Lynparza After Chemo May Not Greatly Impact Quality of Life in High-Risk Early Breast Cancer Subset

Symptoms including fatigue and nausea/vomiting from the use of Lynparza (olaparib) may be easily resolved after treatment completion in patients with germline BRCA1/2 mutations and high-risk HER-2-negative early breast cancer, trial findings demonstrated.

Findings from this sub-study were presented at the 2021 San Antonio Breast Cancer Symposium by Dr. Patricia A. Ganz, a professor of medicine in the David Geffen School of Medicine at UCLA and director of the Center for Cancer Prevention and Control Research at the Jonsson Comprehensive Cancer Center.

“(Lynparza) was well tolerated as adjuvant therapy with no clinically meaningful increase in fatigue during treatment or significant impact on quality of life,” Ganz said during the presentation. “While (Lynparza) treatment led to slight increases in severity of nausea and vomiting, it did not persist after treatment ended. Scores on physical and emotional functioning as well as global health slowly improved during the 24 months after adjuvant chemotherapy, and one year of (Lynparza) did not meaningfully affect this recovery.”

Potential Exacerbation of End-of-Treatment Symptoms

Researchers assessed the impact of one year of adjuvant Lynparza after completing chemotherapy (neoadjuvant or adjuvant) and local therapy on distant disease-free survival (the time when a patient survives without signs of distant cancer), invasive disease-free survival (the time when a patient survives without signs of invasive cancer) and overall survival (the time a patient with cancer is still alive). This sub-study focused on quality-of-life factors.

“The central question for the OlympiA (patient-reported outcomes) study is to understand whether or not (Lynparza) might exacerbate end-of-treatment symptoms such as fatigue and possibly delay improvement in quality of life after chemotherapy,” Ganz said.

Ganz added that previous studies have demonstrated the potential toxicities associated with chemotherapy.

“Research has demonstrated that chemotherapy has substantial acute toxicities, leaving patients with fatigue and decreased physical functioning at the end of treatment, requiring as much as one to two years to recover to pretreatment levels,” she explained. “In OlympiA, patient-reported outcomes were collected to inform discussions between physicians and their patients regarding risks and benefits of this additional adjuvant therapy.”

In particular, information on patient-reported outcomes including fatigue and nausea/vomiting were collected via validated questionnaires before randomization, during treatment (at six months and 12 months) and after treatment (at 18 months and 24 months).

Assessing Quality-of-Life Post-Treatment

This sub-study included 1,751 patients, of whom 875 received neoadjuvant chemotherapy (440 patients assigned Lynparza and 435 patients assigned placebo) and 876 received adjuvant chemotherapy (436 patients assigned Lynparza and 440 assigned placebo). At baseline, patients assigned Lynparza or placebo had similar quality-of-life and symptom scores.

Patients treated with Lynparza had greater fatigue severity compared with those treated with placebo at six months. This was also seen at 12 months. Despite these differences in fatigue severity, they were not considered clinically meaningful based on criteria with the FACIT-Fatigue Scale. Differences in fatigue severity did not significantly differ between both groups at 18 months and 24 months.

Although the differences were small, patients treated with Lynparza had worse nausea and vomiting symptom severity than those treated with placebo at six months and 12 months. Differences were not observed at 18 months and 24 months.

Clinically meaningful differences between the Lynparza and placebo groups were not seen with regards to other symptoms and quality-of-life subscales. In fact, there were improvements in functioning over time.

Ganz mentioned that a limitation of this sub-study is that this analysis was performed before quality-of-life data collection was completed.

“With complete data in the future, there may be a better estimate of quality-of-life recovery in the year after the end of (Lynparza) treatment,” she added. “The final analyses of the (patient-reported outcomes) study will be able to examine the role of important treatment related covariates as they may interact with symptoms and quality of life in patients receiving (Lynparza).”

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