697P - Final analysis of randomized phase III study WJOG4007 comparing irinotecan (CPT-11) with weekly paclitaxel (WPTX) in advanced gastric cancer (AGC) r...

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Anti-Cancer Agents & Biologic Therapy
Gastric Cancer
Presenter Tomohiro Nishina
Authors T. Nishina1, S. Hironaka2, A. Tsuji3, K. Suzuki4, T. Otsuji5, T. Shibata6, S. Morita7, I. Okamoto8, N. Boku9, I. Hyodo10
  • 1Dept. Of Gastroenterology, National Hospital Organization Shikoku Cancer Center, Matsuyama/JP
  • 2Clinical Trial Promotion Centre, Chiba Cancer Center Hospital, 260-8717 - Chiba/JP
  • 3Kochi Health Sciences Center, JP-781-8555 - Kochi City/JP
  • 4Gastrointestinal Oncology, Kushiro City General Hospital, Kushiro/JP
  • 5Gastrointestinal Oncology, Dongo Hospital, Yamatotakata/JP
  • 6Gastrointestinal Oncology, Fujita Health University, Toyoake/JP
  • 7Biostatistics And Epidemiology, Yokohama City University Medical Center, Yokohama/JP
  • 8Medical Oncology, Kinki University School of Medicine, Osakasayama/JP
  • 9Department Of Clinical Oncology, St. Marianna University School of Medicine, 216-8511 - Kawasaki/JP
  • 10Gastrointestinal Oncology, University of Tsukuba, Tsukuba/JP

Abstract

Background

We previously reported the primary results of WJOG4007 trial comparing wPTX with CPT-11 for AGC refractory to combination CT of FP (Ueda et al. ASCO 2012). This trial failed to demonstrate the superiority of CPT-11 to wPTX in OS. Here, we report the results of subgroup analysis, cross-over effect and patients' general conditions at the time of discontinuation of protocol treatments.

Methods

The main inclusion criteria were; 1) refractory to combination CT of FP, 2) no prior CPT-11 or taxane, 3) no severe peritoneal metastasis. Pts with AGC refractory to the 1st-line FP regimen were randomized 1:1 to either CPT-11 (150 mg/m2, days1, 15, q4w) or wPTX (80 mg/m2, days 1, 8, 15, q4w). Cross-over treatment between PTX and CPT-11 was recommended for the third line chemotherapy.

Results

Between Aug 2007 and Aug 2010, 223 pts were enrolled and 219 were eligible; 108 pts were randomized to wPTX and 111 pts to CPT-11. Median OS for wPTX and CPT-11 was 9.5 and 8.4 months (HR 1.13; 95% CI, 0.86-1.49; p = 0.38). Subgroup analysis in OS revealed slightly favorable tendency of wPTX for almost all factors such as age, gender, PS, prior gastrectomy, histological type, presence of target lesion, peritoneal metastasis, number of metastatic sites. At the treatment discontinuation, 85 pts (80%) with wPTX and 77 with CPT-11 (70%) maintained PS 0-1 (p = 0.12), and 2 (2%) and 13 pts (12%) were complicated with infection (p = 0.006), respectively. Thereafter, proportion of pts receiving third line CT was higher in wPTX (89%) than CPT-11 (71%) (p = 0.04). As for the cross-over effect, among 86 pts (80%) in the wPTX group who received CPT-11 containing regimens in the subsequent chemotherapy and 74 pts (67%) in the CPT-11 group who received taxane containing regimens, survival curves were quite similar (10.1months, HR 0.96; 95%CI, 0.69-1.32).

Conclusions

In this trial, while patients in the wPTX group showed better condition at the time of treatment discontinuation, a higher rate of subsequent CT and cross-over CT, quite similar survival curves were observed in pts of both arms who received cross-over treatments. It is speculated that the better condition at the end of the second line chemotherapy resulting in higher proportion of the third line chemotherapy might contribute to more favorable overall survival with wPTX than CPT-11.

Disclosure

T. Nishina: Honoralia from Yakult Honsha, Daiichi Sankyo.

I. Hyodo: Honoralia from Yakult Honsha and Daiichi-Sankyo.

All other authors have declared no conflicts of interest.