High-dose therapy and autologous stem-cell transplantation versus conventional therapy for patients with advanced Hodgkin's lymphoma responding to front-line therapy

Massimo Federico, Monica Bellei, Pauline Brice, Maura Brugiatelli, Arnon Nagler, Christian Gisselbrecht, Luciano Moretti, Philippe Colombat, Stefano Luminari, Francesco Fabbiano, Nicola Di Renzo, Anthony Goldstone, Angelo Michele Carella

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Abstract

Purpose: 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). Patients and 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). Conclusion: 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.

Original languageEnglish
Pages (from-to)2320-2325
Number of pages6
JournalJournal of Clinical Oncology
Volume21
Issue number12
DOIs
Publication statusPublished - Jun 15 2003

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Stem Cell Transplantation
Hodgkin Disease
Confidence Intervals
Doxorubicin
Survival Rate
Therapeutics
Drug Therapy
Dacarbazine
Vinblastine
Groin
Bleomycin
Hematocrit
L-Lactate Dehydrogenase
Thorax
Recurrence

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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High-dose therapy and autologous stem-cell transplantation versus conventional therapy for patients with advanced Hodgkin's lymphoma responding to front-line therapy. / Federico, Massimo; Bellei, Monica; Brice, Pauline; Brugiatelli, Maura; Nagler, Arnon; Gisselbrecht, Christian; Moretti, Luciano; Colombat, Philippe; Luminari, Stefano; Fabbiano, Francesco; Di Renzo, Nicola; Goldstone, Anthony; Carella, Angelo Michele.

In: Journal of Clinical Oncology, Vol. 21, No. 12, 15.06.2003, p. 2320-2325.

Research output: Contribution to journalArticle

Federico, M, Bellei, M, Brice, P, Brugiatelli, M, Nagler, A, Gisselbrecht, C, Moretti, L, Colombat, P, Luminari, S, Fabbiano, F, Di Renzo, N, Goldstone, A & Carella, AM 2003, 'High-dose therapy and autologous stem-cell transplantation versus conventional therapy for patients with advanced Hodgkin's lymphoma responding to front-line therapy', Journal of Clinical Oncology, vol. 21, no. 12, pp. 2320-2325. https://doi.org/10.1200/JCO.2003.11.103
Federico, Massimo ; Bellei, Monica ; Brice, Pauline ; Brugiatelli, Maura ; Nagler, Arnon ; Gisselbrecht, Christian ; Moretti, Luciano ; Colombat, Philippe ; Luminari, Stefano ; Fabbiano, Francesco ; Di Renzo, Nicola ; Goldstone, Anthony ; Carella, Angelo Michele. / High-dose therapy and autologous stem-cell transplantation versus conventional therapy for patients with advanced Hodgkin's lymphoma responding to front-line therapy. In: Journal of Clinical Oncology. 2003 ; Vol. 21, No. 12. pp. 2320-2325.
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abstract = "Purpose: 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). Patients and 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). Conclusion: 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.",
author = "Massimo Federico and Monica Bellei and Pauline Brice and Maura Brugiatelli and Arnon Nagler and Christian Gisselbrecht and Luciano Moretti and Philippe Colombat and Stefano Luminari and Francesco Fabbiano and {Di Renzo}, Nicola and Anthony Goldstone and Carella, {Angelo Michele}",
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T1 - High-dose therapy and autologous stem-cell transplantation versus conventional therapy for patients with advanced Hodgkin's lymphoma responding to front-line therapy

AU - Federico, Massimo

AU - Bellei, Monica

AU - Brice, Pauline

AU - Brugiatelli, Maura

AU - Nagler, Arnon

AU - Gisselbrecht, Christian

AU - Moretti, Luciano

AU - Colombat, Philippe

AU - Luminari, Stefano

AU - Fabbiano, Francesco

AU - Di Renzo, Nicola

AU - Goldstone, Anthony

AU - Carella, Angelo Michele

PY - 2003/6/15

Y1 - 2003/6/15

N2 - Purpose: 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). Patients and 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). Conclusion: 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.

AB - Purpose: 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). Patients and 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). Conclusion: 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.

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