PCR Treatment in Stage III/IV NHL

American Society of Clinical Oncology Annual Meeting, Chicago, Illinois, June 2007

Neal P Christiansen, MD, Raul R Mena, MD, Yudhishtra Markan, MD and Lalita Pandit, MD South Carolina Oncology Associates, Columbia, SC; East Valley Hematology and Oncology Medical Group, Burbank, CA; Chesapeake Oncology Hematology Assoc., Baltimore, MD and Lalita Pandit, MD, Inc., Fountain Valley, CA

Background

The decision to treat indolent B-cell NHL is often based on progressive disease, worsening symptoms, and increasing hematological variations. When treatment is indicated, these lymphoproliferative disorders are very sensitive to combination chemotherapies. Combination therapy with these agents, pentostatin (P), a purine analog, cyclophosphamide (C), a DNA alkylator, and rituximab (R), an anti-CD20 monoclonal antibody, represents a promising approach in the treatment of these patients. Most regimens have utilized fludarabine (F) as the purine analog but the myelosuppression and immunosuppression of F combinations frequently results in severe infections.

Methods

Eligibility criteria allow previously treated and treatment-naïve patients diagnosed with bulky stage II or low-grade stage III/IV NHL (REAL classification) to be enrolled. Treatment consisted of intravenous infusions of P (4 mg/m²), C (600 mg/m²), and R (375 mg/m²) on day 1 of a 21-day cycle for a total of up to 10 cycles. Clinical evaluation was performed after cycles 2, 4, 6, 8, and 10 if necessary.

Results

The intent-to-treat (ITT) population consisted of 99 NHL patients (median age 61, range 29-84) who received a total of 539 cycles (median 6 per patient). The ECOG status was 0 (63.4%), 1 (36.6%) and 2 (0%). The overall response rate of the 91evaluable patients was 72.5% (CR 11.0%, CRu 12.1%, PR 49.5%). 10 cases of grade 4 and 16 cases of grade 3 neutropenia were documented. There were a total of 4 deaths; 1 due to acute myocardial infarction, 1 due to a suspected cardiac event and 2 unknown causes of death.

Conclusions

This immunochemotherapeutic regimen is active in indolent Stage III/IV NHL and the incidence of significant toxicities was low. Future trials evaluating the use of rituximab as maintenance therapy following this PCR regimen may also be warranted with a future goal towards possibly increasing the overall survival of patients with indolent NHL. The presented results are preliminary and the study is currently on-going.