Combination chemotherapy of gemcitabine and vinorelbine for patients in stage IIIB-IV non-small cell lung cancer: a phase II study of the West Japan Thoracic Oncology Group (WJTOG) 9908.
OBJECTIVE
Vinorelbine (V) and gemcitabine (G) are two active single agents used in the treatment of non-small cell lung cancer (NSCLC). A multicenter clinical trial (West Japan Thoracic Oncology Group (WJTOG) 9908) was conducted to evaluate the efficacy and toxicity of V and G in patients (pts) with advanced NSCLC.


METHODS



METHODS
no previous chemotherapy; performance status (PS) 0 or 1; age <75 years old. V, 25mg/m2, was given as a 2-3 min IV infusion, followed by a 30 min IV infusion of G, 1000 mg/m2, on days 1 and 8 of each 21-day cycle.


RESULTS
From April 2000 to September 2000, 52 pts were enrolled in the study. Two pts were ineligible. Baseline characteristics: median age 60, males 30 (60%), Eastern Cooperative Oncology Group (ECOG) PS 0/1=21/29 (58%), stage IIIB/IV=12/38 (76%), adenocarcinoma=35 (70%). The median number of cycles administered was 2. Fifty pts were evaluable for response. The response rate was 18% by the Response Evaluation Criteria in Solid Tumors (RECIST) (no complete response (CR), 9 partial response (PR), 25 stable disease, 12 progressive disease, 4 not evaluable). Grade III/IV toxicities were as follows: neutropenia grade III/IV=66%, anemia grade III/IV=16%, thrombocytopenia grade III/IV=2%, nausea grade III/IV=10%, vomiting grade III/IV=0%, documented infection grade III/IV=10%, skin rash grade III/IV=2%, and hepatic grade III/IV=8%. There were no treatment-related deaths. The median time to progression was 4.1 months. The overall median survival time (MST) was 13.9 months (range, 2.4 to >16.2 months) with a median follow-up time of 13.9 months. The MST for stage IIIB and stage IV was >14.5 and 12.7 months, respectively. The overall estimated 1-year survival rate was 55.4%.


CONCLUSIONS
This regimen has modest activity and is very well tolerated, with an encouraging 1-year survival rate.
Katakami
Nobuyuki
N
Division of Pulmonary Medicine, Kobe City General Hospital, Minatojima Nakamachi 4-6, Chuo-ku, Kobe 650-0046, Japan. katakami@kcgh.gr.jp
Sugiura
Takahiko
T
Nogami
Toshiji
T
Yamamoto
Hidehiko
H
Negoro
Shunichi
S
Nakano
Takashi
T
Okamoto
Naoki
N
Takada
Yoshiki
Y
Kodama
Keiji
K
Ariyoshi
Yutaka
Y
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007564:Japan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine; D000093542:Gemcitabine
D003841:Deoxycytidine; D014747:Vinblastine; D000077235:Vinorelbine; D000093542:Gemcitabine