Clinical Research Papers:
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
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Lei Zhang1,3,*, Sisi Jia1,3,*, Yangyang Ma1,3,*, Ling Li1,3, Xin Li1,3, Xinhua Wang1,3, Xiaorui Fu1,3, Wang Ma1,3, Yanru Qin1,3, Wencai Li2,3, Jingjing Wu1,3, Zhenchang Sun1,3, Xudong Zhang1,3, Feifei Nan1,3, Yu Chang1,3, Zhaoming Li1,3, Dandan Zhang2,3, Guannan Wang2,3, Jiaqin Yan1,3, Liping Su4, Jinghua Wang5, Hongwei Xue6, Ken H. Young7, Mingzhi Zhang1,3
1Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450000, China
2Department of Pathology, The First Affiliated Hospital of Zhengzhou University, Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China
3Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, 450000, China
4Department of Hematology, Shanxi Province Cancer Hospital, Taiyuan, Shanxi, China
5Department of Oncology, Nanjing General Hospital of Nanjing Military Command, Nanjing, Jiangsu, China
6Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
7Department of Hematology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
*These authors have contributed equally to this work
Mingzhi Zhang, email: [email protected]
Keywords: extranodal natural killer/T-cell lymphoma, DDGP, chemotherapy, efficacy, safety
Received: November 03, 2015 Accepted: May 11, 2016 Published: June 17, 2016
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.
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