S-1 and irinotecan plus bevacizumab as second-line chemotherapy for patients with oxaliplatin-refractory metastatic colorectal cancer: a multicenter phase II study in Japan (KSCC1102)

Yuji Miyamoto, Akihito Tsuji, Hiroaki Tanioka, Soichiro Maekawa, Hirofumi Kawanaka, Masaki Kitazono, Eiji Oki, Yasunori Emi, Hidetsugu Murakami, Yutaka Ogata, Hiroshi Saeki, Mototsugu Shimokawa, Shoji Natsugoe, Yoshito Akagi, Hideo Baba, Yoshihiko Maehara

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: Combination chemotherapy with S-1 and irinotecan is one of the standard treatments for metastatic colorectal cancer (mCRC) in Japan. However, there are few alternative practical second-line therapies. We conducted a phase II trial to evaluate the efficacy and safety of the combination of S-1 and irinotecan plus bevacizumab as a second-line treatment for oxaliplatin-refractory mCRC. Methods: Patients with mCRC who were previously treated with oxaliplatin-containing regimens were enrolled. Oral S-1 at a dose of 80 mg/m2 was administered twice daily for 2 weeks, followed by a 1-week drug-free interval. Irinotecan at a dose of 150 mg/m2 and bevacizumab at a dose of 7.5 mg/kg were administered on day 1. The primary endpoint was progression-free survival (PFS). Results: Thirty-seven patients were enrolled, and 34 and 36 patients were assessed for response and safety, respectively. The overall response rate was 20.6 % (95 % confidence interval [CI] 8.7–37.9), and the disease control rate was 76.5 % (95 % CI 58.8–89.3). The median PFS was 5.6 months (95 % CI 3.8–7.0). The median overall survival was 16.4 months (95 % CI 8.1–20.0). The most common grade 3/4 adverse events included neutropenia (25.0 %), anorexia (22.2 %), anemia (16.7 %), and fatigue/malaise (16.7 %). The most common grade 3/4 adverse event of special interest for bevacizumab was hypertension (30.6 %). One treatment-related death caused by gastrointestinal bleeding occurred. Conclusions: The findings suggest that the combination of S-1 and irinotecan plus bevacizumab is effective and tolerable as second-line chemotherapy for patients with oxaliplatin-refractory mCRC.

Original languageEnglish
Pages (from-to)705-712
Number of pages8
JournalInternational Journal of Clinical Oncology
Volume21
Issue number4
DOIs
Publication statusPublished - Aug 1 2016

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irinotecan
oxaliplatin
Colorectal Neoplasms
Japan
Drug Therapy
Disease-Free Survival
Safety
Anorexia
Anniversaries and Special Events
Therapeutics
Combination Drug Therapy
Neutropenia
Fatigue
Anemia
Hemorrhage
Hypertension
Survival
Bevacizumab

All Science Journal Classification (ASJC) codes

  • Surgery
  • Hematology
  • Oncology

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S-1 and irinotecan plus bevacizumab as second-line chemotherapy for patients with oxaliplatin-refractory metastatic colorectal cancer : a multicenter phase II study in Japan (KSCC1102). / Miyamoto, Yuji; Tsuji, Akihito; Tanioka, Hiroaki; Maekawa, Soichiro; Kawanaka, Hirofumi; Kitazono, Masaki; Oki, Eiji; Emi, Yasunori; Murakami, Hidetsugu; Ogata, Yutaka; Saeki, Hiroshi; Shimokawa, Mototsugu; Natsugoe, Shoji; Akagi, Yoshito; Baba, Hideo; Maehara, Yoshihiko.

In: International Journal of Clinical Oncology, Vol. 21, No. 4, 01.08.2016, p. 705-712.

Research output: Contribution to journalArticle

Miyamoto, Y, Tsuji, A, Tanioka, H, Maekawa, S, Kawanaka, H, Kitazono, M, Oki, E, Emi, Y, Murakami, H, Ogata, Y, Saeki, H, Shimokawa, M, Natsugoe, S, Akagi, Y, Baba, H & Maehara, Y 2016, 'S-1 and irinotecan plus bevacizumab as second-line chemotherapy for patients with oxaliplatin-refractory metastatic colorectal cancer: a multicenter phase II study in Japan (KSCC1102)', International Journal of Clinical Oncology, vol. 21, no. 4, pp. 705-712. https://doi.org/10.1007/s10147-015-0943-z
Miyamoto, Yuji ; Tsuji, Akihito ; Tanioka, Hiroaki ; Maekawa, Soichiro ; Kawanaka, Hirofumi ; Kitazono, Masaki ; Oki, Eiji ; Emi, Yasunori ; Murakami, Hidetsugu ; Ogata, Yutaka ; Saeki, Hiroshi ; Shimokawa, Mototsugu ; Natsugoe, Shoji ; Akagi, Yoshito ; Baba, Hideo ; Maehara, Yoshihiko. / S-1 and irinotecan plus bevacizumab as second-line chemotherapy for patients with oxaliplatin-refractory metastatic colorectal cancer : a multicenter phase II study in Japan (KSCC1102). In: International Journal of Clinical Oncology. 2016 ; Vol. 21, No. 4. pp. 705-712.
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abstract = "Background: Combination chemotherapy with S-1 and irinotecan is one of the standard treatments for metastatic colorectal cancer (mCRC) in Japan. However, there are few alternative practical second-line therapies. We conducted a phase II trial to evaluate the efficacy and safety of the combination of S-1 and irinotecan plus bevacizumab as a second-line treatment for oxaliplatin-refractory mCRC. Methods: Patients with mCRC who were previously treated with oxaliplatin-containing regimens were enrolled. Oral S-1 at a dose of 80 mg/m2 was administered twice daily for 2 weeks, followed by a 1-week drug-free interval. Irinotecan at a dose of 150 mg/m2 and bevacizumab at a dose of 7.5 mg/kg were administered on day 1. The primary endpoint was progression-free survival (PFS). Results: Thirty-seven patients were enrolled, and 34 and 36 patients were assessed for response and safety, respectively. The overall response rate was 20.6 {\%} (95 {\%} confidence interval [CI] 8.7–37.9), and the disease control rate was 76.5 {\%} (95 {\%} CI 58.8–89.3). The median PFS was 5.6 months (95 {\%} CI 3.8–7.0). The median overall survival was 16.4 months (95 {\%} CI 8.1–20.0). The most common grade 3/4 adverse events included neutropenia (25.0 {\%}), anorexia (22.2 {\%}), anemia (16.7 {\%}), and fatigue/malaise (16.7 {\%}). The most common grade 3/4 adverse event of special interest for bevacizumab was hypertension (30.6 {\%}). One treatment-related death caused by gastrointestinal bleeding occurred. Conclusions: The findings suggest that the combination of S-1 and irinotecan plus bevacizumab is effective and tolerable as second-line chemotherapy for patients with oxaliplatin-refractory mCRC.",
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T1 - S-1 and irinotecan plus bevacizumab as second-line chemotherapy for patients with oxaliplatin-refractory metastatic colorectal cancer

T2 - a multicenter phase II study in Japan (KSCC1102)

AU - Miyamoto, Yuji

AU - Tsuji, Akihito

AU - Tanioka, Hiroaki

AU - Maekawa, Soichiro

AU - Kawanaka, Hirofumi

AU - Kitazono, Masaki

AU - Oki, Eiji

AU - Emi, Yasunori

AU - Murakami, Hidetsugu

AU - Ogata, Yutaka

AU - Saeki, Hiroshi

AU - Shimokawa, Mototsugu

AU - Natsugoe, Shoji

AU - Akagi, Yoshito

AU - Baba, Hideo

AU - Maehara, Yoshihiko

PY - 2016/8/1

Y1 - 2016/8/1

N2 - Background: Combination chemotherapy with S-1 and irinotecan is one of the standard treatments for metastatic colorectal cancer (mCRC) in Japan. However, there are few alternative practical second-line therapies. We conducted a phase II trial to evaluate the efficacy and safety of the combination of S-1 and irinotecan plus bevacizumab as a second-line treatment for oxaliplatin-refractory mCRC. Methods: Patients with mCRC who were previously treated with oxaliplatin-containing regimens were enrolled. Oral S-1 at a dose of 80 mg/m2 was administered twice daily for 2 weeks, followed by a 1-week drug-free interval. Irinotecan at a dose of 150 mg/m2 and bevacizumab at a dose of 7.5 mg/kg were administered on day 1. The primary endpoint was progression-free survival (PFS). Results: Thirty-seven patients were enrolled, and 34 and 36 patients were assessed for response and safety, respectively. The overall response rate was 20.6 % (95 % confidence interval [CI] 8.7–37.9), and the disease control rate was 76.5 % (95 % CI 58.8–89.3). The median PFS was 5.6 months (95 % CI 3.8–7.0). The median overall survival was 16.4 months (95 % CI 8.1–20.0). The most common grade 3/4 adverse events included neutropenia (25.0 %), anorexia (22.2 %), anemia (16.7 %), and fatigue/malaise (16.7 %). The most common grade 3/4 adverse event of special interest for bevacizumab was hypertension (30.6 %). One treatment-related death caused by gastrointestinal bleeding occurred. Conclusions: The findings suggest that the combination of S-1 and irinotecan plus bevacizumab is effective and tolerable as second-line chemotherapy for patients with oxaliplatin-refractory mCRC.

AB - Background: Combination chemotherapy with S-1 and irinotecan is one of the standard treatments for metastatic colorectal cancer (mCRC) in Japan. However, there are few alternative practical second-line therapies. We conducted a phase II trial to evaluate the efficacy and safety of the combination of S-1 and irinotecan plus bevacizumab as a second-line treatment for oxaliplatin-refractory mCRC. Methods: Patients with mCRC who were previously treated with oxaliplatin-containing regimens were enrolled. Oral S-1 at a dose of 80 mg/m2 was administered twice daily for 2 weeks, followed by a 1-week drug-free interval. Irinotecan at a dose of 150 mg/m2 and bevacizumab at a dose of 7.5 mg/kg were administered on day 1. The primary endpoint was progression-free survival (PFS). Results: Thirty-seven patients were enrolled, and 34 and 36 patients were assessed for response and safety, respectively. The overall response rate was 20.6 % (95 % confidence interval [CI] 8.7–37.9), and the disease control rate was 76.5 % (95 % CI 58.8–89.3). The median PFS was 5.6 months (95 % CI 3.8–7.0). The median overall survival was 16.4 months (95 % CI 8.1–20.0). The most common grade 3/4 adverse events included neutropenia (25.0 %), anorexia (22.2 %), anemia (16.7 %), and fatigue/malaise (16.7 %). The most common grade 3/4 adverse event of special interest for bevacizumab was hypertension (30.6 %). One treatment-related death caused by gastrointestinal bleeding occurred. Conclusions: The findings suggest that the combination of S-1 and irinotecan plus bevacizumab is effective and tolerable as second-line chemotherapy for patients with oxaliplatin-refractory mCRC.

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