction with the specific chemotherapy medication that I will
2. What are the signs or symptoms that I should report, and how quickly should I report them?
3. Can an allergic reaction be life-threatening?
Bevacizumab (Avastin™)-related heart effects - The cardiovascular (heart and blood-vessel related)
complications that have occurred with bevacizumab include high blood pressure, hemorrhage, blood
clots, mini-stroke (transient ischemic attack), blood in the urine (proteinuria), myocardial infarction
(heart attack) and heart failure. Not all patients develop cardiovascular complications. The risk is
greater for patients who already have extra stress on the heart.
This includes patients who are older, who have pre-existing heart disease, or who have another major
medical condition such as diabetes or hyperlipidemia. Your physician will carefully evaluate for pre-
existing conditions before initiating therapy with bevacizumab. If the risks associated with bevacizumab
are too great for you as an individual, there are other treatment options available that do no carry this
type of risk.
Hypertension or high blood pressure is the most common adverse effect associated with bevacizumab.
When it develops, it requires treatment with blood pressure medications (anti-hypertensives). While you
are receiving bevacizumab, keep a record of your blood pressure. Blood pressure readings have two
measurements: the systolic and the diastolic pressures. The top number is the systolic pressure. It
reflects the pressure in the arteries immediately after the force of the heart beat. The diastolic is the
bottom number. It is the pressure in the arteries when the heart is relaxed between heart beats.
Another precaution to follow while you are receiving bevacizumab is to immediately report to your
doctor any headaches, dizziness, ringing in your ears or vision changes. These can be signs of high
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Discuss with your doctor:
1. What is an acceptable blood pressure for me?
2. How will my blood pressure be monitored?
3. Is there anything I can do to decrease my risk of developing hypertension?
4. When would you consider starting me on blood pressure medication?
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The graphs on this page reflect actual patient data that was reported in peer-reviewed scientific medical
journals. In the tables above each graph, you can click on the Study I.D. number for a reference to the
specific journal article in which the results were published.
This information is for educational purposes only and is not a substitute for medical advice or treatment.
The studies included in the database form a selected subset of all the clinical research on this condition,
chosen by our Medical Editorial Board members for their significance in defining current standard
treatments. It is not intended to be a comprehensive catalog of all available research on this condition.
The symbols , , are intended to help you weigh the value of a particular
study. A randomized, multicenter trial is considered the gold standard for clinical research. Other
studies are valued for their ability to fill in gaps in scientific knowledge but usually require further
research to confirm the results. Meta-analyses are valued for their ability to increase the certainty
of the research results by analyzing the combined results of several trials.
Randomized - Participants in a clinical trial are assigned by chance (such as flipping a coin)
to receive one of the treatments being tested. This ensures that healthier or less healthy patients
are not all assigned to one group, creating more favorable or less favorable outcomes for that
Indicates a trial in which patients were enrolled consecutively (one after the other) or
selectively (as selected by the researcher).
Multicenter - More than one institution participated in the study using the same enrollment
requirements and treatment procedures. Researchers consider the results of such trials more
reliable because the greater diversity of people conducting and participating in the trial minimizes
any bias that may occur due to a single institution's particular expertise or patient population.
Indicates a single-center trial.
Meta-Analysis - A method of statistically combining the results of several different studies,
providing much larger numbers of participants, which gives scientists greater certainty in the
results of the study. Panels of experts often use meta-analysis to develop a recommended
standard for treatment.
Indicates the study is not a meta-analysis.
Likelihood of Overall Survival - Chemotherapy
Study ID Key 1 2 3 4 5 6
8 40 14
8 45 11
8 34 9
28 31 7
29 36 10
29 30 13
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21 39 15
25 25 5 4
46 33 11
86 37 16
86 32 12
86 40 13
93 36 13
93 31 10
93 31 11
93 34 11
95 34 11
95 28 15
99 38 16 8 5
99 33 9 4 2
106 30 14 6
120 51 23 10
120 44 15 8
124 37 14 7 4 3 3
124 34 12 4 3 2 1
125 27 8
131 44 19
131 42 14
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