Favourable Quality of Life Reported With Ribociclib Treatment in MONALEESA-2 Study: Presented at ASCO PalliativeCare

By Brian Hoyle

SAN DIEGO -- October 31, 2017 -- Health-related quality of life (HRQoL) is enhanced by treatment with ribociclib in hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer, according to a study presented here at the 2017 ASCO Palliative Care in Oncology Symposium.

These patient-reported outcomes from the MOALESSA-2 phase 3 trial (NCT01958021) come on the heels of the reported success of the combination of ribociclib and letrozole versus placebo and letrozole in significantly extending progression-free survival and boosting response rates in 668 patients with HR+, HER2- breast cancer (Hortobagyi et al. NEJM. 2016;375:1738-1748).

“In addition to significantly improving progression-free survival compared with placebo plus letrozole, ribociclib plus letrozole maintains HRQoL in postmenopausal women with HR+, HER2- advanced breast cancer,” said Sunil Verma, MD, Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, on October 27.

Validated European Organization for Research and Treatment of Cancer (EORTC) questionnaires were used to gauge the responses from patients about their treatment outcomes. The responses carried weight, since >90% of the patients responded through 19 cycles of treatment.

Pain was significantly improved by use of ribociclib by ≥5 points (mean, -6.3-point reduction in EORTC QLQ-C30 pain symptom score) in combination with letrozole through the first 15 cycles of treatment. In contrast, pain was lessened by

HRQoL was similarly maintained in both treatment arms. As expected, when disease progressed or treatment ended, the assessed HRQoL declined. The decline was similar in both treatment arms. The similarities continued when the researchers looked at the time taken for HRQoL to deteriorate to a known extent, but the time was slightly prolonged in patients receiving the ribociclib/letrozole combination (hazard ratio, 0.944; 95% confidence interval, 0.720-1.237). Finally, patient-reported bouts of fatigue, nausea, and vomiting were similar in the treatment arms.

“A clinically meaningful reduction in pain was observed with ribociclib-plus-letrozole treatment, with a nonmeaningful trend in pain reduction observed in the placebo-plus-letrozole arm,” said Dr. Verma.

“In the MONALESSA-2 study, there were no clinically meaningful differences between treatment arms in HRQoL score differences >5 points, suggesting that adverse events did not significantly impact overall HRQoL,” concluded Dr. Verma.

This benefit of ribociclib plus letrozole was maintained throughout chemotherapy.

The findings provide further support for the use of ribociclib, which works by inhibiting molecules called cyclin-dependent kinase (CDK) 4 and 6. CDK 4 and 6 are important in the control of cell division.

The results of the MONALESSA-2 trial were the basis of the US Food and Drug Administration approval earlier this year of ribociclib/letrozole for women with HR+, HER2- advanced or metastatic breast cancer.

Funding for the study was provided by Novartis.

[Presentation title: Health-Related Quality of Life of Postmenopausal Women With Hormone Receptor-Positive, HER2- Advanced Breast Cancer Treated With Ribociclib + Letrozole: Results From MONALEESA-2. Abstract 133]

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