635P - Randomized phase II study of CPT-11 vs PTX vs each combination chemotherapy with s-1 in patients with advanced gastric cancer refractory to s-1 or...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Gastric Cancer
Biological Therapy
Presenter Jin Matsuyama
Citation Annals of Oncology (2014) 25 (suppl_4): iv210-iv253. 10.1093/annonc/mdu334
Authors J. Matsuyama1, H. Imamura2, M. Gotoh3, Y. Kimura4, S. Ueda5, K. Nishikawa6, N. Sugimoto7, J. Fujita8, T. Tamura9, N. Fukushima10, D. Sakai11, T. Shimokawa12, Y. Kurokawa13, T. Satoh14, T. Tsujinaka15, H. Furukawa16
  • 1Department Of Surgery, Yao Municipal Hospital, 581-0069 - Yao/JP
  • 2Surgey, Toyonaka Municipal Hospital, Toyonaka/JP
  • 3Cancer Chemotherapy Center, Osaka Medical College, JP-569-8686 - Takatsuki/JP
  • 4Surgery, Sakai City Hospital, Sakai/JP
  • 5Surgery, Kitano Hospital, Osaka/JP
  • 6Surgery, Osaka General Medical Center,, 558-8558 - Osaka/JP
  • 7Dept. Clinical Oncology / Gastrointestinal, Osaka Medical Center for Cancer and Cardiovascular Dideases, Osaka/JP
  • 8Surgery, NTT West Osaka Hospital, 543-8922 - Osaka/JP
  • 9Department Of Medical Oncology, Kinki University, Faculty of Medicine, Sayama/JP
  • 10Surgery, Yamagata Prefectural Central Hospital, 990-2292 - Ymamagata/JP
  • 11Dept Of Frontier Science For Cancer & Chemotherapy, Osaka University, Suita/JP
  • 12Regional Social Management, Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi, Kofu/JP
  • 13Gastroenterological Surgery, Osaka University, 565-0871 - Suita/JP
  • 14Frontier Science For Cancer And Chemotherapy, Osaka University Graduate School of Medicine, Suita/JP
  • 15Department Of Surgery, Kaizuka City Hospital, Kaizuka/JP
  • 16Surgery, Kinki University School of Medicine, Sayama/JP



S-1 plus cisplatin (SP) is recognized as standard first-line chemotherapy for advanced gastric cancer (AGC) and S-1 monotherapy is recognized as standard adjuvant chemotherapy for locally AGC in Japan. Taxane and CPT-11 are two main options and a retrospective analysis has reported that S-1 combination chemotherapy extended overall survival (OS), as second-line chemotherapy for AGC refractory to S1-based chemotherapy. Thus, this prospective multicenter phase II study was carried out to examine efficacy and safety comparing CPT-11, PTX, and each combination chemotherapy with S-1 refractory to S-1 or SP.


Patients with AGC after first-line chemotherapy with S-1 or SP, or during adjuvant chemotherapy or within 26 weeks after adjuvant chemotherapy completion with S-1 who confirmed disease progression by imaging were eligible. Patients were randomly divided into four groups by treatment as follows; Group A: CPT-11 150 mg/m2, day1, q14days, Group B: PTX 80 mg/m2, day1, 8,15, q28days, Group C1: CPT-11 80 mg/m2, day1, 15, S-1 80 mg/m2, day1-21, q35days, Group C2: PTX 50 mg/m2, day1, 8, S-1 80 mg/m2, day1-14, q21days. Primary endpoint was OS, and secondary endpoints were progression-free survival (PFS), response rate and safety.


From July 2008 to March 2012, 127 patients were enrolled. Reason for terminating the protocol treatment was for progressive disease(PD) in 86/81/86/76 (Group A/B/C1/C2, %), respectively. Median OS was 11.3/11.3/14.6/10.5 months(M) (Group A/B/C1/C2), 11.8 M in Group A + C1 and 11.1 M in Group B + C2 (p = 0.922, HR: 0.981 [0.679-1.419]), and 11.3 M in Group A + B and 11.1 M in Group C1 + C2 (p = 0.808, HR:0.952 [0.643-1.412]), respectively. Median PFS was 3.0/4.4/3.8/3.5 M (Group A/B/C1/C2), 3.6 M in Group A + C1 and 4.1 M in Group B + C2 (p = 0.035, HR:0.674 [0.468-0.972]), and 3.7 M in Group A + B and 3.7 M in Group C1 + C2 (p = 0.931, HR: 1.017 [0.643-1.412]), respectively. Grade 3 or 4 adverse events (Group A/B/C1/C2, %), were leukopenia (12/7/5/0), neutropenia (29/16/24/24), anemia (7/9/14/14), anorexia (10/2/14/10), nausea (7/2/10/5), diarrhea (5/0/10/0), and fatigue (5/2/10/5).


The difference in OS between CPT-11 and PTX, and the efficacy of S-1 sequential therapy were not observed in second-line chemotherapy for AGC refractory to S-1 or SP.


All authors have declared no conflicts of interest.