Abstract
High-dose melphalan has been used in combination with total body irradiation or other chemotherapeutic agents such as fludarabine in myeloablative or nonmyeloablative allogeneic hematopoietic stem cell transplantation. Moderate to severe oral mucositis is a prominent feature of the toxicity of high-dose melphalan, which interferes with nutrition and quality of life, and leads to the secondary infection. We have incorporated oral cryotherapy into the reduced-intensity conditioning consisting of high-dose melphalan for allogeneic hematopoietic stem cell transplantation (HSCT) to prevent high-dose melphalan-induced stomatitis based on the hypothesis that reduced peak drug level on oral mucosa by cryotherapy could ameliorate mucosal injury. Eleven patients conditioned by high-dose melphalan (70mg/m2 ×2) in combination with fludarabine (25mg/m2 ×5; n = 9), fludarabine+TBI (4Gy; n = 1), and fludarabine+high-dose cytarabine (3g/m2×4; n = 1) were evaluable. Stem cell sources were as follows: related bone marrow, 5; unrelated bone marrow, 4; unrelated cord blood, 2. Cyclosporin A + sMTX (n = 4), tacrolimus + sMTX (n = 5), and cyclosporine alone (n = 2) were used for acute GVHD prophylaxis. Patients received oral cyotherapy with ice chips and iced water for 15 minutes before and during the administration of melphalan, and for further 60–90 minutes after the completion of melphalan administration. For toxicity grading of stomatitis, NCI common toxicity criteria was used. Eight patients receiving high-dose melphalan (70mg/m2×2) in combination with fludarabine for allogeneic HSCT without oral cyotherapy were used as a comparable historical control. The grades of stomatitis were 0 (none) or 1 in all 11 patients receiving oral cryotherapy, while grades of stomatitis were 0 or 1 in 1 patient, and 2 or 3 in 7 of 8 patients in the control group (P < 0.05). We conclude that oral cryotherapy prevents stomatitis induced by high-dose melphalan, and recommend that it be incorporated into the conditioning regimen consisting of high-dose melphalan.
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