Study: Quality of life for people with early-stage breast cancer who participated in the OlympiA clinical trial

Contents

STUDY AT A GLANCE

What is this study about?

The OlympiA study is looking at the effects of one year of treatment with the PARP inhibitor olaparib (Lynparza) for people with an inherited BRCA1 or BRCA2 mutation who have early-stage breast cancer with a high risk for recurrence. Early positive results from OlympiA were presented at the June 2021 American Society of Clinical Oncology (ASCO) annual conference. Read our XRAY review about those OlympiA trial results here. Based on results from the OlympiA Study, on March 11, 2022 the FDA approved olaparib as adjuvant treatment for people with an inherited BRCA mutation who have been diagnosed with early-stage HER2-negative breast cancer and are at high risk for recurrence. 

Researchers also looked at participants’ quality of life during the study and presented these results at the San Antonio Breast Cancer Symposium in December 2021. The quality of life results are summarized in this XRAY review. 

Why is this study important?

Based on the early results of OlympiA, the American Society of Clinical Oncology (ASCO) updated their guidelines on the treatment of hereditary breast cancer. Guidelines now recommend a year of treatment with olaparib after the completion of chemotherapy for people with an inherited mutation in BRCA1 or BRCA2 who have been diagnosed with early-stage HER2-negative breast cancer.  Researchers were interested in learning if there were differences in quality of life for participants in OlympiA who received olaparib compared to participants who received placebo.

Study findings

Participants in the OlympiA trial had neoadjuvant chemotherapy (before surgery or radiation) or adjuvant chemotherapy (after surgery).  Participants received olaparib (Lynparza) or placebo for one year after chemotherapy.

While olaparib improved disease-free survival among OlympiA participants, several significant side effects were associated with olaparib, as well as other PARP inhibitors.  For example, almost 70 percent of patients who take olaparib experience nausea and fatigue. 

Patient-reported outcomes suggest that:

• Overall, olaparib was well tolerated and did not reduce quality of life or changes in recovery from chemotherapy.

Participants who received olaparib reported:

• Slightly more fatigue at 6 and 12 months compared to those who received a placebo.
  • Fatigue slowly improved. At 18 and 24 months no differences were seen between groups (those taking olaparib versus placebo).
• Slightly more nausea/vomiting at 6 and 12 months compared to those who received a placebo.
  • Nausea/vomiting slowly improved. At 18 and 24 months no differences were seen between groups.
• No differences in diarrhea.
• No differences in overall quality of life, physical or mental functioning.
  • A gradual improvement of these factors was observed in both groups over 24 months.
    • This was expected because all patients had to recover from intensive chemotherapy, radiation and surgery prior to treatment with olaparib or placebo.

Strengths and limitations

Strengths

• OlympiA is a large, international, phase 3, double-blinded, randomized study that was powered to show overall survival, disease-free survival, safety and quality of life outcomes.
• The study built on prior research that showed olaparib benefited people with an inherited BRCA1 and BRCA2 mutation who had advanced breast cancer.

Limitations

• Quality of life results were self-reported, which may be biased.
• OlympiA is being conducted in North and South America, Europe, the Middle East and Asia. Preliminary results did not mention race and ethnicity. This is important because mutations in the BRCA1 or BRCA2 genes can be prevalent among certain racial and ethnic groups. While there is no indication that olaparib would affect outcomes differently in some racial groups, specific data from this study is lacking.

What does this mean for me?

If you have a BRCA1 or BRCA2 mutation and have been diagnosed with early-stage HER2-negative breast cancer with a high risk for recurrence, you may benefit from one year of maintenance treatment with olaparib. If you do not know whether you have a BRCA1 or BRCA2 mutation, genetic testing may help you learn if you might benefit from additional treatment with olaparib.

Olaparib is FDA-approved to treat certain types of breast cancer. Because this approval does not include adjuvant therapy in people with a BRCA1 or BRCA2 mutation with early-stage breast cancer, some health plans may not cover the cost for this treatment.

If you are treated with olaparib as maintenance therapy, you can expect to have slightly more fatigue, nausea and vomiting (statistically significant in this study) at 6 and 12 months compared to those who do not use olaparib as maintenance therapy. While not significantly different between groups (olaparib versus placebo), quality of life scores (e.g., physical and emotional function) as well as overall health, slowly improved during the 24 months after treatment in all patients.

Context

Some of the most common chemotherapy side effects include nausea and vomiting, fatigue, diarrhea, constipation, hair loss, chemobrain (forgetfulness or difficulty concentrating), changes in appetite and/or weight and lymphedema (chronic painful swelling). However, most patients recover from the effects of chemotherapy within one to two years after treatment.

It is important to know whether additional treatment or maintenance therapy, which is sometimes added after chemotherapy is completed, could worsen or delay recovery.

Olaparib is an oral medication that has been shown to improve treatment outcomes for patients with inherited breast cancer. Importantly, when used as maintenance therapy after completion of chemotherapy, it does not appear to significantly worsen side effects related to chemotherapy. 

Conclusions

Current data from the OlympiA Trial suggests that adjuvant olaparib was effective in reducing recurrence and metastasis of cancer and cancer-related death in patients with a BRCA1 or BRCA 2 mutation.

In a follow-up quality-of-life study, using olaparib for one year after completion of chemotherapy did not worsen chemotherapy related side effects. By two years, chemotherapy-related side effects were similar between participants taking olaparib and those taking placebo.

These findings suggest that more treatment options may be available for people with BRCA mutations who have been diagnosed with early-stage HER2-negative breast cancer.  

References

Ganz PA, on behalf of the OlympiA Steering Committee Members and Trial Investigators. 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 HER-2 negative early breast cancer. 2021 San Antonio Breast Cancer Symposium; December 7-10, 2021; San Antonio, Texas. Abstract number GS4-09.

Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

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posted 2/22/22