https://scholars.lib.ntu.edu.tw/handle/123456789/518187
標題: | Final results of a randomized phase III trial of induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in patients with stage IVA and IVB nasopharyngeal carcinoma-Taiwan Cooperative Oncology Group (TCOG) 1303 Study | 作者: | RUEY-LONG HONG Hsiao C.F. Ting L.L. JENG-YUH KO CHUN-WEI WANG Chang J.T.C. PEI-JEN LOU Wang H.M. Tsai M.H. Lai S.C. Liu T.W. |
公開日期: | 2018 | 出版社: | Oxford University Press | 卷: | 29 | 期: | 9 | 起(迄)頁: | 1972-1979 | 來源出版物: | Annals of Oncology | 摘要: | Background Concurrent chemoradiotherapy (CCRT) is superior to radiotherapy alone for treating locoregionally advanced nasopharyngeal carcinoma (NPC). Whether adding induction chemotherapy (IC) further improves the outcome warrants investigation. Patients and methods This open-label multicenter phase III trial was conducted at 11 institutions in Taiwan. Patients with stage IVA or IVB NPC were randomized to receive IC followed by CCRT (I-CCRT) or CCRT alone. Patients in the I-CCRT arm received three cycles of mitomycin C, epirubicin, cisplatin, and 5-fluorouracil/leucovorin (MEPFL). All patients received 30 mg/m 2 cisplatin weekly during radiotherapy, which was delivered as 1.8-2.2 Gy per fraction with five daily fractions per week, to a total dose of 70 Gy or greater to the primary tumor and 66-70 Gy to the involved neck. The primary end point was disease-free survival (DFS). Results In this study, 240 and 239 patients were randomized to CCRT and I-CCRT arm, respectively. The most prominent toxicities of induction were leukopenia (grade 3 and 4: 47% and 12%) and thrombocytopenia (grade 3 and 4: 24% and 3%). During radiotherapy, severe mucositis was the major side-effect in both arms; an increased number of patients in the I-CCRT arm had myelosuppression; hence, discontinuation of weekly cisplatin was more common. After a median follow-up of 72.0 months, the I-CCRT arm had significantly higher DFS than that of the CCRT arm [5-year rate 61% versus 50%; hazard ratio=0.739, 95% confidence interval (CI)=0.565-0.965; P = 0.0264], after stratified for N3b and LDH, and adjusted for T stage. Conclusion Induction with MEPFL before CCRT was tolerable and significantly improved the DFS of patients with stage IVA and IVB NPC though overall survival not improved. Clinical trial information NCT00201396. ? 2018 The Author(s). |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85054292178&doi=10.1093%2fannonc%2fmdy249&partnerID=40&md5=5fa6cebd1ae823a29bf2d11c2eefb459 https://scholars.lib.ntu.edu.tw/handle/123456789/518187 |
ISSN: | 0923-7534 | DOI: | 10.1093/annonc/mdy249 | SDG/關鍵字: | alanine aminotransferase; bilirubin; cisplatin; creatinine; epirubicin; fluorouracil; folinic acid; mitomycin; antineoplastic agent; adult; Article; atrophy; bone marrow suppression; cancer combination chemotherapy; cancer grading; cancer prognosis; cancer radiotherapy; cancer recurrence; cancer staging; cancer survival; chemoradiotherapy; clinical effectiveness; controlled study; dermatitis; disease free survival; disease severity; distant failure free survival; drug efficacy; drug tolerability; drug withdrawal; dysphagia; febrile neutropenia; female; gastrointestinal hemorrhage; human; infection; leukocyte; leukopenia; liver toxicity; local failure free survival; locoregional failure failure free survival; major clinical study; male; monotherapy; mucosa atrophy; mucosa inflammation; multicenter study; multiple cycle treatment; nasopharynx carcinoma; neck cancer; nephrotoxicity; open study; overall survival; patient compliance; phase 2 clinical trial; primary tumor; priority journal; radiation dose fractionation; randomized controlled trial; sex difference; side effect; skin atrophy; stomatitis; Taiwan; thrombocyte; thrombocytopenia; treatment failure; trismus; vomiting; xerostomia; adolescent; adverse event; aged; chemoradiotherapy; clinical trial; comparative study; epidemiology; follow up; induction chemotherapy; intensity modulated radiation therapy; Kaplan Meier method; middle aged; mortality; nasopharynx carcinoma; nasopharynx tumor; pathology; phase 3 clinical trial; procedures; young adult; Adolescent; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Chemoradiotherapy; Disease-Free Survival; Dose Fractionation, Radiation; Female; Follow-Up Studies; Humans; Induction Chemotherapy; Kaplan-Meier Estimate; Male; Middle Aged; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Neoplasm Staging; Radiotherapy, Intensity-Modulated; Taiwan; Young Adult |
顯示於: | 醫學系 |
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