- Addition of nanoparticle albumin-bound (nab)-paclitaxel to gemcitabine-cisplatin was associated with better survival in advanced biliary tract cancer (BTC) when compared with historical controls treated with gemcitabine-cisplatin.
Why this matters
- Nab-paclitaxel may enhance gemcitabine delivery to pancreatic tumors through depletion of stroma, an effect that might also be effective in other stroma-rich cancers such as BTCs.
- Open-label, single-group, phase 2 study (n=60). Intention-to-treat analysis.
- Funding: Celgene.
- Median PFS: 11.8 (95% CI, 6.0-15.6) months; 12-month PFS rate, 45% (95% CI, 30%-60%).
- Median OS, 19.2 (95% CI, 13.2-not estimable) months; 12-month OS, 66% (95% CI, 51%-78%).
- There was no significant difference in PFS or OS between tumor types or among patients with metastatic or nonmetastatic disease.
- Partial response rate, 45%; disease control rate, 84%.
- 20% of participants converted from nonresectable to resectable disease.
- 58% of patients experienced grade 3 or higher adverse events, most commonly neutropenia (33%).
- 16% withdrew from the trial because of adverse events.
- Small population size.
- Historical controls.