Combination shows promise in advanced biliary tract cancer

  • Shroff RT & al.
  • JAMA Oncol
  • 18 Apr 2019

  • curated by Jim Kling
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • Open-label, single-group, phase 2 study (n=60). Intention-to-treat analysis.
  • Funding: Celgene.

Key results

  • 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.

Limitations

  • Small population size.
  • Open-label.
  • Historical controls.