- In patients with B-cell non-Hodgkin lymphoma (B-NHL), fenretinide + rituximab (Rituxan) delivered moderate, but durable response with encouraging tolerability.
Why this matters
- Fenretinide has demonstrated anti-tumor action in preclinical studies.
- Phase 1/2 study of fenretinide + rituximab in 32 patients with B-NHLs.
- In the phase 1 study, fenretinide was initiated at the maximal dose of 900 mg/m2; dose was reduced to 700 mg/m2 pending dose-limiting toxicities.
- In the phase 2 study, patient received fenretinide at the dose from phase 1 + rituximab 375 mg/m2.
- De-escalation design in cohorts of 6 patients starting at the maximal dose of 900 mg/m2 by mouth twice-daily, on days 1-5 followed by a 2-d drug holiday.
- Funding: National Institutes of Health.
- 7 patients treated in phase 1; 25 patients treated in phase 2.
- In the phase 2 study:
— selected dose: fenretinide 900 mg/m2,
— 24% of patients responded (all in phase 2),
— 47 mo median duration of response,
— 56% disease-control rate,
— 91.7% experienced tumor reduction,
— 8 mo median PFS; median OS was not reached,
— most common grade ≥3 adverse events: rash (3 patients), neutropenia (3 patients).
- Limited sample size.