Efficacy and safety of primary surgery with postoperative radiotherapy in head and neck mucosal melanoma: a single-arm Phase II study
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 C...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2018-12-01
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| Series: | Cancer Management and Research |
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| Online Access: | https://www.dovepress.com/efficacy-and-safety-of-primary-surgery-with-postoperative-radiotherapy-peer-reviewed-article-CMAR |
| _version_ | 1818559978432102400 |
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| author | Yao JJ Zhang F Zhang GS Deng XW Zhang WJ Lawrence WR Zou L Zhang XS Lu LX |
| author_facet | Yao JJ Zhang F Zhang GS Deng XW Zhang WJ Lawrence WR Zou L Zhang XS Lu LX |
| author_sort | Yao JJ |
| collection | DOAJ |
| description | 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 65–70 Gy to CTV1 (high-risk regions including tumor bed) and 50–55 Gy 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 58 years (range 27–83 years), and 61% of the cohort were males. The overall median follow-up duration was 25.3 months (range 5.3–67.1 months). 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 |
| first_indexed | 2024-12-14T00:32:33Z |
| format | Article |
| id | doaj.art-0dc0552b75ea434ab0fb80cef1fbe9c2 |
| institution | Directory Open Access Journal |
| issn | 1179-1322 |
| language | English |
| last_indexed | 2024-12-14T00:32:33Z |
| publishDate | 2018-12-01 |
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| series | Cancer Management and Research |
| spelling | doaj.art-0dc0552b75ea434ab0fb80cef1fbe9c22022-12-21T23:24:46ZengDove Medical PressCancer Management and Research1179-13222018-12-01Volume 106985699643050Efficacy and safety of primary surgery with postoperative radiotherapy in head and neck mucosal melanoma: a single-arm Phase II studyYao JJZhang FZhang GSDeng XWZhang WJLawrence WRZou LZhang XSLu LXJi-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 65–70 Gy to CTV1 (high-risk regions including tumor bed) and 50–55 Gy 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 58 years (range 27–83 years), and 61% of the cohort were males. The overall median follow-up duration was 25.3 months (range 5.3–67.1 months). 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 radiotherapyhttps://www.dovepress.com/efficacy-and-safety-of-primary-surgery-with-postoperative-radiotherapy-peer-reviewed-article-CMARHead and neck mucosal melanomaefficacysafetyprimary surgerypostoperative radiotherapy. |
| spellingShingle | Yao JJ Zhang F Zhang GS Deng XW Zhang WJ Lawrence WR Zou L Zhang XS Lu LX Efficacy and safety of primary surgery with postoperative radiotherapy in head and neck mucosal melanoma: a single-arm Phase II study Cancer Management and Research Head and neck mucosal melanoma efficacy safety primary surgery postoperative radiotherapy. |
| title | Efficacy and safety of primary surgery with postoperative radiotherapy in head and neck mucosal melanoma: a single-arm Phase II study |
| title_full | Efficacy and safety of primary surgery with postoperative radiotherapy in head and neck mucosal melanoma: a single-arm Phase II study |
| title_fullStr | Efficacy and safety of primary surgery with postoperative radiotherapy in head and neck mucosal melanoma: a single-arm Phase II study |
| title_full_unstemmed | Efficacy and safety of primary surgery with postoperative radiotherapy in head and neck mucosal melanoma: a single-arm Phase II study |
| title_short | Efficacy and safety of primary surgery with postoperative radiotherapy in head and neck mucosal melanoma: a single-arm Phase II study |
| title_sort | efficacy and safety of primary surgery with postoperative radiotherapy in head and neck mucosal melanoma a single arm phase ii study |
| topic | Head and neck mucosal melanoma efficacy safety primary surgery postoperative radiotherapy. |
| url | https://www.dovepress.com/efficacy-and-safety-of-primary-surgery-with-postoperative-radiotherapy-peer-reviewed-article-CMAR |
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