A Phase II Study of Dose-reductive XELOX Plus Bevacizumab in Elderly or Vulnerable Patients With Metastatic Colorectal Cancer (MCSGO-1202).

Abstract

BACKGROUND/AIM:

This phase II study (MCSGO-1202) aimed to evaluate the initial dose reduction of oxaliplatin in XELOX plus bevacizumab therapy.

PATIENTS AND METHODS:

This was a phase II, multicenter, open-label, single-arm, prospective, study conducted at 14 Japanese institutions. The study included patients with metastatic colorectal cancer (mCRC) with performance status (PS) of 1 or 2 who had not undergone chemotherapy. Patients received oxaliplatin (100 mg/m2) plus bevacizumab (7.5 mg/kg) on day 1 and capecitabine (2,000 mg/m2/day) on days 1-14 of a 21-day cycle. The primary endpoint was the objective response rate. The secondary endpoints were progression-free and overall survival, 1-year survival rate, disease control rate, dose intensity, and adverse events.

RESULTS:

Between April 2012 and March 2016, 56 patients were enrolled. The median age was 71 years (range=44-85 years), and the majority (90.6%) had a PS of 1. A complete response was observed in three patients (5.7%), partial response in 24 (45.3%), stable disease in 22 (43.4%), and progressive disease in one (1.9%). The median progression-free survival and overall survival were 11.4 and 26.5 months, respectively. The most common grade 3-4 adverse events were leucopenia (15.1%), neutropenia (9.4%), neuropathy (9.4%).

CONCLUSION:

The dose-reduction strategy of oxaliplatin was effective for elderly or vulnerable patients with mCRC.

• Authors: Aya Kato, Norikatsu Miyoshi, Toru Ohtsuru, Daisuke Sakai, Junichi Hasegawa, Ken Nakata, Mitsunobu Imasato, Takeshi Kato, Masakazu Ikenaga, Toshihiro Kudo, Mitsuyoshi Tei, Yoshinori Kagawa, Mamoru Uemura, Hidekazu Takahashi, Taroh Satoh, Masaki Mori, Tsunekazu Mizushima, Hirofumi Yamamoto, Kohei Murata, Yuichiro Doki, Hidetoshi Eguchi
• Journal: Anticancer research (Anticancer Res) Vol. 42 Issue 4 Pg. 1859-1865 (Apr 2022) ISSN: 1791-7530 [Electronic] Greece
• PMID: 35347004 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
• Copyright: Copyright © 2022 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

Chemical References

• Organoplatinum Compounds
• Oxaloacetates
• Deoxycytidine
• Bevacizumab
• Capecitabine
• Fluorouracil

Topics

• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Bevacizumab (administration & dosage)
• Capecitabine (administration & dosage)
• Colorectal Neoplasms (drug therapy, pathology)
• Deoxycytidine (therapeutic use)
• Disease-Free Survival
• Drug Tapering
• Fluorouracil
• Humans
• Organoplatinum Compounds
• Oxaloacetates
• Prospective Studies
• Treatment Outcome