Patient-Reported Outcomes Predict Progression-Free Survival of Patients with Advanced Breast Cancer Treated with Abemaciclib. (11th May 2021)

• Record Type: Journal Article
• Authors: Badaoui, Sarah; Kichenadasse, Ganessan; Rowland, Andrew; Sorich, Michael J.; Hopkins, Ashley M.
• Is Part Of: Oncologist. Volume 26:Number 7(2021)
• Page Start: 562
• Page End: 568
• Publication Date: 2021-05-11
• Subjects: Abemaciclib -- Patient-reported outcome measures -- Progression-free survival -- Advanced breast cancer -- Prognosis; Oncology -- Periodicals; Tumors -- Periodicals; Cancérologie -- Périodiques; Tumeurs -- Périodiques; Oncology; Tumors; Neoplasms; Electronic journals; Periodicals; Periodicals; 616.994
• DOI: 10.1002/onco.13806
• Languages: English
• ISSNs: 1083-7159

Abstract

Abstract: Background: Abemaciclib is a CDK4/6 inhibitor used to treat hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer. The prognostic value of patient-reported outcomes (PROs) has been minimally explored for treatment outcomes with CDK4/6 inhibitors. The performance of PROs compared with Eastern Cooperative Oncology Group performance status (ECOG-PS) is unknown. Materials and Methods: This study pooled data from single-arm trial, MONARCH 1, and randomized trials, MONARCH 2 and 3. In total, 900 patients initiated abemaciclib and 384 comparator therapy. Pretreatment PRO association with progression-free survival (PFS) was modeled using Cox proportional hazards regression. Prediction performance was assessed via the C-statistic ( c ). PROs were recorded via the European Organisation for Research and Treatment of Cancer QLQ-C30. Results: Patient-reported physical function, pain, role function, fatigue, and appetite loss were associated with PFS on univariable and adjusted analysis ( p < .05). Physical function ( c = 0.55) was most predictive, superior to ECOG-PS ( c = 0.54), with multivariable analysis indicating both provide independent information ( p < .02). In the pooled randomized arms of MONARCH 2 and 3, the PFS treatment benefit (hazard ratio [95% confidence interval]) of abemaciclib (vs. comparators) was 0.75 (0.57–1.0) for low physical function, compared with 0.48 (0.40–0.59) for intermediate/high ( p [interaction] = .01). Conclusion: PROs were identified as prognostic factors for PFS in patients initiating abemaciclib, with patient-reported physical function containing independent predictive information beyond ECOG-PS. Low physical function was associated with a decrease in the magnitude of PFS benefit from abemaciclib. PROs should be explored as prognostic, predictive, and stratification factors for clinical use and research trials of CDK4/6 inhibitors. Implications for Practice: For the first time, pretreatment patient-reported outcomes have been shown to be independent prognostic markers for progression-free survival (PFS) in patients diagnosed with hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2−) advanced breast cancer treated with abemaciclib. Importantly, patients with low physical function had a smaller PFS benefit from abemaciclib (vs. comparator) than patients with intermediate/high physical function. The present study demonstrates patient-reported outcomes as a simple, effective, inexpensive, and independent prognostic marker for patients with HR+/HER2− advanced breast cancer treated with abemaciclib. Abstract : Describing a cohort of patients with HR+/HER2− advanced breast cancer treated with abemaciclib, this article evaluates the prognostic association between pretreatment patient-reported outcomes and progression-free survival, the prediction performance of patient-reported outcomes compared with ECOG performance status, and the effect of patient-reported outcomes on the treatment benefit of abemaciclib versus comparator therapy.