Efficacy and safety of primary surgery with postoperative radiotherapy in head and neck mucosal melanoma: a single-arm Phase II study
| Autor: | Li-Xia Lu, Xiao-Shi Zhang, Ji-Jin Yao, Wayne R. Lawrence, Lu Zou, Fan Zhang, Xiao-Wu Deng, Wangjian Zhang, Guang-Shun Zhang |
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| Rok vydání: | 2018 |
| Předmět: |
safety
medicine.medical_specialty medicine.medical_treatment efficacy Postoperative radiotherapy Phases of clinical research head and neck mucosal melanoma 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine primary surgery medicine Head and neck Original Research postoperative radiotherapy business.industry Mucosal melanoma Cancer medicine.disease Surgery Clinical trial Radiation therapy Oncology Cancer Management and Research 030220 oncology & carcinogenesis Cohort business |
| Zdroj: | Cancer Management and Research |
| ISSN: | 1179-1322 |
| Popis: | Ji-Jin Yao,1,2,* Fan Zhang,2,* Guang-Shun Zhang,1 Xiao-Wu Deng,1 Wang-Jian Zhang,3 Wayne R Lawrence,3 Lu Zou,1 Xiao-Shi Zhang,4 Li-Xia Lu1 1Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou 510060, Guangdong Province, People’s Republic of China; 2Department of Radiation Oncology, The Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai 519001, Guangdong Province, People’s Republic of China; 3Department of Environmental Health Sciences, School of Public Health, University at Albany, State University of New York, Rensselaer, NY 12144, USA; 4Department of Melanoma, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou 510060, Guangdong Province, People’s Republic of China *These authors contributed equally to this work Background: There still remains no well-established treatment strategy for head and neck mucosal melanoma (HNMM). We aim to evaluate the effectiveness and safety of primary surgery with postoperative radiotherapy for this disease.Patients and methods: A single-arm, Phase II clinical trial was conducted at Sun Yat-Sen University Cancer Center. Patients with nonmetastatic, histologically proven HNMM were prospectively enrolled. Patients received primary surgery followed by intensity-modulated radiotherapy with an equivalent dose at 2 Gy per fraction of 65–70Gy to CTV1 (high-risk regions including tumor bed) and 50–55Gy to CTV2 (low-risk regions). Additional use of adjuvant chemotherapy (AC) depended on consultation from a multidisciplinary team. This trial is registered with ClinicalTrials.gov, number NCT03138642.Results: A total of 33 patients were enrolled and analyzed between July 2010 and November 2016. There were 18 (54.5%) patients with T3 disease and 15 (45.5%) patients with T4a disease. The median age at diagnosis was 58years (range 27–83years), and 61% of the cohort were males. The overall median follow-up duration was 25.3months (range 5.3–67.1months). The 3-year overall survival (OS), local relapse-free survival (LRFS), regional relapse-free survival (RRFS), and distant metastasis-free survival (DMFS) rates were 44.4, 91.7, 78.1, and 41.7%, respectively. Patients with T4a disease showed significantly inferior OS (P=0.049) and DMFS (P=0.040) than those with T3 disease. Prophylactic neck radiation (PNR) was nearly associated with superior RRFS (P=0.078). However, there was no significant difference in OS, LRFS, RRFS, and DMFS for patients treated with or without AC (P>0.05 for all). Toxicities were generally mild to moderate.Conclusion: Primary surgery with postoperative radiotherapy yielded excellent local control and acceptable toxicity profile for HNMM. Nevertheless, high rates of distant metastases resulted in limited survival. Keywords: head and neck mucosal melanoma, efficacy, safety, primary surgery, postoperative radiotherapy |
| Databáze: | OpenAIRE |
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