Trastuzumab plus chemotherapy prolonged the median overall survival in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC). Among chemotherapy regimens, oxaliplatin is generally more convenient and tolerable than cisplatin, and becoming an increasingly popular option for the treatment of AGC. The aim of the study was to evaluate the efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin (CAPOX) in HER2-positive AGC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Trastuzumab was administered at a loading dose of 8 mg/kg followed by 6 mg/kg infusion every 3 weeks (q3w).
Oxaliplatin was administrated as a 130 mg/m2 infusion, q3w, for up to 6 cycles.
Capecitabine 1000 mg/m2 was given orally twice daily on days 1-14 followed by a 7-day rest interval.
Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh
Loco-regional and Distant Tumor Control After Completion of Treatment
Response Evaluation Criteria in Solid Tumors was used to measure outcome: Complete response (CR): Disappearance of all target lesions. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time frame: 12 months
Progression-free survival (PFS)
Time frame: 28 months
Overall survival (OS)
Time frame: 28 months
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