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Sahar van Waalwijk's avatar

Brilliant analysis... I’ve just read the paper, and one thing is rather puzzeling. They write: “The trial was powered [ ] on the assumption of a median progression‑free survival of 13.0 months in the standard‑therapy group and 19.5 months in the palbociclib group.” This assumption is somewhat surprising, because these medians are very close to those reported years ago in CLEOPATRA (PFS 12.4 m with placebo vs 18.7 m with pertuzumab). In other words, their expected PFS for both arms is much shorter than what one would expect.... This is while PATINA recruited "induction-responder population" (so more favourable biology), with almost twice as many HR+ patients as in CLEOPATRA... all these should increase PFS rather than shorten it... So why do they predict such low PFS in their hypothesis?

Michelino De Laurentiis's avatar

Thank you for this thoughtful and carefully argued appraisal of the PATINA trial. The discussion on informative censoring is particularly important, as this issue often receives less attention than it deserves in oncology trials.

While the trial provides valuable clinical insights, analyses like yours remind us that methodological nuances can meaningfully influence interpretation. Constructive scrutiny of these aspects is essential if we aim to strengthen the design and credibility of future studies.

At the same time, it is important to recognize that this remains a hypothesis-generating perspective, and alternative interpretations may reasonably emerge as the data are further examined and debated.

Thank you again for offering such a stimulating and intellectually honest perspective. I look forward to your continued exploration of these methodological issues, as this kind of critical reflection is invaluable to the oncology community.

Geoffrey Gewurz's avatar

Reading a great breakdown of the PATINA trial today highlighting how progression-free survival can be inflated by censoring bias, open-label assessment, and composite endpoint noise.

It’s a reminder that much of oncology still relies on surrogate time-to-event metrics because historically we couldn’t observe cancer biology in real time.

Longitudinal molecular monitoring changes that paradigm. When you can directly track tumor DNA dynamics over time, response and relapse become biological signals, not radiographic guesses.

The future of oncology endpoints won’t be PFS curves. It will be continuous molecular reality.