688P - A randomised phase III clinical trial of combined therapy with CPT-11/CDDP versus CPT-11 alone in patients with advanced or recurrent gastric cancer...

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Anticancer agents
Gastric Cancer
Biological Therapy
Presenter Hiroko Hasegawa
Authors H. Hasegawa1, K. Nishikawa2, H. Inagaki3, S. Akamaru4, S. Tokunaga5, M. Takagi6, S. Tamura7, S. Morita8, J. Sakamoto9, T. Tsujinaka10
  • 1Gastroenterology, National Hospital Organization Osaka National Hospital, 540-0006 - Osaka/JP
  • 2Surgery, Osaka General Medical Center,, 558-8558 - Osaka/JP
  • 3Surgery, GifuCentral Hospital, 50-1198 - Gifu/JP
  • 4Surgery, Osaka Kose-Nenkin Hospital, 553-0003 - Osaka/JP
  • 5Clinical Oncology, Osaka city General Hospital, 534-0021 - Osaka/JP
  • 6Surgery, Shizuoka General Hospital, 420-8527 - Shizuoka/JP
  • 7Surgery, Kansai Rosai Hospital, 660-8511 - Amagasaki/JP
  • 8Biostatistics And Epidemiology, Yokohama City University Medical Center, Yokohama/JP
  • 9Young Leaders Program, Nagoya Universty, 466-8560 - Nagoya/JP
  • 10Surgery, National Hospital Organization Osaka National Hospital, 540-0006 - Osaka/JP



There has been no established regimen as the second-line treatment for advanced gastric cancer (AGC), though CPT-11 showed survival benefit over BSC. Combination of CPT-11 with CDDP is one of the promising regimens as the second-line chemotherapy after S-1 mono-therapy.


This study was designed as a randomized, multicenter phase III study comparing CPT-11 + CDDP vs. CPT-11 alone in patients with advanced or recurrent gastric cancer resistant to S-1 mono-therapy or prior adjuvant chemotherapy using S-1. Eligibility criteria include: histologically confirmed gastric adenocarcinoma, showing PD after receiving S-1 mono-therapy or recurrence within 6 months after or during S-1 adjuvant chemotherapy, age over 20 years old, PS:0-2, adequate organ functions and written informed consent. Patients received either CPT-11 150 mg/m2day1 / q 2W (Arm A) or CPT-11 60mg/m2 day1 +CDDP 30mg/m2 day1/ q 2W (Arm B). Stratification was made according to PS, advanced or recurrence cases, institution and presence or absence of measurable target lesions. Primary endpoint is overall survival. Secondary endpoints are time to treatment failure (TTF), response rate, and safety (frequency and severity of adverse events). Calculated sample size was 160 assuming 74 events with alpha error 0.05 and beta error 0.2 to detect differences in survival. Planned number was 200 considering 40 for ineligibility or dropout.


168 patients were enrolled between 2007 and 2011. Arm A (n = 84) and Arm B (n = 84) were well balanced for baseline factors.Median age was 67 years old and median number of treatment courses was 5 (range: 1-39).Relative dose intensity (RDI) in Arm A was 97.5% and RDI in Arm B was 98.9%. The most common grade 3/4 toxicities in Arm A vs. Arm B were, neutropenia; 26.2 vs. 15.5%, anemia; 44.0 vs. 27.3%, diarrhea; 0 vs. 11.9%, anorexia; 4.8 vs. 6.0%, nausea and vomiting; 3.5 vs. 6.0%. 17.9% in Arm A and 10.7% in Arm B required dose modification for these toxicities.


In this initial safety analysis, the incidence and severity of adverse events in both Arms were acceptable as second-line treatment. Final efficacy results will be performed at the end of this year.


All authors have declared no conflicts of interest.