Efficacy and safety of cisplatin, dexamethasone, gemcitabine and pegaspargase (DDGP) regimen in newly diagnosed, advanced-stage extranodal natural killer/T-cell lymphoma: interim analysis of a phase 4 study NCT01501149

// Lei Zhang 1, 3, * , Sisi Jia 1, 3, * , Yangyang Ma 1, 3, * , Ling Li 1, 3 , Xin Li 1, 3 , Xinhua Wang 1, 3 , Xiaorui Fu 1, 3 , Wang Ma 1, 3 , Yanru Qin 1, 3 , Wencai Li 2, 3 , Jingjing Wu 1, 3 , Zhenchang Sun 1, 3 , Xudong Zhang 1, 3 , Feifei Nan 1, 3 , Yu Chang 1, 3 , Zhaoming Li 1, 3 , Dandan Zhang 2, 3 , Guannan Wang 2, 3 , Jiaqin Yan 1, 3 , Liping Su 4 , Jinghua Wang 5 , Hongwei Xue 6 , Ken H. Young 7 , Mingzhi Zhang 1, 3 1 Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450000, China 2 Department of Pathology, The First Affiliated Hospital of Zhengzhou University, Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China 3 Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, 450000, China 4 Department of Hematology, Shanxi Province Cancer Hospital, Taiyuan, Shanxi, China 5 Department of Oncology, Nanjing General Hospital of Nanjing Military Command, Nanjing, Jiangsu, China 6 Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China 7 Department of Hematology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA * These authors have contributed equally to this work Correspondence to: Mingzhi Zhang, email: mingzhi_zhang1@163.com Keywords: extranodal natural killer/T-cell lymphoma, DDGP, chemotherapy, efficacy, safety Received: November 03, 2015 Accepted: May 11, 2016 Published: June 17, 2016 ABSTRACT To explore a more effective treatment for newly diagnosed, advanced-stage extranodal natural killer/T-cell lymphoma, nasal type (ENKTL), we conducted a phase 4 study of the cisplatin, dexamethasone, gemcitabine, pegaspargase (DDGP) regimen. The primary end point was the 2-year progression-free survival (PFS) after the protocol treatment. Secondary endpoints included response rate (RR), overall survival (OS) and median survival time (MST). The interim analysis included data only from March 2011 to September 2013, who received six cycles of DDGP chemotherapy. A total of 25 eligible patients were enrolled. Seventeen patients (17/24, 70.83%) achieved complete response (CR) and four (4/24, 16.67%) achieved partial response (PR), three (3/24, 12.50%) had progressive disease (PD). The RR after treatment was 87.50%. After a median follow-up duration of 24.67 months (range 4-48 months). The 2-year PFS and OS rate were 61.80% (95% CI, 42.00% to 81.60%) and 68.50 % (95% CI, 48.70% to 88.30%), respectively. The MST was 36.55 months (95% CI, 29.41 months to 43.70 months). Grade 3/4 leukopenia occurred in fourteen patients (58.33%) and grade 3/4 thrombocytopenia occurred in eleven patients (45.83%). Twelve patients (50.00%) experienced Activated Partial Phromboplastin Ptime (APTT) elongation and fourteen patients (58.33%) experienced hypofibrinogenemia. In conclusion, DDGP regimen is an effective and tolerated treatment for newly diagnosed, advanced-stage ENKTL. This trial was registered at www.ClinicalTrials.gov as #NCT01501149.