TY - JOUR
T1 - A prospective study of XELOX plus bevacizumab as first-line therapy in Japanese patients with metastatic colorectal cancer (KSCC 0902)
AU - Ogata, Yutaka
AU - Shimokawa, Mototsugu
AU - Tanaka, Takaho
AU - Emi, Yasunori
AU - Oki, Eiji
AU - Saeki, Hiroshi
AU - Sadanaga, Noriaki
AU - Kusumoto, Tetsuya
AU - Touyama, Tetsuo
AU - Kimura, Masami
AU - Baba, Hideo
AU - Akagi, Yoshito
AU - Shirouzu, Kazuo
AU - Maehara, Yoshihiko
N1 - Funding Information:
No disclosures—EO, MS, TTa, HS, NS, TK, TTo, MK and KS; college course financially maintained by private donations that Chugai Pharmaceutical Co., Ltd and Yakult Honsha Co. provide—YM; acceptance such as the researchers from Chugai Pharmaceutical Co., Ltd—YM; grant research funding from Chugai Pharmaceutical Co., Ltd.—HB, YO and YM; grant research funding from Yakult Honsha Co., Ltd.—HB and YM; lecturer’s fee from Chugai Pharmaceutical Co., Ltd.—YE, HB and YM; lecturer’s fee from Yakult Honsha Co., Ltd.—HB and YM.
Publisher Copyright:
© 2015, The Author(s).
PY - 2016/4/1
Y1 - 2016/4/1
N2 - Background: This study was designed to evaluate the efficacy and safety of XELOX plus bevacizumab in a Japanese metastatic colorectal cancer population that included elderly patients. Methods: This was a multicenter, single-arm, open-label prospective study. The major inclusion criteria were previously untreated metastatic colorectal cancer, presence of measurable lesions, age ≥20 years; Eastern Cooperative Oncology Group performance status of 0–2, and adequate organ function. Patients received bevacizumab (7.5 mg/kg on day 1) and XELOX (130 mg/m2 oxaliplatin on day 1 plus 1,000 mg/m2 capecitabine b.i.d. on days 1–14) every 3 weeks. The primary endpoint was confirmed objective response rate. Results: The study included 47 patients (male/female 30/17; median age 69 years; age range 38–81 years with 10 patients ≥75 years; PS 0/1/2, 40/5/2) enrolled between May 2010 and March 2011. Responses were assessed in 46 eligible patients. The objective response rate was 52.2 % (95 % confidence interval [CI] 37.0–67.1). The median progression-free survival and overall survival were 10.0 months (95 % CI 7.8–12.3) and 34.6 months (95 % CI 19.9–not estimable), respectively. Frequently encountered grade 3 and 4 adverse events in this study were aspartate aminotransferase elevation (23.4 %), alanine aminotransferase elevation (21.3 %), anorexia (12.8 %), neutropenia (10.6 %), fatigue (8.5 %) and anemia (6.4 %). Grade 3 or 4 peripheral neuropathy was not observed. Conclusion: First-line treatment with XELOX plus bevacizumab showed a promising response rate and an acceptable tolerability profile in the clinical practice of Japanese metastatic colorectal cancer patients that included elderly patients. Registry: UMIN-CTR, ID number: UMIN000003915, URL:https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000004706&language=E
AB - Background: This study was designed to evaluate the efficacy and safety of XELOX plus bevacizumab in a Japanese metastatic colorectal cancer population that included elderly patients. Methods: This was a multicenter, single-arm, open-label prospective study. The major inclusion criteria were previously untreated metastatic colorectal cancer, presence of measurable lesions, age ≥20 years; Eastern Cooperative Oncology Group performance status of 0–2, and adequate organ function. Patients received bevacizumab (7.5 mg/kg on day 1) and XELOX (130 mg/m2 oxaliplatin on day 1 plus 1,000 mg/m2 capecitabine b.i.d. on days 1–14) every 3 weeks. The primary endpoint was confirmed objective response rate. Results: The study included 47 patients (male/female 30/17; median age 69 years; age range 38–81 years with 10 patients ≥75 years; PS 0/1/2, 40/5/2) enrolled between May 2010 and March 2011. Responses were assessed in 46 eligible patients. The objective response rate was 52.2 % (95 % confidence interval [CI] 37.0–67.1). The median progression-free survival and overall survival were 10.0 months (95 % CI 7.8–12.3) and 34.6 months (95 % CI 19.9–not estimable), respectively. Frequently encountered grade 3 and 4 adverse events in this study were aspartate aminotransferase elevation (23.4 %), alanine aminotransferase elevation (21.3 %), anorexia (12.8 %), neutropenia (10.6 %), fatigue (8.5 %) and anemia (6.4 %). Grade 3 or 4 peripheral neuropathy was not observed. Conclusion: First-line treatment with XELOX plus bevacizumab showed a promising response rate and an acceptable tolerability profile in the clinical practice of Japanese metastatic colorectal cancer patients that included elderly patients. Registry: UMIN-CTR, ID number: UMIN000003915, URL:https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000004706&language=E
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U2 - 10.1007/s10147-015-0895-3
DO - 10.1007/s10147-015-0895-3
M3 - Article
C2 - 26338269
AN - SCOPUS:84940705229
SN - 1341-9625
VL - 21
SP - 335
EP - 343
JO - International Journal of Clinical Oncology
JF - International Journal of Clinical Oncology
IS - 2
ER -
