논문검색
Author Heptaplatin Kyung Hee Lee, M.D.1Myung Soo Hyun, M.D.1Hoon-Kyo Kim, M.D.2Hyung Min Jin, M.D.2Jinmo Yang, M.D.2Hong Suk Song, M.D.3Young Rok Do, M.D.3Hun Mo Ryoo, M.D.4Joo Seop Chung, M.D.5Dae Young Zang, M.D.6Ho-Yeong Lim, M.D.7Jong Youl Jin, M.D.8Chang Yeol Yim, M.D.9Hee Sook Park, M.D.10Jun Suk Kim, M.D.11Chang Hak Sohn, M.D.12Soon Nam Lee, M.D.13
Place of duty Korea Cancer Study GroupCollege of Medicine, 1YeungnamUniversity, Daegu, 2The Catholic Universityof Korea, St. Vincent's Hospital, Suwon, 3Keimyung University, Dongsan MedicalCenter, Daegu, 4Daegu Catholic University, Daegu, 5Pusan National University, Busan, 6Hallym Sacred Heart Hospital, Seoul, 7Sungkyunkwan University, SamsungMedical Center, Seoul, 8The Catholic University of Korea, HolyFamily Hospital, Bucheon, 9Chonbuk National University, Chonbuk,10Soon Chun Hyang University, Seoul, 11Korea University, Guro Hospital, Seoul, 12Inje University Pusan Paik Hospital,Busan, and 13Ewha Womans University,Seoul, Korea
Title Randomized, Multicenter, Phase III Trial of Heptaplatin 1-hour Infusion and 5-Fluorouracil CombinationChemotherapy Comparing with Cisplatin and 5-Fluorouracil Combination Chemotherapy in Patients withAdvanced Gastric Cancer
Publicationinfo Cancer Res Treat 2009 Mar; 041(01): 12-18.
Key_word Combination chemotherapy, Advanced gastric cancer,Heptaplatin
Full-Text
Abstract PurposeHeptaplatin (Sunpla) is a cisplatin derivative. A phase IIb trial using heptaplatin resulted in a34% response rate with mild nephrotoxicity. We conducted a randomized phase III trial ofheptaplatin plus 5-FU compared with cisplatin plus 5-FU in patients with advanced gastriccancer. Materials and MethodsOne hundred seventy-four patients (heptaplatin, n=88; cisplatin, n=86) from 13 centers wereenrolled. The eligibility criteria were as follows: patients with pathologically-provenadenocarcinoma, chemonaive patients, or patients who had received only single adjuvantchemotherapy, and who had a measurable or evaluable lesion. On day 1, heptaplatin (400mg/m2) or cisplatin (60 mg/m2) was given over 1 hour with 5-FU (1 gm/m2) on days 1∼5 every 4weeks. ResultsAt the time of survival analysis, the median overall survival was 7.3 months in the 5-FU +heptaplatin (FH) arm and 7.9 months in the 5-FU + cisplatin (FP) arm (p=0.24). Of the FHpatients, 34.2% (complete response [CR], 1.3%; partial response [PR], 32.9%) experienced aconfirmed objective response compared with 35.9% (CR 0%, PR 35.9%) of FP patients(p=0.78). The median-time-to-progression was 2.5 months in the FH arm and 2.3 months in theFP arm. The incidence of neutropenia was higher with FP (28%) than with FH (16%; p=0.06);grade 3∼4 nausea and vomiting were more frequent in the FP than in the FH arm (p=0.01 andp=0.05, respectively). The incidence of increased proteinuria and creatininemia was higherwith FH than with FP; however, there was no statistical difference. There were no treatment-related deaths.ConclusionHeptaplatin showed similar effects to cisplatin when combined with 5-FU in advanced gastriccancer patients with tolerable toxicities.
출판정보 대한암학회지 2009 Mar; 041(01): 12-18.