早期蕈样肉芽肿的治疗：前瞻性皮肤淋巴瘤国际预后指数（PROCLIPI）研究结果
Treatment of early-stage mycosis fungoides: results from the PROspective Cutaneous Lymphoma International Prognostic Index (PROCLIPI) study.
作者信息
Quaglino P, Prince H M, Cowan R, Vermeer M, Papadavid E, Bagot M, Servitjie O, Berti E, Guenova E, Stadler R, Querfeld C, Busschots A M, Hodak E, Patsatsi A, Sanches J, Maule M, Yoo J, Kevin M, Fava P, Ribero S, Zocchi L, Rubatto M, Fierro M T, Wehkamp U, Marshalko M, Mitteldorf C, Akilov O, Ortiz-Romero P, Estrach T, Vakeva L, Enz P A, Wobser M, Bayne M, Jonak C, Rubeta M, Forbes A, Bates A, Battistella M, Amel-Kashipaz R, Vydianath B, Combalia A, Georgiou E, Hauben E, Hong E K, Jost M, Knobler R, Amitay-Laish I, Miyashiro D, Cury-Martins J, Martinez X, Muniesa C, Prag-Naveh H, Stratigos A, Nikolaou V, Quint K, Ram-Wolff C, Rieger K, Stranzenbach R, Szepesi Á, Alberti-Violetti S, Felicity E, Cerroni L, Kempf W, Whittaker S, Willemze R, Kim Y, Scarisbrick J J
机构信息
Dermatologic Clinic, University of Turin Medical School, Turin, Italy.
Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.
出版信息
Br J Dermatol. 2021 Apr;184(4):722-730. doi: 10.1111/bjd.19252. Epub 2021 Feb 18.
BACKGROUND
The PROspective Cutaneous Lymphoma International Prognostic Index (PROCLIPI) study is a prospective analysis of an international database. Here we examine front-line treatments and quality of life (QoL) in patients with newly diagnosed mycosis fungoides (MF).
OBJECTIVES
To identify (i) differences in first-line approaches according to tumour-nodes-metastasis-blood (TNMB) staging; (ii) parameters related to a first-line systemic approach and (iii) response rates and QoL measures.
METHODS
In total, 395 newly diagnosed patients with early-stage MF (stage IA-IIA) were recruited from 41 centres in 17 countries between 1 January 2015 and 31 December 2018 following central clinicopathological review.
RESULTS
The most common first-line therapy was skin-directed therapy (SDT) (322 cases, 81·5%), while a smaller percentage (44 cases, 11·1%) received systemic therapy. Expectant observation was used in 7·3%. In univariate analysis, the use of systemic therapy was significantly associated with higher clinical stage (IA, 6%; IB, 14%; IIA, 20%; IA-IB vs. IIA, P < 0·001), presence of plaques (T1a/T2a, 5%; T1b/T2b, 17%; P < 0·001), higher modified Severity Weighted Assessment Tool (> 10, 15%; ≤ 10, 7%; P = 0·01) and folliculotropic MF (FMF) (24% vs. 12%, P = 0·001). Multivariate analysis demonstrated significant associations with the presence of plaques (T1b/T2b vs. T1a/T2a, odds ratio 3·07) and FMF (odds ratio 2·83). The overall response rate (ORR) to first-line SDT was 73%, while the ORR to first-line systemic treatments was lower (57%) (P = 0·027). Health-related QoL improved significantly both in patients with responsive disease and in those with stable disease.
CONCLUSIONS
Disease characteristics such as presence of plaques and FMF influence physician treatment choices, and SDT was superior to systemic therapy even in patients with such disease characteristics. Consequently, future treatment guidelines for early-stage MF need to address these issues.
背景
前瞻性皮肤淋巴瘤国际预后指数（PROCLIPI）研究是对一个国际数据库的前瞻性分析。在此，我们研究新诊断蕈样肉芽肿（MF）患者的一线治疗及生活质量（QoL）。
目的
确定（i）根据肿瘤-淋巴结-转移-血液（TNMB）分期的一线治疗方法差异；（ii）与一线全身治疗相关的参数；（iii）缓解率及生活质量指标。
方法
在2015年1月1日至2018年12月31日期间，经中心临床病理审核后，从17个国家的41个中心招募了395例新诊断的早期MF（IA-IIA期）患者。
结果
最常见的一线治疗是皮肤定向治疗（SDT）（322例，81.5%），而接受全身治疗的比例较小（44例，11.1%）。7.3%的患者采用观察等待。单因素分析显示，全身治疗的使用与更高的临床分期显著相关（IA期，6%；IB期，14%；IIA期，20%；IA-IB期与IIA期相比，P<0.001）、斑块的存在（T1a/T2a，5%；T1b/T2b，17%；P<0.001）、改良严重性加权评估工具评分更高（>10，15%；≤10，7%；P = 0.01）以及亲毛囊性MF（FMF）（24%对12%，P = 0.001）。多因素分析显示与斑块的存在（T1b/T2b与T1a/T2a相比，比值比3.07）和FMF（比值比2.83）显著相关。一线SDT的总缓解率（ORR）为73%，而一线全身治疗的ORR较低（57%）（P = 0.027）。疾病缓解和疾病稳定的患者健康相关生活质量均显著改善。
结论
斑块和FMF等疾病特征会影响医生的治疗选择，即使对于具有此类疾病特征的患者，SDT也优于全身治疗。因此，未来早期MF的治疗指南需要解决这些问题。
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