- The combination of cisplatin, nab-paclitaxel, and gemcitabine showed encouraging benefit in a phase 1b/2 clinical trial in previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC).
Why this matters
- Although the primary endpoint of complete response was not met, the combination achieved one of the highest objective response rates seen in phase 1b/2 studies.
- Open-label phase 1b/2 trial in 24 patients with previously untreated metastatic PDAC.
- Patients were aggressively hydrated with intravenous (IV) fluids.
- Funding: Seena Magowitz Foundation; Stand Up to Cancer; Mattress Firm; Lustgarten Foundation; TGen Foundation; HonorHealth Foundation.
- A previous study by the researchers found that all pancreatic cancers they genetically sequenced had abnormal repair pathways.
- Maximum tolerable cisplatin dose: 25 mg/m2.
- Median number of cycles completed: 8 (range, 1-15).
- 8% of patients had complete responses, less than the primary endpoint of 25%.
- 62% had partial responses, 17% had stable disease, and 12% had progressive disease.
- Median OS: 16.4 (95% CI, 10.2-25.3) months.
- 1-year survival: 64%.
- 2-year survival: 40%.
- 3-year survival: 16%.
- 4-year survival: 8%.
- Median PFS, 10.1 (95% CI, 6.0-12.5) months.
- Objective response rate, 71%; disease-control rate, 88%.
- Nonrandomized, small sample size.