Busulfan based ASCT protocols are effective therapy for patients (pt.s) with poor risk NHL and HD. This therapy historically required pt.s to be hospitalized to manage treatment related toxicities until neutrophil engraftment with a median stay in most institutions of 21 days. We have developed a comprehensive outpatient approach for the management of pt.s undergoing ASCT. While potential benefits include decreased hospital utilization and increased patient satisfaction, there is paucity of data regarding its feasibility and safety. We report on treatment related mortality (TRM) and outcome results using a comprehensive outpatient care approach in 169 consecutive patients with NHL and HD transplanted at a single institution between February 1998 and December 2006. Excluding the planned admission for stem cell infusion on Day 0, all other aspects of their management (chemotherapy, supportive care) were to be performed in the outpatient facility. Exceptions to this model occurred for pt.s with circumstances that might compromise the safety of the outpatient management, otherwise this was standard practice. Pt.s were seen daily in the clinic during the first 30 days, unless they were hospitalized. The most common reasons for admission included the development of neutropenic fever or mucositis. One hundred sixty-nine consecutive pt.s with a median age of 54 yr.s (22–73) underwent ASCT for NHL (57 diffuse B-cell large cell (DLC), 53 HD, 17 Mantle Cell (MC), 24 Follicular NHL (FL), 6 ALCL, 3 Burkitts, and 9 other subtypes). The conditioning regimen consisted of dose targeted oral BU (1 mg/kg every 6 hours) on days -8 thru -5, CY 60 mg/kg on days -3 and -2 and VP-16 10 mg/kg days -4, -3 and -2. Autologous peripheral blood stem cells were used for 151 pt.s, bone marrow for 8 pt.s and 10 pt.s received both cell sources. The median CD34+ cell dose was 4.9 × 106/kg. Median time to neutrophil and platelet engraftment was 11 (range 9–34) and 17 (range 0–85) days, respectively. There were no (0%) treatment related deaths in the 169 pt.s during either the first 100 days or 1 year post-transplant. Eight high risk patients (3 DLC, 2 ALCL, 1 Burkitts NHL, 1 HD and 1 FL) died of progressive disease by day 100 (days 52 - 85). Stratifying for disease risk per the CIBMTR criteria, the 3-year Kaplan-Meier overall survival (OS) and progressive-free survival (PFS) for pt.s with DLC NHL in all pt.s (n=57), intermediate risk pt.s (n=24) and low risk pt.s (CR1, n= 9) is 67%, 86% and 100%; and 46%; 60% and 100%, respectively. The 3-year OS and PFS for pt.s with HD with low/intermediate risk (n=24) and high risk (n=29) is 78% and 72%; and 51% and 45%, respectively. The 3-year OS and PFS for patients with MC NHL (low risk n=9, intermediate risk n=6) is 68% and 65%, respectively. The 3-year OS for pt.s with FL is 75%. In summary, outpatient ASCT with expectant inpatient management for treatment related toxicities can be conducted safely in the setting of a comprehensive outpatient treatment program with treatment related mortality outcomes that is at least as comparable, if not superior, to those reported in the literature for conventional inpatient ASCT for similar patient cohorts.
Disclosure:Off Label Use: Use of chemotherapy agents busulfan, cyclosphosphamide and etoposide at high doses for the use in autologous stem cell transplant. These agents are not investigational.