title: 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.
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.
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Lei
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Sisi
authors.initials: S
authors.lastname: Jia
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Yangyang
authors.initials: Y
authors.lastname: Ma
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Ling
authors.initials: L
authors.lastname: Li
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Xin
authors.initials: X
authors.lastname: Li
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Xinhua
authors.initials: X
authors.lastname: Wang
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Xiaorui
authors.initials: X
authors.lastname: Fu
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Wang
authors.initials: W
authors.lastname: Ma
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Yanru
authors.initials: Y
authors.lastname: Qin
authors.affiliation: Department of Pathology, The First Affiliated Hospital of Zhengzhou University, Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Wencai
authors.initials: W
authors.lastname: Li
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Jingjing
authors.initials: J
authors.lastname: Wu
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Zhenchang
authors.initials: Z
authors.lastname: Sun
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Xudong
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Feifei
authors.initials: F
authors.lastname: Nan
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Chang
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Zhaoming
authors.initials: Z
authors.lastname: Li
authors.affiliation: Department of Pathology, The First Affiliated Hospital of Zhengzhou University, Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Dandan
authors.initials: D
authors.lastname: Zhang
authors.affiliation: Department of Pathology, The First Affiliated Hospital of Zhengzhou University, Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Guannan
authors.initials: G
authors.lastname: Wang
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Jiaqin
authors.initials: J
authors.lastname: Yan
authors.affiliation: Department of Hematology, Shanxi Province Cancer Hospital, Taiyuan, Shanxi, China.
authors.forename: Liping
authors.initials: L
authors.lastname: Su
authors.affiliation: Department of Oncology, Nanjing General Hospital of Nanjing Military Command, Nanjing, Jiangsu, China.
authors.forename: Jinghua
authors.initials: J
authors.lastname: Wang
authors.affiliation: Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.
authors.forename: Hongwei
authors.initials: H
authors.lastname: Xue
authors.affiliation: Department of Hematology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Ken H
authors.initials: KH
authors.lastname: Young
authors.affiliation: Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.|Lymphoma Diagnosis and Treatment Center of Henan Province, Zhengzhou, Henan, China.
authors.forename: Mingzhi
authors.initials: M
authors.lastname: Zhang
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001215:Asparaginase / Q000008:administration & dosage; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D003907:Dexamethasone / Q000008:administration & dosage; D005260:Female; D006801:Humans; D054391:Lymphoma, Extranodal NK-T-Cell / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage; D055815:Young Adult; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D011092:Polyethylene Glycols; C042705:pegaspargase; D003907:Dexamethasone; D001215:Asparaginase; D002945:Cisplatin; D000093542:Gemcitabine
keywords: DDGP; chemotherapy; efficacy; extranodal natural killer/T-cell lymphoma; safety