TABLE 4.
Study Outcomes: Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer
| Outcome/Timeframe | Study Results and Measurements | Absolute Effect Estimate | Certainty of the Evidence (quality of evidence) | Plain Text Summary | |
|---|---|---|---|---|---|
| Placebo | Olaparib | ||||
| Progression-free survival (primary outcome) | Hazard ratio, 0.53 (95% CI, 0.35 to 0.82) | 904 per 1,000 | 711 per 1,000 | Moderate (1, 4) | Olaparib probably improves progressionfree survival (primary outcome) |
| Based on data from 154 patients in 1 study; follow-up, 24 months | Difference: 193 fewer per 1,000 (95% CI, 344 fewer to 50 fewer) | ||||
| Overall survival | Hazard ratio, 0.91 (95% CI, 0.56 to 1.46) | 640 per 1,000 | 605 per 1,000 | Moderate (1, 2) | Olaparib may have little or no difference on overall survival |
| Based on data from 154 patients in 1 study Follow-up 24 months | Difference: 35 fewer per 1,000 (95% CI, 204 fewer to 81 more) | ||||
| Response rate | Odds Ratio: 2.3 (95% CI, 0.89 to 6.76) | 100 per 1000 | 204 per 1,000 | Very low (1, 3) | Olaparib may have little or no difference on response rate |
| Based on data from 154 patients in 1 study | Difference: 104 more per 1,000 (95% CI, 10 fewer to 329 more) | ||||
| Serious adverse events | Relative risk, 1.56 (95% CI, 0.76 to 3.16) | 150 per 1,000 | 234 per 1,000 | Low (1) | Olaparib may worsen serious adverse events |
| Based on data from 151 patients in 1 study | Difference: 84 more per 1,000 (95% CI, 36 fewer to 324 more) | ||||
| Discontinuation of trial agent as a result of adverse events | Relative risk, 3.3 (95% CI, 0.39 to 27.5) | 17 per 1,000 | 56 per 1,000 | Very low (1, 3) | Olaparib may increase the risk of discontinuation of trial agent because of adverse events |
| Based on data from 151 patients in 1 study | Difference: 39 more per 1,000 (95% CI, 10 fewer to 451 more) | ||||
NOTE. Results from Golan et al.11 (1) Downgrade: only one study, commercially funded. (2) Based on an interim analysis; however, Expert Panel members agreed that this result can be considered moderately certain to be corroborated by final study results. (3) Imprecision: wide confidence interval. (4) Upgrade: large magnitude of effect. Population: platinum-sensitive patients with metastatic pancreatic adenocarcinoma and a germline BRCA1 or BRCA2 mutation. Intervention: poly (ADP-ribose) polymerase inhibitor olaparib as maintenance therapy for disease that has not progressed during first-line platinum-based therapy. Comparator: placebo.