title: Community-based phase II trial of pentostatin, cyclophosphamide, and rituximab (PCR) biochemotherapy in chronic lymphocytic leukemia and small lymphocytic lymphoma.
abstract: We conducted a multicenter, community-based phase II trial of PCR biochemotherapy (pentostatin 4 mg/m2, cyclophosphamide 600 mg/m2, and rituximab 375 mg/m2) every 3 weeks for up to 6 cycles in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study was stopped after enrolling 24 patients because of diminished investigator interest after 8 patients discontinued treatment because of adverse events, and 5 others died during treatment. The median age of patients was 69 years; 11 patients were over age 70, and 71% had Rai stage III or IV disease. The response rate among the 17 evaluable patients who completed 3 cycles of therapy was 58% (35%-81%, 95% confidence interval), with 2 complete responders (both greater than 70 years of age) and 7 partial responders. No patients developed progressive disease while receiving PCR. This is the first report of a trial in CLL utilizing a combination of purine analog, alkylator, and rituximab, in which most patients were older than 65 years and had high-risk disease. PCR is active in CLL/SLL, but appears to be less active and associated with more complications in the community setting, compared to trials with younger, lower risk patients who travel to academic referral centers for treatment.
authors.affiliation: Hoag Cancer Center, Newport Beach, CA 92658, USA. rdillman@hoaghospital.org
authors.forename: Robert O
authors.initials: RO
authors.lastname: Dillman
authors.forename: Marshall T
authors.initials: MT
authors.lastname: Schreeder
authors.forename: Jeremy K
authors.initials: JK
authors.lastname: Hon
authors.forename: Elizabeth F
authors.initials: EF
authors.lastname: Connelly
authors.forename: Carol
authors.initials: C
authors.lastname: DePriest
authors.forename: Kathy
authors.initials: K
authors.lastname: Cutter
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000276:immunology* / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D003520:Cyclophosphamide / Q000009:adverse effects / Q000627:therapeutic use*; D003695:Delivery of Health Care; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007167:Immunotherapy / Q000009:adverse effects; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D008297:Male; D008562:Membrane Glycoproteins; D008875:Middle Aged; D015649:Pentostatin / Q000009:adverse effects / Q000627:therapeutic use*; D000069283:Rituximab; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D008562:Membrane Glycoproteins; C071037:TI 1 protein, Mustela vison; D015649:Pentostatin; D000069283:Rituximab; D003520:Cyclophosphamide