Olaparib (Lynparza) in women who have advanced high-grade epithelial ovarian cancer with a BRCA mutation

In 2019, the Institute for Quality and Efficiency (IQWiG, Germany) looked into whether olaparib has any advantages or disadvantages compared with the watchful waiting approach in women who have advanced high-grade epithelial ovarian cancer with a BRCA mutation, are receiving platinum-based chemotherapy for the first time, and are benefiting from it.

The manufacturer provided one study involving a total of 391 women with usable data. Almost all of the women had serous ovarian cancer. The term "serous" refers to a certain characteristic of tumor tissue.

The study is still on-going, but an interim analysis was completed after about 5 years. Overall, 260 women in the study received olaparib and 131 women were given the standard treatment (watchful waiting). Early analyses suggest that olaparib has the following advantages and disadvantages:

What are the advantages of olaparib?

No advantages were found compared with the standard treatment.

What are the disadvantages of olaparib?

Severe side effects: Early estimates suggest that olaparib has a disadvantage here compared to the watchful waiting approach. Severe side effects occurred in about 39 out of 100 women in the olaparib group, and in only 19 out of 100 women in the comparison group.

Treatment stopped due to severe side effects: Early analyses suggest that olaparib has a disadvantage here compared to the watchful waiting approach. 12 out of 100 women in the olaparib group stopped the treatment due to side effects, compared to only 2 out of 100 women in the comparison group.

Severe anemia: Early analyses suggest that olaparib has a disadvantage here, too. Severe anemia occurred in about 21 out of 100 women who used olaparib and in only about 2 out of 100 women in the comparison group.

Early analyses suggest that olaparib has a disadvantage regarding the following side effects, too:

  • Loss of taste / Changes in taste
  • Shortness of breath
  • Nausea and vomiting
  • Inflammation of the membranes lining the mouth and other parts of the body
  • Muscle spasms
  • Lack of strength (asthenia)

No difference

General health: No difference was found here.

Health-related quality of life: There was no relevant difference here either.

What remains unanswered?

Life expectancy: There was no difference here. But the observation period was very short and there weren't enough deaths to be able to draw any reliable conclusions. About 21 out of 100 women died in each of the groups.

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Olaparib (Ovarian cancer) – Benefit assessment according to §35a Social Code Book V . Dossier assessment; Commission A19-56. October 11, 2019. (IQWiG reports; Volume 826).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Created on November 7, 2019
Next planned update: 2022

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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