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Jie Jin,1,2 Rumiko Okamoto,3 Sung-Soo Yoon,4 Lee-Yung Shih,5 Jun Zhu,6 Ting Liu,7 Xiaonan Hong,8 Lixia Pei,9 Brendan Rooney,10 Helgi van de Velde,11 Huiqiang Huang12 1Department of Hematology, The First Affiliated Hospital of Zhejiang University College of Medicine, Hangzhou, Zhejiang, China; 2Key Laboratory of Hematologic Malignancies, Diagnosis and Treatment, Hangzhou, Zhejiang, China; 3Department of Chemotherapy, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan; 4Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; 5Division of Hematology–Oncology, Chang Gung Memorial Hospital-Linkou, Chang Gung University, Taoyuan, Taiwan; 6Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China; 7Division of Hematology, Department of Internal Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan, China; 8Lymphoma and GI Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; 9Janssen Research & Development, LLC, Raritan, NJ, USA; 10Janssen Research & Development, High Wycombe, Buckinghamshire, UK; 11Oncology Clinical Research, Millennium Pharmaceuticals, Inc., Boston, MA, USA; 12Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China Introduction: This subgroup analysis of the LYM-3002 Phase III study (NCT00722137) investigated whether substituting bortezomib for vincristine in frontline R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy could improve outcomes in East Asian patients with newly diagnosed mantle-cell lymphoma (MCL). Materials and methods: A total of 121 East Asian patients from China, Taiwan, Japan, and the Republic of Korea with stage II–IV MCL who were ineligible or not considered for stem-cell transplantation were enrolled to six to eight 21-day cycles of R-CHOP or VR-CAP (R-CHOP with bortezomib replacing vincristine). Results: The primary end point was progression-free survival. After a median follow-up of 42.4 months, median progression-free survival in East Asian patients was 13.9 (R-CHOP) versus 28.6 (VR-CAP) months (HR 0.7, P=0.157; 43% improvement with VR-CAP). Secondary end points (R-CHOP vs VR-CAP), including complete response rate (47% vs 63%), duration of complete response (median 16.6 vs 46.7 months), and treatment-free interval (median 21 vs 46.5 months), were improved with VR-CAP. VR-CAP was associated with increased but manageable toxicity. The most frequent adverse events were hematologic toxicities. Conclusion: VR-CAP was effective in East Asian patients with newly diagnosed MCL, and could be considered for patients in whom stem-cell transplantation is not an option. Keywords: mantle-cell lymphoma, bortezomib, VR-CAP, R-CHOP |
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