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Opinion (Markman)
This commentator is unaware of the specific circumstances surrounding the decision to design the study as reported,1 but the effect of the decision is clearly evident and distressing.
Overall, there was no difference in progression-free survival between the study arms (weekly vs every-3-week paclitaxel),1 in striking contrast to the previously noted Japanese data.2
What can we conclude from the conduct of this large US government–funded, multicenter, multiyear, Phase III, randomized trial? Essentially nothing, despite the fact almost 700 patients were entered at considerable taxpayer expense.
References
- Chan JK, Brady MF, Penson RT, et al. Weekly vs. every-3-week paclitaxel and carboplatin for ovarian cancer. N Engl J Med. 2016;374(8):738-748, PMID: 26933849.
- Katsumata N, Yasuda M, Isonishi S, et al. Long-term results of dose-dense paclitaxel and carboplatin versus conventional paclitaxel and carboplatin for treatment of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (JGOG 3016): a randomised, controlled, open-label trial. Lancet Oncol. 2013;14(10):1020-1026, PMID: 23948349.
- Burger RA, Brady MF, Bookman MA, et al. Incorporation of bevacizumab in the primary treatment of ovarian cancer. N Engl J Med. 2011;365(26):2473-2483, PMID: 22204724.
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