中华皮肤科杂志 ›› 2024, Vol. 57 ›› Issue (1): 1-7.doi: 10.35541/cjd.20230317
中国中西医结合学会皮肤性病专业委员会皮肤肿瘤学组 中国抗癌协会黑色素瘤专业委员会
收稿日期:2023-06-06
修回日期:2023-10-12
发布日期:2024-01-05
通讯作者:
高天文；李春英
E-mail:gaotw75401@163.com; lichying@fmmu.edu.cn
Skin Cancer Research Group, Committee on Dermatology, Chinese Association of Integrative Medicine; Melanoma Society of China Anti-Cancer Association
Received:2023-06-06
Revised:2023-10-12
Published:2024-01-05
Contact:
Gao Tianwen; Li Chunying
E-mail:gaotw75401@163.com; lichying@fmmu.edu.cn
摘要： 【摘要】 人干扰素α1b是我国首个基因工程Ⅰ类新药，已获批应用于黑色素瘤等多种肿瘤的治疗。人干扰素α1b作为黑色素瘤术后辅助治疗及晚期系统治疗药物，可有效改善黑色素瘤患者生存且安全性好。中国中西医结合学会皮肤性病专业委员会皮肤肿瘤学组及中国抗癌协会黑色素瘤专业委员会组织本领域专家，结合临床应用经验并参考新近文献，制订本共识，以期为黑色素瘤临床治疗决策提供参考。
中国中西医结合学会皮肤性病专业委员会皮肤肿瘤学组 中国抗癌协会黑色素瘤专业委员会. [开放获取] 人干扰素α1b治疗黑色素瘤专家共识（2024版）[J]. 中华皮肤科杂志, 2024,57(1):1-7. doi:10.35541/cjd.20230317
Skin Cancer Research Group, Committee on Dermatology, Chinese Association of Integrative Medicine, Melanoma Society of China Anti-Cancer Association. Expert consensus on human interferon α1b for the treatment of melanoma （2024）[J]. Chinese Journal of Dermatology, 2024, 57(1): 1-7.doi:10.35541/cjd.20230317
| ［1］ | Arnold M, Singh D, Laversanne M, et al. Global burden of cutaneous melanoma in 2020 and projections to 2040［J］. JAMA Dermatol, 2022,158（5）:495⁃503. doi: 10.1001/jamadermatol.2022. 0160. |
| ［2］ | Wu Y, Wang Y, Wang L, et al. Burden of melanoma in China, 1990 -2017: findings from the 2017 global burden of disease study［J］. Int J Cancer, 2020,147（3）:692⁃701. doi: 10.1002/ijc.32764. |
| ［3］ | Chi Z, Li S, Sheng X, et al. Clinical presentation, histology, and prognoses of malignant melanoma in ethnic Chinese: a study of 522 consecutive cases［J］. BMC Cancer, 2011,11:85. doi: 10.1186/1471⁃2407⁃11⁃85. |
| ［4］ | Dickson PV, Gershenwald JE. Staging and prognosis of cutaneous melanoma［J］. Surg Oncol Clin N Am, 2011,20（1）:1⁃17. doi: 10.1016/j.soc.2010.09.007. |
| ［5］ | Newell F, Kong Y, Wilmott JS, et al. Whole⁃genome landscape of mucosal melanoma reveals diverse drivers and therapeutic targets［J］. Nat Commun, 2019,10（1）:3163. doi: 10.1038/s41467⁃ 019⁃11107⁃x. |
| ［6］ | Farshidfar F, Rhrissorrakrai K, Levovitz C, et al. Integrative molecular and clinical profiling of acral melanoma links focal amplification of 22q11.21 to metastasis［J］. Nat Commun, 2022,13（1）:898. doi: 10.1038/s41467⁃022⁃28566⁃4. |
| ［7］ | Shi Q, Liu L, Chen J, et al. Integrative genomic profiling uncovers therapeutic targets of acral melanoma in Asian populations［J］. Clin Cancer Res, 2022,28（12）:2690⁃2703. doi: 10.1158/1078⁃0432.CCR⁃21⁃3344. |
| ［8］ | Tang B, Chi Z, Chen Y, et al. Safety, efficacy, and biomarker analysis of toripalimab in previously treated advanced melanoma: results of the POLARIS⁃01 multicenter phaseⅡ trial［J］. Clin Cancer Res, 2020,26（16）:4250⁃4259. doi: 10. 1158/1078⁃0432.CCR⁃19⁃3922. |
| ［9］ | Si L, Zhang X, Shu Y, et al. A phase Ib study of pembrolizumab as second⁃line therapy for Chinese patients with advanced or metastatic melanoma （KEYNOTE⁃151）［J］. Transl Oncol, 2019,12（6）:828⁃835. doi: 10.1016/j.tranon.2019.02.007. |
| ［10］ | Kirkwood JM, Strawderman MH, Ernstoff MS, et al. Interferon alfa⁃2b adjuvant therapy of high⁃risk resected cutaneous melanoma: the Eastern Cooperative Oncology Group Trial EST 1684［J］. J Clin Oncol, 2023,41（3）:425⁃435. doi: 10.1200/JCO. 22.02264. |
| ［11］ | Kirkwood JM, Ibrahim JG, Sondak VK, et al. High⁃ and low⁃dose interferon alfa⁃2b in high⁃risk melanoma: first analysis of intergroup trial E1690/S9111/C9190［J］. J Clin Oncol, 2000,18（12）:2444⁃2458. doi: 10.1200/JCO.2000.18.12.2444. |
| ［12］ | Kirkwood JM, Ibrahim JG, Sosman JA, et al. High⁃dose interferon alfa⁃2b significantly prolongs relapse⁃free and overall survival compared with the GM2⁃KLH/QS⁃21 vaccine in patients with resected stage ⅡB⁃Ⅲ melanoma: results of intergroup trial E1694/S9512/C509801［J］. J Clin Oncol, 2001,19（9）:2370⁃2380. doi: 10.1200/JCO.2001.19.9.2370. |
| ［13］ | Ives NJ, Suciu S, Eggermont A, et al. Adjuvant interferon⁃α for the treatment of high⁃risk melanoma: an individual patient data meta⁃analysis［J］. Eur J Cancer, 2017,82:171⁃183. doi: 10.1016/j.ejca.2017.06.006. |
| ［14］ | Kirkwood JM, Bender C, Agarwala S, et al. Mechanisms and management of toxicities associated with high⁃dose interferon alfa⁃2b therapy［J］. J Clin Oncol, 2002,20（17）:3703⁃3718. doi: 10.1200/JCO.2002.03.052. |
| ［15］ | Shi Q, Liu L, Zhang W, et al. Interferon⁃α1b for the treatment of metastatic melanoma: results of a retrospective study［J］. Anticancer Drugs, 2021,32（10）:1105⁃1110. doi: 10.1097/CAD. 0000000000001120. |
| ［16］ | Zhu G, Shi Q, Zhao B, et al. Efficacy and safety of interferon⁃alpha 1b combined with PD⁃1 monoclonal antibody in patients with unresectable stage Ⅳ melanoma: a retrospective study［J］. J Cancer Res Clin Oncol, 2023,149（9）:6263⁃6269. doi: 10. 1007/s00432⁃023⁃04596⁃3. |
| ［17］ | National Comprehensive Cancer Network. The NCCN clinical practice guidelines in oncology for cutaneous: melanoma （version 3. 2023）［Z/OL］. ［2023⁃10⁃12］. https://www.nccn.org/guidelines/guidelines⁃detail?category=1&id=1492. |
| ［18］ | 樊代明, 郭军. 中国肿瘤整合诊治指南 黑色素瘤 2022［M］. 天津: 天津科学技术出版社, 2022:93. |
| ［19］ | Weissmann C, Nagata S, Boll W, et al. Structure and expression of human IFN⁃alpha genes［J］. Philos Trans R Soc Lond B Biol Sci, 1982,299（1094）:7⁃28. doi: 10.1098/rstb.1982.0102. |
| ［20］ | Pestka S. The human interferon⁃alpha species and hybrid proteins［J］. Semin Oncol, 1997,24（3 Suppl 9）:S9⁃4⁃S9⁃17. |
| ［21］ | 侯云德, 张智清, 杨新科, 等. 人白细胞干扰素基因的克隆化及其在大肠杆菌中的表达［J］. 中国医学科学院学报, 1982（6）:327⁃335. |
| ［22］ | Zitvogel L, Galluzzi L, Kepp O, et al. TypeⅠinterferons in anticancer immunity［J］. Nat Rev Immunol, 2015,15（7）:405⁃414. doi: 10.1038/nri3845. |
| ［23］ | Kirkwood JM, Richards T, Zarour HM, et al. Immunomodulatory effects of high⁃dose and low⁃dose interferon alpha2b in patients with high⁃risk resected melanoma: the E2690 laboratory corollary of intergroup adjuvant trial E1690［J］. Cancer, 2002,95（5）:1101⁃1112. doi: 10.1002/cncr.10775. |
| ［24］ | Paquette RL, Hsu NC, Kiertscher SM, et al. Interferon⁃alpha and granulocyte⁃macrophage colony⁃stimulating factor differentiate peripheral blood monocytes into potent antigen⁃presenting cells［J］. J Leukoc Biol, 1998,64（3）:358⁃367. doi: 10.1002/jlb.64.3. 358. |
| ［25］ | Papewalis C, Jacobs B, Wuttke M, et al. IFN⁃alpha skews monocytes into CD56+⁃expressing dendritic cells with potent functional activities in vitro and in vivo［J］. J Immunol, 2008,180（3）:1462⁃1470. doi: 10.4049/jimmunol.180.3.1462. |
| ［26］ | Parlato S, Santini SM, Lapenta C, et al. Expression of CCR⁃7, MIP⁃3beta, and Th⁃1 chemokines in typeⅠIFN⁃induced monocyte⁃derived dendritic cells: importance for the rapid acquisition of potent migratory and functional activities［J］. Blood, 2001,98（10）:3022⁃3029. doi: 10.1182/blood.v98.10.3022. |
| ［27］ | Brinkmann V, Geiger T, Alkan S, et al. Interferon alpha increases the frequency of interferon gamma⁃producing human CD4+ T cells［J］. J Exp Med, 1993,178（5）:1655⁃1663. doi: 10. 1084/jem.178.5.1655. |
| ［28］ | Palmer KJ, Harries M, Gore ME, et al. Interferon⁃alpha （IFN⁃alpha） stimulates anti⁃melanoma cytotoxic T lymphocyte （CTL） generation in mixed lymphocyte tumour cultures （MLTC）［J］. Clin Exp Immunol, 2000,119（3）:412⁃418. doi: 10.1046/j.1365⁃2249.2000.01159.x. |
| ［29］ | Moschos SJ, Edington HD, Land SR, et al. Neoadjuvant treatment of regional stage ⅢB melanoma with high⁃dose interferon alfa⁃2b induces objective tumor regression in association with modulation of tumor infiltrating host cellular immune responses［J］. J Clin Oncol, 2006,24（19）:3164⁃3171. doi: 10.1200/JCO.2005.05.2498. |
| ［30］ | Ilander M, Kreutzman A, Rohon P, et al. Enlarged memory T⁃cell pool and enhanced Th1⁃type responses in chronic myeloid leukemia patients who have successfully discontinued IFN⁃α monotherapy［J/OL］. PLoS One, 2014,9（1）:e87794. doi: 10.1371/ journal.pone.0087794. |
| ［31］ | Yurkovetsky ZR, Kirkwood JM, Edington HD, et al. Multiplex analysis of serum cytokines in melanoma patients treated with interferon⁃alpha2b［J］. Clin Cancer Res, 2007,13（8）:2422⁃2428. doi: 10.1158/1078⁃0432.CCR⁃06⁃1805. |
| ［32］ | Novikov A, Cardone M, Thompson R, et al. Mycobacterium tuberculosis triggers host typeⅠIFN signaling to regulate IL⁃1β production in human macrophages［J］. J Immunol, 2011,187（5）:2540⁃2547. doi: 10.4049/jimmunol.1100926. |
| ［33］ | Pfeffer LM, Dinarello CA, Herberman RB, et al. Biological properties of recombinant alpha⁃interferons: 40th anniversary of the discovery of interferons［J］. Cancer Res, 1998,58（12）:2489⁃2499. |
| ［34］ | Walter MR. Three⁃dimensional models of interferon⁃alpha subtypes IFN⁃con1, IFN⁃alpha8, andIFN⁃alpha1 derived from the crystal structure of IFN⁃alpha2b［J］. Semin Oncol, 1997,24（3 Suppl 9）:S9⁃52⁃S9⁃62. |
| ［35］ | Pestka S, Krause CD, Walter MR. Interferons, interferon⁃like cytokines, and their receptors［J］. Immunol Rev, 2004,202:8⁃32. doi: 10.1111/j.0105⁃2896.2004.00204.x. |
| ［36］ | Weck PK, Apperson S, May L, et al. Comparison of the antiviral activities of various cloned human interferon⁃alpha subtypes in mammalian cell cultures［J］. J Gen Virol, 1981,57（Pt 1）:233⁃237. doi: 10.1099/0022⁃1317⁃57⁃1⁃233. |
| ［37］ | Ortaldo JR, Mason A, Rehberg E, et al. Effects of recombinant and hybrid recombinant human leukocyte interferons on cytotoxic activity of natural killer cells［J］. J Biol Chem, 1983,258（24）:15011⁃15015. |
| ［38］ | Masci P, Olencki T, Wood L, et al. Gene modulatory effects, pharmacokinetics, and clinical tolerance of interferon⁃alpha1b: a second member of the interferon⁃alpha family［J］. Clin Pharmacol Ther, 2007,81（3）:354⁃361. doi: 10.1038/sj.clpt.6100081. |
| ［39］ | 冯晨, 童梅, 林福玉, 等. 干扰素α1b对黑色素瘤细胞A375增殖、迁移和凋亡的影响［J］. 现代生物医学进展,2018,18（3）:453⁃457. doi: 10.13241/j.cnki.pmb.2018.03.011. |
| ［40］ | Liu Y, Ma J, Yang Y, et al. Impact of interferon⁃alpha1b （IFN⁃α1b） on antitumor immune response: an interpretation of the promising therapeutic effect of IFN⁃alpha1b on melanoma［J］. Med Sci Monit, 2020,26:e922790. doi: 10.12659/MSM.922790. |
| ［41］ | Indraccolo S, Gola E, Rosato A, et al. Differential effects of angiostatin, endostatin and interferon⁃alpha1 gene transfer on in vivo growth of human breast cancer cells［J］. Gene Ther, 2002,9（13）:867⁃878. doi: 10.1038/sj.gt.3301703. |
| ［42］ | De Boüard S, Guillamo JS, Christov C, et al. Antiangiogenic therapy against experimental glioblastoma using genetically engineered cells producing interferon⁃alpha, angiostatin, or endostatin［J］. Hum Gene Ther, 2003,14（9）:883⁃895. doi: 10. 1089/104303403765701178. |
| ［43］ | 赵艳红. 361例黑素瘤回顾性临床分析［D］. 西安: 第四军医大学, 2018. |
| ［44］ | 孙薇, 乔逸, 郭丽, 等. 小儿注射重组人干扰素α1b治疗病毒性肺炎的耐受性及安全性［J］. 中国新药杂志, 2011,20（23）:2340⁃2344. |
| ［45］ | 申昆玲, 张国成, 尚云晓, 等. 重组人干扰素⁃α1b在儿科的临床应用专家共识［J］. 中华实用儿科临床杂志, 2015,30（16）:1214⁃1219. doi: 10.3760/cma.j.issn.2095⁃428X.2015.16.006. |
| ［46］ | Dueck AC, Mendoza TR, Mitchell SA, et al. Validity and reliability of the US National Cancer Institute′s patient⁃reported outcomes version of the common terminology criteria for adverse events （PRO⁃CTCAE）［J］. JAMA Oncol, 2015,1（8）:1051⁃1059. doi: 10.1001/jamaoncol.2015.2639. |
| ［47］ | Thompson JA, Schneider BJ, Brahmer J, et al. Management of immunotherapy⁃related toxicities, version 1.2022, NCCN clinical practice guidelines in oncology［J］. J Natl Compr Canc Netw, 2022,20（4）:387⁃405. doi: 10.6004/jnccn.2022.0020. |
| ［48］ | Meyers CA, Weitzner MA, Valentine AD, et al. Methylphenidate therapy improves cognition, mood, and function of brain tumor patients［J］. J Clin Oncol, 1998,16（7）:2522⁃2527. doi: 10.1200/JCO.1998.16.7.2522. |
| ［49］ | Weitzner MA, Meyers CA, Valentine AD. Methylphenidate in the treatment of neurobehavioral slowing associated with cancer and cancer treatment［J］. J Neuropsychiatry Clin Neurosci, 1995,7（3）:347⁃350. doi: 10.1176/jnp.7.3.347. |
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