Treatment-related mortality in 1000 consecutive patients receiving high-dose chemotherapy and peripheral blood progenitor cell transplantation in community cancer centers

Summary: cancer centers. 10‐14 This report describes the 100-day treatment-related mortality (TRM) of the first 1000 consecutive patients receiving high-dose myeloablative chemotherapy High-dose chemotherapy (HDC) with autologous peripheral blood progenitor cell (PBPC) is being increas- within a multicentered community-based clinical trials program. ingly utilized as a therapeutic modality for patients with chemotherapy-sensitive disease. Several published HDC regimens have become relatively widely used. The purpose of this analysis was to determine treatment-related Materials and methods mortality (TRM) following administration of five different HDC regimens in community cancer centers. A Patient selection retrospective evaluation of 1000 consecutive patients Between February 1989 and 15 September 1994, 1000 conwith leukemia, non-Hodgkin’s lymphoma, Hodgkin’s secutive patients were enrolled on protocols administering disease, multiple myeloma, sarcoma, ovarian cancer, or HDC. 10‐13 Patients were eligible for study if they had a breast cancer who received one of five published HDC malignant disease that could potentially benefit from HDC, regimens followed by PBPC infusion over a 5-year per- were between age 18‐65 years, had ECOG performance iod in community cancer centers was performed to status of 0‐2 and evidence of adequate hepatic, renal and determine TRM. Fifty-nine patients (5.9%) died within cardiac function. Patients were treated on clinical protocols 100 days of PBPC infusion. Twenty-five patients (2.5%) designed by investigators of Response Oncology Inc (ROI) died predominantly of causes related to disease pro- and approved by the institutional review board of the hospigression. Thirty-four patients (3.4%) died of TRM, 15 tal where the therapy was administered and all patients patients (1.5%) died from infection and 19 (1.9%) died signed a protocol-specific informed consent. from regimen-related toxicities (RRT). In a logistic model, increasing age (P = 0.001) and lower numbers of CD34 + cells/kg (P = 0.003) were associated with an Treatment centers increased risk of 100-day TRM. High-dose cyclophosPatients analyzed for this report were treated in 28 medical phamide, thiotepa, and carboplatin was associated with centers in the US under the care of 159 community medical a lower risk of mortality than other regimens (P =