Phase II trial of gemcitabine and docetaxel in patients with completely resected stage IIA-IIIA non-small-cell lung cancer

• Published in: Cancer chemotherapy and pharmacology 2007-09, Vol.60 (4), p.495-501
• Main Authors: KAWAMURA, Masafumi, EGUCHI, Keisuke, IZUMI, Yotaro, YAMATO, Yasushi, KOIKE, Teruaki, SAKAGUCHI, Hirozo, HADA, Enjo, KOBAYASHI, Koichi
• Format: Article
• Language: English
• Subjects: Aged; Anorexia; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols; Biological and medical sciences; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - surgery; Chemotherapy; Chemotherapy, Adjuvant; Corticoids; Corticosteroids; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Drug Administration Schedule; Female; Gemcitabine; Health services; Humans; Lung cancer; Lung diseases; Lung Neoplasms - drug therapy; Lung Neoplasms - surgery; Male; Medical sciences; Middle Aged; Neutropenia; Neutropenia - chemically induced; Non-small cell lung carcinoma; Patients; Pharmacology. Drug treatments; Platinum; Pneumology; Small cell lung carcinoma; Survival; Survival Rate; Taxoids - administration & dosage; Taxoids - adverse effects; Thrombocytopenia; Toxicity; Tumors of the respiratory system and mediastinum
• ISSN: 0344-5704; 1432-0843
• DOI: 10.1007/s00280-006-0391-6

Few clinical phase II studies using non-platinum doublet as adjuvant chemotherapy following complete resection of non-small-cell lung cancer (NSCLC) have been published, so this clinical study was designed to evaluate the toxicity profile and efficacy of the non-platinum doublet of docetaxel (DOC) + gemcitabine (GEM). Eligibility criteria included completely resected NSCLC, pathological stage II or IIIA, younger than 76 years old, and performance status 0-1. Treatment consisted of DOC 60 mg/m2 on day 8, and GEM 1,000 mg/m2 on days 1, 8, and 15 every 4 weeks (4 cycles). The GEM dosage was decreased to 800 mg/m2 after the initial 21 patients because 3 patients developed interstitial lung disease (ILD). Thirty-five patients (male/female 21/14) were enrolled. The median age was 62 years (range 47-74), with five (14.3%) over the age of 70. Performance status was 0 in 34 patients. The diagnosis was ad in 28 patients, sq in 6, and adsq in 1. The pathological stage was IIA in 5 patients, IIB in 1 and stage IIIA in 29 (82.9%). All patients underwent at least one cycle of chemotherapy, with 29 patients completing three cycles of chemotherapy and 23 (66%) had four cycles. The main grade 3/4 toxicities comprised neutropenia (n = 21, 60%), thrombocytopenia (n = 3, 8.6%), anorexia (n = 4, 11.4%), and ILD (n = 3, 8.6%), which responded well to corticosteroids. There were no treatment-related deaths. The 4-year recurrence-free survival rate was 42.9%, and the 4-year survival rate was 65.8%. The non-platinum doublet regimen of DOC + GEM as adjuvant chemotherapy following complete resection of NSCLC is feasible, with good compliance, the only problem being ILD.