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That's cool - F. Cappuzzo 25 settembre 2010

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COOL - Community in Oncology On Lung Cancer
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That's cool - F. Cappuzzo 25 settembre 2010

  1. 1. Should we give maintenance therapy in NSCLC? Factors influencing the decision • Patient preference • Risk of progression – Response to front-line chemotherapy – EGFR status • Performance status • Age
  2. 2. Maintenance therapy paradigm First-line platinum-based chemotherapy x 4-6 cycles No Progression-PS 0-1 In favor of therapyRefuse of any therapy Prevent PS deterioration: strict FU (q 4-6 weeks) Maintenance therapy
  3. 3. Maintenenance therapy more effective in NSCLC with high risk of progression OSprobability 1.0 0.8 0.6 0.4 0.2 0 0 3 6 9 12 15 18 21 24 27 30 33 36 Time (months) 9.6 11.9 1.0 0.8 0.6 0.4 0.2 0 0 3 6 9 12 15 18 21 24 27 30 33 36 Time (months) 12.0 12.5 Log-rank p=0.0019 HR=0.72 (0.59–0.89) Erlotinib (n=252) Placebo (n=235) Log-rank p=0.6181 HR=0.94 (0.74–1.20) Erlotinib (n=184) Placebo (n=210) SD CR/PR *OS is measured from time of randomisation into the maintenance phase
  4. 4. SATURN: OS according to EGFR mutation status 0 3 6 9 12 15 18 21 24 27 30 33 36 OSprobability 1.0 0.8 0.6 0.4 0.2 0 Time (months) 0 3 6 9 12 15 18 21 24 27 30 33 36 1.0 0.8 0.6 0.4 0.2 0 Time (months) EGFR mutation+ EGFR wild-type Log-rank p=0.6810 HR=0.83 (0.34–2.02) Erlotinib (n=199) Placebo (n=189) Erlotinib (n=22) Placebo (n=27)* Log-rank p=0.0243 HR=0.77 (0.61–0.97) *Note that 67% of patients with EGFR mutation+ disease in the placebo arm received a second-line EGFR TKI
  5. 5. Maintenance treatment of Gemcitabine +BSC vs. BSC Gemcitabine + Carboplatin X 4 cycles R A N D O M I Z E Gemcitabine q 21 days + BSC N= 128 BSC N= 127 CR, PR SD Off study PD Randomization factors: • PS status • Stage • Best tumour repsonse Primary Endpoint OS Belani et al, ASCO 2010 ~60% of PS2 Patients
  6. 6. Lack of survival benefit with maintenance gemcitabine in PS 2 patients Overall Survival (months) 0 6 12 18 24 30 36 42 48 54 60 1.0 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0.0 Gemcitabine 8.0 mos. BSC 9.3 mos. HR=0.97 (95% CI:0.72, 1.30) P =0.838
  7. 7. Maintenance Chemotherapy – OS: Curves Separate Early and Come Together by 20 Months 0.8 1 0.6 0.4 0.2 0 Placebo: 10.18 mos (95% CI: 8.57-13.17) Pemetrexed: 13.01 mos (95% CI: 11.40-14.42) 0.8 1 0.6 0.4 0.2 0 Months 55% censored OS HR = 0.798 (95% CI: 0.63-1.01) 0 3 6 9 12 15 18 21 24 27 30 0 4 8 12 16 20 24 28 32 36 40 44 48 52 Probability Immediate D (N = 153) Delayed D (N = 156) Median OS, months (95% CI) 12.3 9.7 12-month survival, % (95% CI) 51.1% 43.5 Months Pemetrexed vs. Placebo Docetaxel vs. Placebo Ciuleanu T et al. The Lancet 2009;374(9699):1432-1440. Fidias PM, et al. J Clin Oncol. 2009;27(4):591-598. Probability Pemetrexed Placebo Immediate Docetaxel Delayed Docetaxel
  8. 8. Maintenance Erlotinib – SATURN OS: Curves Separate Late and Stay Separated for Many Months 1.0 0.8 0.6 0.4 0.2 0 6 12 18 24 30 33 363 9 15 21 270 Erlotinib (N = 438) Placebo (N = 451) Months HR = 0.81 (95% CI: 0.70-0.95); Log-rank p = 0.0088 Probability

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