Multicenter phase II study of biweekly CAPIRI plus bevacizumab as second-line therapy in patients with metastatic colorectal cancer (JSWOG-C3 study)

Nobuaki Suzuki, Shoichi Hazama, Takeshi Nagasaka, Hiroaki Tanioka, Yasuo Iwamoto, Yuji Negoro, Masami Yamauchi, Michiya Kobayashi, Hiroshi Okuda, Noriaki Fujishima, Taku Nishimura, Naoki Yamanaka, Kazuhiro Toyota, Yoshiko Mori, Yuki Nakagami, Mototsugu Shimokawa, Hiroaki Nagano, Masazumi Okajima

Research output: Contribution to journalArticle

Abstract

Background: Triweekly capecitabine plus irinotecan (CAPIRI) was not a replacement for fluorouracil, leucovorin, and irinotecan (FOLFIRI) in the treatment of metastatic colorectal cancer (mCRC) because of the potential for greater toxicity. Recently, it has reported that mCAPIRI is well tolerated and non-inferior to FOLFIRI. In this study, we conducted a multicenter phase II trial to assess the efficacy and safety of biweekly CAPIRI plus bevacizumab as second-line chemotherapy for mCRC with reduced toxicity and preserved efficacy. Methods: Patients with mCRC who had received prior chemotherapy, including oxaliplatin-based regimens, were eligible for this study. The treatment protocol administered capecitabine at 1000 mg/m2 twice daily from the evening of day 1 to the morning of day 8, intravenous irinotecan at 150 mg/m2 on day 1, and bevacizumab at 10 mg/kg on day 1 every 2 weeks. Primary endpoints for this study were progression-free survival (PFS) and safety. Secondary endpoints were overall survival (OS), time to treatment failure, response rate (RR), and disease control rate (DCR). Results: Fifty-one patients were enrolled in this study. Median PFS was 5.5 months [95% confidence interval (CI) 4.23–7.40 months], and median OS was 13.5 months (95% CI 11.57–20.23 months). The RR was 14.6% (95% CI 6.5–28.4%), and the DCR was 66.7% (95% CI 51.5–79.2%). Hypertension was the most common Grade 3 adverse event (27.5%), followed by neutropenia (17.6%). Only two patients suffered from grade 3 hand–foot syndrome. Conclusions: In mCRC patients, biweekly CAPIRI + bevacizumab appears effective and feasible as a second-line chemotherapy with relatively low toxicities, and has potential as a useful substitute for FOLFIRI + bevacizumab.

Original languageEnglish
JournalInternational Journal of Clinical Oncology
DOIs
Publication statusPublished - Jan 1 2019

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irinotecan
Colorectal Neoplasms
Confidence Intervals
oxaliplatin
Drug Therapy
Disease-Free Survival
Therapeutics
Safety
Survival
Leucovorin
Clinical Protocols
Neutropenia
Treatment Failure
Fluorouracil
Capecitabine
Bevacizumab
Hypertension

Keywords

  • Bevacizumab
  • Biweekly
  • CAPIRI
  • mCRC
  • Second line

ASJC Scopus subject areas

  • Surgery
  • Hematology
  • Oncology

Cite this

Multicenter phase II study of biweekly CAPIRI plus bevacizumab as second-line therapy in patients with metastatic colorectal cancer (JSWOG-C3 study). / Suzuki, Nobuaki; Hazama, Shoichi; Nagasaka, Takeshi; Tanioka, Hiroaki; Iwamoto, Yasuo; Negoro, Yuji; Yamauchi, Masami; Kobayashi, Michiya; Okuda, Hiroshi; Fujishima, Noriaki; Nishimura, Taku; Yamanaka, Naoki; Toyota, Kazuhiro; Mori, Yoshiko; Nakagami, Yuki; Shimokawa, Mototsugu; Nagano, Hiroaki; Okajima, Masazumi.

In: International Journal of Clinical Oncology, 01.01.2019.

Research output: Contribution to journalArticle

Suzuki, N, Hazama, S, Nagasaka, T, Tanioka, H, Iwamoto, Y, Negoro, Y, Yamauchi, M, Kobayashi, M, Okuda, H, Fujishima, N, Nishimura, T, Yamanaka, N, Toyota, K, Mori, Y, Nakagami, Y, Shimokawa, M, Nagano, H & Okajima, M 2019, 'Multicenter phase II study of biweekly CAPIRI plus bevacizumab as second-line therapy in patients with metastatic colorectal cancer (JSWOG-C3 study)', International Journal of Clinical Oncology. https://doi.org/10.1007/s10147-019-01473-3
Suzuki, Nobuaki ; Hazama, Shoichi ; Nagasaka, Takeshi ; Tanioka, Hiroaki ; Iwamoto, Yasuo ; Negoro, Yuji ; Yamauchi, Masami ; Kobayashi, Michiya ; Okuda, Hiroshi ; Fujishima, Noriaki ; Nishimura, Taku ; Yamanaka, Naoki ; Toyota, Kazuhiro ; Mori, Yoshiko ; Nakagami, Yuki ; Shimokawa, Mototsugu ; Nagano, Hiroaki ; Okajima, Masazumi. / Multicenter phase II study of biweekly CAPIRI plus bevacizumab as second-line therapy in patients with metastatic colorectal cancer (JSWOG-C3 study). In: International Journal of Clinical Oncology. 2019.
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abstract = "Background: Triweekly capecitabine plus irinotecan (CAPIRI) was not a replacement for fluorouracil, leucovorin, and irinotecan (FOLFIRI) in the treatment of metastatic colorectal cancer (mCRC) because of the potential for greater toxicity. Recently, it has reported that mCAPIRI is well tolerated and non-inferior to FOLFIRI. In this study, we conducted a multicenter phase II trial to assess the efficacy and safety of biweekly CAPIRI plus bevacizumab as second-line chemotherapy for mCRC with reduced toxicity and preserved efficacy. Methods: Patients with mCRC who had received prior chemotherapy, including oxaliplatin-based regimens, were eligible for this study. The treatment protocol administered capecitabine at 1000 mg/m2 twice daily from the evening of day 1 to the morning of day 8, intravenous irinotecan at 150 mg/m2 on day 1, and bevacizumab at 10 mg/kg on day 1 every 2 weeks. Primary endpoints for this study were progression-free survival (PFS) and safety. Secondary endpoints were overall survival (OS), time to treatment failure, response rate (RR), and disease control rate (DCR). Results: Fifty-one patients were enrolled in this study. Median PFS was 5.5 months [95{\%} confidence interval (CI) 4.23–7.40 months], and median OS was 13.5 months (95{\%} CI 11.57–20.23 months). The RR was 14.6{\%} (95{\%} CI 6.5–28.4{\%}), and the DCR was 66.7{\%} (95{\%} CI 51.5–79.2{\%}). Hypertension was the most common Grade 3 adverse event (27.5{\%}), followed by neutropenia (17.6{\%}). Only two patients suffered from grade 3 hand–foot syndrome. Conclusions: In mCRC patients, biweekly CAPIRI + bevacizumab appears effective and feasible as a second-line chemotherapy with relatively low toxicities, and has potential as a useful substitute for FOLFIRI + bevacizumab.",
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T1 - Multicenter phase II study of biweekly CAPIRI plus bevacizumab as second-line therapy in patients with metastatic colorectal cancer (JSWOG-C3 study)

AU - Suzuki, Nobuaki

AU - Hazama, Shoichi

AU - Nagasaka, Takeshi

AU - Tanioka, Hiroaki

AU - Iwamoto, Yasuo

AU - Negoro, Yuji

AU - Yamauchi, Masami

AU - Kobayashi, Michiya

AU - Okuda, Hiroshi

AU - Fujishima, Noriaki

AU - Nishimura, Taku

AU - Yamanaka, Naoki

AU - Toyota, Kazuhiro

AU - Mori, Yoshiko

AU - Nakagami, Yuki

AU - Shimokawa, Mototsugu

AU - Nagano, Hiroaki

AU - Okajima, Masazumi

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: Triweekly capecitabine plus irinotecan (CAPIRI) was not a replacement for fluorouracil, leucovorin, and irinotecan (FOLFIRI) in the treatment of metastatic colorectal cancer (mCRC) because of the potential for greater toxicity. Recently, it has reported that mCAPIRI is well tolerated and non-inferior to FOLFIRI. In this study, we conducted a multicenter phase II trial to assess the efficacy and safety of biweekly CAPIRI plus bevacizumab as second-line chemotherapy for mCRC with reduced toxicity and preserved efficacy. Methods: Patients with mCRC who had received prior chemotherapy, including oxaliplatin-based regimens, were eligible for this study. The treatment protocol administered capecitabine at 1000 mg/m2 twice daily from the evening of day 1 to the morning of day 8, intravenous irinotecan at 150 mg/m2 on day 1, and bevacizumab at 10 mg/kg on day 1 every 2 weeks. Primary endpoints for this study were progression-free survival (PFS) and safety. Secondary endpoints were overall survival (OS), time to treatment failure, response rate (RR), and disease control rate (DCR). Results: Fifty-one patients were enrolled in this study. Median PFS was 5.5 months [95% confidence interval (CI) 4.23–7.40 months], and median OS was 13.5 months (95% CI 11.57–20.23 months). The RR was 14.6% (95% CI 6.5–28.4%), and the DCR was 66.7% (95% CI 51.5–79.2%). Hypertension was the most common Grade 3 adverse event (27.5%), followed by neutropenia (17.6%). Only two patients suffered from grade 3 hand–foot syndrome. Conclusions: In mCRC patients, biweekly CAPIRI + bevacizumab appears effective and feasible as a second-line chemotherapy with relatively low toxicities, and has potential as a useful substitute for FOLFIRI + bevacizumab.

AB - Background: Triweekly capecitabine plus irinotecan (CAPIRI) was not a replacement for fluorouracil, leucovorin, and irinotecan (FOLFIRI) in the treatment of metastatic colorectal cancer (mCRC) because of the potential for greater toxicity. Recently, it has reported that mCAPIRI is well tolerated and non-inferior to FOLFIRI. In this study, we conducted a multicenter phase II trial to assess the efficacy and safety of biweekly CAPIRI plus bevacizumab as second-line chemotherapy for mCRC with reduced toxicity and preserved efficacy. Methods: Patients with mCRC who had received prior chemotherapy, including oxaliplatin-based regimens, were eligible for this study. The treatment protocol administered capecitabine at 1000 mg/m2 twice daily from the evening of day 1 to the morning of day 8, intravenous irinotecan at 150 mg/m2 on day 1, and bevacizumab at 10 mg/kg on day 1 every 2 weeks. Primary endpoints for this study were progression-free survival (PFS) and safety. Secondary endpoints were overall survival (OS), time to treatment failure, response rate (RR), and disease control rate (DCR). Results: Fifty-one patients were enrolled in this study. Median PFS was 5.5 months [95% confidence interval (CI) 4.23–7.40 months], and median OS was 13.5 months (95% CI 11.57–20.23 months). The RR was 14.6% (95% CI 6.5–28.4%), and the DCR was 66.7% (95% CI 51.5–79.2%). Hypertension was the most common Grade 3 adverse event (27.5%), followed by neutropenia (17.6%). Only two patients suffered from grade 3 hand–foot syndrome. Conclusions: In mCRC patients, biweekly CAPIRI + bevacizumab appears effective and feasible as a second-line chemotherapy with relatively low toxicities, and has potential as a useful substitute for FOLFIRI + bevacizumab.

KW - Bevacizumab

KW - Biweekly

KW - CAPIRI

KW - mCRC

KW - Second line

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