Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2011
A phase II study of biweekly mitomycin C and irinotecan combination therapy in patients with fluoropyrimidine-resistant advanced gastric cancer: a report from the Gastrointestinal Oncology Group of the Japan Clinical Oncology Group (JCOG0109-DI Trial).
Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed, 18 citations in OpenAlex.
- Evaluations of primary lesions by endoscopy clearly distinguishes prognosis in patients with gastric cancer who receive chemotherapy.PloS one · 2017Trial
- Mitomycin C and capecitabine in pretreated patients with metastatic gastric cancer: a multicenter phase II study.Journal of cancer research and clinical oncology · 2014Trial
- Randomized, Double-Blind, Placebo-Controlled Phase III Study of Paclitaxel ± Napabucasin in Pretreated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022Article
- Histological evaluations of primary lesions are independently associated with prognosis in patients with gastric cancer who receive neoadjuvant chemotherapy.Oncology letters · 2017Article
- Second-line chemotherapy for patients with advanced gastric cancer.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2017Review
- Second-line treatment of metastatic gastric cancer: Current options and future directions.World journal of gastroenterology · 2015Review
- Irinotecan plus mitomycin C as second-line chemotherapy for advanced gastric cancer resistant to fluoropyrimidine and Cisplatin: a retrospective study.Gastroenterology research and practice · 2012Article
- Progression-free Survival Decreases with Each Subsequent Therapy in Patients Presenting for Phase I Clinical Trials.Journal of Cancer · 2012Article
- Second-line chemotherapy with paclitaxel and doxifluridine after failure of S-1 in elderly patients with unresectable advanced or recurrent gastric cancer.Journal of cancer research and clinical oncology · 2011Article
Corrections and comments
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Authors and funding
14 authors at 13 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPreclinical studies have shown that mitomycin C (MMC) acts synergistically with irinotecan (CPT-11). In this phase II study, we evaluated the efficacy and toxicity of MMC/CPT-11 therapy as second-line chemotherapy for patients with fluoropyrimidine-resistant advanced gastric cancer.
methodsEligible patients had evidence of tumor progression despite prior treatment with fluoropyrimidine-based regimens or had relapsed within 6 months after completion of therapy with adjuvant fluoropyrimidines. Treatment consisted of MMC (5 mg/m(2)) and CPT-11 (150 mg/m(2)) administered i.v. every 2 weeks. The primary endpoint was the response rate (RR). Our hypothesis was that this combination therapy was efficacious when the lower boundary of the 95% confidence interval (CI) of the RR exceeded 20% of the threshold RR.
resultsBetween April 2002 and July 2003, 45 eligible patients were registered and analyzed. Among the 45 patients, 40 (89%) had previously received chemotherapy for metastasis and 24 (53%) had a performance status (PS) of 0. Thirteen partial responses were obtained among the 45 patients, resulting in an overall RR of 29% (95% CI, 16-42%). The median time to progression was 4.1 months, and the median survival time was 10 months, with a 1-year survival rate of 36%. Grade 4 neutropenia was observed in 29% of the patients, whereas febrile neutropenia occurred in 9%. The incidence rates of grade 3 nausea and diarrhea were 13 and 2%, respectively.
conclusionsAlthough this study did not achieve the per-protocol definition of activity, the progression-free survival and overall survival appeared to be promising, with acceptable tolerability. Thus, MMC/CPT-11 therapy as second-line chemotherapy for fluoropyrimidine-resistant advanced gastric cancer presents a potential treatment option in patients with a good PS.
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