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V. Leblond et al.
Acknowledgments
The authors would like to thank the patients and their fami- lies, and the GREEN study investigators and site staff. They would also like to acknowledge Miriam Amor for her valuable contribution to the statistical analyses. Third-party medical
writing assistance, under the direction of the authors, was pro- vided by Cheryl Wright, PhD of Gardiner-Caldwell Communications (Macclesfield, UK), and was funded by F. Hoffmann-La Roche Ltd. GREEN was sponsored by F. Hoffmann-La Roche Ltd.
References
1. Goede V, Fischer K, Busch R, et al. Chemoimmunotherapy with GA101 plus chlorambucil in patients with chronic lym- phocytic leukemia and comorbidity: results of the CLL11 (BO21004) safety run-in. Leukemia. 2013;27(5):1172-1174.
2. Goede V, Fischer K, Busch R, et al. Obinutuzumab plus chlorambucil in patients with CLL and coexisting condi- tions. N Engl J Med. 2014;370(12):1101- 1110.
3. Goede V, Fischer K, Engelke A, et al. Obinutuzumab as frontline treatment of chronic lymphocytic leukemia: updated results of the CLL11 study. Leukemia. 2015;29(7):1602-1604.
4. Cartron G, de Guibert S, Dilhuydy MS, et al. Obinutuzumab (GA101) in relapsed/refractory chronic lymphocytic leukemia: final data from the phase 1/2 GAUGUIN study. Blood. 2014; 124(14):2196-2202.
5. Byrd JC, Flynn JM, Kipps TJ, et al. Randomized phase 2 study of obinutuzum- ab monotherapy in symptomatic, previous- ly untreated chronic lymphocytic leukemia. Blood. 2016;127(1):79-86.
6. Brown JR, O’Brien S, Kingsley CD, et al. Obinutuzumab plus fludarabine/ cyclophosphamide or bendamustine in the initial therapy of CLL patients: the phase 1b GALTON trial. Blood. 2015; 125(18):2779-2785.
7. Danilov A, Yimer H, Boxer M, et al. Results of a phase II multicenter study of obinu- tuzumab plus bendamustine in pts with previously untreated chronic lymphocytic leukemia (CLL). Haematologica. 2017;102:71 [abstract P249].
8. Gazyva® (obinutuzumab) injection, for intravenous infusion. Full prescribing infor- mation. Revised 2/2016.
9. Gazyvaro® (obinutuzumab) 1,000 mg con- centrate for solution for infusion. Summary of product characteristics. Last updated 28/07/2016.
10. Hallek M, Cheson BD, Catovsky D, et al;
International Workshop on Chronic Lymphocytic Leukemia. Guidelines for the diagnosis and treatment of chronic lym- phocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood. 2008;111(12):5446- 5456.
11. Eichhorst B, Robak T, Montserrat E, et al; ESMO Guidelines Committee: Chronic lymphocytic leukaemia. ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26 Suppl 5:v78-v84.
12. Wierda WG, Zelenetz AD, Gordon LI, et al. NCCN guidelines insights: chronic lym- phocytic leukemia/small lymphocytic leukemia, version 1.2017. J Natl Compr Canc Netw. 2017;15(3):293-311.
13. Sehn LH, Chua N, Mayer J, et al. Obinutuzumab plus bendamustine versus bendamustine monotherapy in patients with rituximab-refractory indolent non- Hodgkin lymphoma (GADOLIN): a ran- domised, controlled, open-label, multicen- tre, phase 3 trial. Lancet Oncol. 2016;17(8):1081-1093.
14. Sehn LH, Goy A, Offner FC, et al. Randomized phase II trial comparing obin- utuzumab (GA101) with rituximab in patients with relapsed CD20+ indolent B- cell non-Hodgkin lymphoma: final analysis of the GAUSS study. J Clin Oncol. 2015;33(30):3467-3474.
15. Salles GA, Morschhauser F, Solal-Céligny P, et al. Obinutuzumab (GA101) in patients with relapsed/refractory indolent non- Hodgkin lymphoma: results from the phase II GAUGUIN study. J Clin Oncol. 2013; 31(23):2920-2926.
16. Morschhauser FA, Cartron G, Thieblemont C, et al. Obinutuzumab (GA101) monotherapy in relapsed/refractory diffuse large B-cell lymphoma or mantle-cell lym- phoma: results from the phase II GAU- GUIN study. J Clin Oncol. 2013; 31(23):2912-2919.
17. Radford J, Davies A, Cartron G, et al.
Obinutuzumab (GA101) plus CHOP or FC in relapsed/refractory follicular lymphoma: results of the GAUDI study (BO21000). Blood. 2013;122(7):1137-1143.
18. Marcus R, Davies A, Ando K, et al. Obinutuzumab for the first-line treatment of follicular lymphoma. N Engl J Med. 2017;377(14):1331-1334.
19. Dawson K, Moran M, Guindon K, Wan H. Managing infusion-related reactions for patients with chronic lymphocytic leukemia receiving obinutuzumab. Clin J Oncol Nurs. 2016;20(2):E41-E48.
20. Eichhorst B, Fink AM, Bahlo J, et al. International group of investigators; German CLL Study Group (GCLLSG). First-line chemoimmunotherapy with ben- damustine and rituximab versus fludara- bine, cyclophosphamide, and rituximab in patients with advanced chronic lymphocytic leukaemia (CLL10): an inter- national, open-label, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2016;17(7):928-942.
21. Fischer K, Bahlo J, Fink AM, et al. Long- term remissions after FCR chemoim- munotherapy in previously untreated patients with CLL: updated results of the CLL8 trial. Blood. 2016;127(2):208-215.
22. Skarbnik AP, Faderl S. The role of com- bined fludarabine, cyclophosphamide and rituximab chemoimmunotherapy in chron- ic lymphocytic leukemia: current evidence and controversies. Ther Adv Hematol. 2017;8(3):99-105.
23. Hallek M, Fischer K, Fingerle-Rowson G, et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomized, open-label, phase 3 trial. Lancet. 2010; 376(9747):1164-1174.
24. Nunes AA, da Silva AS, Souza KM, Koury Cde N, de Mello LM. Rituximab, fludara- bine, and cyclophosphamide versus fludarabine and cyclophosphamide for treatment of chronic lymphocytic leukemia: a systematic review with meta- analysis. Crit Rev Oncol Hematol. 2015; 94(3):261-269.
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