Cholangiocarcinoma: nab-paclitaxel/gemcitabine offers alternative

  • Sahai V & al.
  • JAMA Oncol
  • 1 Dec 2018

  • curated by Jim Kling
  • Univadis Clinical Summaries
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Takeaway

  • Nanoparticle albumin-bound (nab)-paclitaxel combined with gemcitabine is well-tolerated and shows efficacy in patients with metastatic cholangiocarcinoma.
  • The combination failed to meet the alternative hypothesis of 70% improvement in PFS.

Why this matters

  • Paclitaxel has the potential to improve gemcitabine efficacy by inhibiting the metabolizing enzyme; the nanoparticle formulation reduces toxicity.
  • Findings suggest that the new combination could be an acceptable alternative to standard therapy with gemcitabine plus a platinum analog.

Study design

  • Single-arm, phase 2 trial of 74 patients (median age, 62 [range, 36-87] years, 44 women) receiving nab-paclitaxel plus gemcitabine.
  • Median number of cycles, 6 (range, 1-18).
  • Median follow-up, 10.2 (range, 0.6-27.3) months. 
  • Primary endpoint: PFS (null and alternative hypotheses of 55% and 70%, respectively).
  • Funding: Celgene.

Key results

  • PFS at 6 months was 61% (95% CI, 48%-73%), failing to meet the alternate hypothesis of 70%.
  • Median PFS, 7.7 months (95% CI, 5.4-13.1).
  • Median OS, 12.4 months (95% CI, 9.2-15.9).
  • Median time to progression, 7.7 months (95% CI, 6.1-13.1).
  • Confirmed best overall response rate, 30%. Confirmed best disease control rate, 66%.
  • 97% of patients experienced a treatment-related adverse event (AE) (grade ≥3, 88%).
  • Most common AEs: fatigue (70%), neutropenia (68%), peripheral neuropathy (55%).

Limitations

  • Uncontrolled study.
  • Small sample size.

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