دورية أكاديمية
Adjuvant Capecitabine Following Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized Clinical Trial.
| العنوان: | Adjuvant Capecitabine Following Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized Clinical Trial. |
|---|---|
| المؤلفون: | Miao J; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, Guangdong, PR China., Wang L; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, Guangdong, PR China., Tan SH; Division of Clinical Trials & Epidemiological Sciences, National Cancer Centre Singapore, Singapore.; Oncology Academic Programme, Duke-NUS Medical School, Singapore., Li JG; Department of Radiation Oncology, Jiangxi Cancer Hospital of Nanchang University, Nanchang, China.; National Health Commission Key Laboratory of Personalized Diagnosis and Treatment of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital of Nanchang University, Nanchang, China., Yi J; Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, PR China., Ong EHW; Division of Medical Sciences, National Cancer Centre Singapore, Singapore., Tan LLY; Department of Head and Neck and Thoracic Cancers, Division of Radiation Oncology, National Cancer Centre Singapore, Singapore.; Ministry of Health Holdings, Singapore., Zhang Y; Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, PR China., Gong X; Department of Radiation Oncology, Jiangxi Cancer Hospital of Nanchang University, Nanchang, China.; National Health Commission Key Laboratory of Personalized Diagnosis and Treatment of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital of Nanchang University, Nanchang, China., Chen Q; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, Guangdong, PR China., Xiang YQ; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, Guangdong, PR China., Chen MY; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, Guangdong, PR China., Guo Y; Department of Clinical Trials Center, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, Guangdong, PR China., Lv X; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, Guangdong, PR China., Xia WX; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, Guangdong, PR China., Tang L; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, Guangdong, PR China., Deng X; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, Guangdong, PR China., Guo X; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, Guangdong, PR China., Han F; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, Guangdong, PR China., Mai HQ; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, Guangdong, PR China., Chua MLK; Oncology Academic Programme, Duke-NUS Medical School, Singapore.; Division of Medical Sciences, National Cancer Centre Singapore, Singapore.; Department of Head and Neck and Thoracic Cancers, Division of Radiation Oncology, National Cancer Centre Singapore, Singapore., Zhao C; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, Guangdong, PR China. |
| المصدر: | JAMA oncology [JAMA Oncol] 2022 Oct 13. Date of Electronic Publication: 2022 Oct 13. |
| Publication Model: | Ahead of Print |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Medical Association Country of Publication: United States NLM ID: 101652861 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2374-2445 (Electronic) Linking ISSN: 23742437 NLM ISO Abbreviation: JAMA Oncol Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Chicago, Il : American Medical Association, [2015]- |
| مستخلص: | Importance: Induction or adjuvant chemotherapy with concurrent chemoradiotherapy (CCRT) are first-line treatment options for treatment of locoregionally advanced nasopharyngeal carcinoma (LA-NPC). Adjuvant platinum regimens are, however, poorly tolerated, highlighting the unmet need for an efficacious, tolerable adjuvant regimen. Objective: To investigate the efficacy and safety of adjuvant capecitabine with CCRT for the treatment of patients with LA-NPC. Design, Setting, and Participants: This open-label randomized clinical trial recruited patients from March 31, 2014, to July 27, 2018, at 3 institutions in China, with at least 3 years of follow-up. The data collection cutoff date was February 9, 2022. Eligibility included stage III-IVb nasopharyngeal carcinoma and at least 1 of the following: T3-4N2 or T1-4N3; plasma Epstein-Barr virus DNA titer higher than 20 000 copies/mL; primary gross tumor volume larger than 30.0 cm3; fluorodeoxyglucose F 18 positron emission tomography/computed tomography maximum standard uptake value of the primary gross tumor volume larger than 10.0; or multiple nodal metastases and any larger than 4.0 cm. Interventions: Patients were randomly assigned 1:1 to receive either capecitabine (1000 mg/m2 twice daily for 14 days every 3 weeks for 8 cycles) or observation following CCRT (100 mg/m2 cisplatin every 3 weeks for 2 to 3 cycles, depending on duration of radiotherapy). Main Outcomes and Measures: Failure-free survival in the intention-to-treat cohort was assessed using Kaplan-Meier survival curves compared with the log-rank test. Unstratified Cox proportional hazards regression models were used to estimate hazard ratios, with corresponding 95% CIs based on the Wald test. Results: There were 180 patients enrolled (median [IQR] age, 47 [40-55] years; 143 [79.4%] men). Among 90 patients in the capecitabine group, 76 (84.4%) had at least 2 high-risk factors; among 90 patients in the control group, 80 (88.9%) had at least 2 high-risk factors. All patients completed CCRT, except 1 patient in the capecitabine group who received 1 cycle of cisplatin. Of the 90 patients in the capecitabine group, 85 (94.4%) received capecitabine, with 71 (78.9%) completing 8 cycles. With a median (IQR) follow-up of 58.0 (49.5-80.1) months, 18 events were recorded in the capecitabine group vs 31 events in the control group. Failure-free survival was improved with adjuvant capecitabine (3 years, 83.3% vs 72.2%; 5 years, 78.5% vs 65.9%; hazard ratio, 0.53 [95% CI, 0.30-0.94]; P = .03). The incidence of grade 3 treatment-related adverse events (TRAEs) was higher in the capecitabine group than in the control group (54 of 90 patients [60.0%] vs 46 of 90 patients [51.1%]). Treatment-related adverse events included xerostomia (17 [18.9%] vs 9 [10.0%] patients), mucositis (21 [23.3%] vs 15 [16.7%] patients), and anorexia (8 [8.9%] vs 4 [4.4%] patients). The incidence of grade 3 delayed treatment-related adverse events was comparable in both groups (9 of 83 [10.8%] vs 7 of 81 [8.6%] patients). Conclusions and Relevance: In this randomized clinical trial, adjuvant capecitabine at the full dose following CCRT was well tolerated and improved failure-free survival among patients with LA-NPC and high-risk factors. Further investigations assessing optimal dose and duration are warranted. Trial Registration: ClinicalTrials.gov Identifier: NCT02143388. |
| References: | Eur J Cancer. 2011 Mar;47(5):656-66. (PMID: 21112774) J Natl Cancer Inst. 2016 Dec 7;109(4):. (PMID: 27927756) Jpn J Clin Oncol. 2008 Apr;38(4):244-9. (PMID: 18407933) Crit Rev Oncol Hematol. 2015 Jul;95(1):46-61. (PMID: 25656744) Eur J Cancer. 2017 Apr;75:150-158. (PMID: 28235726) Chin J Cancer. 2011 Aug;30(8):565-73. (PMID: 21801605) J Clin Oncol. 1998 Apr;16(4):1310-7. (PMID: 9552031) J BUON. 2008 Jan-Mar;13(1):37-42. (PMID: 18404784) Oral Oncol. 2015 Apr;51(4):363-9. (PMID: 25655559) Lancet. 2016 Mar 5;387(10022):1012-1024. (PMID: 26321262) Radiat Oncol. 2013 Nov 13;8:265. (PMID: 24219818) Clin Cancer Res. 2022 Jun 13;28(12):2679-2689. (PMID: 35381064) Oncotarget. 2015 Sep 15;6(27):24511-21. (PMID: 26087194) J Clin Oncol. 2005 Sep 20;23(27):6730-8. (PMID: 16170180) Int J Cancer. 2013 Jun 1;132(11):2471-8. (PMID: 22927096) N Engl J Med. 2019 Sep 19;381(12):1124-1135. (PMID: 31150573) Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6. (PMID: 7713792) Chin J Cancer. 2016 Jan 06;35:9. (PMID: 26738743) J Clin Oncol. 2018 Jul 10;:JCO2018777847. (PMID: 29989858) Clin Oncol (R Coll Radiol). 2011 Mar;23(2):128-33. (PMID: 20943358) Radiother Oncol. 2012 Sep;104(3):300-4. (PMID: 22300609) JAMA Oncol. 2022 May 1;8(5):715-716. (PMID: 35323867) Chin J Cancer. 2016 May 05;35:41. (PMID: 27146632) JAMA Oncol. 2022 Apr 1;8(4):524-525. (PMID: 35175303) CA Cancer J Clin. 2021 May;71(3):209-249. (PMID: 33538338) BMC Cancer. 2015 Nov 24;15:930. (PMID: 26603423) Chin J Cancer. 2014 Dec;33(12):581-90. (PMID: 25418193) Nat Med. 2021 Sep;27(9):1536-1543. (PMID: 34341578) Lancet. 2016 Oct 15;388(10054):1883-1892. (PMID: 27567279) Cancer. 2015 Apr 15;121(8):1328-38. (PMID: 25529384) J Clin Oncol. 2022 Apr 10;40(11):1135-1138. (PMID: 35213233) Oral Oncol. 2003 Jun;39(4):361-6. (PMID: 12676255) Chin J Cancer. 2017 Nov 9;36(1):90. (PMID: 29122009) Int J Radiat Oncol Biol Phys. 2004 Sep 1;60(1):156-64. (PMID: 15337551) JAMA Oncol. 2022 Apr 01;8(4):553-561. (PMID: 35175316) Lancet. 2021 Jul 24;398(10297):303-313. (PMID: 34111416) Lancet Oncol. 2012 Feb;13(2):163-71. (PMID: 22154591) Int J Radiat Oncol Biol Phys. 2014 May 1;89(1):21-9. (PMID: 24725686) Cancer. 2011 May 1;117(9):1874-83. (PMID: 21509764) J Clin Oncol. 2022 Apr 10;40(11):1163-1173. (PMID: 34990291) J Clin Oncol. 2021 Mar 1;39(7):840-859. (PMID: 33405943) Clin Transl Radiat Oncol. 2021 Nov 26;32:59-68. (PMID: 34935776) Lancet Oncol. 2016 Nov;17(11):1509-1520. (PMID: 27686945) N Engl J Med. 2001 Dec 27;345(26):1877-82. (PMID: 11756578) J Clin Oncol. 2005 Oct 1;23(28):6966-75. (PMID: 16192584) |
| سلسلة جزيئية: | ClinicalTrials.gov NCT02143388 |
| تواريخ الأحداث: | Date Created: 20221013 Latest Revision: 20240216 |
| رمز التحديث: | 20240217 |
| مُعرف محوري في PubMed: | PMC9562101 |
| DOI: | 10.1001/jamaoncol.2022.4656 |
| PMID: | 36227615 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 2374-2445 |
|---|---|
| DOI: | 10.1001/jamaoncol.2022.4656 |