Comparison of efficacy and safety of capecitabine and oxaliplatin (CAPOX) with epirubicin, oxaliplatin plus capecitabine (EOX) as first line treatment for advanced gastric cancer (AGC), a randomized clinical study.

Authors

null

Smita Kayal

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

Organizations

Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Puducherry, India, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India

Research Funding

No funding sources reported

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.

Results with CAPOX versus EOX.

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%)00.011
Grade III/IV diarrhea(%)6(17.6%)00.002

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Abstract Details

Meeting

2015 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Citation

J Clin Oncol 33, 2015 (suppl; abstr e15026)

DOI

10.1200/jco.2015.33.15_suppl.e15026

Abstract #

e15026

Abstract Disclosures