Relevance Rating: High
- This study is directly relevant for those with metastatic pancreatic cancer who also have BRCA mutations.
- Because the target population of this study are BRCA mutation carriers, this information is not fully generalizable.
- The study is limited in that did not look at people with mutations in other genes or with a family history of pancreatic cancer without a known mutation.
- The intervention, maintenance olaparib (Lynparza) has not been approved by the FDA for metastatic pancreatic cancer, so this is not yet clinically useful.
- This drug is approved for use for breast, ovarian, Fallopian tube and primary peritoneal cancers for individuals with BRCA mutations.
Scientific Strength Rating: High
- This is a well-designed randomized, double-blind, placebo-controlled phase 3 clinical trial.
- This study builds on prior knowledge of olaparib as a treatment for other types of cancer and early safety trials for olaparib for pancreatic cancer patients.
- The controls and intervention (olaparib) and statistical analyses of the data are well described and appropriate.
- The conclusions that the researchers reach are appropriate for the data observed.
- The conclusions are limited in that the study participants included only those with BRCA mutation so there is no information about the utility of olaparib for other gene mutations. Similarly, people whose cancer progress before the start of the study were excluded; it is not known whether olaparib would be helpful for those individuals.
Clinical Timeline: Late Clinical Trials (phase 3)