High-dose therapy and autologous stem-cell transplantation versus conventional therapy for patients with advanced Hodgkin's lymphoma responding to front-line therapy.
OBJECTIVE
To determine whether high-dose therapy (HDT) with autologous stem-cell transplantation (ASCT) should be included in the initial consolidative treatment of patients with advanced, unfavorable Hodgkin's lymphoma (HL).


METHODS
One hundred sixty-three patients achieving complete remission (CR) or partial remission (PR) with four initial courses of doxorubicin, bleomycin, vinblastine, and dacarbazine, or other doxorubicin-containing regimens, were randomly assigned to receive HDT plus ASCT (83 patients) versus four courses of conventional chemotherapy (80 patients). Unfavorable HL was defined as the presence of at least two of the following poor prognostic factors: high lactate dehydrogenase level, large mediastinal mass (greater than at least 33% of the thoracic diameter), more than one extranodal site, low hematocrit level, and inguinal involvement.


RESULTS
At the end of the treatment program, 92% of patients in arm A and 89% in arm B achieved a CR (P =.6). After a median follow-up of 48 months, the 5-year failure-free survival rates were 75% (95% confidence interval [CI], 65 to 85) in arm A and 82% (95% CI, 73 to 90) in arm B (P =.4). The 5-year overall survival rates were 88% (95% CI, 80 to 96) in arm A and 88% (95% CI, 79 to 96) in arm B (P =.99). The 5-year relapse-free survival rates were 88% in arm A (95% CI, 80 to 96) and 94% in arm B (95% CI, 88 to 100), and the difference was not significant (P =.3).


CONCLUSIONS
Patients with advanced unfavorable HL achieving CR or PR after four courses of doxorubicin-containing regimens have a favorable outcome with conventional chemotherapy. No benefit from an early intensification with HDT and ASCT was shown.
Federico
Massimo
M
Dipartimento di Oncologia ed Ematologia, Università di Modena e Reggio Emilia, Centro Oncologico Modenese, via del Pozzo, 71 41100 Modena, Italy. federico@unimore.it
Bellei
Monica
M
Brice
Pauline
P
Brugiatelli
Maura
M
Nagler
Arnon
A
Gisselbrecht
Christian
C
Moretti
Luciano
L
Colombat
Philippe
P
Luminari
Stefano
S
Fabbiano
Francesco
F
Di Renzo
Nicola
N
Goldstone
Anthony
A
Carella
Angelo Michele
AM
D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001761:Bleomycin; D016009:Chi-Square Distribution; D003131:Combined Modality Therapy; D003606:Dacarbazine; D004317:Doxorubicin; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006689:Hodgkin Disease / Q000473:pathology / Q000628:therapy*; D006801:Humans; D008130:Lomustine; D008297:Male; D008466:Mechlorethamine; D008875:Middle Aged; D011241:Prednisone; D011344:Procarbazine; D016019:Survival Analysis; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014747:Vinblastine; D014750:Vincristine
D001761:Bleomycin; D011344:Procarbazine; D008466:Mechlorethamine; D014750:Vincristine; D014747:Vinblastine; D008130:Lomustine; D003606:Dacarbazine; D004317:Doxorubicin; D011241:Prednisone