No PFS gain with dose-dense weekly chemotherapy in epithelial ovarian cancer
medwireNews: The 3-weekly regimen of carboplatin and paclitaxel should remain the first-line standard of care for women with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, say the ICON8 researchers who did not find a progression-free survival (PFS) benefit with dose-dense weekly chemotherapy.
The phase III trial recruited women who had stage Ic/IIa disease with high-grade histology or stage IIb/IV disease with any histology and had either undergone immediate primary surgery or were scheduled to receive delayed surgery.
Median PFS was 17.9 months for the 522 women who were randomly assigned to receive six cycles of the standard 3-weekly schedule of carboplatin dosed to an area under the concentration–time curve (AUC) of 5/6 plus paclitaxel 175 mg/m2.
This was comparable to the median PFS of 20.6 months achieved by the 522 participants given carboplatin on the same schedule alongside weekly paclitaxel at a dose of 80 mg/m2 for six cycles and the 21.1 months achieved by the 521 women who received carboplatin to AUC 2 and paclitaxel 80 mg/m2 on a weekly basis also for six cycles.
Addressing the delegates of the ESMO 2017 Congress in Madrid, Spain, lead author Andrew Clamp (Christie NHS Foundation Trust and The University of Manchester, UK) noted that the overall survival (OS) data were not mature at the time of data lock, but initial analyses suggest similar median OS durations across the treatment arms.
He pointed out that these findings of the ICON8 study, conducted primarily in European patients, were in contrast to those of the Japanese Gynecologic Oncology Group 3016 trial, which showed significantly longer PFS and OS with the weekly schedule in Japanese women.
Clamp said in a press release that the reasons for the differences were “not entirely clear,” but suspected that “pharmacogenomic differences between these two ethnic groups” could play a role.
And he added that “it remains appropriate to continue to offer weekly dose-dense paclitaxel as a treatment option to Japanese women.”
The dose-dense weekly schedule was associated with slightly higher levels of grade 3 or 4 toxicity, with rates of 42% in the standard regimen arm versus 63% and 53% in the weekly paclitaxel and weekly carboplatin and paclitaxel groups, respectively. But the study authors point out that “this increase was predominantly due to uncomplicated haematological toxicity.”
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