title: Phase 2 trial of daily, oral Polyphenon E in patients with asymptomatic, Rai stage 0 to II chronic lymphocytic leukemia.
abstract: BACKGROUND
  The objective of the current study was to follow up the results of phase 1 testing by evaluating the clinical efficacy of the green tea extract Polyphenon E for patients with early stage chronic lymphocytic leukemia (CLL).
  
  
  METHODS
  Previously untreated patients with asymptomatic, Rai stage 0 to II CLL and an absolute lymphocyte count (ALC) ≥ 10 × 10(9) /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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors: Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota 55905, USA. shanafelt.tait@mayo.edu
authors: Tait D
authors: TD
authors: Shanafelt
authors: Timothy G
authors: TG
authors: Call
authors: Clive S
authors: CS
authors: Zent
authors: Jose F
authors: JF
authors: Leis
authors: Betsy
authors: B
authors: LaPlant
authors: Deborah A
authors: DA
authors: Bowen
authors: Michelle
authors: M
authors: Roos
authors: Kristina
authors: K
authors: Laumann
authors: Asish K
authors: AK
authors: Ghosh
authors: Connie
authors: C
authors: Lesnick
authors: Mao-Jung
authors: MJ
authors: Lee
authors: Chung S
authors: CS
authors: Yang
authors: Diane F
authors: DF
authors: Jelinek
authors: Charles
authors: C
authors: Erlichman
authors: Neil E
authors: NE
authors: Kay
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D058070:Asymptomatic Diseases; D002392:Catechin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy*; D018655:Lymphocyte Count; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D002392:Catechin; C472086:polyphenon E