Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Puducherry, India
Smita Kayal , Chinmaya kumar Pani , Dubashi Biswajit , Surendrakumar Verma , Sarath Chandra Sistla , Sunu Lazar Cyriac
Background: Chemotherapy is the mainstay of treatment for AGC. There is no standard recommendation whether doublet or triplet chemotherapy is better. Hence our study aims to compare CAPOX with EOX as first line treatment for AGC. Methods: Patients with histologically proven AGC were randomly assigned to EOX (epirubicin 50mg/m2 on day1, capecitabine 625mg/m2 twice daily for 21 day and oxaliplatin 130mg/m2 on day1 three weekly for 8 cycle) or CAPOX (capecitabine 1gm/m2 /day twice daily for fourteen days and oxaliplatin 130 mg /m2 on day 1 in a three weekly cycle for 8 cycle). The primary end point was progression free survival (PFS) and secondary end points included overall survival (OS), overall response rate (ORR) and toxicity. Results: From December 2012 to December 2014, total of 69 patients were randomized; 34 in CAPOX arm and 35 in EOX arm. Median age at diagnosis was 55 years (18-70) and 57 (81.4%) patients had metastatic disease in the entire cohort. The baseline patients characteristics were similar in both groups except baseline weight (44.4±10.45 vs. 50±10.84, p-0.033) and hemoglobin (9.6±1.63 vs. 10.7±2.09, p=0.018), which were significantly higher in the EOX arm. The results are shown in table 1. Median follow up was 15.2 month. There were no toxic deaths. Conclusions: No statistically significant difference was observed between the two regimens with respect to response rate, PFS and OS . However toxicity profile favors the EOX group.
Group A CAPOX(n=34) | Group B EOX(n=35) | P value | |
---|---|---|---|
Median no. of cycles (range) | 6.5(3-8) | 8(2-8) | 0.236 |
ORR (CR/PR/SD) | 18(54.5%) | 25 (71.4%) | 0.149 |
Median OS (months) | 8.16 [95% CI( 2.5-13.8)] | 10.93 [95% CI (6.7-15.1)] | 0.298 |
1 year OS (%) | 45.1% | 49.4% | 0.298 |
Median PFS (months) | 5.56 [95% CI(5.004-6.12)] | 8.36 [95% CI(6.7-10.02)] | 0.06 |
1 year PFS (%) | 17.9% | 24.8% | 0.06 |
Chemotherapy discontinuation toxicity(%) | 15( 44%) | 8 (22.9%) | 0.061 |
Dose modification of any drug (%) | 24(70.6%) | 20(57.1%) | 0.245 |
Grade III/IV neutropenia(%) | 1 (2.9%) | 8 (22.8%) | 0.028 |
Grade III/IV vomiting(%) | 8(23.5%) | 0 | 0.011 |
Grade III/IV diarrhea(%) | 6(17.6%) | 0 | 0.002 |
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