Phase 2 trial of daily, oral polyphenon E in patients with asymptomatic, Rai stage 0 to II chronic lymphocytic leukemia
Shanafelt TD et al. – Daily oral EGCG in the Polyphenon E preparation was well tolerated by patients with CLL in this phase 2 trial. Durable declines in the ALC and/or lymphadenopathy were observed in the majority of patients.Methods
- Previously untreated patients with asymptomatic, Rai stage 0 to II CLL and an absolute lymphocyte count (ALC) >/= 10 × 109/L were eligible for this phase 2 trial.
- Polyphenon E with a standardized dose of epigallocatechin gallate (EGCG) (2000 mg per dose) was administered twice daily.
- A total of 42 patients received Polyphenon E at a dose of 2000 mg twice daily for up to 6 months.
- Of these patients, 29 (69%) had Rai stage I to II disease.
- Patients received a median of 6 cycles of treatment (range, 1 cycle-6 cycles).
- The most common grade 3 side effects (according to National Cancer Institute Common Terminology Criteria for Adverse Events) were transaminitis (1 patient), abdominal pain (1 patient), and fatigue (1 patient).
- Clinical activity was observed, with 13 patients (31%) experiencing a sustained reduction of ? 20% in the ALC and 20 of 29 patients (69%) with palpable adenopathy experiencing at least a 50% reduction in the sum of the products of all lymph node areas.
- EGCG plasma levels after 1 month of therapy were found to be correlated with reductions in lymphadenopathy (correlation co-efficient, 0.44; P = .02).
- Overall, 29 patients (69%) fulfilled the criteria for a biologic response with either a sustained decline >/= 20% in the ALC and/or a reduction ? 30% in the sum of the products of all lymph node areas at some point during the 6 months of active treatment.