immunochemotherapy

Effectiveness of the Initial Escalation of Immunochemotherapy in Patients with High Risk MALT-Lymphoma: Pilot Study Results

LYMPHOID TUMORS , , , , ,

AK Smol’yaninova, NG Gabeeva, SA Tatarnikova, AV Belyaeva, AM Kovrigina, EG Gemdzhyan, EE Zvonkov

National Research Center for Hematology, 4 Novyi Zykovskii pr-d, Moscow, Russian Federation, 125167

For correspondence: Anna Konstantinovna Smol’yaninova, MD, PhD, 4 Novyi Zykovskii pr-d, Moscow, Russian Federation, 125167; Tel.: +7(495)612-48-10; e-mail: annmo8@mail.ru.

For citation: Smol’yaninova AK, Gabeeva NG, Tatarnikova SA, et al. Effectiveness of the Initial Escalation of Immunochemotherapy in Patients with High Risk MALT-Lymphoma: Pilot Study Results. Clinical oncohematology. 2018;11(4):338–48.

DOI: 10.21320/2500-2139-2018-11-4-338-348

ABSTRACT

Background. MALT-lymphoma is usually characterized with an indolent course. The factors underlying the effectiveness of the standard chemotherapy in patients with MALT-lymphomas include MALT-IPI risk group and a high SUVmax according to the results of positron emission tomography (PET). All well-known MALT-lymphoma risk factors indirectly indicate a high risk of transformation to large cell lymphoma. The search for an effective chemotherapy continues.

Aim. To evaluate the effectiveness of the R-EPOCH/R-BAC escalated immunochemotherapy for MALT-lymphoma patients with poor prognosis factors.

Materials & Methods. In the period of 2016–2017 the study included 5 female MALT-lymphoma patients (the mean age of 41 years), of which 1 patient had an early relapse after surgery and 4 patients were newly diagnosed. Prior to therapy 4 patients were evaluated with PET. The mean SUVmax was 10.04. According to MALT-IPI 2 patients belonged to a high-risk group and 3 belonged to a middle-risk group. All the patients received R-EPOCH/R-BAC regimen therapy. A month after completing the treatment all the patients were again evaluated with PET.

Results. In 4 patients with 10–24 months follow-up complete remission was reported, which was confirmed by the results of histology and PET. The treatment of 1 patient was not completed. The immunotherapy was well tolerated by the patients. Hematological toxicity grade 3–4 occurred only after completing R-BAC treatment regimens. No severe infectious complications were reported.

Conclusion. MALT-lymphoma patients need to be evaluated in terms of all prognostic factors to identify the high-risk patients for whom escalated therapy is to be used already in the first line treatment. This pilot study of the use of R-EPOCH/R-BAC for treatment of MALT-lymphoma patients with poor prognosis factors yielded positive results and showed its acceptable tolerance.

Keywords: MALT-lymphoma, immunochemotherapy, positron emission tomography, prognosis factors, rituximab, ribomustin, cytarabine.

Received: April 10, 2018

Accepted: August 3, 2018

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First-Line Treatment of Mantle-Cell Lymphoma: Analysis of Effectiveness and Cost-Effectiveness

LYMPHOID TUMORS , , , ,

KD Kaplanov1, NP Volkov1, TYu Klitochenko1, AL Shipaeva1, IV Matveeva1, MN Shirokova1, AC Proskurina1, NA Red’kina1, EG Gemdzhyan2

1 Volgograd Regional Clinical Oncologic Centre, 78 Zemlyachki str., Volgograd, Russian Federation, 400138

2 National Medical Hematology Research Center, 4а Novyi Zykovskii pr-d, Moscow, Russian Federation, 125167

For correspondence: Kamil’ Daniyalovich Kaplanov, MD, PhD, 78 Zemlyachki str., Volgograd, Russian Federation, 400138; e-mail: kamilos@mail.ru

For citation: Kaplanov KD, Volkov NP, Klitochenko TYu, et al. First-Line Treatment of Mantle-Cell Lymphoma: Analysis of Effectiveness and Cost-Effectiveness. Clinical oncohematology. 2018;11(2):150–9.

DOI: 10.21320/2500-2139-2018-11-2-150-159

ABSTRACT

Aim. To study the correlation between efficacy of mantle-cell lymphoma treatment in clinical practice and failure of first-line therapy and direct expenses depending on the first-line therapy selection.

Methods. During the period from 2008 to 2016 a comparative single-center controlled trial was performed to evaluate the effectiveness and toxicity of R-hyper-CVAD-R-HD-AraC (n = 16) regimen. The control group included patients treated with 6–8 cycles of R-CHOP (n = 39). Cytarabine dose was lower than the original regimen and contained not more than 1 g/m2 twice a day for 2 days. R-hyper-CVAD regimen included the standard drug doses. R-HD-AraC treatment started on day 28 from the beginning of the R-hyper-CVAD therapy. The R-hyper-CVAD-R-HD-AraC group consisted of patients with the following characteristics: the median age was 56 years (range 40–66), older than 60 — 6 (38 %), male patients — 12 (75 %), stage IV — 12 (75 %), bulky — 7 (44 %), with bone marrow involved — 11 (69 %), MIPIb high-risk — 8 (50 %), blastoid variant — 7 (44 %). Only 2 patients of the R-hyper-CVAD-R-HD-AraC group received high-dose consolidation treatment with autologous HSC transplantation. HSCT was not performed in the control group. The results of comparative analysis were adjusted to age. In terms of the other significant factors the groups under comparison were similar.

Results. All the patients of the study group were treated with 3 R-hyper-CVAD and 3 R-HD-AraC regimens. The rate of complete remission was significantly higher than in the control group —12 (75 %) vs. 14 (36 %). No differences were observed in the 5-year overall survival: 55 % in the R-hyper-CVAD-R-HD-AraC group and 58 % in the R-CHOP group (p = 0.75). Second-line therapy was received by 8 out of 15 (47 %) patients treated with R-hyper-CVAD-R-HD-AraC, and by 18 out of 23 (78 %) patients treated with R-CHOP. Median time before second-line therapy was significantly higher in the R-hyper-CVAD-R-HD-AraC group — 26 vs. 6 months (p = 0.018). The costs of the first and subsequent therapy lines were analysed using a Markov model. Cost analysis of first-line therapy variants to be compared was based on cost-effectiveness ratio (CER) and incremental cost-effectiveness ratio (ICER). The analysis proved the cost-effectiveness of R-hyper-CVAD-R-HD-AraC program.

Conclusion. R-hyper-CVAD-R-HD-AraC program meets eligibility criteria for effectiveness, toxicity and cost-effectiveness and can, therefore, be recommended as first-line therapy of mantle-cell lymphoma and be used for the further comparative clinical trials.

Keywords: mantle-cell lymphoma, immunochemotherapy, pharmacoeconomics, Markov model, cost-effectiveness analysis.

Received: January 7, 2018

Accepted: March 3, 2018

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