Triplet Combination Based on Fractionated Docetaxel Does Not Improve Outcomes Over Standard Regimen in Advanced Gastric Cancer

The triplet combination of fractionated docetaxel, oxaliplatin, and capecitabine was not associated with improved outcomes compared to standard treatment epirubicin, oxaliplatin, and capecitabine in patients with inoperable, locally advanced or metastatic gastric cancer, according to the phase 3 lega trial.

“A new combination based on fractional docetaxel has been developed in an attempt to increase the efficacy of epirubicin, oxaliplatin, and capecitabine and reduce the heavy toxicity of classical docetaxel regimens,” wrote lead author Gerardo Rosati, MD, Azienda Ospedaliera San Carlo, Potenza, Italy, and colleagues.

The trial included 169 patients with previously untreated gastric cancer. Patients were randomized to epirubicin, oxaliplatin, and capecitabine (arm A) or fractionated docetaxel, oxaliplatin, and capecitabine (arm B). The primary end point was progression-free survival (PFS) and secondary end points included overall survival (OS), overall response rate (ORR), disease control rate, and tolerability. An interim analysis for futility was planned after the first 127 events.

At the cut-off date for the interim analysis, median PFS was 6.3 months [95% confidence interval (CI) 5.0 to 8.1] in arm A vs 6.3 months (95% CI 5.0 to 7.8) in arm B. OS was also comparable in the two arms: 12.4 months in arm A (95% CI 9.1 to 19.2) vs 11.5 months in arm B (95% CI 8.6–15.0). The disease control rate was 68% and 67%, respectively. The ORR was 33% and 24%.

The number of patients with grade ≥3 adverse events was higher among patients receiving the fractionated docetaxel regimen vs the epirubicin regimen (42 vs 35). Treatment modification was also higher in the docetaxel arm vs epirubicin arm (91% vs 78%,  P = .017).

“A triplet regimen based on the fractional dose of docetaxel achieves no improvement over [epirubicin, oxaliplatin, and capecitabine] which remains a potential standard treatment in many patients with inoperable, locally advanced or metastatic gastric cancer,” Dr Rosati and colleagues concluded.

Source:
Rosati G, Cella C, Cavanna L, et al. A randomized phase III study of fractionated docetaxel, oxaliplatin, capecitabine (low-tox) vs epirubicin, oxaliplatin and capecitabine (eox) in patients with locally advanced unresectable or metastatic gastric cancer: the lega trial. Gastric Cancer. Published online March 30, 2022. doi:10.1007/s10120-022-01292-y.