1276P - Second-line erlotinib therapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Cytotoxic agents
Non-small-cell lung cancer
Biological therapy
Presenter Elisabeth Quoix
Authors E. Quoix1, V. Westeel2, J. Oster3, E. Pichon4, J. Dauba5, D. Debieuvre6, L. Baudrin7, F. Morin8, B. Milleron9, G. Zalcman10
  • 1Pneumologie, HUS, 67091 - Strasbourg/FR
  • 2Pneumologie, CHU, Besançon/FR
  • 3Pneumologie, CH, Colmar/FR
  • 4Pneumologie, CHU, Tours/FR
  • 5Pneumologie, CH, Mont-de-Marsan/FR
  • 6Pneumology, General hospital, 68070 - Mulhouse/FR
  • 7Biostatistics, IFCT, Paris/FR
  • 8IFCT, 75009 - PARIS/FR
  • 9Pneumologie, AP-HP Hôpital Tenon, PARIS/FR
  • 10Service De Pneumologie, CHU, Caen/FR



The IFCT-0501 randomised, phase 3 trial showed a significant survival benefit for the experimental arm using carboplatin-weekly paclitaxel doublet chemotherapy (Arm B) over vinorelbine or gemcitabine monotherapy (Arm A), in elderly patients with advanced NSCLC (Quoix et al, Lancet 2011; 378:1079-88). In case of progression or toxicity, second-line (2nd) treatment with erlotinib was administered in both arms. Here we report the results of this 2nd-line therapy.


Patients aged 70 to 89 years, with locally advanced or metastatic NSCLC, received erlotinib 150 mg daily as 2nd-line treatment until disease progression or excessive toxicity.


Among 443 patients who completed first-line chemotherapy, 292 received 2nd-line erlotinib, at the same proportion in both arms (A: 64%, B: 67%, p = 0.46). Median duration of erlotinib treatment was not different according to first-line treatment arm, 2.01 and 2.24 months for arm A and arm B, respectively. Ability to receive 2nd-line treatment was significantly associated with performance status (0-1 vs. 2-3), weight loss (≤5% vs. >5%), MMS (≤23 vs. >23) and ADL (<6 vs. 6) scores, and stage (III vs. IV), but not with age (≤80 vs. > 80), sex or histology (squamous vs. non squamous). Response evaluated after 2 months of erlotinib was: CR: 1 (0,35%), PR : 25 (8,77%) and SD : 63 (22,1%). From the Day 1 of erlotinib administration, median overall survival was 4 and 6.8 months in arm A and B, respectively, with a 1-yr survival rate of 26.4% and 33.7%, respectively (p = 0.08). Progression-Free Survival was 2.2 and 2.6 months, respectively (p = 0.36). Grade 3/4/5 toxicity was 19.9/1/0%.


In elderly patients with advanced NSCLC, administration of 2nd-line erlotinib is feasible, well tolerated, with a response rate comparable to that observed in previous trials, and maintained the survival advantage obtained with first-line carboplatin-weekly paclitaxel (NCT002598415).


E. Quoix: Travel grants for meetings : lilly roche Advisory board : Lilly,Roche Grants for the study given to IFCT: BMS, pierre Fabre, Roche.

V. Westeel: stock ownership: No membership on an advisory board or board of directors: roche, Lilly corporate-sponsored research: Roche other substantive relationships: Roche, Lilly, AstraZeneca, Boehringer Ingelheim.

B. Milleron: stock ownership: No membership on an advisory board or board of directors: Yes Lilly, Roche corporate-sponsored research: No other substantive relationships: travel grants from Lilly and Roche.

All other authors have declared no conflicts of interest.