The addition of docetaxel to 5-fluorouracil/capecitabine and oxaliplatin demonstrated no improvement in overall survival (OS) among patients with advanced gastroesophageal junction (GEJ) and gastric cancers, according to results from a phase 3 trial. The study also showed that continuing chemotherapy beyond 6 months was not associated with any improvement in survival.

These results were presented by lead author, Anant Ramaswamy, MD, Tata Memorial Hospital, Mumbai, India, at the 2024 ASCO Gastrointestinal Cancers Symposium in San Francisco, California.

The open-label, randomized controlled phase 3 trial enrolled 324 adult patients with advanced GEJ/gastric cancer and adequate organ function. Patients were randomized in a 1:1 ratio to receive modified CAPOX every 3 weeks or modified FOLFOX-7 every 2 weeks for a maximum of 6 months followed by observation (Arm A) or modified FLOT or DOX every 2 weeks for a maximum of 4 months followed by docetaxel every 3 weeks until disease progression, unacceptable toxicity, or patient's choice to withdraw.

The primary end point was OS. Secondary end points included progression-free survival (PFS) and rates of adverse events.

Of the 324 patients randomized, 305 were evaluable (156 patients in Arm A and 149 patients in Arm B). For the entire cohort, the median follow-up was 19.2 months (95% confidence interval [CI], 16.5 to 21.9). Median OS was 10.1 months (96% CI, 9.2 to 10.9) in Arm A and 8.9 months (95% CI, 7.3 to 10.5) in Arm B, though this difference was not statistically significant (P = 0.70). Median PFS was 7.1 months (95% CI, 6.1 to 8.1) in Arm A and 6.2 months (95% CI, 5.7 to 6.8) in Arm B, though this difference was also not statistically different (P = 0.39).

For adverse events, there was an increased proportion of grade 3/4 neutropenia observed in Arm B (21%) compared to Arm A (5.1%; P <.001). Other treatment-related side effects were comparable between the 2 arms. Authors noted that more patients in Arm A received second-line therapy (38%) vs those in Arm B (26%; P = 0.07).

In conclusion, adding docetaxel to a doublet regimen containing 5-fluorouracil/capecitabine and oxaliplatin shows to improvement in OS in this patients population nor does continuing chemotherapy beyond 6 months.

Source:

Ramaswamy A, Bhargava PB, Dubashi B, et al. 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). Presented at 2024 ASCO Gastrointestinal Cancer Symposium; January 18-20, 2024; San Francisco, California. Abstract LBA248.