A two-arm randomized open-label prospective design superiority phase III clinical trial to compare the efficacy of docetaxel-oxaliplatin-capecitabine/5 fluorouracil (DOC/F) followed by docetaxel versus CAPOX/mFOLFOX-7 in advanced gastric cancers (DOC-GC study).

Authors

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Anant Ramaswamy

Tata Memorial Hospital (HBNI), Mumbai, India

Anant Ramaswamy , Prabhat Ghanshyam Bhargava , Biswajit Dubashi , Akhil Kapoor , Sujay Srinivas , Omshree Shetty , Rajiv Kumar Kaushal , Aekta Shah , Vanita Noronha , Amit Joshi , Nandini Sharrel Menon , Chaitali Nashikkar , Anuj Gupta , Bal Krishna Mishra , Smita Kayal , Ramesh Ananthakrishnan , Suman Kumar , Prasanth Ganesan , Kumar Prabhash , Vikas S. Ostwal

Organizations

Tata Memorial Hospital (HBNI), Mumbai, India, JIPMER, Puducherry, India, Homi Bhabha Cancer Hospital, Varanasi, Varanasi, India, Tata Memorial Centre, Mumbai, India, Tata Memorial Centre (HBNI), Mumbai, India, JIPMER, Puducherry, Puducherry, India, Department of Medical Oncology, Regional Cancer Centre, Dhanavantri Nagar, JIPMER, Puducherry, India

Research Funding

Indian Cooperative Oncology Network
Tata Memorial Hospital, Nag Foundation

Background: The choice of optimal chemotherapy in advanced (unresectable/metastatic) gastroesophageal junction and gastric (GEJ/G) adenocarcinomas remains undecided with regard to the addition of docetaxel to a FOLFOX/CAPOX backbone in improving outcomes with equipoise with regard to the optimal duration of chemotherapy as well. Methods: The DOC GC study is a multicentric open-label, randomized controlled phase III trial, in adults ≥18 years with advanced GEJ/G adenocarcinoma and adequate end-organ function. Patients were randomized 1:1 to one of two arms: Arm A - modified CAPOX (3 weekly) or modified FOLFOX-7 (2 weekly) for a maximum of 6 months and then observation OR Arm B: modified FLOT (5-FU/leucovorin /Oxaliplatin/Docetaxel) or DOX (docetaxel/oxaliplatin/capecitabine) every 2 weeks for a maximum of four months followed by Docetaxel (60mg/m2) every 3 weeks till disease progression, unacceptable toxicity, or patient's decision to withdraw. The primary endpoint of the study is Overall survival (OS), as calculated by Kaplan-Meier method, while key secondary endpoints include Progression-free survival, and adverse event rates. Results: Of the 324 patients randomized between July 2020 and November 2022, 305 patients were evaluable for analysis (Arm A: 156; Arm B: 149). With a median follow-up time of 19.2 months (95% CI: 16.5 – 21.9) for the entire cohort, the median OS was 10.1 months (95%: 9.2-10.9) in Arm A and 8.9 months (95% CI: 7.3-10.5) in arm B and this difference was not statistically significant [p=0.70]. There were no statistical differences in median PFS between the two arms [Arm A: 7.1 months (95% CI: 6.1-8.1); Arm B: 6.2 months (95% CI: 5.7 – 6.8); p=0.39]. An increased proportion of grade 3/4 neutropenia (21% vs. 5.1%; p<0.001) was seen in patients in Arm B, with other treatment related side effects being comparable between the two arms. A greater proportion of patients in Arm A tended to receive second line therapy compared to Arm B (38% vs. 26%; p=0.07). Conclusions: The addition of docetaxel to a doublet regimen comprising 5-fluorouracil/capecitabine and oxaliplatin did not improve overall survival in patients with advanced GEJ/G cancers. Continuing chemotherapy beyond six months also does not appear to improve survival in this group of cancers. Clinical trial information: CTRI/2020/03/023944.

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Abstract Details

Meeting

2024 ASCO Gastrointestinal Cancers Symposium

Session Type

Rapid Oral Abstract Session

Session Title

Rapid Oral Abstract Session A: Cancers of the Esophagus and Stomach

Track

Esophageal and Gastric Cancer,Other GI Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

CTRI/2020/03/023944

Citation

J Clin Oncol 42, 2024 (suppl 3; abstr LBA248)

DOI

10.1200/JCO.2024.42.3_suppl.LBA248

Abstract #

LBA248

Abstract Disclosures