Refractory or relapsed HL: ESHAOx displays modest activity, acceptable safety in phase 2

  • Won YW & al.
  • Ann Hematol
  • 2 Jan 2020

  • curated by Miriam Davis, PhD
  • Univadis Clinical Summaries
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Takeaway

  • A phase 2 study of salvage chemotherapy with etoposide, methylprednisolone, high-dose cytarabine, and oxaliplatin (ESHAOx) found modest activity and an acceptable safety profile in patients with refractory or relapsed Hodgkin's lymphoma (HL).

Why this matters

  • Guidance is lacking on how to treat refractory or relapsed HL.
  • The findings reported here suggest that ESHAOx is a feasible option.

Study design

  • Open-label, nonrandomized, multicenter trial of ESHAOx in Korea (N=36).
  • Patients with refractory or relapsed HL were given ESHAOx, consisting of intravenous (IV) etoposide 40 mg/m2 on days 1 to 4, IV methylprednisolone 500 mg on days 1 to 5, IV cytarabine 2 g/m2 on day 5, and IV oxaliplatin 130 mg/m2 on day 1; up to 6 cycles were repeated every 3 weeks.
  • Funding: National Cancer Center, Goyang, Korea.

Key results

  • Objective response rate, 72.2% (33.3% complete and 38.9% partial).
  • Median time to progression, 34.9 (95% CI, 23.1-46.7) months.
  • Most common grade 3 or 4 hematologic adverse events:
    • Neutropenia, 43.2%.
    • Thrombocytopenia, 27.0%.
  • Most common grade 3 or 4 nonhematologic adverse events:
    • Nausea, 8.1%.
    • Anorexia, 5.4%.
    • Mucositis, 2.7%.
    • Skin rash, 2.7%.
  • Poorer OS was associated with high serum levels of cytokines tumor necrosis factor-α (P=.00005) and C-reactive protein (P=.0004).

Limitations

  • Nonrandomized, open-label design.
  • No control group.