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Obinutuzumab plus lenalidomide in advanced, previously untreated follicular lymphoma in need of systemic therapy: a LYSA study

Emmanuel Bachy 1, 2 Roch Houot 3, 4 Pierre Feugier 5 Krimo Bouabdallah 6 Reda Bouabdallah 7 Emmanuelle Nicolas Virelizier 8 Marie Maerevoet 9 Christophe Fruchart 10 Sylvia Snauwaert 11 Steven Le Gouill 12, 13, 14, 15, 16 Jean-Pierre Marolleau 17, 18 Lysiane Molina 19 Cecile Molucon-Chabrot 20 Catherine Thieblemont 21, 22 Herve Tilly 23, 24 Fontanet Bijou 25 Corinne Haioun 26, 27 Eric van Den Neste 28 Bettina Fabiani 29 Michel Meignan 26, 30 Guillaume Cartron 31 Gilles Salles 32 Olivier Casasnovas 33 Franck Morschhauser 34, * 
* Auteur correspondant
Abstract : Obinutuzumab and lenalidomide (referred to as the GALEN combination) is an active immunomodulatory combination with a manageable safety profile in multiple types of lymphoma. We report efficacy and safety results for the phase 2 GALEN study in previously untreated patients with advanced follicular lymphoma (FL). Eligible patients aged ≥18 years had an Eastern Cooperative Oncology Group performance status ≤2 and high-tumor burden, grade 1 to 3a FL. Induction treatment was obinutuzumab (1000 mg IV, days 8, 15, and 22, cycle 1; day 1, cycles 2-6) plus lenalidomide (20 mg/d, days 1-21, cycle 1; days 2-22, cycles 2-6) for six 28-day cycles. Maintenance included obinutuzumab (1000 mg every 2 cycles) plus lenalidomide (10 mg, days 2-22) for ≤12 cycles (year 1) followed by obinutuzumab (1000 mg every 56 days) for 6 cycles (year 2). The primary end point was complete response rate (CRR) after induction per the 1999 International Working Group criteria. From October 2015 to February 2017, a total of 100 patients were enrolled. CRR after induction was 47%, and the overall response rate (ORR) was 92%. Post hoc analyses per the 2014 Lugano classification, including patients with missing bone marrow assessments, identified an additional 13 patients fulfilling CRR criteria, resulting in a complete metabolic response of 80% and an ORR of 94%. At a median follow-up of 3.7 years, 3-year progression-free survival and overall survival were 82% and 94%, respectively. The most common adverse event was neutropenia (48% any grade; 47% grade ≥3). Only 2% of patients presented with febrile neutropenia; others were mainly grade ≤2. No other specific grade ≥3 toxicity occurred at a frequency >3%. Overall, these results showed promising clinical efficacy for the chemotherapy-free GALEN backbone in previously untreated patients with high tumor burden FL. Except for neutropenia, the safety profile of the combination is remarkable. The study was registered at clinicaltrials.gov as #NCT01582776.
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https://hal-u-picardie.archives-ouvertes.fr/hal-03679319
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Soumis le : jeudi 16 juin 2022 - 11:33:37
Dernière modification le : vendredi 17 juin 2022 - 03:42:31

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Emmanuel Bachy, Roch Houot, Pierre Feugier, Krimo Bouabdallah, Reda Bouabdallah, et al.. Obinutuzumab plus lenalidomide in advanced, previously untreated follicular lymphoma in need of systemic therapy: a LYSA study. Blood, American Society of Hematology, 2022, 139 (15), pp.2338-2346. ⟨10.1182/blood.2021013526⟩. ⟨hal-03679319⟩

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