依维莫司治疗转移性肾细胞癌患者口腔炎和皮肤毒性与临床结局的相关性
Correlation of Stomatitis and Cutaneous Toxicity With Clinical Outcome in Patients With Metastatic Renal-Cell Carcinoma Treated With Everolimus.
作者信息
Conteduca Vincenza, Santoni Matteo, Medri Matelda, Scarpi Emanuela, Burattini Luciano, Lolli Cristian, Rossi Lorena, Savini Agnese, Berardi Rossana, Stanganelli Ignazio, Cascinu Stefano, De Giorgi Ugo
机构信息
Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Department of Medical Oncology, University Hospital, Ancona, Italy.
出版信息
Clin Genitourin Cancer. 2016 Oct;14(5):426-431. doi: 10.1016/j.clgc.2016.02.012. Epub 2016 Feb 23.
BACKGROUND
In clinical practice, discontinuation or dose reduction of everolimus may be induced not only by grade 3 or 4 toxicities but also by prolonged grade 2 toxicities, such as stomatitis and/or cutaneous toxicity, which share some pathogenetic mechanisms. We assessed the correlation between either everolimus discontinuation or dose reduction induced by stomatitis-cutaneous toxicity events (SCTE) and clinical outcome of patients with metastatic renal-cell cancer (mRCC).
PATIENTS AND METHODS
We retrospectively reviewed the clinical data of patients with mRCC treated with everolimus in 2 Italian centers. Clinical evidence of SCTE was evaluated, and corresponding clinical data were reviewed for response and clinical outcome.
RESULTS
Seventy-nine mRCC patients treated with everolimus (57 male, 22 female; median age 66 years; range, 44-88 years) were evaluated. SCTE were observed in 20 (25%) of 79 patients at a median of 30.5 days of everolimus treatment (range, 10-270 days). Partial response or stable disease was achieved in 15 (79%) of 19 evaluable patients with SCTE compared to 28 (48%) of 58 with no SCTE (P = .03). At a median follow-up of 19 months, a significant difference was found in the median PFS equal to 7.8 months (95% confidence interval [CI], 2.8-24.4) in SCTE patients versus 4.3 months (95% CI, 2.7-7.5) in non-SCTE patients (P = .029), and in the median OS equal to 30.6 months (95% CI, 19.6-not reached) in SCTE patients versus 13.5 months (95% CI, 9.9-17.7) in non-SCTE patients (P = .0007).
CONCLUSION
These data suggest that SCTE may be a predictive marker of favorable outcome in mRCC patients treated with everolimus.
背景
在临床实践中，依维莫司的停药或减量不仅可能由3级或4级毒性引起，还可能由长期的2级毒性引起，如口腔炎和/或皮肤毒性，它们具有一些共同的发病机制。我们评估了口腔炎-皮肤毒性事件（SCTE）导致的依维莫司停药或减量与转移性肾细胞癌（mRCC）患者临床结局之间的相关性。
患者与方法
我们回顾性分析了意大利两个中心接受依维莫司治疗的mRCC患者的临床资料。评估SCTE的临床证据，并审查相应的临床数据以了解疗效和临床结局。
结果
共评估了79例接受依维莫司治疗的mRCC患者（57例男性，22例女性；中位年龄66岁；范围44 - 88岁）。79例患者中有20例（25%）出现SCTE，依维莫司治疗的中位时间为30.5天（范围10 - 270天）。19例可评估的SCTE患者中有15例（79%）达到部分缓解或疾病稳定，而58例无SCTE的患者中有28例（48%）达到部分缓解或疾病稳定（P = .03）。中位随访19个月时，SCTE患者的中位无进展生存期（PFS）为7.8个月（95%置信区间[CI]，2.8 - 24.4），显著长于非SCTE患者的4.3个月（95% CI，2.7 - 7.5）（P = .029）；SCTE患者的中位总生存期（OS）为30.6个月（95% CI，19.6 - 未达到），显著长于非SCTE患者的13.5个月（95% CI，9.9 - 17.7）（P = .0007）。
结论
这些数据表明，SCTE可能是接受依维莫司治疗的mRCC患者预后良好的预测指标。
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