Single Dose Per Cycle Pegfilgrastim Successfully Supports Full Dose CHOP-21 in Patients with Post-Transplant Lymphoproliferative Disorders (PTLD).

Background: PTLD is a life-threatening complication after transplantation of organs. There exists no common strategy for the treatment of patients with PTLD. Some patients benefit from reduction of immunsuppression or virostatic therapy, but most patients are treated by adriamycin based chemotherapy. Administration of chemotherapy is complicated by immunosuppressive therapy which induces bone marrow and renal insufficiency. Cytotoxic chemotherapy is frequently accompanied by febrile neutropenia and even lethal courses. Previous studies with CHOP 21 has demonstrated the need for growth factor (Filgrastim) to conduct chemotherapy in these patients. The aim of this study was to assess the ability of Pegfilgrastim, a pegylated form of Filgrastim, to support the 21 day CHOP chemotherapy. Pegfilgrastim has a sustained-duration effect relative to filgrastim, as a result of decreased renal clearance of the pegfilgrastim molecule.

Methods: Chemotherapy consisted of cyclophosphamide 750mg/m2, doxorubicin 50mg/m2 and vincristine 1,4mg/m2 at day 1 and prednisone 100mg day 1–5 and was administered at 21 days intervals for 4 cycles. Pegfilgrastim was administered by a single dose (6 mg s.c.) on day 3 of each cycle of chemotherapy

Results: In total 5 patients (4 after kidney- and 1 after liver-transplantation) were included in this study. The mean age of patients is 54 years (19–75) with two females and three males. A total of 15 cycles of CHOP has been administered. 14 of 15 cycles of CHOP could regularly be administered at day 21. In three patients five episodes of grade 4 neutropenia occurred, but none of the patients experienced infectious complications. Three patients experienced grade 3 neutropenia and two patients three episodes of grade 2 neutropenia. The lowest granulocyte count was 0.327 x 10⁹/l. The rate of serious adverse events was low and no episode of febrile neutropenia occurred.

Conclusion: These results support the use of once-per-cycle pegfilgrastim (6 mg s.c.) for safe and effective on time delivery of a regimen with CHOP-21 in patients with Post-transplant Lymphoproliferative Disorders (PTLD).