Chemotherapy+selective internal radiotherapy shows first-line promise in intrahepatic cholangiocarcinoma

  • Edeline J & al.
  • JAMA Oncol
  • 31 Oct 2019

  • curated by Jim Kling
  • Univadis Clinical Summaries
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Takeaway

  • Selective internal radiotherapy (SIRT) combined with cisplatin/gemcitabine led to downstaging to surgery in some patients with inoperable intrahepatic cholangiocarcinoma (ICC).

Why this matters

  • This is the first prospective study to combine SIRT with chemotherapy in this population.

Study design

  • Phase 2 open-label, single-group trial (MISPHEC; n=41) of patients with unresectable ICC who had never undergone chemotherapy or intra-arterial therapy.
  • Eight 21-day cycles of first-line cisplatin (25 mg/m2) and gemcitabine (1000 mg/m2; days 1 and 8).
  • Gemcitabine was reduced to 300 mg/m2 in the cycles during and after SIRT.
  • Disease involving both hemilivers received SIRT during cycles 1 and 3, whereas single-hemiliver disease received SIRT during cycle 1.
  • SIRT was delivered using glass Y90 microspheres.
  • Funding: BTG; Ligue Contre le Cancer.

Key results

  • Objective response rate at 3 months, 39% (90% CI, 26%-53%); disease control rate, 98% (95% CI, 89%-99%).
  • Median PFS, 14 (95% CI, 8-17) months.
  • Median OS, 22 (95% CI, 14-52) months; 12-month OS, 75% (95% CI, 62%-89%); 24-month OS, 45% (95% CI, 30%-61%).
  • 9 patients (22%) were downstaged to surgical intervention, 8 of whom underwent R0 resection. Postsurgical OS was 88.9% at 12 months and 88.9% at 24 months.

Limitations

  • Open-label, small population size.