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Purpose <p>Using patient-reported outcomes (PROs) and more objective measures, we evaluated adherence to adjuvant palbociclib and ET in the PALLAS trial, and the impact of palbociclib on ET adherence.</p> Methods <p>The open-label, global, phase 3 PALLAS trial randomized patients with hormone receptor-positive (HR+), HER2-negative stage II–III breast cancer (1:1) to either 26 cycles of palbociclib (125&#xa0;mg/day for 21&#xa0;days and then 7&#xa0;days off) plus adjuvant ET, versus ET alone. After 23.7&#xa0;months median follow-up, palbociclib was stopped due to futility of the intervention and patients were moved to follow-up. For each cycle, daily adherence to ET was measured with study diaries; for palbociclib, study diaries and pill counts. At cycles 2, 3, 6, 12, 18 and 24, patients completed the McHorney Adherence Questionnaire. Mean persistence was defined in months from treatment initiation to cessation.</p> Results <p>Four thousand six hundred eighty-eight of 5796 total PALLAS participants were included. Across all cycles, mean daily ET adherence values measured by study diary were &gt; 98.0% and did not differ between treatment arms. Mean persistence to ET was similar between arms (19.2&#xa0;months for palbociclib + ET vs. 19.6&#xa0;months for ET alone). However, patient-reported maximal ET adherence was higher across time for palbociclib + ET compared to ET alone (<i>p</i> = 0.05).</p> Conclusion <p>In the PALLAS trial, addition of palbociclib did not decrease adherence to adjuvant ET. Though numbers declined over time, daily adherence for palbociclib and ET remained relatively high at each cycle.</p> <p>Trial Registration: The trial is registered with ClinicalTrials.gov (NCT02513394; 07-31-2015) and EudraCT (2014-005181-30).</p>

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Impact of adding palbociclib on treatment adherence to ongoing adjuvant endocrine treatment in the global randomized PALLAS randomized trial in patients with early breast cancer

  • 期刊论文

  • 发表日期：

    2025年3月27日

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  • Eileen Shinn,
  • David Zahrieh,
  • Angela DeMichele,
  • Nick Zdenkowski,
  • Julie Lemieux,
  • Jun Mao,
  • Vesna Bjelic-Radisic,
  • Michelle J. Naughton,
  • Georg Pfeiler,
  • Karen Gelmon,
  • Justin M. Balko,
  • Daniel Egle,
  • Gabriele Zoppoli,
  • Tiffany Traina,
  • Miguel Martin Jimenez,
  • Silvia Antolin Novoa,
  • Tufia Haddad,
  • Arlene Chan,
  • Alistair Ring,
  • Antonio Wolff,
  • William Fraser Symmans,
  • Jose Ponce Lorenzo,
  • Dhanusha Sabanathan,
  • Hal J. Burstein,
  • Zbigniew Ireneusz Nowecki,
  • Gunda Pristauz-Telsnigg,
  • Adam Brufsky,
  • Meritxell Bellet-Ezquerra,
  • Theodoros Foukakis,
  • Yelena Novik,
  • Gabor Rubovszky,
  • Christian F. Singer,
  • Karoline Muehlbacher,
  • Otto Metzger Filho,
  • Theodora Goulioti,
  • Ernest Law,
  • Ann H. Partridge,
  • Lisa A. Carey,
  • Alex Zoroufy,
  • Dominik Hlauschek,
  • Christian Fesl,
  • Erica L. Mayer,
  • Michael Gnant

摘要

Purpose

Using patient-reported outcomes (PROs) and more objective measures, we evaluated adherence to adjuvant palbociclib and ET in the PALLAS trial, and the impact of palbociclib on ET adherence.

Methods

The open-label, global, phase 3 PALLAS trial randomized patients with hormone receptor-positive (HR+), HER2-negative stage II–III breast cancer (1:1) to either 26 cycles of palbociclib (125 mg/day for 21 days and then 7 days off) plus adjuvant ET, versus ET alone. After 23.7 months median follow-up, palbociclib was stopped due to futility of the intervention and patients were moved to follow-up. For each cycle, daily adherence to ET was measured with study diaries; for palbociclib, study diaries and pill counts. At cycles 2, 3, 6, 12, 18 and 24, patients completed the McHorney Adherence Questionnaire. Mean persistence was defined in months from treatment initiation to cessation.

Results

Four thousand six hundred eighty-eight of 5796 total PALLAS participants were included. Across all cycles, mean daily ET adherence values measured by study diary were > 98.0% and did not differ between treatment arms. Mean persistence to ET was similar between arms (19.2 months for palbociclib + ET vs. 19.6 months for ET alone). However, patient-reported maximal ET adherence was higher across time for palbociclib + ET compared to ET alone (p = 0.05).

Conclusion

In the PALLAS trial, addition of palbociclib did not decrease adherence to adjuvant ET. Though numbers declined over time, daily adherence for palbociclib and ET remained relatively high at each cycle.

Trial Registration: The trial is registered with ClinicalTrials.gov (NCT02513394; 07-31-2015) and EudraCT (2014-005181-30).