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      Intensity-modulated radiotherapy combined with sequential cisplatin and fluorouracil chemotherapy for locoregionally advanced nasopharyngeal carcinoma

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          Abstract

          To investigate the efficacy and toxicity of intensity-modulated radiotherapy (IMRT) combined with induction-adjuvant cisplatin and fluorouracil (PF) in locoregionally advanced nasopharyngeal carcinoma (NPC).

          A total of 91 biopsy-proven NPC patients treated with IMRT were retrospectively analyzed. All patients received induction chemotherapy (IC) consisting of cisplatin 25 mg/m2 on day 1 to 3, and 5-Fu 2500 mg/m 2 as an intravenous infusion over 120 hours every 3 weeks for 2 cycles. Adjuvant chemotherapy of the same regime was given 28 days after the end of IMRT.

          A total of 87 patients completed 2 cycles of IC. During adjuvant chemotherapy phase, 74.7% patients received at least 1 cycle. With a median follow-up time of 45 months (10–123 months), the 5-year local control, regional control, distant metastasis-free (DMF) and overall survival (OS) rates were 84.1%, 86.9%, 81.3%, and 74.4%, respectively. The 5-year local control rates for patients with Stage T1-2 and T3-4 was 94.6% and 76.5%, respectively ( P = .045). The 5-year DMF rates for patients with N0-1 and N2-3 diseases were 90.6% and 73.3%, respectively ( P = .072). During radiotherapy (RT), 24.2% patients suffered severe acute mucositis (grade 3–4). Severe late toxicities included cranial nerve palsy in 1 patient and grade 3 hearing impairment in 1 patient.

          IMRT combined with induction-adjuvant chemotherapy consisting of PF regimen is well tolerated and provides satisfactory local-regional control for locoregionally advanced NPC. Further treatment strategies to control distant metastasis are needed in the future.

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          Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: phase III randomized Intergroup study 0099.

          M Al-Sarraf, M. Leblanc, P Giri … (1998)
          The Southwest Oncology Group (SWOG) coordinated an Intergroup study with the participation of Radiation Therapy Oncology Group (RTOG), and Eastern Cooperative Oncology Group (ECOG). This randomized phase III trial compared chemoradiotherapy versus radiotherapy alone in patients with nasopharyngeal cancers. Radiotherapy was administered in both arms: 1.8- to 2.0-Gy/d fractions Monday to Friday for 35 to 39 fractions for a total dose of 70 Gy. The investigational arm received chemotherapy with cisplatin 100 mg/m2 on days 1, 22, and 43 during radiotherapy; postradiotherapy, chemotherapy with cisplatin 80 mg/m2 on day 1 and fluorouracil 1,000 mg/m2/d on days 1 to 4 was administered every 4 weeks for three courses. Patients were stratified by tumor stage, nodal stage, performance status, and histology. Of 193 patients registered, 147 (69 radiotherapy and 78 chemoradiotherapy) were eligible for primary analysis for survival and toxicity. The median progression-free survival (PFS) time was 15 months for eligible patients on the radiotherapy arm and was not reached for the chemo-radiotherapy group. The 3-year PFS rate was 24% versus 69%, respectively (P < .001). The median survival time was 34 months for the radiotherapy group and not reached for the chemo-radiotherapy group, and the 3-year survival rate was 47% versus 78%, respectively (P = .005). One hundred eighty-five patients were included in a secondary analysis for survival. The 3-year survival rate for patients randomized to radiotherapy was 46%, and for the chemoradiotherapy group was 76% (P < .001). We conclude that chemoradiotherapy is superior to radiotherapy alone for patients with advanced nasopharyngeal cancers with respect to PFS and overall survival.
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            Randomized trial of radiotherapy versus concurrent chemoradiotherapy followed by adjuvant chemotherapy in patients with American Joint Committee on Cancer/International Union against cancer stage III and IV nasopharyngeal cancer of the endemic variety.

            Joseph Wee, Eng Tan, Bee Tai … (2005)
            The Intergroup 00-99 Trial for nasopharyngeal cancer (NPC) showed a benefit of adding chemotherapy to radiotherapy. However, there were controversies regarding the applicability of the results to patients in endemic regions. This study aims to confirm the findings of the 00-99 Trial and its applicability to patients with endemic NPC. Between September 1997 and May 2003, 221 patients were randomly assigned to receive radiotherapy (RT) alone (n = 110) or chemoradiotherapy (CRT; n = 111). Patients in both arms received 70 Gy in 7 weeks using standard RT portals and techniques. Patients on CRT received concurrent cisplatin (25 mg/m2 on days 1 to 4) on weeks 1, 4, and 7 of RT and adjuvant cisplatin (20 mg/m2 on days 1 to 4) and fluorouracil (1,000 mg/m2 on days 1 to 4) every 4 weeks (weeks 11, 15, and 19) for three cycles after completion of RT. All patients were analyzed by intent-to-treat analysis. The median follow-up time was 3.2 years. Distant metastasis occurred in 38 patients on RT alone and 18 patients on CRT. The difference in 2-year cumulative incidence was 17% (95% CI, 14% to 20%; P = .0029). The hazard ratio (HR) for disease-free survival was 0.57 (95% CI, 0.38 to 0.87; P = .0093). The 2- and 3-year overall survival (OS) rates were 78% and 85% and 65% and 80% for RT alone and CRT, respectively. The HR for OS was 0.51 (95% CI, 0.31 to 0.81; P = .0061). This report confirms the findings of the Intergroup 00-99 Trial and demonstrates its applicability to endemic NPC. This study also confirms that chemotherapy improves the distant metastasis control rate in NPC.
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              Randomized trial of radiotherapy plus concurrent-adjuvant chemotherapy vs radiotherapy alone for regionally advanced nasopharyngeal carcinoma.

              Anne Lee, Stewart Y Tung, Daniel T T Chua … (2010)
              Current practice of adding concurrent-adjuvant chemotherapy to radiotherapy (CRT) for treating advanced nasopharyngeal carcinoma is based on the Intergroup-0099 Study published in 1998. However, the outcome for the radiotherapy-alone (RT) group in that trial was substantially poorer than those in other trials, and there were no data on late toxicities. Verification of the long-term therapeutic index of this regimen is needed. Patients with nonkeratinizing nasopharyngeal carcinoma staged T1-4N2-3M0 were randomly assigned to RT (176 patients) or to CRT (172 patients) using cisplatin (100 mg/m(2)) every 3 weeks for three cycles in concurrence with radiotherapy, followed by cisplatin (80 mg/m(2)) plus fluorouracil (1000 mg per m(2) per day for 4 days) every 4 weeks for three cycles. Primary endpoints included overall failure-free rate (FFR) (the time to first failure at any site) and progression-free survival. Secondary endpoints included overall survival, locoregional FFR, distant FFR, and acute and late toxicity rates. All statistical tests were two-sided. The two treatment groups were well balanced in all patient characteristics, tumor factors, and radiotherapy parameters. Adding chemotherapy statistically significantly improved the 5-year FFR (CRT vs RT: 67% vs 55%; P = .014) and 5-year progression-free survival (CRT vs RT: 62% vs 53%; P = .035). Cumulative incidence of acute toxicity increased with chemotherapy by 30% (CRT vs RT: 83% vs 53%; P < .001), but the 5-year late toxicity rate did not increase statistically significantly (CRT vs RT: 30% vs 24%; P = .30). Deaths because of disease progression were reduced statistically significantly by 14% (CRT vs RT: 38% vs 24%; P = .008), but 5-year overall survival was similar (CRT vs RT: 68% vs 64%; P = .22; hazard ratio of CRT = 0.81, 95% confidence interval = 0.58 to 1.13) because deaths due to toxicity or incidental causes increased by 7% (CRT vs RT: 1.7% vs 0, and 8.1% vs 3.4%, respectively; P = .015). Adding concurrent-adjuvant chemotherapy statistically significantly reduced failure and cancer-specific deaths when compared with radiotherapy alone. Although there was no statistically significant increase in major late toxicity, increase in noncancer deaths narrowed the resultant gain in overall survival.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Medicine (Baltimore)
                Journal ID (iso-abbrev): Medicine (Baltimore)
                Journal ID (publisher-id): MEDI
                Title: Medicine
                Publisher: Wolters Kluwer Health
                ISSN (Print): 0025-7974
                ISSN (Electronic): 1536-5964
                Publication date Collection: December 2018
                Publication date (Electronic): 14 December 2018
                Volume: 97
                Issue: 50
                Electronic Location Identifier: e13361
                Affiliations
                [a ]Department of Radiation Oncology, Fudan University Shanghai Cancer Center
                [b ]Department of Oncology, Shanghai Medical College, Shanghai, China.
                Author notes
                [∗ ]Correspondence: Xiayun He, 270 Dongan Road, Fudan University Shanghai Cancer Center, 200032, Shanghai, China (e-mail: donganlu270hao@ 123456gmail.com ).
                Article
                Publisher ID: MD-D-18-03478 Accession ID: 13361
                DOI: 10.1097/MD.0000000000013361
                PMC ID: 6320135
                PubMed ID: 30557987
                SO-VID: 3b3a706e-301d-413d-9879-61ed52d6d6de
                Copyright © Copyright © 2018 the Author(s). Published by Wolters Kluwer Health, Inc.
                License:

                This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0

                History
                Date received : 17 May 2018
                Date accepted : 31 October 2018
                Categories
                Subject: 5700
                Subject: Research Article
                Subject: Observational Study
                Custom metadata
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                Keywords: cisplatin and fluorouracil,intensity-modulated radiotherapy,nasopharyngeal carcinoma,sequential chemotherapy
                Data availability:
                Keywords: cisplatin and fluorouracil, intensity-modulated radiotherapy, nasopharyngeal carcinoma, sequential chemotherapy

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