Selection Criteria and Treatment Outcome for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Unfit for Platinum-Based First-Line Therapy: Results of the MOON-OSS Observational Trial

Simple Summary The treatment of advanced NSCLC patients unfit for a platinum combination is challenging and no clear evidence is available. We retrospectively collected data on advanced NSCLC not receiving a first-line platinum combination, focusing on clinical selection criteria. 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 performance status. A single agent chemotherapy was offered with the prevalence of oral metronomic vinorelbine. In the whole population, progression-free survival and overall survival ranged from 4.5 to 5 months and from 9 to 10.5 months, respectively. 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.

Automated summary

The treatment of advanced NSCLC patients unfit for a platinum combination is challenging, and clinical selection criteria, such as older age, comorbidities, and poor performance status, play a crucial role in determining the treatment options. The use of oral metronomic vinorelbine as a single-agent chemotherapy appears to be a frequent choice with acceptable efficacy and safety profiles. However, more research is needed to establish clear guidelines for the selection and outcomes of single-agent chemotherapy in this patient population.