About 5 to 7% of patients with pancreatic cancer have an inherited mutation in the BRCA1 or BRCA2 genes. In these patients, if the disease is controlled by platinum-containing chemotherapy, the chemotherapy can be stopped and olaparib tablets continued as maintenance treatment. In this study, olaparib almost doubled the time the disease stayed under control (about 7.4 vs 3.8 months) and gave patients more time without chemotherapy. However, median survival did not change significantly, although some patients had a long-lasting benefit. This is why inherited genetic testing is recommended for all patients with pancreatic cancer.
Germline BRCA1/2 mutation and metastatic disease that has not progressed during at least 16 weeks of first-line platinum-based chemotherapy
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Olaparib (tablets) | 300 mg twice daily | Oral | Continuous |
Dose and indication from the FDA label and POLO. For creatinine clearance 31 to 50 mL/min, 200 mg twice daily.
On the page “Pancreatic cancer” · Metastatic disease: first-line, maintenance and later lines
No progression after at least 16 weeks of first-line platinum chemotherapy
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Olaparib | 300 mg | Oral (with or without food) | Twice daily (about every 12 hours) |
On the page “Olaparib (Lynparza)” · Standard dosing (FDA label)
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Olaparib tablets 300 mg orally twice daily as maintenance therapy, started 4 to 8 weeks after the last dose of first-line platinum-based chemotherapy and continued until radiological disease progression (investigator-assessed, modified RECIST 1.1) or unacceptable toxicity.
Matching oral placebo on the same schedule; crossover to olaparib was not allowed.
Source of the regimen details: Full text of the paper (PMC6810605, Methods section) and the FDA label for olaparib
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Primary endpoint: progression-free survival by blinded independent central review.
Secondary endpoints: overall survival, health-related quality of life and safety; in the final report, time to second progression and time to subsequent therapy.
Grade 3 or higher adverse events occurred in 40% of the olaparib group and 23% of the placebo group (difference 16 percentage points; 95% CI: −0.02 to 31). 5% and 2% of patients, respectively, discontinued treatment because of an adverse event. No significant difference in global quality of life was observed. In the final analysis, no new safety signal was seen.
Based on POLO, in 2019 the FDA approved olaparib for maintenance treatment of germline BRCA-mutated metastatic pancreatic adenocarcinoma that has not progressed after at least 16 weeks of platinum chemotherapy; the drug is also licensed in Europe. The ESMO 2023 guideline recommends BRCA testing for all metastatic patients and maintenance olaparib for patients with stable or responding disease on platinum at level [I, B] (ESMO-MCBS 2; ESCAT I-A). NCCN (Version 4.2026) considers olaparib the preferred targeted maintenance therapy after 4 to 6 months of platinum therapy without progression. ASCO 2020 lists it as one of the options alongside continued chemotherapy.
The sample size was small and an overall survival benefit was not significantly shown. The control group received placebo, whereas in practice many patients receive maintenance chemotherapy. Only germline BRCA mutations were studied (not somatic mutations or PALB2).
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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