Docetaxel, Oxaliplatin with Capecitabine (TEX) Regimen In Metastatic Gastric And Gastroesophageal Junction (GE Junction) Adenocarcinoma: A Prospective Single Arm Observational Study.

Abstract

Background: Metastatic gastric cancer has a 5-year survival rate <5%. The 2 weekly TEX regimen has been shown to increase response rates and provide a favourable progression free survival (PFS) and overall survival (OS) .

Objectives: The primary objective were response rates and toxicity profile. The secondary objectives were progression free survival (PFS) and overall survival (OS) .

Study design: Prospective observational study enrolled patients from November 2017 to December 2018.

Participants: Patients registered in RCC, SKIMS with measurable metastatic gastric or GE Junction adenocarcinoma, with no prior taxane or platinum exposure, in the age group of 18 to 70 years, and with ECOG £ 2 after proper informed consent were enrolled in the study.

Methods: Patients were assessed clinically and radiologically every 4 cycles for response and toxicity

Results: Sixty patients were enrolled with a median age of 59 years (range 26-70 years) .47 (78.3%) were males and 13 (21.7%) females.49 patients (81.7%) had gastric and 11 (18.3%) had GE Junction as primary site.57 cases (95%) were newly diagnosed metastatic cancers.90% of the patients reported symptomatic improvement, one had complete response (1.7%) , 41 had partial response (67.8%) and 16 (23.7%) had stable disease; with an overall response rate of 69.5%. The median PFS was 16.6 months and overall survival was not reached. One year OS and PFS were 80% and 62% respectively. Grade 3 or 4 adverse events (NCIC CTCAE v4.0) were neutropenia (36.7%) , leukopenia (26.7%) , thrombocytopenia (13.3%) , fatigue (20 %) , peripheral neuropathy (8.3 %) and diarrhea (6.7 %) .

Conclusion: The TEX regimen offers better response rate with lower toxicity as compared to other regimens making it a potential first line treatment for fit patients.

Implication: This study gives real world data for the use of TEX regimen which requires further validation in a randomised study.