A Phase II Study of Dose-reductive XELOX Plus Bevacizumab in Elderly or Vulnerable Patients With Metastatic Colorectal Cancer (MCSGO-1202).
Anticancer Res
; 42(4): 1859-1865, 2022 Apr.
Article
in En
| MEDLINE
| ID: mdl-35347004
ABSTRACT
BACKGROUND/AIM:
This phase II study (MCSGO-1202) aimed to evaluate the initial dose reduction of oxaliplatin in XELOX plus bevacizumab therapy. PATIENTS ANDMETHODS:
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Colorectal Neoplasms
/
Drug Tapering
Type of study:
Clinical_trials
/
Observational_studies
/
Risk_factors_studies
Limits:
Aged
/
Humans
Language:
En
Journal:
Anticancer Res
Year:
2022
Document type:
Article
Affiliation country:
Japan