Adding docetaxel to standard-of-care does not improve outcomes in gastric cancer

Presented by

Dr Anant Ramaswamy, Tata Memorial Centre, India

Conference

ASCO GI 2024

Trial

Phase 3, DOC-GC

Doi
https://doi.org/10.55788/1bd52b11

Docetaxel added to capecitabine plus oxaliplatin (CAPOX) or to 5-FU plus oxaliplatin (mFOLFOX7) did not improve overall survival (OS) in patients with advanced gastric cancers, but it did increase toxicity. Therefore, CAPOX and mFOLFOX7 remain the standard-of-care chemotherapies in this population.

The open-label, prospective, phase 3 DOC-GC study randomised 324 participants with advanced HER2 negative gastro-oesophageal junction or gastric adenocarcinoma to one of the standard regimens (i.e. CAPOX or mFOLFOX7) up to a maximum of 6 months, or to either CAPOX or mFOLFOX7 plus docetaxel for a maximum duration of 4 months followed by docetaxel monotherapy. Dr Anant Ramaswamy (Tata Memorial Centre, India) presented the OS primary endpoint results [1].

After a median follow-up of 19.2 months, no difference in OS was observed between the 2 arms. The median OS was 8.9 months in the experimental arm and 10.1 months in the control arm (P=0.30). Likewise, the median progression-free survival data did not reveal clinical benefits of one regimen over the other with 6.24 months and 7.05 months in the docetaxel arm and standard-of-care arm, respectively (P=0.88).

However, grade 3 or 4 treatment-related adverse events were more common in the experimental arm (53% vs 33%; P<0.001). More specifically, neutropaenia (21% vs 3%), hand-foot-syndrome (9% vs 4%), and peripheral neuropathy (17% vs 7%) occurred significantly more frequently in participants who received docetaxel.

“mFOLFOX7 or CAPOX, for a duration of 6 months, should continue to remain the standard chemotherapy in patients with HER2 negative gastric and gastro-oesophageal junction adenocarcinomas,” concluded Dr Ramaswamy.

Ramaswamy A, et al. A two-arm randomized open-label prospective superiority design phase III clinical trial to compare the efficacy of docetaxel-oxaliplatin capecitabine/5 fluorouracil followed by docetaxel versus CAPOX/mFOLFOX-7 in advanced gastric cancers (DOC-GC study). LBA 248, ASCO Gastrointestinal Cancers Symposium 2024, 18– 20 January, San Francisco, CA, USA.

Related Articles