Camerini Andrea, Del Conte Alessandro, Pezzuto Aldo, Scotti Vieri, Facchinetti Francesco, Ciccone Lucia Pia, Perna Marco, Sartori Giulia, Puccetti Cheti, Ricci Alberto, Santo Antonio, Tiseo Marcello, Amoroso Domenico
Medical Oncology, Versilia Hospital, Via Aurelia 335, 55043 Lido di Camaiore, LU, Italy.
S.O.C. Oncologia Medica e dei Tumori Immunocorrelati-CRO/IRCCS Aviano Via Gallini 2, 33081 Pordenone, PN, Italy.
Cancers (Basel). 2022 Dec 9;14(24):6074. doi: 10.3390/cancers14246074.
Limited evidence is available concerning the selection criteria and the outcomes of platinum unfit newly diagnosed advanced NSCLC patients receiving single-agent chemotherapy. We retrospectively collected data on consecutive, stage IIIB-IV, EGFR/ALK negative and PD-L1 < 50% NSCLC patients treated with first-line single agent chemotherapy. Baseline characteristics, outcome measures and toxicities were recorded, as well as criteria according to which treatment selection was made and what percentage of patients did not receive a first-line platinum-based chemotherapy. Two-hundred and twenty-one patients were included. Median age was 79 (range 56−92) years, M/F 165(74.6%)/56(25.4%), ECOG performance status (PS) 0/1/ ≥ 2 23(10.9%)/94(42.5%)/103(46.6%), with a median of two serious comorbidities. A median of 25% (range 10%-30%) of newly diagnosed NSCLC did not receive a first-line platinum combination. Clinical criteria according to which decision was made were older age (76.5%), comorbidities (72%), poor PS (55.2%) and familiar or social issues (10%). Single-agent treatment consisted of oral metronomic vinorelbine (MetV 78.6%), gemcitabine (Gem 10%), oral standard vinorelbine (Vin 8.2%) and other (O 3.2%). Median progression-free survival (PFS) and overall survival (OS) of single agent treatments ranged from 4.5 to 5 months and from 9 to 10.5 months, respectively. All grade toxicities did not differ among single agents, while grade 3−4 toxicities were less frequent with MetV. Up to 30% of newly diagnosed advanced EGFR/ALK negative and PD-L1 < 50% NSCLC patients do not receive a first-line platinum doublet. Main clinical selection criteria were older age (>70 years), comorbidities and poor PS. An oral treatment was frequently proposed with MetV being the most frequent choice according to its safety profile.
关于铂类不适用的新诊断晚期非小细胞肺癌（NSCLC）患者接受单药化疗的选择标准和治疗结果，现有证据有限。我们回顾性收集了连续的IIIB-IV期、表皮生长因子受体（EGFR）/间变性淋巴瘤激酶（ALK）阴性且程序性死亡受体配体1（PD-L1）<50%的NSCLC患者接受一线单药化疗的数据。记录了基线特征、疗效指标和毒性，以及治疗选择所依据的标准和未接受一线铂类化疗的患者比例。共纳入221例患者。中位年龄为79岁（范围56-92岁），男性/女性为165例（74.6%）/56例（25.4%），东部肿瘤协作组（ECOG）体能状态（PS）为0/1/≥2的患者分别为23例（10.9%）/94例（42.5%）/103例（46.6%），合并症中位数为2种。新诊断的NSCLC患者中，有25%（范围10%-30%）的患者未接受一线铂类联合化疗。做出决策所依据的临床标准包括年龄较大（76.5%）、合并症（72%）、PS较差（55.2%）以及家庭或社会问题（10%）。单药治疗包括口服节拍性长春瑞滨（MetV，78.6%）、吉西他滨（Gem，10%）、口服标准长春瑞滨（Vin，8.2%）和其他药物（O，3.2%）。单药治疗的中位无进展生存期（PFS）和总生存期（OS）分别为4.5至5个月和9至10.5个月。所有级别毒性在各单药之间无差异，而MetV导致的3-4级毒性发生率较低。高达30%的新诊断晚期EGFR/ALK阴性且PD-L1<50%的NSCLC患者未接受一线铂类双联化疗。主要临床选择标准为年龄较大（>70岁）、合并症和PS较差。根据其安全性，经常建议采用口服治疗，其中MetV是最常用的选择。
