Second-line Weekly Nab-paclitaxel Noninferior to Paclitaxel for Gastric Cancer
Paclitaxel is a standard second-line chemotherapy regimen for advanced gastric cancer.
In patients requiring second-line treatment for advanced gastric cancer, weekly nanoparticle albumin-bound paclitaxel (nab-paclitaxel) was noninferior to weekly solvent-based paclitaxel with respect to overall survival, a study published in The Lancet Gastroenterology & Hepatology has shown.1
Solvent-based paclitaxel administered weekly is a standard second-line chemotherapy regimen for advanced gastric cancer. Compared with solvent-based paclitaxel, nab-paclitaxel does not need premedication to avoid infusion-related reactions and higher doses can be administered over a shorter infusion time. Therefore, researchers sought to investigate the efficacy and safety of nab-paclitaxel vs solvent-based paclitaxel in patients with previously treated gastric cancer.
For the multicenter, open-label, noninferiority, phase 3 trial (Japan Pharmaceutical Information Center Clinical Trial Identifier: JapicCTI-132059), researchers enrolled 741 Japanese patients aged 20 years or older with advanced gastric adenocarcinoma refractory to a fluoropyrimidine-containing first-line chemotherapy regimen who experienced disease progression or a relapse fewer than 24 weeks after the final dose of adjuvant chemotherapy.
Participants were randomly assigned 1:1:1 to receive intravenous nab-paclitaxel on day 1 of each 3-week cycle, nab-paclitaxel on days 1, 8, and 15 of each 28-day cycle, or solvent-based paclitaxel on days 1, 8, and 15 of each 28-day cycle.
After a median follow-up of nearly 10 months, researchers found that weekly nab-paclitaxel was noninferior to weekly solvent-based paclitaxel (hazard ratio [HR], 0.97; 97.5% CI, 0.76-1.23; P =.0085), while paclitaxel given every 3 weeks was not noninferior to solvent-based paclitaxel (HR, 1.06; 95% CI, 0.87-1.31; P =.062).
Results showed that median overall survival was 10.3 months (95% CI, 8.7-11.4) with nab-paclitaxel given every 3 weeks, 11.1 months (95% CI, 9.9-13.0) with weekly nab-paclitaxel, and 10.9 months (95% CI, 9.4-11.8) with weekly solvent-based paclitaxel.
Patients who received nab-paclitaxel every 3 weeks and those given weekly nab-paclitaxel were less likely to experience hypersensitivity reactions than those in the solvent-based paclitaxel group.
Grade 3 or worse neutropenia, peripheral sensory neuropathy, and febrile neutropenia were more common in patients who received nab-paclitaxel every 3 weeks, while the incidence of those adverse events were similar between the weekly nab-paclitaxel and weekly solvent-based paclitaxel arms.
Given the advantages of the nab-paclitaxel formulation, the findings ultimately suggest that it is a potential regimen for the second-line treatment of patients with advanced gastric cancer.
1. Shitara K, Takashima A, Fujitani K, et al. Nab-paclitaxel versus solvent-based paclitaxel in patients with previously treated advanced gastric cancer (ABSOLUTE): an open-label, randomised, non-inferiority, phase 3 trial. Lancet Gastroenterol Hepatol. 2017 Jan 18. doi: 10.1016/S2468-1253(16)30219-9. [Epub ahead of print]