Facchinetti Francesco, Camerini Andrea, Bennati Chiara, Bordi Paola, De Carlo Elisa, Mazzoni Francesca, Metro Giulio, Bertolini Federica, Longo Lucia, Ricciardi Serena, Pilotto Sara, Giardina Donatella, Passiglia Francesco, Scotti Vieri, Piacentini Paolo, Frega Stefano, Calabrò Luana, Guida Annalisa, Grosso Maria Antonietta, Longobardi Jenny, Merlini Alessandra, Cosso Federica, Leonetti Alessandro, Gariazzo Eleonora, Guaitoli Giorgia, Belluomini Lorenzo, Bearz Alessandra, Tognetto Michele, Bria Emilio, Cortinovis Diego Luigi, Novello Silvia, Maio Massimo Di, Tiseo Marcello
Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, USA; Gruppo Oncologico di Ricerca Clinica (GOIRC), Parma, Italy.
Medical Oncology, Versilia Hospital, Azienda USL Toscana Nord Ovest, Lido di Camaiore, Italy.
Lung Cancer. 2025 Jun;204:108580. doi: 10.1016/j.lungcan.2025.108580. Epub 2025 May 17.
Therapeutic strategies for patients with advanced NSCLC and an ECOG performance status (PS) 2 at diagnosis are supported by limited evidence.
We led a prospective, observational study in 20 Italian centers on patients with advanced NSCLC and ECOG PS 2. Patients with EGFR mutations, ALK fusions or receiving first-line targeted treatments were excluded. We recorded physicians' attitudes in addressing first-line treatments and clinical outcomes. The primary endpoint was progression-free rate at six months.
From March 2022 to October 2023, 198 consecutive patients were included. Median age was 73 years (range 43-91). Forty-four patients (22%) were candidate to best supportive care, 49 (25%) to single agent chemotherapy, 14 (7%) to platinum doublet, 40 (20%) to mono-immunotherapy, 52 (26%) to chemo-immunotherapy. At a median follow-up of 9.4 months (95 % CI 7.2 - 11.7), 6-month progression-free rate was 15.3%, with a median progression-free survival of 1.6 months (95 % CI 1.3 - 1.9). Six-months overall survival (OS) rate was 27.7%, with a median OS of 2.8 months (95 % CI 2.0 - 3.6). Patients receiving chemo-immunotherapy (PD-L1 < 50%) had 6-month progression-free and OS rates of 22.9% and 29.1% respectively, with median PFS 1.9 months and median OS 3.7 months; mono-immunotherapy for patients with PD-L1 ≥ 50% led to slightly better outcomes. Among 155 patients receiving active treatment, no clinical-pathological characteristic harbored a prognostic role. One third of patients receiving immunotherapy-containing regimens encountered early clinical progression or death before the first radiological evaluation. No relevant safety signals emerged across treatments.
Less than half of patients with NSCLC and ECOG PS 2 were candidates to the regimens recommended for fit pts, i.e. mono-immunotherapy or chemo-immunotherapy according to PD-L1. Even with immunotherapy, most of these patients have dismal outcomes, suggesting that trials dedicating to PS 2 perform an intrinsic patient selection.
晚期非小细胞肺癌（NSCLC）且诊断时东部肿瘤协作组（ECOG）体能状态（PS）为2的患者的治疗策略证据有限。
我们在20个意大利中心对晚期NSCLC且ECOG PS为2的患者开展了一项前瞻性观察性研究。排除有表皮生长因子受体（EGFR）突变、间变性淋巴瘤激酶（ALK）融合或接受一线靶向治疗的患者。我们记录了医生在选择一线治疗方案时的态度以及临床结局。主要终点是6个月时的无进展率。
2022年3月至2023年10月，连续纳入198例患者。中位年龄为73岁（范围43 - 91岁）。44例患者（22%）适合最佳支持治疗，49例（25%）适合单药化疗，14例（7%）适合含铂双药化疗，40例（20%）适合单药免疫治疗，52例（26%）适合化疗联合免疫治疗。中位随访9.4个月（95%置信区间7.2 - 11.7），6个月无进展率为15.3%，中位无进展生存期为1.6个月（95%置信区间1.3 - 1.9）。6个月总生存率（OS）为27.7%，中位OS为2.8个月（95%置信区间2.0 - 3.6）。接受化疗联合免疫治疗（程序性死亡配体1[PD - L1]<50%）的患者6个月无进展率和OS率分别为22.9%和29.1%，中位无进展生存期为1.9个月，中位OS为3.7个月；PD - L1≥50%的患者接受单药免疫治疗的结局稍好。在155例接受积极治疗的患者中，没有临床病理特征具有预后作用。接受含免疫治疗方案的患者中有三分之一在首次影像学评估前出现早期临床进展或死亡。各治疗组均未出现相关安全信号。
不到一半的NSCLC且ECOG PS为2的患者适合推荐给体能状态良好患者的方案，即根据PD - L1进行单药免疫治疗或化疗联合免疫治疗。即使采用免疫治疗，这些患者中的大多数结局仍较差，这表明针对PS为2患者的试验存在内在的患者选择偏倚。
