title: Comparison of weekly versus triweekly cisplatin delivered concurrently with radiation therapy in patients with locally advanced nasopharyngeal cancer: A multicenter randomized phase II trial (KCSG-HN10-02).
abstract: OBJECTIVE
  Triweekly delivery of cisplatin concurrent with a course of radiation therapy (RT) has been the standard regimen for treatment of locally advanced nasopharyngeal carcinoma (NPC) despite a high level of concern regarding treatment-related complications. We conducted a randomized phase II study to compare weekly and triweekly cisplatin delivery during RT with respect to efficacy and toxicity profiles.
  
  
  METHODS
  Patients with locally advanced NPC (stage II-IVb) were randomly assigned to a regimen of either seven doses of cisplatin (40 mg/m(2)) given once a week or three doses of cisplatin (100mg/m(2)) given every 3 weeks concurrently during RT.
  
  
  RESULTS
  Of 109 eligible patients, 53 were assigned to the weekly regimen and 56 to the triweekly regimen. The two groups were comparable with respect to demographic and clinical characteristics. There were no significant differences in mean RT dose (68.3 Gy vs. 67.3 Gy, p=0.559) and mean cisplatin dose (248.9 mg/m(2)vs. 256.6 mg/m(2), p=0.433) between the two regimens. The primary endpoint was 3-year progression-free survival, which was not different between the regimens (64.9% vs. 63.8%, p=0.074). Overall, the occurrence of grade 3-4 toxicities was similar between the two arms (47.2% vs. 39.3%, p=0.443). Quality of life (QoL) related to functional outcomes 3 weeks after treatment completion was better for the weekly regimen.
  
  
  CONCLUSIONS
  Although no definitive conclusions can be made, a once-weekly cisplatin regimen appears to be associated with improved QoL and is not inferior to the standard triweekly regimen with respect to efficacy and toxicity profiles.
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Ji Yun
authors.initials: JY
authors.lastname: Lee
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Jong-Mu
authors.initials: JM
authors.lastname: Sun
authors.affiliation: Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Dong Ryul
authors.initials: DR
authors.lastname: Oh
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Sung Hee
authors.initials: SH
authors.lastname: Lim
authors.affiliation: Department of Biostatistics and Bioinformatics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Juna
authors.initials: J
authors.lastname: Goo
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Se-Hoon
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Sung-Bae
authors.initials: SB
authors.lastname: Kim
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Republic of Korea.
authors.forename: Keon Uk
authors.initials: KU
authors.lastname: Park
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, St. Vincent's Hospital, The Catholic University of Korea College of Medicine, Suwon, Republic of Korea.
authors.forename: Hoon-Kyo
authors.initials: HK
authors.lastname: Kim
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea.
authors.forename: Dae Sik
authors.initials: DS
authors.lastname: Hong
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea.
authors.forename: Jun Suk
authors.initials: JS
authors.lastname: Kim
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Pusan National University, Yangsan, Republic of Korea.
authors.forename: Seong-Geun
authors.initials: SG
authors.lastname: Kim
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyaung, Republic of Korea.
authors.forename: Seong Yoon
authors.initials: SY
authors.lastname: Yi
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Chungnam National University College of Medicine, Daejeon, Republic of Korea.
authors.forename: Hwan Jung
authors.initials: HJ
authors.lastname: Yun
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Yeungnam University College of Medicine, Daegu, Republic of Korea.
authors.forename: Myung Soo
authors.initials: MS
authors.lastname: Hyun
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.
authors.forename: Hyo Jung
authors.initials: HJ
authors.lastname: Kim
authors.affiliation: Department of Biostatistics and Bioinformatics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Sin-Ho
authors.initials: SH
authors.lastname: Jung
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Keunchil
authors.initials: K
authors.lastname: Park
authors.affiliation: Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: ahnyc@skku.edu.
authors.forename: Yong Chan
authors.initials: YC
authors.lastname: Ahn
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: silkahn@skku.edu.
authors.forename: Myung-Ju
authors.initials: MJ
authors.lastname: Ahn
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D002277:Carcinoma; D059248:Chemoradiotherapy / Q000379:methods*; D002945:Cisplatin / Q000008:administration & dosage* / Q000627:therapeutic use; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077274:Nasopharyngeal Carcinoma; D009303:Nasopharyngeal Neoplasms / Q000628:therapy*; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin
keywords: Concurrent chemoradiation therapy; Efficacy; Nasopharyngeal cancer; Quality of life; Toxicity