• This record comes from PubMed

Immunochemotherapy and Maintenance With Obinutuzumab or Rituximab in Patients With Previously Untreated Marginal Zone Lymphoma in the Randomized GALLIUM Trial

. 2022 Mar ; 6 (3) : e699. [epub] 20220224

Status PubMed-not-MEDLINE Language English Country United States Media electronic-ecollection

Document type Journal Article

Persistent link   https://www.medvik.cz/link/pmid35233508

The aim of this study was to explore the efficacy and safety of obinutuzumab (G)- versus rituximab (R)-chemotherapy in a subgroup of patients with previously untreated marginal zone lymphoma (MZL) in the phase III GALLIUM trial (NCT01332968). Patients had stage III/IV (or stage II with bulky disease), splenic, nodal, or extranodal MZL requiring treatment. Patients were randomized 1:1 to receive G- or R-chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone; cyclophosphamide, vincristine, and prednisone; or bendamustine, allocated at patient level). Patients with complete/partial response at the end of induction (EOI) received G/R maintenance. Investigator-assessed progression-free survival (PFS), other time-to-event endpoints, response, and safety were assessed. Overall, 195 patients with MZL were included in this analysis: G-chemotherapy (n = 99), R-chemotherapy (n = 96). Median observation time: 59.3 months. No meaningful difference was observed between arms for PFS (4-y PFS rates: G-chemotherapy, 72.6%; R-chemotherapy, 64.1%), other time-to-event endpoints, or EOI response rates (by computed tomography [CT; G-chemotherapy, 81.8%; R-chemotherapy, 81.3%] and positron emission tomography CT [G-chemotherapy, 79.2%; R-chemotherapy, 87.5%]). All patients experienced ≥1 adverse event (AE). G-chemotherapy was associated with a higher incidence of grade 3-5 (86.1% versus 77.4%), grade 5 (14.9% versus 9.7%), and serious (66.3% versus 51.6%) AEs versus R-chemotherapy. Both arms had a higher incidence of grade 3-5 and serious AEs than patients with follicular lymphoma (GALLIUM), with G-chemotherapy being less tolerable than R-chemotherapy. Based on the observed tolerability of G-chemotherapy versus R-chemotherapy, and the comparable efficacy of G-chemotherapy and R-chemotherapy in this analysis, G-chemotherapy cannot be recommended as first-line treatment for MZL.

Erratum In

PubMed

See more in PubMed

Denlinger NM, Epperla N, William BM. Management of relapsed/refractory marginal zone lymphoma: focus on ibrutinib. Cancer Manag Res. 2018;10:615–624. PubMed PMC

Al-Hamadani M, Habermann TM, Cerhan JR, et al. . Non-Hodgkin lymphoma subtype distribution, geodemographic patterns, and survival in the US: a longitudinal analysis of the National Cancer Data Base from 1998 to 2011. Am J Hematol. 2015;90:790–795. PubMed

Swerdlow SH, Campo E, Pileri SA, et al. . The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016;127:2375–2390. PubMed PMC

Salar A, Domingo-Domenech E, Panizo C, et al. . First-line response-adapted treatment with the combination of bendamustine and rituximab in patients with mucosa-associated lymphoid tissue lymphoma (MALT2008-01): a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2014;1:e104–e111. PubMed

Kalpadakis C, Pangalis GA, Angelopoulou MK, et al. . Treatment of splenic marginal zone lymphoma with rituximab monotherapy: progress report and comparison with splenectomy. Oncologist. 2013;18:190–197. PubMed PMC

Arcaini L, Orlandi E, Scotti M, et al. . Combination of rituximab, cyclophosphamide, and vincristine induces complete hematologic remission of splenic marginal zone lymphoma. Clin Lymphoma. 2004;4:250–252. PubMed

Zucca E, Conconi A, Laszlo D, et al. . Addition of rituximab to chlorambucil produces superior event-free survival in the treatment of patients with extranodal marginal-zone B-cell lymphoma: 5-year analysis of the IELSG-19 randomized study. J Clin Oncol. 2013;31:565–572. PubMed

Zucca E, Conconi A, Martinelli G, et al. . Final results of the IELSG-19 randomized trial of mucosa-associated lymphoid tissue lymphoma: improved event-free and progression-free survival with rituximab plus chlorambucil versus either chlorambucil or rituximab monotherapy. J Clin Oncol. 2017;35:1905–1912. PubMed

Noy A, de Vos S, Thieblemont C, et al. . Targeting Bruton tyrosine kinase with ibrutinib in relapsed/refractory marginal zone lymphoma. Blood. 2017;129:2224–2232. PubMed PMC

Herter S, Herting F, Mundigl O, et al. . Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013;12:2031–2042. PubMed

Mössner E, Brünker P, Moser S, et al. . Increasing the efficacy of CD20 antibody therapy through the engineering of a new type II anti-CD20 antibody with enhanced direct and immune effector cell-mediated B-cell cytotoxicity. Blood. 2010;115:4393–4402. PubMed PMC

Golay J, Da Roit F, Bologna L, et al. . Glycoengineered CD20 antibody obinutuzumab activates neutrophils and mediates phagocytosis through CD16B more efficiently than rituximab. Blood. 2013;122:3482–3491. PubMed

Marcus R, Davies A, Ando K, et al. . Obinutuzumab for the first-line treatment of follicular lymphoma. N Engl J Med. 2017;377:1331–1344. PubMed

Cheson BD, Pfistner B, Juweid ME, et al. . Revised response criteria for malignant lymphoma. J Clin Oncol. 2007;25:579–586. PubMed

Kalpadakis C, Pangalis GA, Sachanas S, et al. . Rituximab monotherapy in splenic marginal zone lymphoma: prolonged responses and potential benefit from maintenance. Blood. 2018;132:666–670. PubMed

Iannitto E, Bellei M, Amorim S, et al. . Efficacy of bendamustine and rituximab in splenic marginal zone lymphoma: results from the phase II BRISMA/IELSG36 study. Br J Haematol. 2018;183:755–765. PubMed

Salar A, Domingo-Domenech E, Panizo C, et al. . Long-term results of a phase 2 study of rituximab and bendamustine for mucosa-associated lymphoid tissue lymphoma. Blood. 2017;130:1772–1774. PubMed

Townsend W, Buske C, Cartron G, et al. . Obinutuzumab-based immunochemotherapy prolongs progression-free survival and time to next anti-lymphoma treatment in patients with previously untreated follicular lymphoma: four-year results from the Phase III GALLIUM study. Blood. 2018;132(suppl 1):1597–1597.

Becnel MR, Nastoupil LJ, Samaniego F, et al. . Lenalidomide plus rituximab (R2) in previously untreated marginal zone lymphoma: subgroup analysis and long-term follow-up of an open-label phase 2 trial. Br J Haematol. 2019;185:874–882. PubMed PMC

Lossos IS, Fabregas JC, Koru-Sengul T, et al. . Phase II study of (90)Y Ibritumomab tiuxetan (Zevalin) in patients with previously untreated marginal zone lymphoma. Leuk Lymphoma. 2015;56:1750–1755. PubMed

Find record

Citation metrics

Archiving options