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A randomised phase II trial of capecitabine plus cisplatin versus S-1 plus cisplatin as a first-line treatment for advanced gastric cancer: Capecitabine plus cisplatin ascertainment versus S-1 plus cisplatin randomised PII trial (XParTS II).
Nishikawa, Kazuhiro; Tsuburaya, Akira; Yoshikawa, Takaki; Kobayashi, Michiya; Kawada, Junji; Fukushima, Ryoji; Matsui, Takanori; Tanabe, Kazuaki; Yamaguchi, Kazuya; Yoshino, Shigefumi; Takahashi, Masazumi; Hirabayashi, Naoki; Sato, Seiji; Nemoto, Hiroshi; Rino, Yasushi; Nakajima, Junta; Aoyama, Toru; Miyagi, Yohei; Oriuchi, Noboru; Yamaguchi, Kensei; Miyashita, Yumi; Morita, Satoshi; Sakamoto, Junichi.
Afiliación
  • Nishikawa K; Department of Surgery, Osaka National Hospital, Osaka, Japan. Electronic address: kazuno13@hotmail.co.jp.
  • Tsuburaya A; Department of Surgery, Tsuboi Cancer Center Hospital, Koriyama, Japan.
  • Yoshikawa T; Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.
  • Kobayashi M; Department of Human Health and Medical Science, Kochi Medical School, Nankoku, Japan.
  • Kawada J; Department of Surgery, Osaka General Medical Center, Osaka, Japan.
  • Fukushima R; Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan.
  • Matsui T; Department of Surgery, Aichi Cancer Center Aichi Hospital, Okazaki, Japan.
  • Tanabe K; Department of Gastroenterological and Transplant Surgery, Hiroshima University, Hiroshima, Japan.
  • Yamaguchi K; Department of Surgical Oncology, Gifu University, Gifu, Japan.
  • Yoshino S; Oncology Center, Yamaguchi University Hospital, Ube, Japan.
  • Takahashi M; Division of Gastroenterological Surgery, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.
  • Hirabayashi N; Department of Surgery, Hiroshima City Asa Hospital, Hiroshima, Japan.
  • Sato S; Department of Gastroenterological Surgery, Saga-Ken Medical Center Koseikan, Saga, Japan.
  • Nemoto H; Department of Surgery, Ebina General Hospital, Ebina, Japan.
  • Rino Y; Department of Surgery, Yokohama City University, Yokohama, Japan.
  • Nakajima J; Department of 3rd Internal Medicine, Obihiro-Kosei General Hospital, Obihiro, Japan.
  • Aoyama T; Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.
  • Miyagi Y; Molecular Pathology and Genetics Division, Kanagawa Cancer Center Research Institute, Yokohama, Japan.
  • Oriuchi N; Advanced Clinical Research Center, Fukushima Medical University, Fukushima, Japan.
  • Yamaguchi K; Department of Gastroenterological Chemotherapy, The Cancer Institute Hospital Japanese Foundation for Cancer Research, Tokyo, Japan.
  • Miyashita Y; Epidemiological & Clinical Research Information Network (ECRIN), Okazaki, Japan.
  • Morita S; Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
  • Sakamoto J; Epidemiological & Clinical Research Information Network (ECRIN), Okazaki, Japan; Tokai Central Hospital, Kakamigahara, Japan.
Eur J Cancer ; 101: 220-228, 2018 09.
Article en En | MEDLINE | ID: mdl-30096702
BACKGROUND: Capecitabine plus cisplatin (XP) is a standard global regimen, while S-1 plus cisplatin (SP) is a Japanese standard for first-line treatment of advanced gastric cancer (AGC). We conducted a phase II trial comparing XP with SP for patients with AGC to confirm whether these regimens can be used as controls in a phase III study and to explore whether histological subtypes favour XP or SP. PATIENTS AND METHODS: Eligible patients were randomised to receive either S-1 40 mg/m2 for 21 days plus cisplatin 60 mg/m2 (q5w) or capecitabine 1000 mg/m2 for 14 days plus cisplatin 80 mg/m2 (q3w). The primary end-point was progression-free survival (PFS). The secondary end-points were overall survival (OS), overall response rate (ORR) and safety. RESULTS: In 110 eligible patients, 24-week PFS was higher in both groups (SP 50.9%, XP 43.5%) than the protocol-specified threshold of 40%. The median PFS for SP versus XP was 5.6 and 5.1 months (hazard ratio [HR], 1.126; p = 0.5626); OS was 13.5 and 12.6 months (HR, 0.942; p = 0.7769) and the ORR was 42.4% and 69.4% (p = 0.0237), respectively. The most common grade ≥3 adverse events with SP/XP were anaemia (16%/20%), neutropenia (9%/18%) and anorexia (18%/13%). Subgroup analysis by histological classification showed no statistical difference between treatments. CONCLUSIONS: XP and SP are comparable and can be recommended as control arms in a phase III study for AGC. Histological subtypes were not sensitive markers for the selection of XP or SP. CLINICAL TRIAL REGISTRATION: NCT00140624.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Gástricas / Adenocarcinoma / Protocolos de Quimioterapia Combinada Antineoplásica Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Risk_factors_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Eur J Cancer Año: 2018 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Gástricas / Adenocarcinoma / Protocolos de Quimioterapia Combinada Antineoplásica Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Risk_factors_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Eur J Cancer Año: 2018 Tipo del documento: Article Pais de publicación: Reino Unido