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


METHODS
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).


RESULTS
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%.


CONCLUSIONS
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.
Kawamura
Masafumi
M
Division of General Thoracic Surgery, Keio University Hospital, 35 Shinanomachi, Tokyo 160-8582, Japan. kawamura@sc.itc.keio.ac.jp
Eguchi
Keisuke
K
Izumi
Yotaro
Y
Yamato
Yasushi
Y
Koike
Teruaki
T
Sakaguchi
Hirozo
H
Hada
Enjo
E
Kobayashi
Koichi
K
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D000093542:Gemcitabine
D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine