Κυριακή, 28 Φεβρουαρίου 2016

WEEKLY PACLITAXEL IN OVARIAN CANCER?

Assignment to a dose-dense regimen of paclitaxel given weekly did not prolong progression-free survival compared with paclitaxel given every 3 weeks in a group of patients with ovarian cancer treated with or without bevacizumab. 
However, data from the Gynecologic Oncology Group (GOG)-0262 study, published in the New England Journal of Medicine, showed that in patients who did not elect to receive bevacizumab as part of their treatment, the weekly schedule of paclitaxel did significantly prolong progression-free survival compared with the every-3-week schedule.
“These findings were consistent with results in the group that received weekly paclitaxel in the [Japanese Gynecologic Oncologic Group] trial. However, the aggregated analysis of our study did not show an effect of weekly paclitaxel,” wrote John K. Chan, MD, of Sutter Cancer Research Institute in San Francisco, and colleagues. “This result may be due to the fact that 84% of the patients in our trial elected to receive bevacizumab. Thus, it is possible that the overall difference was dominated by the addition of bevacizumab to the study treatment.”
In the study, 692 patients with newly diagnosed ovarian cancer were grouped by whether or not they elected to receive bevacizumab and then randomly assigned to paclitaxel given intravenously at 175 mg/m2 body surface every 3 weeks plus carboplatin for 6 cycles or paclitaxel given weekly at 80 mg/m2 plus carboplatin for 6 cycles.
Patients were followed for a median of 28 months, after which 67% were alive. The study found that assignment to dose-dense weekly paclitaxel had no significant effect on progression-free survival (PFS) compared with paclitaxel every 3 weeks (14.7 months vs 14 months; hazard ratio [HR], 0.89 [98% CI, 0.74–1.06]; P = .18).
When the researchers looked at the outcome data by whether or not patients were treated with bevacizumab, they found that those patients who did not receive bevacizumab had significantly longer PFS when assigned to weekly paclitaxel compared with paclitaxel every 3 weeks (14.2 months vs 10.3 months; HR, 0.62 [95% CI, 0.40–0.95]; P = .03). Among those patients who did receive bevacizumab, the frequency of paclitaxel had no effect on PFS.
The researchers also noted no survival difference when patients were grouped by degree of macroscopic residual disease, or by whether or not they received neoadjuvant chemotherapy followed by interval cytoreduction compared with primary cytoreduction.
A similar rate of patient-reported neuropathy was reported for both treatment groups in the study; however, patients assigned to weekly paclitaxel reported greater severity of neuropathy. In addition, patients assigned to weekly paclitaxel had greater rates of grade 3 or higher anemia compared with patients assigned to the every-3-week regimen (36% vs 16%; P < .001). In contrast, weekly paclitaxel was associated with less grade 3 or higher neutropenia compared with the every-3-week regimen of paclitaxel (72% vs 83%; P < .001).
“Comparative effectiveness studies are needed with consideration of economic costs,” the researchers added. “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.”

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