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Medline ® Abstract for Reference 50

of 'Management of gastrointestinal lymphomas'

50
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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.
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Zucca E, Conconi A, Martinelli G, Bouabdallah R, Tucci A, Vitolo U, Martelli M, Pettengell R, Salles G, Sebban C, Guillermo AL, Pinotti G, Devizzi L, Morschhauser F, Tilly H, Torri V, Hohaus S, Ferreri AJM, Zachée P, Bosly A, Haioun C, Stelitano C, Bellei M, Ponzoni M, Moreau A, Jack A, Campo E, Mazzucchelli L, Cavalli F, Johnson P, Thieblemont C
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J Clin Oncol. 2017;35(17):1905. Epub 2017 Mar 29.
 
Purpose There is no consensus on the optimal systemic treatment of patients with extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue. The IELSG-19 phase III study, to our knowledge, was the first such study to address the question of first-line treatment in a randomized trial. Patients and Methods Eligible patients were initially randomly assigned (1:1 ratio) to receive either chlorambucil monotherapy (6 mg/m(2)/d orally on weeks 1 to 6, 9 to 10, 13 to 14, 17 to 18, and 21 to 22) or a combination of chlorambucil (same schedule as above) and rituximab (375 mg/m(2) intravenously on day 1 of weeks 1, 2, 3, 4, 9, 13, 17, and 21). After the planned enrollment of 252 patients, the protocol was amended to continue with a three-arm design (1:1:6 ratio), with a new arm that included rituximab alone (same schedule as the combination arm) and with a final sample size of 454 patients. The main end point was event-free survival (EFS). Analysis of chlorambucil versus the combination arm was performed and reported separately before any analysis of the third arm. Results At a median follow-up of 7.4 years, addition of rituximab to chlorambucil led to significantly better EFS (hazard ratio, 0.54; 95% CI, 0.38 to 0.77). EFS at 5 years was 51% (95% CI, 42 to 60) with chlorambucil alone, 50% (95% CI, 42 to 59) with rituximab alone, and 68% (95% CI, 60 to 76) with the combination ( P = .0009). Progression-free survival was also significantly better with the combination ( P = .0119). Five-year overall survival was approximately 90% in each arm. All treatments were well tolerated. No unexpected toxicities were recorded. Conclusion Rituximab in combination with chlorambucil demonstrated superior efficacy in mucosa-associated lymphoid tissue lymphoma; however, improvements in EFS and progression-free survival did not translate into longer overall survival.
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Emanuele Zucca and Franco Cavalli, Oncology Institute of Southern Switzerland, Bellinzona; Luca Mazzucchelli, Cantonal Institute of Pathology, Locarno, Switzerland; Annarita Conconi, Ospedale degli Infermi, Biella; Giovanni Martinelli, European Institute of Oncology; Liliana Devizzi, Fondazione Istituto Nazionale Tumori; Valter Torri, Mario Negri Institute; Andrés J.M. Ferreri, San Raffaele Scientific Institute; Maurilio Ponzoni, San Raffaele Hospital, Milan; Alessandra Tucci, Spedali Civili, Brescia; Umberto Vitolo, University-Hospital Cittàdella Salute e della Scienza, Turin; Maurizio Martelli, Sapienza University; Stefan Hohaus, Catholic University of the Sacred Heart, Rome; Graziella Pinotti, Fondazione Macchi Hospital, Varese; Caterina Stelitano, Bianchi-Melacrino-Morelli Hospitals, Reggio Calabria; Monica Bellei, University of Modena and Reggio Emilia, Modena, Italy; Reda Bouabdallah, Institut Paoli-Calmettes, Marseille; Gilles Salles, Hospices Civils de Lyon and UniversitéClau
PMID