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Carmustine Replacement in Intensive Chemotherapy Preceding Reinjection of Autologous Hscs in Hodgkin and Non-Hodgkin Lymphoma: a Review

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Carmustine Replacement in Intensive Chemotherapy Preceding Reinjection of Autologous Hscs in Hodgkin and Non-Hodgkin Lymphoma: a Review Bone Marrow Transplantation (2017) 52, 941–949 © 2017 Macmillan Publishers Limited, part of Springer Nature. All rights reserved 0268-3369/17 www.nature.com/bmt REVIEW Carmustine replacement in intensive chemotherapy preceding reinjection of autologous HSCs in Hodgkin and non-Hodgkin lymphoma: a review G Damaj1,2, J Cornillon3, K Bouabdallah4, R Gressin5, S Vigouroux3, T Gastinne6, F Ranchon7, H Ghésquières8, G Salles8, I Yakoub-Agha9 and E Gyan10 for Lymphoma Study Association and the French Society of Bone Marrow Transplantation and Cellular Therapy High-dose chemotherapy preceding autologous hematopoietic stem cell transplantation (auto-HSCT) is one treatment option for patients with Hodgkin (HL) or non-Hodgkin lymphoma (NHL). The most frequently used intensive chemotherapy is a combination of carmustine (BCNU), etoposide, cytarabine and melphalan (BEAM). However, BCNU is consistently in short supply, and there has been a recent dramatic increase in its cost, necessitating the utilization of conditioning alternatives. The busulfan-based conditioning regimen known as the busulfan–cyclophosphamide–etoposide (BuCyE) combination is the second most-studied conditioning regimen worldwide after BEAM, and it exhibits a benefit/risk ratio that is comparable to that of BEAM. In addition to these two combinations, the present manuscript also summarizes data reported for other conditioning combinations. Owing to the lack of prospective and comparative studies, a comparison of the toxicities and medicoeconomical profiles of these treatments is warranted to identify effective replacements for BCNU-based conditioning. Bone Marrow Transplantation (2017) 52, 941–949; doi:10.1038/bmt.2016.340; published online 23 January 2017 INTRODUCTION prospective study of patients who underwent transplant as a first 10 Intensive chemotherapy followed by autologous hematopoietic response. stem cell transplantation (auto-HSCT) is one therapeutic option for When selecting high-dose therapy, both long-term treatment a subset of eligible patients with Hodgkin lymphoma (HL) or efficacy and potential short- and long-term toxicities must be non-Hodgkin lymphoma (NHL).1 A previous European Blood and considered. The toxicity of TBI in the setting of auto-HSCT has Marrow Transplantation Society survey reported on 1880 patients progressively decreased its use because of the risk of acute leukemia, secondary myelodysplastic syndromes and cumulative with HL and 6000 patients with NHL who received auto-HSCT in 11,12 2013.2 Auto-HSCT has been increasingly performed over the years organ toxicity in the case of previous radiation, primarily in HL. and has become one of the most common treatment approaches The BEAM regimen, which utilizes a combination of for aggressive forms of lymphoma.2 carmustine (BCNU), etoposide, cytarabine and melphalan, fi is the most frequently used conditioning regimen before Auto-HSCT was not widely adopted as a rst-line treatment for 2–4 high-risk patients with diffuse large B-cell lymphoma in the auto-transplantation. However, BCNU is in short supply and fi rituximab era, and this treatment has consequently not been has a high cost, necessitating the identi cation of conditioning recommended outside of clinical trials. However, auto-HSCT alternatives. In the absence of prospective randomized studies has recognized benefits for chemosensitive patients presenting comparing different types of conditioning, we reviewed the data with initially chemotherapy-refractory disease or those who have from the most important and largest published studies to propose relapsed after first-line therapy and are eligible for intensive recommendations for alternative chemotherapies to be used as therapy.3,4 For mantle cell lymphoma, auto-HSCT has demon- conditioning regimens before auto-HSCT. strated benefits associated with response and survival.5 For follicular lymphoma, auto-HSCT is not recommended as a consolidation first-line treatment because of its excessive toxicity METHODOLOGY and lack of benefit for overall survival (OS).6 However, this The French Society of Bone Marrow Transplantation and Cellular therapeutic approach is used in patients with sensitive relapse.7,8 Therapy (SFGMTC) and the Lymphoma Study Association (LYSA) The role of auto-HSCT for the treatment of peripheral T-cell established a collaborative work group. The group met to discuss lymphoma is not clearly established because of the rarity of this BEAM conditioning alternatives for auto-transplantation for disease and the absence of randomized studies.9 Nevertheless, a lymphoma. An extensive literature review was performed focusing Nordic team recently reported a high PFS rate of 44% in a phase II on high-dose therapy in the setting of lymphoma. The group 1Institut d'hématologie de Basse Normandie, Centre Hospitalier Universiatire, Faculté de médecine, Université de Basse-Normandie, Caen, France; 2Microenvironnement Cellulaire et Pathologies, Normandie University, Caen, France; 3Hématologie, Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez, France; 4Hématologie et Thérapie Cellulaire, CHU de Bordeaux, Pessac, France; 5Hématologie, CHU de Grenoble, Grenoble, France; 6Hématologie, CHU de Nantes, Nantes, France; 7Unité de Pharmacie Clinique Oncologique, Groupement Hospitalier Sud, Hospices Civils de Lyon, Lyon, France; 8Hématologie, Hospices Civils de Lyon, Lyon, France; 9Maladies du sang, CHRU de Lille, Lille, France and 10Hématologie et Thérapie Cellulaire, CHU de Tours, Tours, France. Correspondence: Professor G Damaj, Institut d’Hématologie de Basse Normandie, Centre Hospitalier Universiatire (CHU), Faculté de médecine, Université de Basse-Normandie, Avenue de la Côte de Nacre, Caen 14033, France. E-mail: [email protected] and [email protected] Received 29 March 2016; revised 8 November 2016; accepted 16 November 2016; published online 23 January 2017 Conditioning regimens for lymphoma G Damaj et al 942 Table 1. Main toxicities related to BCNU-based conditioning regimens Caballero et al.87 Puig et al.13 Kim et al.82 Sakellari et al.88 Histology NHL, HL NHL, HL NHL NHL, HL No. of patients 148 113 65 137 Disease status at transplant,n(%) First line 49 (33) 61 (54) First relapse = 15 (23) First relapse = 33 (24) More than first line 99 (67) 52 (46) More than first relapse = 50 (77) More than first relapse = 104 (76) Age, median (range) 42 (4–63) CBV = 36 (18–62) BEAM = 46 (15–65) o34 Years = 72 BEAM = 48 (18–70) BuCyE = 46,5 (28–65) 434 Years = 65 Mucositis,n(%) 84% Gr ⩾ 2 G1–2 Not specified CBV = 47 BEAM = 17 BEAM = 38/BuEM = 25 G3–4 30% BEAM = 13 BuCyE = 9 BEAM = 3/BuEM = 24 P = 0.004 P = NS Po0.001 Gastroenteritis,n(%) 69% Gr ⩾ 2 G1–2 Not specified CBV = 17; BEAM = 6 BEAM = 17 BEAM = 19/BuEM = 22 G3–4 n = 25 P = NS BuCyE = 4 BEAM = 24/BuEM = 8 P = NS Po0.001 Kidney failure,n(%) — G1–2 8% (Gr 1) CBV = 9; BEAM = 0 BEAM = 7/BuEM = 3 G3–4 P = 0.02 P = NS PMN recovery time BM = 20 (11–51) CBV = 14 (9–26) BEAM = 11 (8–20) BEAM = 9(6–20) 40.5 G/L; days, (range) CSP = 12 (9–27) BEAM = 12 (9–25) BuCyE = 9(8–17) BuEM = 10 (8–31) Platelet recovery time BM = 24 (10–250) CBV = 14 (9–58) BEAM = 13.5 (7–31) BEAM = 11 (3–25) 420 G/L, days, (range) CSP = 17 (10–160) BEAM = 12 (8–56) BuCyE = 11 (5–38) BuEM = 11 (6–150) Toxicity-related mortality, n (%) 5.4% CBV = 25% BEAM = 4.1% BEAM = 3.44% BEAM = 7% BuCyE = 9.1% BuEM = 0% P = 0.02 P = NS P = NS Median PFS/DFS DFS = 76% Not specified BEAM = 16.1 Mo BEAM = 63.2% 3 Years BuCyE = 11.3 Mo BuEM = 65.6% EFS; P = NS PFS Median OS 68% Not specified BEAM = 30.6 Mo BEAM = 76.7% 3 Years BuCyE = 22.6 Mo BuEM = 78.8% P = NS P = NS Abbreviations: BEAM = BCNU+etoposide+aracytine+melphalan; BM = bone marrow; BuCyE = busulfan+cyclophosphamide+etoposide; BuEM = busulfan +etoposide+melphalan; CBV = cyclophosphamide+BCNU+VP16 (etoposide); DFS = disease-free survival; EFS = event-free survival; Mo = month; NS = not significant; OS = overall survival; PMN = polymorphonuclear; PSC = peripheral stem cell. Sinusoidal obstruction syndrome was reported in the studies by Kim et al.82 (two for BEAM and one for BuCyE) and Sakellari et al.88 (in one case after BEAM). In the study by Sakellari et al.,88 sepsis was significantly higher following BuEM than BEAM (P = 0.006). members were responsible for reviewing and synthesizing all the Toxicities data and writing the manuscript. The final document was sent to In a 2006 study published by a Spanish team, the toxicities of CBV readers who provided their opinion on the text before submission and BEAM were retrospectively compared in 113 patients.13 The for review by the scientific boards of the Lymphoma Study results showed comparable hematological toxicities between the Association and the French Society of Bone Marrow Transplanta- two conditioning regimens. However, higher non-hematological tion and Cellular Therapy. toxicities, including mucositis (63% versus 34%, P = 0.004), renal failure (12% versus 0%, P = 0.02), sinusoidal obstruction syndrome (7% versus 0%, P = 0.04) and pulmonary toxicities, were noted in OVERVIEW OF CARMUSTINE-BASED CONDITIONING REGIMENS the CBV group. Treatment-related mortality (TRM) was primarily infection-related, with rates of 5% for BEAM and 24% for CBV Several types of BCNU-based conditioning regimens have been (P = 0.02). The excessive toxicity of CBV was associated with the developed (Supplementary Table 1). Unfortunately, none of these higher total BCNU dose in the CBV regimen (800 mg/m2) versus regimens has been compared in prospective or randomized the BEAM regimen (300 mg/m2). The total etoposide dose was studies. Each regimen involves a combination of two to four comparable between the two regimens (750 versus 800 mg/m2). drugs, including alkylating agents. The CBV (cyclophosphamide Another more recent analysis evaluated 4917 patients (Cy), BCNU and etoposide), BEAM (BCNU, etoposide, aracytine and (NHL = 3905, HL = 1012) who received auto-HSCT after high-dose melphalan) and BEAC regimens (BCNU, etoposide, aracytine and therapy with BEAM (n = 1730), CBV (n = 1853; CBVlow Cy) are the most frequently used.
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