Comparison of efficacy of aspirin plus epirubicin, oxaliplatin, and capecitabine versus epirubicin, oxaliplatin, and capecitabine alone in patients with locally advanced and metastatic gastric cancer: A randomized clinical trial.

Authors

null

Esha Jafa

Jafa Surgical Centre, Lucknow, India

Esha Jafa , Biswajit Dubashi , Smita Kayal , Vikram Kate , Rajesh Nachiappa Ganesh , Sunitha V. C. , Charles L. , Yadav Nisha

Organizations

Jafa Surgical Centre, Lucknow, India, JIPMER, Puducherry, India, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Puducherry, India

Research Funding

Other

Background: Aspirin was long known to prevent cancer, the last decade revealed its therapeutic role via varied mechanisms like inhibition of platelet activation, COX and PI3K pathway. Since PI3K/AKT/mTOR is one of the pathways activated in gastric cancer and Giampieri et al (2016) showed improved response rates, PFS and OS with addition of aspirin to capecitabine in heavily pretreated metastatic colorectal cancer,a cancer in which efficacy of aspirin is related to presence of PI3K mutations,we aimed to compare the efficacy of aspirin added to a standard regime EOX with EOX alone in locally advanced and metastatic gastric cancer. Methods: All patients with advanced gastric cancer coming to JIPMER,Department of Medical oncology between march 2017 to may 2019 were screened for eligibility in the trial.Those eligible were randomly assigned to standard EOX or standard EOX plus 150 mg of daily aspirin.Tumor measurements were performed at baseline,then after 3-4 cycles (interim response) and the response to treatment was assessed by the radiologist who was blinded to treatment arms according to RECIST1.1 criteria.Toxicity profiles were recorded as per CTCAE v 4.03.In per protocol analysis,response rates, PFS(progression free survival) and OS (overall analysis) were analysed for patients who received ≥3 cycles and had an evaluable interim response. Results: 95 patients were randomised.In per protocol analysis, 70 patients were included. The results are shown in table. Conclusions: No statistically significant difference was seen with respect to response rates, PFS, OS and toxicity, although there was a higher ORR (overall response rate=complete response,CR +partial response, PR) and OS seen in EOX plus aspirin arm. Clinical trial information: CTRI/2017/11/010651. JIPMER,Puducherry,India

Results of Per Protocol analysis (n=70).

EOX arm
N=37
EOX plus aspirin arm
N=33
p value
ORR(CR+PR)27 %42.46 %0.176
DCR(CR+PR+SD)75.68%72.72%0.778
Median OS12 months
(10.18-13.8)
15 months
(4.8-25)
0.696
Median PFS9 months
(4.2-13.7)
8 months
(6.66-9.339)
0.467

DCR(disease control rate), SD (stable disease)

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Abstract Details

Meeting

2020 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Esophageal and Gastric Cancer and Other GI Cancers

Track

Esophageal and Gastric Cancer,Other GI Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

CTRI/2017/11/010651

Citation

J Clin Oncol 38, 2020 (suppl 4; abstr 384)

Abstract #

384

Poster Bd #

E17

Abstract Disclosures