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08-04-2022 | Breast cancer | News

monarchE PRO data bolster adjuvant abemaciclib use in early breast cancer

Author: Shreeya Nanda

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medwireNews: The patient-reported outcomes (PROs) from the monarchE trial add support for the addition of abemaciclib to endocrine therapy (ET) in the treatment of high-risk, early breast cancer, say the researchers.

They also report on the mature safety data from the study, which confirm that the combination “has a manageable and acceptable safety profile as adjuvant therapy and supports a positive benefit-risk balance” for these patients with hormone receptor-positive, HER2-negative disease.

The phase 3 study, comprising 5637 participants, previously demonstrated a significant invasive disease-free survival benefit with the combination of abemaciclib plus adjuvant ET versus ET alone. The CDK4/6 inhibitor was given for the initial 2 years of the 5–10-year course of ET.

This benefit did not come at the cost of tolerability, say the investigators, noting that the mean total score on the FACT-B health-related quality of life (HRQoL) questionnaire did not differ significantly between the groups at the assessments at 3, 6, 12, and 18 months.

The mean scores for certain ET symptoms, namely arthralgia and hot flushes, as well as for fatigue were similarly comparable between the treatment arms during the course of the study.

With regard to diarrhea, the mean change from baseline at the 3- and 6-month marks was greater for abemaciclib-treated patients than controls, and was also greater than the prespecified minimally important difference. But the change from baseline in the abemaciclib group fell below this threshold at the 12- and 18-month assessments.

And the study authors note that the mean scores for the item “I am bothered by side effects of treatment” were also comparable between the abemaciclib and control arms.

Hope Rugo (University of California San Francisco, USA) and colleagues also share data from safety analyses conducted at a median follow-up of 27 months, which showed a higher incidence of grade 3 or worse adverse events (AEs) in the abemaciclib than control group, at 49.7% versus 16.3%.

These tended to be laboratory abnormalities, such as neutropenia (19.6 vs 0.8%) and leukopenia (11.3 vs 0.4%), and “were effectively managed with dose adjustments per protocol and rarely caused serious complications, like febrile neutropenia or infections,” they add.

Serious AEs also occurred more commonly among participants given abemaciclib plus ET versus those given ET alone, at rates of 15.2% and 8.8%, respectively, but the rates of discontinuation due to serious AEs were low and similar between groups (0.9 vs 0.6%).

Discussing the study limitations, Rugo et al point out that “the frequency of PRO assessments was insufficient to capture patient-reported side effects and HRQoL within the first 3 months.”

And they conclude in the Annals of Oncology that “[i]n routine clinical practice, more frequent monitoring of patient reported symptoms captured electronically, plus offering alternative modes of administration to assure vulnerable patients report their symptoms, may improve side effect management and patient outcomes.”

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2022 Springer Healthcare Ltd, part of the Springer Nature Group

Ann Oncol 2022; doi:10.1016/j.annonc.2022.03.006

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