Ji Yun Lee1, Jong-Mu Sun1, Dong Ryul Oh2, Sung Hee Lim1, Juna Goo3, Se-Hoon Lee1, Sung-Bae Kim4, Keon Uk Park5, Hoon-Kyo Kim6, Dae Sik Hong7, Jun Suk Kim8, Seong-Geun Kim9, Seong Yoon Yi10, Hwan Jung Yun11, Myung Soo Hyun12, Hyo Jung Kim13, Sin-Ho Jung3, Keunchil Park1, Yong Chan Ahn14, Myung-Ju Ahn15. 1. Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 2. Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 3. Department of Biostatistics and Bioinformatics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 4. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. 5. Division of Hematology-Oncology, Department of Medicine, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Republic of Korea. 6. Division of Hematology-Oncology, Department of Medicine, St. Vincent's Hospital, The Catholic University of Korea College of Medicine, Suwon, Republic of Korea. 7. Division of Hematology-Oncology, Department of Medicine, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea. 8. Division of Hematology-Oncology, Department of Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea. 9. Division of Hematology-Oncology, Department of Medicine, Pusan National University, Yangsan, Republic of Korea. 10. Division of Hematology-Oncology, Department of Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyaung, Republic of Korea. 11. Division of Hematology-Oncology, Department of Medicine, Chungnam National University College of Medicine, Daejeon, Republic of Korea. 12. Division of Hematology-Oncology, Department of Medicine, Yeungnam University College of Medicine, Daegu, Republic of Korea. 13. Division of Hematology-Oncology, Department of Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea. 14. Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: ahnyc@skku.edu. 15. Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: silkahn@skku.edu.
Abstract
PURPOSE: 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. MATERIAL AND 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.
RCT Entities:
PURPOSE: 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. MATERIAL AND 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: Muhammad Shahid Iqbal; Cheng Chaw; Josef Kovarik; Shahzeena Aslam; Aaron Jackson; John Kelly; Werner Dobrowsky; Charles Kelly Journal: Int Arch Otorhinolaryngol Date: 2016-12-19