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Long-Term Outcome with Pentostatin Treatment in Hairy Cell Leukemia Patients

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Long-Term Outcome with Pentostatin Treatment in Hairy Cell Leukemia Patients Leukemia (2003) 17, 45–51 2003 Nature Publishing Group All rights reserved 0887-6924/03 $25.00 www.nature.com/leu Long-term outcome with pentostatin treatment in hairy cell leukemia patients. A French retrospective study of 238 patients F Maloisel1, L Benboubker2, M Gardembas3, B Coiffier4, M Divine5, C Sebban6, M Blanc7, J-F Abgrall8, P Lederlin9, J-L Harousseau10, A-M Blaise11, B Grosbois12, P Morice13, C Ghandour14 and S Castaigne15 1De´partement d’He´matologie et d’Oncologie, HUS, Strasbourg, France; 2Service d’Oncologie Me´dicale et des Maladies du Sang, CHU, Tours, France; 3Service des Maladies du Sang, CHU, Angers, France; 4Service d’He´matologie, Clinique Centre Hospitalier Lyon Sud Pierre Benite, France; 5Service d’He´matologie Hopital Henri Mondor, Creteil, France; 6Service d’He´matologie Hopital Edouard Herriot, Lyon, France; 7Service de Me´decine A7, Centre Hospitalier, Chambe´ry, France; 8Service d’He´matologie-Oncologie-He´mostase, Hopital Augustin Morvan, Brest, France; 9Service de Me´decine A, CHU Brabois, Nancy, France; 10Service d’He´matologie, Clinique Hopital Hotel-Dieu, Nantes, France; 11De´partement de Me´decine Interne et d’He´matologie, Clinique Hopital Robert Debre´, Reims, France; 12Service de Me´decine G, CHRU Hopital Sud, Rennes, France; 13Service d’He´matologie et d’Oncologie Me´dicale, Hopital Yves Le Foll, St Brieuc, France; 14Cabinet d’He´matologie-Oncologie Polyclinique Sevigne´, Rennes, France; and 15Service d’He´matologie et d’Oncologie, CH de Versailles, France With the introduction of new drugs such as alpha-interferon mately 4 years before systemiceffectivetherapy was intro- (IFN) and purine analogs, the management of hairy cell leuke- duced.2 Splenectomy was the first treatment modality to be mia (HCL) patients has changed. However, deoxycoformycin (DCF) produced higher complete remission rates than IFN. The regularly used in HCL and it was able to achieve a rapid per- current study was undertaken to provide long-term data on dur- ipheral hematologic reconstitution even in the presence of ation of overall survival (OS) and disease-free survival (DFS) severe cytopenia.3 Although splenectomy decreased cyto- and incidence of subsequent malignancies. We retrospectively penia, it had no effect on bone marrow infiltration, meaning analyzed the data of patients treated with DCF (4 mg/m2/day, that eventually another treatment was necessary. With the every 2 weeks) from 39 French centers. In 84 of 238 included introduction of new drugs, such as alpha-interferon (IFN), 2Ј patients, DCF was the first-line therapy. Pretreatment variables Ј influencing the achievement of complete remission, DFS, and deoxycoformycin (DCF), and 2 -chlorodeoxyadenosine OS were identified by multivariate analysis. Two hundred and (2CdA), the management of HCL patients changed. The last thirty-eight patients received a median of nine cycles (range, two were purine analogs that differ in their interaction with 1–19 cycles). A complete remission was obtained in 182 of 230 adenosine deaminase, the enzyme that plays a role in the evaluable patients (79%) and a partial response was obtained purine metabolism and which is present in high concen- in 38 patients, for an overall response rate of 95.6%. In the trations in lymphoid tissues.4 The proportion of patients multivariate analysis hemoglobin level less than 100 g/l and leukocytes less than 2 × 109/l were parameters adversely influ- obtaining a response with IFN ranged from 0% to 43% for encing complete remission achievement. With a median follow- complete remission (CR) and rose to 90% for partial response up of 63.5 months (range, 0.39–138.4 months), disease recur- (PR), but the majority of patients relapsed after stopping ther- rence was observed in 34 of 220 responding patients (15%). apy.5 A randomized study, with a cross-over design, compar- The estimated 5-years and 10-years DFS was 88.1% and 68.8%, ing DCF to IFN demonstrated that DCF produced a higher respectively. Hemoglobin level less than 100 g/l and leukocytes complete remission rate with more durable response, but × 9 less than 2 10 /l were the pre-treatment variables associated 6 with a shorter DFS. The estimated 5-year and 10-year OS were without differences in terms of survival. Since the first publi- 89.4% and 88.7%, respectively. Hemoglobin level less than 100 cation on DCF activity in HCL patients, numerous studies con- g/l, leukocytes less than 2 × 109/l, and adenopathy were signifi- firmed this observation.7–11 In the first clinical trials, patients cant factors of reduced survival. Hematologic toxicity was the were treated with higher doses but severe neurologicadverse main side-effect, followed by infection and emesis. During the events were noted and, secondarily, it was reported that lower period of follow-up, 18 patients developed second cancer, but doses (4 mg/m2) was less toxic with the same efficacy.7 the standardized incidence ratio was 0.95. Pentostatin is a highly effective regimen for hairy cell leukemia that produces Recently, the appearence of second malignancies after purine durable complete responses. Toxicity of DCF is acceptable. analogs was regarded as a potential problem and was Subsequent malignancies do not appear to be increased with observed in 10% of patients treated with DCF.2 pentostatin treatment. We report here a large cohort of patients with HCL treated Leukemia (2003) 17, 45–51. doi:10.1038/sj.leu.2402784 with DCF and a median follow-up of 63.5 months. Keywords: hairy cell leukemia; deoxycoformycin; long-term follow- up; secondary cancer Materials and methods Introduction Patients, treatment schedule and criteria of response Hairy cell leukemia (HCL) is a rare lymphoproliferative malig- Retrospectively, data of HCL patients from 39 French centers nancy first described in 1958 and referred to originally as leu- treated with DCF between March 1989 and December 1997 1 kemicreticuloendotheliosis. The natural history of this were analyzed. Data files were reviewed before inclusion in lymphoproliferative disorder varies. Studies on HCL from the present analysis and patients were required to have: (1) a 1958 to 1984 showed a median survival time of approxi- confirmed diagnosis of HCL on the basis of peripheral blood, bone marrow biopsy, and immunophenotype; (2) an active disease as manifested by progressive cytopenia (neutrophil Correspondence: F Maloisel, Department of Hematology and count less than 1 × 109/l, or hemoglobin level less than 100 Oncology, Hoˆpital Civil, 1 place de l’hoˆpital, 67091 Strasbourg, × 9 France; Fax: 33–388 115805; Email: Frederic.Maloisel@chru- g/l, or thrombocytopenia less than 100 10 /l), recurrent strasbourg.fr infections, or massive splenomegaly; (3) patients required Received 3 May 2002; accepted 22 August 2002 abdominal evaluation by CT scans; (4) an adequate renal and Pentostatin in hairy cell leukemia F Maloisel et al 46 liver function (creatinin less than 1.5 N and liver enzymes less mentioned above. The proportional hazard assumption was than 2.5 N); (5) patients could have been either untreated or validated on the most statistically significant covariates. have previously been treated with splenectomy, systemic To determine whether there was an excess of secondary chemotherapy, or both. primary tumors (occurring after the diagnosis of HCL), we DCF was given at a dose of 4 mg/m2 by intravenous bolus computed standardized incidence ratio calculated by injection every 2 weeks and was continued to the point of determining the ratio of the observed to expected number of maximal response or treatment failure. No maintenance ther- individuals with second malignancies. The expected number apy was given. Any recurrence of cytopenia after the fourth of individuals with secondary invasive malignancies course would postpone treatment until recuperation to near (excluding non-melanoma skin cancer) was determined using normal values. age, sex, and calendar-year-specific incidence rate extra- Established response criteria were used and are summarized polated from the main French cancer registries.14 as follows: CR was defined as (1) disappearence of any evi- Results presented here are based on data available as of 15 dence of HCL cell in blood and bone marrow; (2) achieve- March 2001. Statistical analysis was carried out by Biotrial, ment of hemoglobin level greater than 120 g/l, platelet count Rennes, France. greater than 100 × 109/l, and absolute neutrophil count (ANC) greater than 1.5 × 109/l; (3) normalization of spleen size if originally abnormal; and (4) resolution of adenopathy if orig- Results inally present. Patients who presented all peripheral blood CR criteria except the bone marrow control were considered as Patient’s characteristics unconfirmed CR (CRu). PR required all the following: (1) nor- mal blood counts as stated above; (2) reduction of initial Table 1 shows the main clinical features at the start of treat- spleen size by more than 50%; (3) a 50% reduction or greater ment for the 238 patients included in the present study: 154 in the percentage of hairy cell infiltration in the bone marrow. (64.7%) patients had received prior treatment, including inter- Patients who did not fulfill the above criteria were classified as non-responders. Relapse was defined as reappearance of cytopenia, blood infiltration, or increase in the percentage of Table 1 Patient demographics hairy cells originally found in the bone marrow biopsy. Untreated Previously Total Toxicity was graded by standard World Health Organiza- treated tion (WHO) criteria. Second malignancies appearing after DCF treatment were recorded. Follow-up intervals varied Number 84 154 238 depending on habit of each center, but all patients were exam- Age ined at a minimun of 6-month intervals. Bone marrow exam- Median (years) 61.1 60 60.2 inations were not routinely performed unless cytopenia reap- Range 31–86 33–85 31–86 peared but all patients underwent at least two bone marrow Sex controls over the first 3 years.
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