CHICAGO — Weekly dosing of paclitaxel and standard biweekly dosing resulted in nearly identical PFS among women with higher-risk early-stage breast cancer who had undergone surgery, according to results of a phase 3 clinical trial presented at the ASCO Annual Meeting.
However, adverse effects were more common with the biweekly dosing, indicating that a weekly dosing schedule could be preferred.
G. Thomas Budd
“Our results suggest that either regimen will give a good outcome, but the weekly schedule seems to result in better quality of life for patients, causing less muscle and bone pain and allergic reactions,” G. Thomas Budd, MD, a medical oncologist in the department of solid tumor oncology at the Cleveland Clinic, said in a press release. “The findings provide assurance that women can choose the lower-dose therapy without sacrificing their chances of survival.”
Budd and colleagues assigned 3,294 patients with node-positive and high-risk node-negative surgery-candidate breast cancer to either paclitaxel at 80 mg/m2 once a week for 12 weeks or standard-dose paclitaxel at 175 mg/m2 every 2 weeks for 12 weeks.
Patients in the standard-dose treatment group received pegfilgrastim (Neulasta, Amgen) supportive care to boost white blood cell counts.
Results showed the dosing schedules were associated with comparable 5-year PFS rates — 82% for the weekly regimen vs. 81% for biweekly.
However, researchers noted significant differences in the toxicity profiles. The biweekly schedule was associated with higher incidence of allergic reactions (1.4% vs. 0.6%), skin toxicities (2.7% vs. 1.9%) and musculoskeletal pain (11% vs. 3%) than the weekly schedule.
The incidence of neurologic toxicity — including numbness, tingling and pain of the fingers and toes — also was higher in the biweekly regimen (17% vs. 10%), but this disparity could have been less significant if the patients had received only four cycles of bi-weekly regimen rather than six cycles.
For more information:
Budd GT. Abstract #CRA1008. Presented at: ASCO Annual Meeting; May 31-June 4, 2013; Chicago.
Disclosure: The researchers report consulting/advisory positions with and research funding/honoraria from Amgen, Genentech, Novartis and Roche.