In the POLO study, patients with metastatic pancreatic cancer who had an inherited mutation in a BRCA gene, and whose disease had been controlled by platinum chemotherapy, took olaparib tablets or a placebo (dummy tablet). This final report showed that the average (median) survival was almost the same in the two groups, but a group of patients on olaparib lived longer (after 3 years about 34% vs 18%), and patients on olaparib spent more time without needing chemotherapy again. The tablets were well tolerated. BRCA genetic testing helps your doctor know whether this treatment is an option for you.
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: Abstract of the paper and full text of the original POLO paper (NEJM 2019; PMC6810605, Methods section)
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.
Patients with metastatic pancreatic adenocarcinoma and a deleterious or suspected deleterious germline BRCA mutation whose disease had not progressed after at least 16 weeks of first-line platinum-based chemotherapy.
Primary endpoint: progression-free survival (PFS). Secondary endpoints: overall survival (OS), time to second disease progression or death, time to first and second subsequent anticancer therapy or death, time to study treatment discontinuation or death, and safety and tolerability.
Olaparib was well tolerated and no new safety signal was observed.
This final analysis did not show a statistically significant overall survival benefit for maintenance olaparib, but the progression-free survival benefit reported in the primary analysis, together with the delay in need for subsequent chemotherapy and longer survival in a subgroup of patients, kept olaparib as a maintenance treatment option for patients with a germline BRCA mutation whose disease has not progressed on platinum chemotherapy. These results underline the importance of germline genetic testing in all patients with metastatic pancreatic cancer.
Small number of patients (154); the trial was not designed with overall survival as the primary endpoint and subsequent therapies may have affected overall survival. The 3-year survival and the separation of the curves after about 24 months are descriptive findings. The control group received placebo, not continued chemotherapy.
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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