The docetaxel (DOC) and gemcitabine (GEM) combination as adjuvant chemotherapy in patients with non-small cell lung cancer (NSCLC): A multi-institutional phase II trial

Abstract

17157 Background: As clinical phase II studies with non-platinum doublet for adjuvant chemotherapy after complete resection of NSCLC has been scarcely reported, this clinical study was designed to evaluate the toxicity profile and the efficacy of the adjuvant chemotherapy with non-platinum doublet of DOC+GEM. Methods: Eligibility criteria included: completely resected NSCLC, pathological stage II and IIIA, younger than 76 years old, and performance status 0–1. Patients treated preoperatively were excluded. Treatment consisted of DOC, 60 mg/m2, on day 8, and GEM, 1000 mg/m2, on day 1, 8, and 15 every 4 week (4 cycles). Dose of GEM was decreased to 800 mg/m2 after the initial 21patients because interstitial pneumonitis (IP) occurred in 3 among them. Results: Between August 2000 and August 2002, 35 patients (M/F: 21/14) were enrolled. The median age was 62 years (range 47–74) were enrolled with 5 patients (14.3%) over the age of 70. 34 patients had ECOG PS of 0. 28 patients had adenocarcinomas, 6 had squamous cell carcinomas, and one had adenosquamous carcinoma. Pathological stages were stage IIA in 5 patients, stage IIB in 1 and stage IIIA in 29 (82.9%). All patients received at least one cycle of chemotherapy. 29 patients received 3 cycles of chemotherapy and 23 (66%) completed 4 cycles. The main grade 3/4 toxicity (according to WHO scale) consisted of leukocytopenie (n = 19, 54.3%), thrombocytopenia (n = 3, 8.6%), appetiteloss (n = 4, 11.4%), dyspnea (n = 3, 8.6%), and vomiting (n = 1, 2.9%). IP, which caused dyspnea in these 3 patients, were well treated with steroid and suspension of chemotherapy. There was no treatment related death. Median follow-up period was 52 months. The 4 year recurrent free survival rate was 42.9% and the 4 year survival rate was 65.8%. Conclusions: Non-platinum doublet regimen with DOC+GEM as adjuvant chemotherapy for the NSCLC patients with complete resection was feasible and showed good compliance besides IP. No significant financial relationships to disclose.