TITAN EMCTO slides by B6hL9Nfj


									  Efficacy and safety of erlotinib versus
 chemotherapy in second-line advanced
non-small-cell lung cancer (NSCLC) with
poor prognosis: the phase III TITAN study

       Tudor Ciuleanu,1 Lilia Stelmakh,2 Saulius Cicenas,3
 Emilio Esteban Gonzalez,4 on behalf of the TITAN investigators

         of Oncology Ion Chiricuta, Cluj-Napoca, Romania; 2Pavlov State Medical

    University, St Petersburg, Russia; 3Institute of Oncology, Vilnius Hospital,
         Vilnius, Lithuania; 4Hospital General de Asturias, Oviedo, Spain
                               TITAN study design
                                             Non-PD                                      SATURN
  Up to 4 cycles of
  1st-line platinum-                                                                     Erlotinib
   based doublet                              PD                                        150mg/day
       (n=2,590)                             during             1:1
                                                               Open                     Docetaxel or
                                                               label                    Pemetrexed*
    tumor sampling                                                     *At investigator’s discretion; standard regimens

 Primary endpoint                                              Stratification factors
  Overall survival (OS)                                        Stage of disease at start of chemotherapy
                                                                  (IIIB vs IV)
 Secondary endpoints
                                                                ECOG PS (0 or 1 vs 2)
  OS by EGFR IHC status
                                                                Smoking history (current vs former vs never)
  PFS in all patients and by EGFR IHC status
                                                                Region
  ORR, time to symptom progression, safety, PK/PD
  Biomarker analyses

PD = progressive disease; IHC = immunohistochemistry; ORR = overall response rate;
PK/PD = pharmacokinetics/pharmacodynamics
                   TITAN secondary endpoints: PFS and
                  ORR with erlotinib versus chemotherapy

                  1.0             HR=1.19 (0.97–1.46)
                                      Log-rank p=0.0885
                  0.8                                                            Erlotinib   Chemotherapy
PFS probability

                                                                    ORR, n (%)   (n=203)        (n=221)
                                      Erlotinib (n=203)             CR             0 (0)         0 (0)
                                      Chemotherapy (n=221)          PR           16 (7.9)       14 (6.3)
                  0.4                                               SD           54 (26.6)     81 (36.7)

                        0   3     9    12   15    18      21   24   27   30

                                                  Time (months)

  CR = complete response; PR = partial response; SD = stable disease
 First prospective head-to-head trial investigating erlotinib versus
  systemic therapies in second-line NSCLC
  – in patients who progressed during first-line platinum-doublet

 Similar OS observed in both treatment arms
  – results consistent across most subgroups
  – results in EGFR WT population similar to ITT population

 Toxicity profile in the two arms as expected
  – no new safety signals
  – no haematological toxicity with erlotinib
  – rash and diarrhoea comprised the majority of AEs in the
    erlotinib arm (mostly grade 1–2)

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