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Prepublished online as a Blood First Edition Paper on March 27, 2003; DOI 10.1182/blood-2002-08-2476.
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Blood, 15 July 2003, Vol. 102, No. 2, pp. 749-755
TRANSPLANTATION
Long-term remission in mantle cell lymphoma following high-dose sequential chemotherapy and in vivo rituximab-purged stem cell autografting (R-HDS regimen)
Alessandro M. Gianni,
Michele Magni,
Maurizio Martelli,
Massimo Di Nicola,
Carmelo Carlo-Stella,
Silvana Pilotti,
Alessandro Rambaldi,
Sergio Cortelazzo,
Caterina Patti,
Guido Parvis,
Fabio Benedetti,
Saveria Capria,
Paolo Corradini,
Corrado Tarella, and
Tiziano Barbui
From the Division of Medical Oncology C–Donazione Cristina Gandini, Istituto Nazionale Tumori, Milan; Medical Oncology, University of Milan; Experimental Molecular Pathology Unit, Department of Pathology, Istituto Nazionale Tumori, Milan; Department of Cellular Biotechnology and Hematology, University La Sapienza, Rome; Division of Hematology, Ospedali Riuniti, Bergamo; Division of Hematology, Ospedale Cervello, Palermo; Division of Internal Medicine and Hematology, Ospedale San Luigi, Orbassano, Turin; Institute of Hematology, University of Verona; Department of Hematology, University of Turin; and Division of Hematology, Istituto Nazionale Tumori, and Chair of Hematology I, University of Milan, Italy
Mantle cell lymphoma (MCL) is rarely cured with standard-dose chemotherapy. From January 1997 to February 2000, 28 previously untreated advanced-stage MCL patients younger than 61 years of age were treated at 9 Italian hematologic departments with 3 cycles of standard-dose debulking chemotherapy followed by a high-dose rituximab-supplemented sequence (R-HDS) including intravenous administration of high-dose cyclophosphamide, high-dose cytarabine, high-dose melphalan, and high-dose mitoxantrone plus melphalan. Study end points included toxicity, clinical and molecular response rates, long-term event-free survival (EFS), and overall survival (OS) rates, as well as the ability to harvest tumor-free peripheral blood stem cells. Optimal amounts of polymerase chain reaction–negative (PCR-negative) CD34+ cells were collected from all 20 informative patients. One patient died of toxicity. All 27 patients assessable for response achieved a complete response (CR), of which 24 remain in continuous complete remission (CCR) after a median follow-up of 35 months. Three patients had transient evidence of PCR-detectable disease in the bone marrow. The OS and EFS rates at 54 months were 89% and 79%, respectively. These results compare with the 42% OS rate and the 18% EFS rate observed in 35 age-matched historic controls treated with standard-dose chemotherapy at the participating centers. The use of rituximab in combination with high-dose chemotherapy represents a very effective in vivo purging method. The R-HDS regimen can be safely applied in a multicenter hematology setting and leads to long-term EFS and OS in the majority of patients with an otherwise incurable disease.
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