A multicenter phase II randomized trial of gemcitabine followed by erlotinib at progression, versus the reverse sequence, in vulnerable elderly patients with advanced non small-cell lung cancer selected with a comprehensive geriatric assessment (the GFPC 0505 study).

BACKGROUND: The aim of this randomized phase II trial was to evaluate the feasibility and activity of weekly gemcitabine (G) followed by erlotinib at disease progression (arm A) versus erlotinib followed by G at progression (arm B) in vulnerable elderly patients with advanced non small-cell lung cancer (NSCLC), selected on the basis of a comprehensive geriatric assessment (CGA). METHODS: Vulnerable elderly chemotherapy-naive patients with stage IIIB/IV NSCLC were selected after a CGA (socioeconomic, cognitive and emotional status, depression, nutritional status, ADL and IADL assessments). The primary endpoint was the time to second progression (TTP2). Overall survival (OS), time to first progression (TTP1) and safety were secondary endpoints. RESULTS: Between May 2006 and January 2010, 21 centers enrolled 100 patients, of whom 94 were eligible. TTP2 was 4.3 and 3.5 months in arm A and arm B, respectively; TTP1 was 2.5 and 2.2 months; and the median OS time was 4.4 and 3.9 months. The respective one-year survival rates were 27.3% and 20%. There was no major unexpected toxicity. CONCLUSION: In vulnerable elderly patients with NSCLC not selected for EGFR expression, both strategies were feasible but had modest efficacy. Further studies are needed to identify elderly patients who should receive palliative care only.

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).

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.

An open multicenter phase II trial of docetaxel-gemcitabine in Charlson score and performance status (PS) selected elderly patients with stage IIIB pleura/IV non-small-cell lung cancer (NSCLC): the GFPC 02-02a study.

UNLABELLED: The aim of this study was to determine the impact of patient selection based on age, comorbidity and performance status on the efficacy of platinum-free combination therapy on non-small-cell lung cancer after 65 years of age. We analyzed the overall response rate, the median survival time, the 1-year survival rate, toxicity and quality of life after one to three 6-week cycles of docetaxel 30mg/m(2) weekly and gemcitabine 900mg/m(2) at weeks 1, 2, 4 and 5. Fifty patients (median age 73.7 years) were eligible. The mean number of comorbid conditions per patient was 0.8 [Balducci L. Lung cancer and aging. ASCO 2005. Educational book. p. 587-91; Piquet J, Blanchon F, Grivaux M, et al. Primary bronchial carcinoma in elderly subjects in France. Rev Mal Respir 2003;20:691-9; Jatoi A, Hillman S, Stella P, et al. Should elderly non-small-cell lung cancer patients be offered elderly-specific trials? Results of a pooled analysis from the North Central Cancer Treatment Group. J Clin Oncol 2005;23:9113-9; Balducci L, Extermann M. Management of cancer in the older person: a practical approach. Oncologist 2000;5:224-37]. Forty-five patients were assessable: 17 (34%) had an objective response, 18 (36%) had stable disease and 10 progressed (20%). The median survival time was 7 months and the 1-year survival rate 23.5%. The main grade III-IV adverse event was neutropenia (32% of patients). CONCLUSION: Platinum-free dual-agent chemotherapy gives similar results in patients over 65, selected on the basis of their precise age and comorbidity, to that reported in younger subjects.

Carboplatin-etoposide combination in small cell lung cancer patients older than 70 years: a phase II trial.

BACKGROUND: No standard treatment is defined for elderly patients with small cell lung cancer (SCLC). Carboplatin and etoposide are highly active agents against SCLC. In this study, we evaluated the activity and toxicity of a combination of these two agents. PATIENTS AND METHODS: Thirty-four untreated patients with limited or extensive SCLC and median age of 73.9 years entered the study. Chemotherapy consisted of carboplatin i.v. on day 1 (AUC 5 using Calvert's formula) and etoposide 100 mg/m(2) given orally on days 1-5, every 4 weeks, and thoracic irradiation was given to limited disease patients after chemotherapy. RESULTS: The overall response rates was 59% (95% CI: 43-76). The median survival for all patients was 37 weeks (range 3-76 weeks). The toxicity was mainly haematological with grade 3-4 neutropenia in 59% of courses, febrile neutropenia in 15% of courses, and toxic death in 9% of patients. CONCLUSION: The results of this regimen are disappointing with worse response and survival, and more haematological toxicity than expected and previously reported, despite the use of Calvert's formula. Possible explanations are the use of etoposide per os rather than i.v., the frequent comorbidities of older patients and the inclusion of patients with poor prognosis factors.