First-line bevacizumab and capecitabine–oxaliplatin in elderly patients with mCRC: GEMCAD phase II BECOX study

Abstract

Background:Subgroup analyses of clinical studies suggest that bevacizumab plus XELOX is effective and tolerable in elderly patients with metastatic colorectal cancer (mCRC). The prospective BECOX study examined the efficacy and safety of bevacizumab plus XELOX, followed by bevacizumab plus capecitabine in elderly patients with mCRC.Methods:Patients aged ⩾70 years with Eastern Cooperative Oncology Group performance status 0 out of 1 and confirmed mCRC were included. Patients received bevacizumab 7.5 mg kg−1 and oxaliplatin 130 mg m−2 on day 1, plus capecitabine 1000 mg m−2 bid orally on days 1–14 every 21 days; oxaliplatin was discontinued after 6 cycles. The primary end point was time to progression (TTP).Results:The intent-to-treat population comprised 68 patients (65% male, median age 76 years). Median TTP was 11.1 months; median overall survival was 20.4 months; overall response rate was 46%. Grade 3 or 4 adverse events included diarrhoea (18%) and asthenia (16%). Grade 3 or 4 adverse events of special interest for bevacizumab included deep-vein thrombosis (6%) and pulmonary embolism (4%).Conclusions:Bevacizumab plus XELOX was effective and well tolerated in elderly patients in the BECOX study. The adverse-event profile was similar to previous reports; no new safety concerns were identified. Fit elderly patients with mCRC should be considered for treatment with bevacizumab plus XELOX.

Experience with S-1 in older Caucasian patients with metastatic colorectal cancer (mCRC): Findings from an observational chart review

“…Our findings indicate that the SOx regimen is well tolerated even in older patients with a low rate of clinical adverse events similar to what would be expected with other fluoropyrimidine-oxaliplatin-based combinations, albeit with a much lower rate of HFS [20]. The rate of hematological adverse events also appears to be lower with SOx compared with other fluoropyrimidine-oxaliplatin combinations.…”

Dynamic soluble changes in sVEGFR1, HGF, and VEGF promote chemotherapy and bevacizumab resistance: A prospective translational study in the BECOX (GEMCAD 09-01) trial

“…The main inclusion criteria were previously published. 13 Briefly, they were the following: elderly patients (≥70 years old), performance status of 0 or 1, histologically confirmed diagnosis of mCRC not suitable for resection, measurable disease according to RECIST version 1.1, not prior systemic therapy for metastatic disease, and prior adjuvant chemotherapy ended >12 months before starting the study. Exclusion criteria included brain metastases, clinically significant cardiac disease, clinical use of full-dose anticoagulants, and major surgical procedures within 28 days before study entry.…”

“…The BECOX trial was designed to investigate the efficacy and safety of a bevacizumab plus XELOX regimen as a first-line treatment in elderly population diagnosed of mCRC. 13 …”

Capecitabine, Oxaliplatin, and Bevacizumab (BCapOx) Regimen for Metastatic Colorectal Cancer

“…[13][14][15][16] The studies reviewed reported nausea from 1% to 59% and vomiting from 3% to 32%, with grade 3 or 4 nausea in 1% to 2% of patients and grade 3 or 4 vomiting in 3% to 7%. [1][2][3][4] Prophylactic antiemetic therapy with a steroid and serotonin antagonist is recommended. [13][14][15][16] One group suggests addition of a neurokinin (NK 1 ) antagonist may be appropriate in some patients.…”

“…For regimens with an incidence of febrile neutropenia less than 10%, routine prophylactic use of CSFs is not recommended. 26,27 Because febrile neutropenia was reported in 1% to 2% of patients and grade 3 or 4 neutropenia was reported in 4% to 22% of patients in the trials reviewed, [1][2][3][4] primary prophylactic use of CSFs is not recommended. [1][2][3][4] CSFs should be considered if a patient experiences febrile neutropenia or grade 4 neutropenia in a prior cycle of BCapOx.…”