A Phase II Study of Combined Chemotherapy with 5-Week Cycles of S-1 and CPT-11 plus Bevacizumab in Patients with Metastatic Colon Cancer

Mizushima, Tsunekazu; Ide, Yoshito; Murata, Kohei; Ohashi, Ichiro; Yasumasa, Keigo; Fukunaga, Masao; Takemoto, Hiroyuki; Hasegawa, Junichi; Hata, Taishi; Takemasa, Ichiro; Ikeda, Masataka; Yamamoto, Hirofumi; Sekimoto, Mitsugu; Nezu, Riichiro; Doki, Yuichiro; Mori, Masaki

doi:10.1159/000356018

Cited by 8 publications

(7 citation statements)

References 34 publications

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“…In our study, the administered dose of irinotecan was lower. However, recent studies have reported good outcomes with oral S-1 and irinotecan plus bevacizumab, used instead of FOLFIRI plus bevacizumab, in patients with MCRC who had not previously received chemotherapy [30,31,32]. The effectiveness of combination chemotherapy with S-1, irinotecan, and bevacizumab in our study was consistent with the findings of previous studies.…”

Section: Discussionsupporting

confidence: 91%

“…In previous studies, irinotecan was administered in the following doses: 100 mg/m 2 biweekly by Komatsu et al [30], 80 mg/m 2 biweekly by Mizushima et al [32], and 150 mg/m 2 triweekly by Yamada et al [31]. In all of these studies, irinotecan was given as a 90-min infusion.…”

Section: Discussionmentioning

confidence: 99%

“…Combination chemotherapy with irinotecan, S-1, and bevacizumab has been reported to have a high response rate and good progression-free survival (PFS) in previously untreated patients with advanced colorectal cancer [30,31,32]. We now report the results of a phase II study of combined chemotherapy with oral S-1, irinotecan, given biweekly as a 24-hour continuous infusion, and bevacizumab in patients with previously treated or previously untreated MCRC.…”

Section: Introductionmentioning

confidence: 99%

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A Phase II Trial of Combined Chemotherapy with Oral S-1 and 24-Hour Infusions of Irinotecan plus Bevacizumab in Patients with Metastatic Colorectal Cancer

et al. 2015

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Objectives: Protracted low-dose infusion of irinotecan has been suggested to enhance antitumor activity. A phase II study was conducted to evaluate the safety and efficacy of oral S-1 combined with 24-hour infusion of irinotecan and intravenous bevacizumab for metastatic colorectal cancer (MCRC). Methods: The subjects were 79 patients with MCRC; 57 were chemotherapy naïve. Irinotecan (125 mg/m²) was administered as a 24-hour infusion on days 1 and 15, S-1 (80 mg/m²) was administered orally on days 1-14, and bevacizumab (5.0 mg/kg) was given on days 1 and 15. The treatment was repeated every 4 weeks. Results: Median follow-up was 20.0 months, and the mean number of cycles was 7. The overall response rate was 79.7% (95% CI, 69.2-88.0), 86.0% (95% CI, 74.2-93.7) for first-line and 63.6% (95% CI, 40.7-82.8) for second-line treatment. The median progression-free survival was 16.4 months (95% CI, 13.9-21.0) for first-line and 9.4 months (95% CI, 4.9-16.5) for second-line treatment. The median overall survival was not reached. Grade 3-4 toxicities were neutropenia (43%), leukopenia (20.3%), anorexia (19.0%), and diarrhea (10.1%). Toxicity was tolerable. Conclusions: Combination chemotherapy with oral S-1 and biweekly 24-hour infusions of irinotecan plus bevacizumab appears to be highly active and well tolerated both as first-line and second-line chemotherapy for MCRC.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A Phase II Trial of Combined Chemotherapy with Oral S-1 and 24-Hour Infusions of Irinotecan plus Bevacizumab in Patients with Metastatic Colorectal Cancer

et al. 2015

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“…Via steps of screening the title and reading the abstract, 6 studies were identified (Van den Brande et al, 2003;Kim et al, 2009;Yokoyama et al, 2009;Zang et al, 2009;Mizushima et al, 2013;Zhu et al, 2011). These studies had been carried out in China, Japan, Korea and Belgium.…”

Section: Resultsmentioning

confidence: 99%

A Systemic Analysis of S-1 Regimens for Treatment of Patients with Colon Cancer

Zhang

Cao²,

Cheng³

et al. 2014

Asian Pacific Journal of Cancer Prevention

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Background: Fluorouracil-based regimens have been widely accepted and recommended in the guidelines for treating patients with early or advanced staged colon cancer, although results are controversial. Here we performed a systemic analysis to evaluate the impact of S-1 based regimens on response and survival of patients with colon cancer. Methods: Clinical studies evaluating the impact of S-1 based regimens on response and survival of patients with colon cancer were identified using a predefined search strategy. Summary response rates (RRs) to treatment were calculated. Results: Six clinical studies which including 227 patients with advanced colorectal cancer were considered eligible for inclusion. Two studies were conducted using combination of S-1 and Oxaliplatin, and four studies featured S-1 and irinotecan. Systemic analysis showed that, in all patients, pooled RRs was 43.17%. Major adverse effects were hematological toxicities, gastrointestinal disturbance, neurosensory toxicity. No treatment related death occurred. Conclusion: This systemic analysis suggests that S-1 based regimens, both with oxaliplatin or irinotean are associated with acceptable response and toxicity in patients with colon cancer.

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“…CDHP enhances the serum concentration of 5-FU by the inhibiting of dihydropyrimidine dehydrogenase (DPD) 1) , and potassium oxonate inhibits damage of gastrointestinal mucosa 2) . S-1 is reported to be effective for the treatment of various cancers including gastric 3) , pancreas 4) , and colorectal 5) cancers. S-1 is the first drug that improved overall survival in patients with stage II -III gastric cancer as adjuvant therapy 3) .…”

Section: Introductionmentioning

confidence: 99%

S-1-associated hand-foot syndrome as a prognostic factor in patients with metastatic breast cancer

Hirano

Hattori

Inoue

et al. 2015

Ann. Cancer Res. Therap.

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Purpose: S-1, an orally administered fluorinated pyrimidine (FP), is reported to be effective for the treatment of metastatic breast cancer (MBC). Although capecitabine, another oral FP, is widely accepted as the third-line chemotherapy for MBC, many patients treated with capecitabine suffer from hand-foot syndrome (HFS). HFS also affects survival in patients with metastatic colorectal and breast cancer. We retrospectively evaluated the potential association of HFS and survival in patients with MBC receiving S-1. Methods: Forty-four patients with MBC treated with S-1 between 2005 and 2012 were analyzed. S-1 was administered at a standard dose of 50 mg/body twice daily for 4 weeks, followed by a 2-week interval. Partly, the drug was administered for 2 weeks, followed by a one-week interval. Trastuzumab (2 mg/kg/week) was added to the regimen for HER2-positive patients. Results:The median follow-up period was 25.8 months and 12 patients (27.3%) developed HFS. Grade (G) 1 HFS was observed in 9 patients (20.5%) and G2 in 3 patients (6.8%). No G3/4 HFS was observed. Baseline demographic characteristics were comparable between the HFS and non-HFS patient groups. The HFS group showed a superior response rate (50.0% vs. 9.4%; P=0.0046), and improved median PFS (9.8 vs. 4.7 months; log-rank P=0.0446) and OS (51.5 vs. 17.5 months; logrank P=0.0196). In multivariate analysis, HFS is the only and independent prognostic factor (HR 2.93; 95% CI, 1.12 to 9.27; P=0.0269) of OS. Conclusion: HFS observed in patients with S-1 not only correlates with an antitumor effect, but is also an independent prognostic factor.

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A Phase II Study of Combined Chemotherapy with 5-Week Cycles of S-1 and CPT-11 plus Bevacizumab in Patients with Metastatic Colon Cancer

Cited by 8 publications

References 34 publications

A Phase II Trial of Combined Chemotherapy with Oral S-1 and 24-Hour Infusions of Irinotecan plus Bevacizumab in Patients with Metastatic Colorectal Cancer

A Phase II Trial of Combined Chemotherapy with Oral S-1 and 24-Hour Infusions of Irinotecan plus Bevacizumab in Patients with Metastatic Colorectal Cancer

A Systemic Analysis of S-1 Regimens for Treatment of Patients with Colon Cancer

S-1-associated hand-foot syndrome as a prognostic factor in patients with metastatic breast cancer

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