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Pulmonary Toxicity Following Carmustine-Based Preparative Regimens and Autologous Peripheral Blood Progenitor Cell Transplantation in Hematological Malignancies

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Pulmonary Toxicity Following Carmustine-Based Preparative Regimens and Autologous Peripheral Blood Progenitor Cell Transplantation in Hematological Malignancies Bone Marrow Transplantation (2000) 25, 309–313 2000 Macmillan Publishers Ltd All rights reserved 0268–3369/00 $15.00 www.nature.com/bmt Pulmonary toxicity following carmustine-based preparative regimens and autologous peripheral blood progenitor cell transplantation in hematological malignancies EP Alessandrino1, P Bernasconi1, A Colombo1, D Caldera1, G Martinelli1, P Vitulo2, L Malcovati1, C Nascimbene2, M Varettoni1, E Volpini2, C Klersy3 and C Bernasconi1 1Centro Trapianti di Midollo Osseo, Istituto di Ematologia, 2Divisione di Pneumologia, 3Biometry-Scientific Direction IRCCS, Policlinico S Matteo, Pavia, Italy Summary: the use of BCNU is suspected to be caused by damage to the glutathione system.2 BCNU has been included in high- Sixty-five patients with hematological malignancies (25 dose conditioning regimens for gliomas, breast cancer, multiple myeloma, 18 Hodgkin’s disease, 22 non-Hodg- Hodgkin’s disease, non-Hodgkin’s lymphomas, multiple kin’s lymphomas) who received a carmustine-based myeloma. Toxic pulmonary reactions have been recognized regimen followed by autologous PBPC transplantation, in as many as 16–64% of patients;3–13 onset generally were studied retrospectively to evaluate the incidence of occurs within 1 year of starting BCNU. Events occurring post-transplant non-infective pulmonary complications up to 17 years later have been reported.14 The drug seems (NIPCs), risk factors predictive of NIPCs, and response to cause pulmonary damage in a dose-related manner:5,10,11 to steroids. Carmustine (BCNU) given i.v. at a dose of Phillips et al6 reported a 9.5% incidence of fatal pulmonary 600 mg/m2 was combined with etoposide and cyclophos- toxicity in patients receiving BCNU doses as high as 1.200 phamide in 40 patients (BCV regimen) and with etopo- mg/m2 as a single agent; another report suggests no pul- side and melphalan in 25 patients (BEM regimen). Sev- monary toxicity at doses of less than 1000 mg/m2.7 The enteen of 65 patients (26%) had one episode of NIPCs. threshold dose for BCNU toxicity is still controversial: lung The median time to NIPCs was 90 days (52–289). Fac- toxicity may occur at 600 mg/m2 when the drug is associa- tors that increased the risk of developing NIPCs on ted with other toxic agents like CY.1,15 multivariate analysis were female sex (P Ͻ 0.001) and This report deals with patients with hematological malig- BCV regimen (P Ͻ 0.05). All patients with NIPCs nancies who received a carmustine-based preparative regi- received prednisone at a dose of 1 mg/kg body weight men; the drug was combined with cyclophosphamide and for 10 days then tapered by 5 mg every two days; com- etoposide or with etoposide and melphalan and both regi- plete response to steroids was achieved in 15 of 17 mens were followed by autologous peripheral blood pro- patients; one unresponsive patient died of interstitial genitor cell (PBPC) transplantation. The aim of this retro- pneumonia. BCNU given at the dose of 600 mg/m2 is spective analysis was to characterize the incidence of well tolerated when associated with melphalan and eto- pulmonary toxicity in patients treated with two diverse car- poside. In females and in patients receiving BCNU with mustine-containing regimens, and also to determine predic- cyclophosphamide, a BCNU dose reduction may be tive risk factors and response to steroid therapy. advisable. Bone Marrow Transplantation (2000) 25, 309–313. Keywords: carmustine; pulmonary toxicity; autologous Methods peripheral blood progenitor cell transplantation The medical records of 65 patients undergoing autologous PBSC transplantation who had received a BCNU-contain- ing preparative regimen were reviewed to assess the inci- There is evidence that several agents used in the preparative dence of pulmonary complications occurring within 12 regimens for both autologous and allogeneic bone marrow months from transplant and the risk factors for their devel- transplantation may induce lung injury without evidence of opment; response to steroid therapy was also evaluated. All infection. Agents that have been implicated include carmus- data concerning the total dose of cyclophosphamide, bleo- tine (BCNU), busulphan, cyclophosphamide (CY), and mycine, history of radiation and mediastinal involvement, 1 total body irradiation. BCNU causes toxic lung reactions history of smoking, previous history of pneumonitis or characterized by chronic interstitial fibrosis, cough, dyspnea other lung diseases were taken into account. Episodes of and decrease in lung diffusing capacity; toxicity related to pulmonary toxicity occurring after the first 12 months were excluded. The study includes only patients with normal Correspondence: EP Alessandrino, Centro Trapianti di Midollo Osseo, pulmonary function tests before transplant. Istituto di Ematologia, IRCCS Policlinico S Matteo, 27100 Pavia (I), Italy All pulmonary complications occurring within 12 months Received 15 May 1999; accepted 28 September 1999 from transplant were recorded. They were classified as fol- Pulmonary complications following carmustine-based regimens EP Alessandrino et al 310 lows: (1) minor complications: reduction by 20% of single- Kaplan–Meier estimates of pulmonary complications were breath carbon monoxide diffusing capacity (DLCO) with- computed and curves drawn for selected variables. A P out any other sign or symptoms; (2) major complications: value of 0.05 was considered statistically significant. Stata reduction of the above-reported parameter with symptoms 5.0 (College Station, TX, USA) was used for computation. (cough, dyspnea, fever) and signs (tachypnea, tachycardia, crackles or wheezes on auscultation) associated or not asso- ciated with evidence of interstitial pneumonia on chest Results radiograph. Patients with minor or major complications without evidence of bacterial, viral or fungal infection Patients’ characteristics despite extensive examination, were classified as having non-infective pulmonary complication (NIPC). Patients Sixty-five patients undergoing autologous PBPC transplan- with NIPC received prednisone therapy orally at a dose of tation who had received a BCNU-containing preparative 1 mg/kg body weight for 10 days, then tapered by 5 mg regimen were identified. Their main characteristics are every other day. shown in Table 1. The median age was 40 years (range 13– 61). Thirty–three were male and 32 female. Thirteen had a history of smoking. Previous pulmonary complications Preparative regimens were recorded in two cases; both had bacterial pneumonia. Patients received as conditioning regimen a combination of Eighteen patients with HD had received bleomycine BCNU, etoposide, melphalan (BEM regimen) or BCNU, together with adriamycin, vincristine and dacarbazine etoposide and cyclophosphamide (BVC regimen). The (ABVD scheme). Twenty-three patients had had medias- BEM regimen was given to 25 patients with multiple myel- tinal involvement and 12 of these had received radiotherapy oma: it consisted of BCNU 600 mg/m2/day on day −4, eto- to the mediastinum with a median dose of 35 Gy (range 25– poside 1000 mg/m2/continous infusion on day −3, mel- 40 Gy). Twenty-five patients with MM received the BEM phalan 200 mg/m2 on day −2. With the BVC regimen, regimen, while 40 patients with advanced HD or NHL had BCNU was given at a dose of 600 mg/m2 on day −5; it the BCV regimen (Table 2). PBPC were mobilized by 2 was administered with etoposide administered at a dose of cyclophosphamide given at a dose of 4000 mg/m followed ␮ 1000 mg/m2 by 1 day continuous infusion on day −4 and by G-CSF (5 g/kg/day) in all cases. One or two leukapher- with cyclophosphamide 4000 mg/m2 over 2 consecutive days (day −3 and day −2). Eighteen patients with HD and 22 with NHL received a transplant after the BVC regimen. Table 1 Main characteristics On day 0 all patients received a minimum dose of × 6 + 4 10 /kg autologous CD34 peripheral cells. Patients were Parameters No. cases (%) nursed in single rooms with laminar flow. All patients received the same antiseptic and anti-fungal mouth care and Total number of cases 65 irradiated blood product support. Median age (years) 40 (13–61) years Pulmonary function evaluation Sex Male 33 (50.8) Pulmonary function tests including spirometry and DLCO Female 32 (49.2) were performed before transplant in all patients. Patients Diagnosis were routinely followed monthly for 3 months and every NHL 22 (33.8) 3 months thereafter. Patients with cough, fever, or chest HD 18 (27.7) MM 25 (38.5) tightness underwent post-transplant chest radiography and Conditioning regimen additional spirometry with DLCO. In some cases broncho- BEM 25 (38.5) alveolar lavage (BAL) and trans-bronchial biopsy were per- BCV 40 (61.5) formed; patients were selected for these procedures if they Smokers 13 (20) had major complications and gave their informed consent. Previous pulmonary complications 2 (3.1) Previous bleomycine therapy 18 (27.7) Statistics Mediastinal involvement at diagnosis 23 (35.4) Descriptive statistics have been calculated for all variables. Radiotherapy on mediastinal field 12 (18.5) Data on patient ages, sex, diagnosis, previous radiation Pulmonary complications 24 (36.9) treatment, history of smoking, mediastinal involvement, Infection-related complications 7 (10.8) mediastinal field radiotherapy, pretransplant pulmonary Non-infection-related complications 17 (26.1) complications, previous treatment with bleomycine, and Major 11 (16.9) conditioning regimen were analyzed to assess by a Cox Minor 6 (9.2) model their predictive value for the occurrence
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