We performed a phase II study to determine the efficacy of maximal cytoreductive
therapy with up to five cycles of
Dexa-BEAM (
dexamethasone,
carmustine [
BCNU],
etoposide,
cytarabine, and
melphalan) followed by high-dose
chemotherapy (HDCT) and autologous
stem cell transplantation (ASCT) for patients with advanced relapsed or refractory indolent
lymphoma. Thirty-two patients with primary refractory or relapsed indolent
lymphoma were treated with the
Dexa-BEAM regimen. Thirteen patients had primary refractory disease, 4 patients partial remission, and 15 patients first or subsequent relapse. Patients achieving PR or CR received HDCT with ASCT. The conditioning regimen used was BEAM (
carmustine [
BCNU],
etoposide,
cytarabine, and
melphalan). Twenty-two patients responded to
Dexa-BEAM resulting in a response rate of 78%. Maximum response was observed after 3.2 (range 2-5) courses. One patient with progressive disease died in
septic shock during
neutropenia. Nineteen patients with partial or complete remission after
Dexa-BEAM received HDCT. Hematopoietic stem cells (HSC) were collected after two cycles of
Dexa-BEAM. The median number of CD34+ HSC reinfused was 3.1 x 10(6)/kg (range 1.6-8.2 x 10(6)/kg). There was no
transplantation-related death. All patients receiving HDCT achieved complete remission. Overall survival (OS) and freedom from treatment failure (FFTF) for all patients are estimated to be 68% and 65% at two years, respectively. With a mean follow-up of 20 months (range 8-42 months), 16/19 patients receiving HDCT are in continuous complete remission. The
Dexa-BEAM regimen is effective in overcoming drug resistance in patients with indolent
lymphoma who failed to respond to conventional treatment or who relapsed. The CR rate of 100% of those patients receiving HDCT and ASCT after maximal cytoreductive treatment with
Dexa-BEAM suggests the use of HDCT at the time of maximal response.