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Weekly paclitaxel fails to prolong PFS in ovarian cancer
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A dose-dense weekly schedule of paclitaxel conferred no PFS advantage compared with administration every 3 weeks as part of primary treatment for ovarian cancer, according to results of a randomized, phase 3 study.
Prior studies showed weekly administration of paclitaxel in combination with carboplatin every 3 weeks demonstrated efficacy for ovarian cancer treatment. Greater frequency of drug delivery may “enhance [paclitaxel’s] antineoplastic effect by eliciting antiangiogenic and proapoptitic properties,” researchers wrote.
In the GOG-0262 study, John K. Chan, MD, of Sutter Cancer Research Institute and colleagues evaluated whether dose-dense weekly paclitaxel plus carboplatin prolonged PFS compared with paclitaxel every 3 weeks plus carboplatin
The analysis included 692 patients with newly diagnosed, previously untreated, incompletely resected stage III or any stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer.
Researchers randomly assigned half of the patients to IV paclitaxel 175 mg/m2 every 3 weeks plus carboplatin (area under the curve, 6) for six cycles. The other half of patients received IV paclitaxel 80 mg/m2 every week plus six cycles of carboplatin.
The majority (85%) of study participants also opted to receive 15 mg bevacizumab (Avastin, Genentech) every 3 weeks until progression.
In the overall intention-to-treat analysis, weekly paclitaxel did not significantly prolong PFS compared with administration every 3 weeks (14.7 months vs. 14 months; HR = 0.89, 95% CI, 0.74-1.06).
When researchers stratified results based on bevacizumab receipt, they determined weekly paclitaxel conferred a significant median PFS benefit to study participants who did not receive bevacizumab (14.2 months vs. 10.3 months; HR = 0.62; 95% CI, 0.4-0.95). However, the dose-dense schedule offered no significant benefit to study participants who received bevacizumab (14.9 months vs. 14.7 months; HR = 0.99; 95% CI, 0.83-1.2).
A test designed to assess homogeneity of the treatment effect revealed a significant difference for bevacizumab treatment vs. no treatment (P for interaction = .047).
Patients who received weekly paclitaxel reported lower quality-of-life scores and greater severity of neuropathy than those who received paclitaxel every 3 weeks.
Patients who received weekly paclitaxel experienced higher rates of grade 3 or grade 4 anemia (36% vs. 16%), as well as grade 2 to grade 4 sensory neuropathy (26% vs. 18%). However, those assigned to paclitaxel every 3 weeks experienced a higher rate of grade 3 or grade 4 neutropenia (83% vs. 72%).
Comparative effectiveness studies that account for economic costs are necessary, the researchers wrote.
“Although paclitaxel and carboplatin administered every 3 weeks and combined with bevacizumab may be more convenient than weekly paclitaxel and carboplatin without bevacizumab, the every-3-week regimen is also associated with higher costs, with an incremental cost-effectiveness ratio as calculated by others of $401,088 vs. $5,809 per progression-free life–year saved,” Chan and colleagues wrote. – by Kristie L. Kahl
Disclosure: The researchers report support from the NCI and Genentech.
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