A phase I trial of S-1 with concurrent radiotherapy in patients with locally recurrent rectal cancer

Wada, Hitoshi; Nemoto, Kenji; Nomiya, Takuma; Murakami, M.; Suzuki, Motohisa; Kuroda, Y; Ichikawa, Mayumi; Ota, Ibuki; Hagiwara, Yasuhito; Ariga, Hiroyoshi; Takeda, Ken; Takai, Kenji; Fujimoto, Keisuke; Kenjo, Masahiro; Ogawa, Kazuhiko

doi:10.1007/s10147-012-0375-y

Cited by 7 publications

(3 citation statements)

References 26 publications

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“…the radiotherapy regimen included s-1 (taiho Pharmaceutical Co, tokyo, Japan) as a radiosensitizer from day 1 to day 10, with an s-1 dose of 60 mg/m 2 /day; s-1 has been shown to be a radiosensitizer. [13][14][15][16] the detailed protocol for the radiotherapy regimen applied in this study has been described previously. 17 the target interval between the completion of radiotherapy and surgery was 4 weeks.…”

Section: Short-course Chemoradiotherapy With Delayed Surgerymentioning

confidence: 99%

Feasibility of Modified Short-Course Radiotherapy Combined With a Chemoradiosensitizer for T3 Rectal Cancer

Beppu

Matsubara

Kakuno

et al. 2015

Diseases of the Colon &Amp; Rectum

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Section: Short-course Chemoradiotherapy With Delayed Surgerymentioning

confidence: 99%

Feasibility of Modified Short-Course Radiotherapy Combined With a Chemoradiosensitizer for T3 Rectal Cancer

Beppu

Matsubara

Kakuno

et al. 2015

Diseases of the Colon &Amp; Rectum

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“…DLTs included grade 3 anorexia, nausea, fatigue and leucopenia. S-1-based chemoradiotherapy has been proven to be safe and effective in some malignancies, and the recommended dose of S-1 is usually 60-80 mg/m 2 daily based on several phase I studies [21][22][23][24]. In this dose-escalation study, the MTD of S-1 was determined to be 70 mg/m 2 daily.…”

Section: Discussionmentioning

confidence: 99%

Phase I study of postoperative radiotherapy concurrent with S-1 in patients with gastric cancer

Meng

Peng

et al. 2015

Med Oncol

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Postoperative chemoradiotherapy (CRT) with concurrent 5-fluorouracil is the standard care for gastric cancer patients after curative surgery. The previous studies revealed that the subgroup of patients with high recurrence risk would benefit most from adjuvant CRT. S-1, a novel oral fluorouracil, has showed very effective in metastatic gastric cancer and became the standard option for gastric cancer with D2 dissection. The safety and dosage of S-1 combined with postoperative radiotherapy have not yet been evaluated. This study is to determine the maximum tolerate dose (MTD) and dose-limiting toxicity (DLT) of S-1 given concurrently with postoperative high-dose radiotherapy in gastric cancer. Patients with more advanced stage (pT4 and/or pN+) after R0 resection were recruited. Eligible patients received one cycle standard SOX (S-1 plus oxaliplatin) chemotherapy, then S-1 monotherapy with concurrent radiotherapy for 6 weeks, followed by additional three cycles of SOX. During the concurrent CRT, S-1 was administered on every radiotherapy treatment day according to a predefined dose-escalation schedule. Radiotherapy (3D-RT or IMRT) was given to a total dose of 50.4 Gy in 28 fractions. DLT was defined as grade 3 or 4 hematologic and non-hematologic toxicity. From March 2011 to October 2012, 21 patients were enrolled at five dose levels: 40 (n = 3), 50 (n = 3), 60 (n = 6), 70 (n = 6) and 80 mg/m(2)/day (n = 3). D2-dissection was performed in 18 patients (85.7 %) and 15 patients (71.4 %) had stage III disease. The most common dose-related toxicity was anorexia, nausea and vomiting, fatigue and leucopenia. DLT was occurred in one patient at 60 mg/m(2)/day (grade 3 fatigue), one patient at 70 mg/m(2)/day (grade 3 vomiting and anorexia), two patients at 80 mg/m(2)/day (one with grade 3 vomiting and anorexia; another with grade 3 febrile leucopenia). Four patients did not complete CRT as planned. Overall, this phase I study demonstrated that postoperative CRT with daily S-1 was feasible in gastric cancer and the MTD of S-1 concurrent with radiotherapy was 70 mg/m(2)/day. This S-1-based postoperative CRT will be investigated in a multicenter phase III study in West China.

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“…Several clinical studies have demonstrated that NA-CRT combined with S-1 is associated with mild toxicity and exhibits an efficacy equivalent to that of other CRT regimens used for RC (8)(9)(10)(11)(12). Clinical studies of irinotecan (CPT-11) plus S-1 combination therapy have been reported to produce non-inferiority outcomes for metastatic colorectal cancer.…”

Section: Introductionmentioning

confidence: 99%

2035 Diffusion-weighted magnetic resonance imaging for the prediction of the tumor response to neoadjuvant chemoradiotherapy using irinotecan plus S-1 for rectal cancer

Doi¹,

Beppu²,

Kato³

et al. 2015

European Journal of Cancer

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A phase I trial of S-1 with concurrent radiotherapy in patients with locally recurrent rectal cancer

Abstract: This phase I trial of S-1 chemotherapy with pelvic radiotherapy for locally recurrent rectal cancer revealed that the MTD for S-1 was 70 mg/m(2)/day and the RD was 60 mg/m(2)/day.

Cited by 7 publications

References 26 publications

Feasibility of Modified Short-Course Radiotherapy Combined With a Chemoradiosensitizer for T3 Rectal Cancer

Feasibility of Modified Short-Course Radiotherapy Combined With a Chemoradiosensitizer for T3 Rectal Cancer

Phase I study of postoperative radiotherapy concurrent with S-1 in patients with gastric cancer

2035 Diffusion-weighted magnetic resonance imaging for the prediction of the tumor response to neoadjuvant chemoradiotherapy using irinotecan plus S-1 for rectal cancer

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