A multicentre phase II randomised trial of weekly docetaxel/gemcitabine followed by erlotinib on progression, vs the reverse sequence, in elderly patients with advanced non small-cell lung cancer selected with a comprehensive geriatric assessment (the GFPC 0504 study)

Abstract

Background:Elderly cancer patients form a heterogeneous population in which therapeutic decision-making is often difficult. The aim of this randomised phase II trial was to evaluate the feasibility and activity of weekly docetaxel/gemcitabine (DG) followed by erlotinib after progression (arm A) vs erlotinib followed by DG after progression (arm B) in fit elderly patients with advanced non small-cell lung cancer (NSCLC).Methods:Elderly chemotherapy-naive patients with stage IIIB/IV NSCLC were selected after a comprehensive geriatric assessment (socioeconomic, cognitive, depression, ADL and IADL assessments). The primary endpoint was the time to second progression (TTP2). Overall survival (OS), the time to first progression (TTP1) and safety were secondary endpoints.Results:Between July 2006 and November 2008, 22 centres enrolled 100 patients. TTP2 was 7.5 and 5.8 months in arm A and arm B, respectively; TTP1 was 4.7 and 2.7 months; and the median OS time was 9.4 and 7.1 months; the respective 1-year survival rates were 36.2 and 31.4%. There was no major unexpected toxicity.Conclusion:These results suggest that weekly DG, followed by erlotinib, is a promising treatment for fit elderly patients with NSCLC; the efficacy of the reverse sequence was insufficient to recommend it for EGFR-non-selected patients.

Use of the Epidermal Growth Factor Receptor Inhibitors Gefitinib, Erlotinib, Afatinib, Dacomitinib, and Icotinib in the Treatment of Non-Small-Cell Lung Cancer: A Systematic Review

“…In one trial, pfs was longer in the egfr inhibitor group: 4.57 months for erlotinib versus 2.53 months for vinorelbine (hr: 0.6444; 95% ci: 0.4325 to 0.9601; p = 0.0308) 21 . In five trials, pfs was longer in the chemotherapy group 13,15,17,19,20 . Several of the trials found that pfs significantly favoured chemotherapy 13,15,19 .…”

“…In one study, the response rate favoured the egfr inhibitor 21 , and in four studies, it favoured chemotherapy 13,14,[19][20][21] . The study by Reck et al 19 found a significantly higher response rate in patients randomized to chemotherapy (p = 0.0001).…”

“…Several of the trials found that pfs significantly favoured chemotherapy 13,15,19 . One trial examined time to progression and found that it was longer with chemotherapy, but not significantly so 20 . One trial reported nonsignificant improvements in os in the egfr inhibitor group 21 .…”

“…One trial reported nonsignificant improvements in os in the egfr inhibitor group 21 . In seven trials, os was prolonged with chemotherapy [13][14][15][17][18][19][20] . In the largest trial (torch), os was significantly worse for patients randomized to erlotinib 13 .…”

Prognostic role of a comprehensive geriatric assessment on the management of elderly patients with advanced non-small cell lung cancer (NSCLC): a pooled analysis of two prospective phase II trials by the GFPC Group

“…In elderly patients with advanced-stage NSCLC, several phase II trials and a large phase III trial failed to show a clear benefit of using the CGA for allocation treatment (5,(15)(16)(17)(18)(19). In addition, the CGA has been criticised for being time-consuming, cumbersome and not standardised, and its real influence on treatment decisions in clinical practice has been questioned (12).…”