Phase 2 trial of daily,oral polyphenon E in patients with asymptomatic,Rai stage 0 to II chronic lymphocytic leukemia

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 × 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.

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. Cancer 2013. © 2012 American Cancer Society.     

Designing and Operationalizing a Customized Internal Evaluation Model for Cancer Treatment Support Programs

Be The Match® Patient and Health Professional Services (PHPS) supports patients undergoing hematopoietic cell transplant (HCT) and caregivers by providing educational programs and resources. HCT is a potentially curative therapy for blood cancers such as leukemia and lymphoma. To help meet the increasing demand for support services, PHPS implemented a multipronged plan to build and sustain the organization’s capacity to conduct evaluation of its programs and resources. To do so, PHPS created and operationalized an internal evaluation model, developed customized resources to help stakeholders incorporate evaluation in program planning, and implemented utilization-focused evaluation for quality improvement. Formal mentorship was also critical in the development of an evidence-based, customized model and navigating inherent challenges throughout the process. Our model can serve as a guide for evaluators on establishing and operationalizing an internal evaluation program. Ultimately, we seek to improve support and education services from the time of diagnosis through survivorship.     

Autism in the criminal justice detention system: A review of the literature

Little is known about the experience of people with autism in custody. A review of the literature that explored the relationship between autism and criminality and the criminal justice detention system was conducted. Literature suggests that people with autism are potentially overrepresented within the criminal justice system. There is little research that has examined the experiences of people with autism spectrum disorders in custody. There is very little to guide service design to develop autism support services for people in prison.