Clinical Oncology News - Randomized Phase II trials: A Pragmatic Way To Inform Clinical Practice

Clinical Oncology News - Randomized Phase II trials: A Pragmatic Way To Inform Clinical Practice

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Consider, for example, the recent report on the biological activity of single-agent, nanoparticle albumin-bound paclitaxel in the second-line treatment of epithelial ovarian cancer.¹ This nonrandomized study, conducted by the Gynecologic Oncology Group, revealed an objective response rate of 23%, similar to that previously reported with the far less expensive generic paclitaxel.^2,3
But is it possible that this agent is actually superior to paclitaxel in that treatment with nanoparticle albumin-bound paclitaxel achieves a similar degree of objective clinical benefit (e.g., degree of tumor shrinkage and delay in time to progression) but with a measurably more favorable toxicity profile that includes a substantially reduced risk for peripheral neuropathy?
Unfortunately, in the complete absence of data from a randomized trial, the answer to this specific question will simply be unknown because any suggested “superior” outcomes may solely reflect the inadvertent selection bias resulting from the favorable baseline clinical features inherent in all nonrandomized studies........