A Phase 2 Study of Induction Chemotherapy Using Docetaxel, Cisplatin, and S-1 for Gastric Cancer with Peritoneal Metastasis (KUGC06) View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2019-02-14

AUTHORS

Hiroshi Okabe, Hiroaki Hata, Hisahiro Hosogi, Shugo Ueda, Shuji Ota, Yousuke Kinjo, Nobuaki Hoshino, Shigeo Hisamori, Shigeru Tsunoda, Kazutaka Obama, Yoshiharu Sakai, The Kyoto University Surgical Oncology Group (KUSOG)

ABSTRACT

BACKGROUND: The authors previously showed the significant efficacy of S-1 plus cisplatin for gastric cancer with limited peritoneal metastasis. They conducted a phase 2 study to evaluate the safety and efficacy of induction chemotherapy using a docetaxel, cisplatin, and S-1 (DCS) triplet regimen to treat gastric cancer with peritoneal metastasis. METHODS: The key eligibility criteria were gastric cancer with peritoneal metastasis or positive peritoneal cytology but no other distant metastases and capability of oral administration. The patients received three 28-day cycles of DCS (60 mg/m2 of cisplatin, 40 mg/m2 of docetaxel on day 1, and 80 mg/m2 of S-1 from day 1 to day 14), then underwent D2 gastrectomy if R0 was possible. The primary end point was the R0 resection rate. The sample size was determined to have 80% power for detecting a 20% improvement in the R0 resection rate over a 45% baseline for a one-tailed alpha of 0.1. RESULTS: Among 30 enrolled patients, 24 completed three cycles of DCS. The most frequent grade 3 or 4 toxicity was neutropenia (60%). A complete response of peritoneal metastasis was observed in 16 patients, and 14 patients achieved R0 resection (47%; 95% confidence interval 28-66%). When the extent of peritoneal metastasis was classified as P0CY1, P1, P2, and P3 according to the Japanese classification, the R0 resection rates were respectively 63%, 60%, 46% and 0%. CONCLUSIONS: Induction chemotherapy with DCS is safe and can achieve R0 resection for some patients with limited peritoneal metastasis or positive peritoneal cytology. The efficacy, however, appears similar to that of S-1 plus cisplatin. More... »

PAGES

1-8

References to SciGraph publications

  • 2009-12. Induction Chemotherapy with S-1 Plus Cisplatin Followed by Surgery for Treatment of Gastric Cancer with Peritoneal Dissemination in ANNALS OF SURGICAL ONCOLOGY
  • 2011-06. Japanese classification of gastric carcinoma: 3rd English edition in GASTRIC CANCER
  • 2012-07. Long-term follow up of patients who were positive for peritoneal lavage cytology: final report from the CCOG0301 study in GASTRIC CANCER
  • 2007-10. Phase I study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer in BRITISH JOURNAL OF CANCER
  • 2005-09. When Is Curative Gastrectomy Justified for Gastric Cancer with Positive Peritoneal Lavage Cytology but Negative Macroscopic Peritoneal Implant? in WORLD JOURNAL OF SURGERY
  • 2017-03. A phase II study of preoperative chemotherapy with docetaxel, cisplatin, and S-1 followed by gastrectomy with D2 plus para-aortic lymph node dissection for gastric cancer with extensive lymph node metastasis: JCOG1002 in GASTRIC CANCER
  • 2010-09. Phase II study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer in CANCER CHEMOTHERAPY AND PHARMACOLOGY
  • 2012-02. A multicenter phase II study of combined chemotherapy with docetaxel, cisplatin, and S-1 in patients with unresectable or recurrent gastric cancer (KDOG 0601) in CANCER CHEMOTHERAPY AND PHARMACOLOGY
  • 2013-03. Pharmacokinetics of docetaxel in gastric cancer patients with malignant ascites in CANCER CHEMOTHERAPY AND PHARMACOLOGY
  • 2018-01. Prognostic significance of peritoneal lavage cytology in staging gastric cancer: systematic review and meta-analysis in GASTRIC CANCER
  • 2010-12. Positive Peritoneal Cytology in Patients with Gastric Cancer: Natural History and Outcome of 291 Patients in ANNALS OF SURGICAL ONCOLOGY
  • 2018-10-03. A phase II study of neoadjuvant chemotherapy with docetaxel, cisplatin, and S-1, followed by gastrectomy with D2 lymph node dissection for high-risk advanced gastric cancer: results of the KDOG1001 trial in GASTRIC CANCER
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    http://scigraph.springernature.com/pub.10.1245/s10434-019-07229-7

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    http://dx.doi.org/10.1245/s10434-019-07229-7

    DIMENSIONS

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    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/30767179


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    25 schema:description BACKGROUND: The authors previously showed the significant efficacy of S-1 plus cisplatin for gastric cancer with limited peritoneal metastasis. They conducted a phase 2 study to evaluate the safety and efficacy of induction chemotherapy using a docetaxel, cisplatin, and S-1 (DCS) triplet regimen to treat gastric cancer with peritoneal metastasis. METHODS: The key eligibility criteria were gastric cancer with peritoneal metastasis or positive peritoneal cytology but no other distant metastases and capability of oral administration. The patients received three 28-day cycles of DCS (60 mg/m2 of cisplatin, 40 mg/m2 of docetaxel on day 1, and 80 mg/m2 of S-1 from day 1 to day 14), then underwent D2 gastrectomy if R0 was possible. The primary end point was the R0 resection rate. The sample size was determined to have 80% power for detecting a 20% improvement in the R0 resection rate over a 45% baseline for a one-tailed alpha of 0.1. RESULTS: Among 30 enrolled patients, 24 completed three cycles of DCS. The most frequent grade 3 or 4 toxicity was neutropenia (60%). A complete response of peritoneal metastasis was observed in 16 patients, and 14 patients achieved R0 resection (47%; 95% confidence interval 28-66%). When the extent of peritoneal metastasis was classified as P0CY1, P1, P2, and P3 according to the Japanese classification, the R0 resection rates were respectively 63%, 60%, 46% and 0%. CONCLUSIONS: Induction chemotherapy with DCS is safe and can achieve R0 resection for some patients with limited peritoneal metastasis or positive peritoneal cytology. The efficacy, however, appears similar to that of S-1 plus cisplatin.
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