Olaparib is well tolerated as an additional treatment

Adjuvant treatment with the PARP-inhibitor olaparib showed beneficial effects for patients with BRCA1/2 mutations and high-risk, HER2-negative, early-stage, primary breast cancer. In addition, patient-reported outcomes (PROs) demonstrated no negative impact on the quality of life.

OlympiA (NCT02032823) is a randomised, double-blind, placebo-controlled, phase 3 trial evaluating the efficacy and safety of the PARP-inhibitor olaparib in patients with germline BRCA1/2 mutations and high-risk, HER2-negative, early-stage, primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy. A recently published interim analysis at a median follow-up of 2.5 years showed the 3-year invasive disease–free survival to be 85.9% in the olaparib group and 77.1% in the placebo group [1]. In the OlympiA trial, PROs were collected to inform the discussion between physicians and patients regarding the risks and benefits of additional adjuvant therapy. Dr Patricia Ganz (UCLA School of Medicine, CA, USA) presented the results [2].

A total of 1,836 patients were randomised (1:1) to 1 year adjuvant olaparib or placebo. PRO assessments were done at baseline and every 6 months up to 2 years. Data from 1,535 patients were available for these analyses. Baseline scores for fatigue were well balanced between study arms and clinically meaningfully lower in OlympiA patients compared with healthy women. Patients treated with olaparib experienced a higher increase in fatigue scores at 6 and 12 months compared with patients treated with placebo. However, this difference (-1.3 at 6 months, P=0.024 and -1.5 at 12 months, P=0.025) did not reach the prespecified border of a clinically meaningful difference of 3 points. At 18 and 24 months, no differences in fatigue scores between patients treated with olaparib or placebo were observed. Scores for nausea and vomiting were clinically meaningfully higher in patients treated with olaparib at 6 months (P<0.001) and 12 months (P<0.001), but not at 18 and 24 months. Diarrhoea was not increased for either treatment group during the study. Physical functioning, emotional functioning, nor global health status was impaired over time for either treatment group.

“In conclusion, these results show that treatment with olaparib comes with a clinically meaningful increase in nausea and vomiting during the first year of treatment,” said Dr Ganz. “Olaparib does not induce a clinically meaningful increase of fatigue, diarrhoea or a decrease in quality of life.”

1. Tutt ANJ, et al. N Engl J Med 2021;384:2394–2405.
2. Ganz PA, et al. Quality of life results from OlympiA: A phase III, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients with germline BRCA1/2 mutations and high risk HER2 negative breast cancer. GS4-09, SABCS 2021 Virtual Meeting, 7–10 December.

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Posted on 31 January 202227 March 2024