631P - Impacts of progression type on overall survival in advanced gastric cancer: Randomized PIII study of S-1 + oxaliplatin vs. S-1 + cisplatin

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Gastric Cancer
Presenter Kazuhiro Nishikawa
Citation Annals of Oncology (2014) 25 (suppl_4): iv210-iv253. 10.1093/annonc/mdu334
Authors K. Nishikawa1, Y. Yamada2, K. Higuchi3, M. Gotoh4, N. Fuse5, N. Sugimoto6, T. Nishina7, K. Amagai8, K. Chin9, Y. Niwa10, A. Tsuji11, H. Imamura12, M. Tsuboi13, H. Yasui14, H. Fujii15, K. Yamaguchi16, H. Yasui17, S. Hironaka18, C. Hamada19, I. Hyodo20
  • 1Department Of Surgery, Osaka General Medical Center, 558-8558 - Osaka/JP
  • 2Gastrointestinal Oncology Division, National Cancer Center Hospital, JP-104-0045 - Tokyo/JP
  • 3Department Of Gastroenterology, Kitasato University East Hospital, 252-0380 - Sagamihara/JP
  • 4Cancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki/JP
  • 5Division Of Gastrointestinal Oncology And Digestive Endoscopy, National Cancer Center Hospital East, Kashiwa/JP
  • 6Department Of Clinical Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka/JP
  • 7Department Of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama/JP
  • 8Department Of Gastroenterology, Ibaraki Prefectural Central Hospital, Kasama/JP
  • 9Department Of Gastroenterology, Cancer Institute Hospital of JFCR, Tokyo/JP
  • 10Department Of Endoscopy, Aichi Cancer Center Hospital, Nagoya/JP
  • 11Department Of Medical Oncology, Kochi Health Sciences Center, JP-781-8555 - Kochi/JP
  • 12Department Of Surgery, Sakai City Hospital, Sakai/JP
  • 13Department Of Gastroenterological Oncology, Hyogo Cancer Center, 6738558 - Akashi/JP
  • 14Division Of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-gun/JP
  • 15Division Of Clinical Oncology, Jichi Medical University, 3290498 - Shimotsuke/JP
  • 16Division Of Gastroenterology, Saitama Cancer Center, Kita-adachi-gun/JP
  • 17Department Of Medical Oncology, National Hospital Organization Kyoto Medical Center, JP-612-0861 - Kyoto/JP
  • 18Clinical Trial Promotion Department, Chiba Cancer Center, 260-8717 - Chiba/JP
  • 19Faculty Of Engineering, Tokyo University of Science, Tokyo/JP
  • 20Division Of Gastroenterology, University of Tsukuba, Tsukuba/JP

Abstract

Aim

Randomized phase III study for the first-line treatment of advanced gastric cancer (AGC) (G-SOX PIII) demonstrated the non-inferiority of S-1 plus oxaliplatin (SOX) for S-1 plus cisplatin (CS) on PFS (HR for SOX vs. CS 1.004, 95% confidence interval [CI] 0.840-1.199; Higuchi, JCO 2013;30:Suppl, Abstract 60) and on OS (HR 0.958, 95% CI 0.803-1.142). Reporting of separate analyses for individual progression types is recommended (European Medicines Agency. Appendix 1 to the guideline on the evaluation of anticancer medicinal products in man). Thus, we aimed to assess the association between progression types and OS in this study.

Methods

Tumor lesions were assessed every 6 weeks until disease progression and independently reviewed according to the RECIST v1.0. We applied the Cox regression including two time-dependent covariates, i.e., progressive disease with new lesions (PDNL) or without new lesions (PDwoNL) in each treatment group, and estimated their effects compared to no progression (Non-PD).

Results

The results of analysis are shown in the table below. PDNL and PDwoNL were identified for 88 and 166 patients in SOX group (317 patients), and 95 and 146 patients in CS group (324 patients), respectively. The hazards of death in Non-PD were different between treatment groups (HR 0.582). However, association between progression types and OS were similar in both treatment groups. Both progression types were strong prognostic factors for OS, and greater effects were seen in PDNL (HR 8.277 in SOX, 5.997 in CS).

Conclusions

The progression accompanied by new lesions gives a strong negative impact on OS in patients treated with S-1 and platinum for AGC. Examining progression types would be useful for evaluating efficacy of anticancer treatment on OS.

HR (95%CI) P
SOX vs. CS
in Non-PD 0.582 (0.371-0.914) 0.019
in PDwoNL 1.111 (0.868-1.589) 0.403
in PDNL 0.803 (0.593-1.089) 0.158
SOX
PDwoNL vs. Non-PD 5.447 (3.609-8.221) <0.001
PDNL vs. Non-PD 8.277 (4.250-8.462) <0.001
CS
PDwoNL vs. Non-PD 2.854 (2.038-3.995) <0.001
PDNL vs. Non-PD 5.997 (4.250-8.462) <0.001

Disclosure

Y. Yamada: honoraria: Yakult Honsha, Taiho, Chugai, Pfizer, Takeda, Bristol-Myers, Dainippon Sumitomo, Johnson & Johnson, Novartis, Daiichi Sankyo Research Funding: Yakult Honsha, Otsuka, Chugai, Pfizer, Astra Zeneca, Novartis, Daiichi Sankyo, Bayer, Merck; K. Higuchi: I have received honoraria from Yakult Honsha; M. Gotoh: I have received honoraria from Yakult Honsha; N. Fuse: I have received honoraria from Taiho and research funding from Yakult Honsha and Taiho. N. Sugimoto: I have received honoraria and research funding from Yakult Honsha and Taiho; T. Nishina: I have received honoraria and research funding from Yakult Honsha and Taiho; A. Tsuji: I have received honoraria from Yakult Honsha and Taiho; K. Yamaguchi: I have received honoraria from Chugai, Bristol-Myers, Takeda, and Merck; H. Yasui: I have received honoraria from Yakult Honsha, Medicon, Chugai, Taiho, and Bristol-Myers. S. Hironaka: I have received honoraria from Yakult Honsha and Taiho; C. Hamada: I have received consultant fees and honoraria from Yakult Honsha, Taiho, and Chugai; I. Hyodo: I have held an advisory Role for Yakult Honsha and Taiho. I have received honoraria from Yakult Honsha and Taiho. All other authors have declared no conflicts of interest.