A Prospective Observational Study Of Peri-Operative Chemotherapy With Docetaxel, Oxaliplatin And Capecitabine In Gastric And Gastroesophageal Junction Adenocarcinoma

Abstract

Background: Gastric and gastro-esophageal (GE) junction adenocarcinoma is the most common malignancy in this part of the world. FLOT chemotherapy is one of the standard perioperative chemotherapy protocols in the treatment of this disease. FLOT and its modification TEX (DOCETAXEL, OXALIPLATIN AND CAPECITABINE) has shown better response rate and overall survival.

Objectives: Primary - radiological and pathological response; Secondary - disease-free survival and overall survival.

Study deign: Prospective observational study.

Participants: Sixty patients of locally advanced gastric and GE junction adenocarcinoma, registered in RCC SKIMS, aged 18-70 years, who gave consent were enrolled from January 2018 to December 2018.

Methods: Eligible patients were treated with eight perioperative cycles of docetaxel, oxaliplatin and capecitabine. Radiological response was assessed with RECIST 1.1, pathological response with Mandard Regression Grading and chemo toxicity with NCI CTCAE v4.0.

Results: Out of sixty enrolled patients, 51 (85%) were males and 9 (15%) females, and median age was 60 years (range 22-70) . In 46 (77%) patients primary site was gastric and 14 (23%) was gastro-esophageal junction. Most common histology was intestinal type in 36 (65%) , followed by diffuse in 35%. Average duration of presenting symptoms was 3-4 weeks, which included pain abdomen in 33%, dyspepsia and dysphagia in 31% each. Half of the patients completed the planned neoadjuvant chemotherapy, with median 3.8 cycles (range 3-7) .6.8% achieved complete response, 61% partial response, 25% stable disease and 6.8% progressed.26 patients underwent surgery after NACT, out of which 5 had complete pathological regression, while 6 showed no response to chemotherapy. Most common grade 3-4 chemo toxicity was neutropenia and hand foot syndrome in 6.6% each followed by peripheral neuropathy and diarrhea in 5% each. One patient developed febrile neutropenia and died. Dose reduction was done in 40%, and 3% by level one and two respectively. After a median follow up of 13.5 months, OS was 96%, and PFS was 88%.

Conclusion: The current regimen yields high response rates with a low toxicity profile.

Implications: This protocol is highly efficacious with less toxicity in our population. This study paves the way for randomized control trials comparing different perioperative modalities in gastric and gastro-esophageal junction cancers.