Preliminary results of the Four-Arm Cooperative Study (FACS) for advanced non-small cell lung cancer (NSCLC) in Japan

Category: Non-Small-Cell Lung Cancer

Authors: Y. Ohe, N. Saijo, Y. Ohashi, Y. Nishiwaki, K. Nakagawa, T. Tamura, S. Negoro, K. Kubota, Y. Ariyoshi, M. Fukuoka; National Cancer Center Hospital, Tokyo, Japan; FACS Cooperative Group, Tokyo, Japan


Abstract:FACS was designed to compare 3 platinum-based combination regimens to cisplatin (80 mg/m², day 1) plus irinotecan (60 mg/m², days 1, 8, 15) (IP, q4wks) as the reference arm. The experimental regimens were: carboplatin (AUC 6, day 1) plus paclitaxel (200 mg/ m², day 1) (TC, q3wks); cisplatin (80 mg/ m², day 1) plus gemcitabine (1000 mg/ m², days 1, 8) (GP, q3wks); cisplatin (80 mg/ m², day 1) plus vinorelbine (25 mg/ m², days 1,8) (NP, q3wks). Each patient (pt) had to fulfill the following criteria: histologically and/or cytologically documented NSCLC, clinical stage IV or IIIB (malignant pleural effusion and/or metastasis in the same lobe), PS 0 or 1, age from 20 to 74 years, no prior chemotherapy, measurable lesion, adequate organ functions. Between Oct. 2000 and June 2002, 602 pts were registered from 44 hospitals in Japan. Age, gender, PS, stage, LDH and albumin were well balanced in each arm. Objective tumor response rates in intention-to-treat basis were 30% (45/151) in IP, 31% (47/150) in TC, 28% (43/151) in GP, 31% (47/150) in NP. As of Oct. 2002, toxicity data of 182 pts were assessable. Frequency of grade 3 or greater neutropenia (IP/TC/GP/NP: 80%/87%/62%/87%) was lower in GP, however, grade 3 or greater thrombocytopenia (IP/TC/GP/NP: 0%/9%/31%/3%) was higher in GP. Frequency of grade 2 or greater nausea (IP/TC/GP/NP: 62%/22%/54%/39%) was lower in TC, however, grade 2 or greater sensory neuropathy (IP/TC/GP/NP: 2%/20%/0%/0%) was higher in TC. Frequency of grade 2 or greater diarrhea (IP/TC/GP/NP: 49%/4%/4%/5%) was lower in TC, GP and NP. Response and toxicity data of all pts in each arm and combined survival will be presented. The final analysis of the difference of survival in each arm will be made in Nov. 2003.