Abstract
Background Brentuximab vedotin (SGN-35) is a treatment option for patients with relapsed or refractory Hodgkin’s lymphoma (HL) and systemic anaplastic large-cell lymphoma (ALCL), with only two phase II studies. Purpose To evaluate the effectiveness and safety of SGN-35 in patients with relapsed or refractory HL and ALCL. Material and methods Type of study: retrospective observational cohort study. Inclusion criteria: patients with relapsed or refractory HL and ALCL, treated with SGN-35 in monotherapy from 05/2012 to 09/2014. Variables: age, sex, type of lymphoma, stage and International Prognostic Index (IPI score); number of prior courses of chemotherapy, autologous stem-cell transplantation (auto-SCT) and clinical response to prior treatment; number of cycles, dose reductions, clinical response according to the Revised Response Criteria for Malignant Lymphoma: complete remission (CR), partial remission (PR), stable disease (SD) and progressed disease (PD). Incidence and severity of side effects (CTCAE v4.03 criteria). Results We included 5 patients (3 women, 2 men) aged 47 (30; 52) years. 4 patients suffered from HL, stages II-A, II-B, III-A, IV-B, and 1 ALCL stage IV-A. The IPI score was: III 2 patients, IV 1 patient (2 patients not specified). Our patients had received 2 (2; 4) chemotherapy cycles before SGN-35 and 3 of them had undergone an auto-SCT. Clinical response to prior therapy was CR in 2 and PR in 3 patients. After 4 (2; 16) cycles (1 patient with a 17% reduction of dose because of his previous hepatic impairment) 2 patients achieved CR, 1 PR and 1 PD. At the end of the follow-up period, 3 patients carried on with the treatment (1 without evaluation of the response) and 2 patients had died (1 CR and 1 PD) with a time to progression of 2.5 (2; 3) months. 1 patient suffered from side effects: facial rash and a post-infusion reaction grades I-II. Conclusion In our population 3 of 5 patients treated with SGN-35 achieved an objective response for 2.5 months, with favourable safety profile. References and/or Acknowledgements JCO30 (18):2190–6 JCO30 (18):2183–9 No conflict of interest.
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