Ariana Pelosci

The FDA has granted priority review for olaparib (Lynparza) for patients with 

-mutated HER2-negative high-risk early breast cancer who have previously been treated with chemotherapy before or after surgery, according to a press release from the PARP inhibitor’s developer, AstraZeneca.1

Olaparib was assessed as part of the phase 3 OlympiA trial (NCT02032823). which showed that patients had an improvement in invasive disease-free survival (iDFS), reducing the risk of breast cancer recurrence by 42% compared with those in the placebo group (HR, 0.58; 99.5% CI, 0.41-0.82; 

 <.0001). A prescription drug user fee act date has been set for early 2022.

A total of 1836 patients, including 6 men, were randomly assigned to receive either olaparib at 300 mg or the matching placebo twice daily for 52 weeks.2 In the intent-to-treat population, the median follow-up was 2.5 years. Additionally, 82.2% of patients had triple-negative breast cancer. Half of all patients received adjuvant chemotherapy and half received neoadjuvant chemotherapy. In 72.3% of patients, 

At the prespecified interim analysis, the efficacy boundary was crossed. At 3 years, a total of 85.9% of patients in the olaparib group and 77.1% of patients in the placebo group were alive and free of invasive disease. A total of 106 patients in the olaparib group and 178 in the placebo group experienced invasive disease or death.

At 3 years, the distant DFS was 87.5% in the olaparib group and 80.4% in the placebo group. Those who received olaparib had significantly longer distant DFS compared with the placebo group (HR, 0.57; 99.5% CI, 0.39-0.83; 

 <.001). In the olaparib group, 59 deaths were reported compared with 86 in the placebo group (HR, 0.68; 99% CI, 0.44-1.05; 

 = .02). In 93% patients in the olaparib group and 95% in the placebo group, the primary cause of death was breast cancer. Two patients who did not have a previous event of invasive disease died in the olaparib group. 

The safety analysis included 911 patients from the olaparib group and 904 in the placebo group. Discontinuation of treatment occurred in 25.9% patients in the olaparib group and 20.7% in the placebo group.

Adverse effects (AEs) of grade 3 or higher in the olaparib group included anemia (8.7%), decreased neutrophil count (4.8%), decreased white-cell count (3.0%), fatigue (1.8%), and lymphopenia (1.2%). Within the placebo group, AEs of grade 3 or higher did not occur in more than 1% of patients. A total of 5.8% patients in the olaparib group and 0.9% in the placebo group received blood transfusions, with 4.1% patients in the olaparib group only receiving 1 transfusion.

Serious AEs were repoted in 8.7% of patients in the olaparib group and 8.4% in the placebo group. In the olaparib group, 1 patient had cardiac arrest that led to death, and 1 patient in the placebo group developed acute myeloid leukemia (AML) and ovarian cancer. AEs of special interest included pneumonitis, radiation pneumonitis, myelodysplastic syndrome, or AML.

In the United States, Olaparib has been previously approved for first-line maintenance treatment of 

-mutated ovarian cancer following response to platinum-based chemotherapy, first-line maintenance treatment plus bevacizumab (Avastin) for homologous recombination deficient–positive advance ovarian cancer, and 

-mutated HER2-negative metastatic breast cancer previously treated with chemotherapy, with additional indications for treatment in prostate and pancreatic cancer.

This article was originally posted on Cancer Network®. 

1. Lynparza granted priority review in the US for BRCA-mutated HER2-negative high-risk early breast cancer. News Release. AstraZeneca. November 30, 2021. Accessed November 30, 2021. https://bit.ly/3llGA9m

2. Tutt ANJ, Garber JE, Kaufman B, et al. Adjuvant olaparib for patients with BRCA1- or BRCA2-mutated breast cancer. 

. 2021;384(25):2394-2405. doi:10.1056/NEJMoa2105215

Articles

Olaparib, which was granted priority review by the FDA, has been shown to improve invasive disease-free survival for patients with BRCA-mutated HER2-negative high-risk early breast cancer.

 FDA grants olaparib priority review in BRCA-mutated HER2-negative high-risk early breast cancer

Consideration for the whole family and psychosocial supports needs is particularly important for patients with breast cancer who have dependent children, with those who have a poor health-related quality of life (HRQOL), little social support, and single mothers having higher psychosocial needs, according to a study published in 

Findings from the study indicated that that 59.3% of patients with children expressed a current phycological support need and 33.3% expressed needs for their children. A bivariate association was identified indicating that a lack of social support and a poor maternal HRQOL resulted in higher psychosocial need among patients and their children.

A total of 561 patients met the study’s inclusion criteria and filled out a questionnaire, 23.0% of whom had received psychosocial support with their family prior to the rehabilitation program. For patients living in a metropolitan area, 30.4% had previously utilized psychosocial support compared with 17.4% of patients in rural areas. Psychosocial services were more frequently used by those who did not have a partner (34.5%), compared with patients who had a partner (20.5%). Additionally, 74.7% of patients who had not previously received family-centered psychosocial support felt that they had sufficient support from home, 48.5% did not feel a need for the services, and 42.3% did not know about the support offers.

In total, 87.1% expressed a need to support their children processing the disease, with 84.6% desiring support to determine whether their child’s reaction was appropriate. Moreover, 73.3% wanted support for their partners. Statements that referred to the patients' behavior, such as discussing their disease within the family, were less approved compared with statements regarding the well-being of the family as a whole.

Patients stated that family-centered support was mostly needed during the diagnostic stage (62.0%) and treatment stage (73.4%). In total, 24.4% of patients felt a need for family-centered support when finishing treatment, in addition to 22.3% who required support during rehabilitation. Additionally, 6.3% of patients did not specify the need for support. Over time, the need for psychosocial support remained stable (36.8%), and 33.1% did not need psychosocial support. Additionally, 17.9% had an increased need for support and 12.2% had a decreased need.

When seeking support, 81.4% of patients saw a psycho-oncologist and 12.7% used a professional counseling center.

If the patient did not have a partner, children trended towards having higher psychosocial support needs (51.3%) compared with patients who had a partner (29.6%). Additionally, patients less often expressed a need for psychosocial services for their partner and whole family (25.8% vs 22.9%).

Those without immediate social support or network tended to have higher psychosocial needs for themselves (76.1% vs 57.9%) and their children (63.2% vs 31.4%).

Patients who were reported to have psychosocial support needs were reported to have a lower HRQOL compared with those without. Patients showed a large difference on the social function scale. Emotional function had an even larger difference, but investigators reported that there was not an applicable threshold. Severa, medium differences were reported, including cognitive functioning, fatigue, sleep disturbances, and financial impact.

Hammersen F, Pursche T, Fischer D, Katalinic A, Waldmann A. Psychosocial and family-centered support among breast cancer patients with dependent children. 

. 2021;30(3):361-368. doi:10.1002/pon.5585

Attention needs to be paid to the psychosocial needs of patients, especially those with poor health-related quality of life, who have little support, or are single mothers.

Ariana Pelosci

Articles

FDA grants olaparib priority review in BRCA-mutated HER2-negative high-risk early breast cancer

Consideration towards the psychosocial support needs of patients with breast cancer who have dependent children is imperative