Stratmann JA, Timalsina R, Atmaca A, Rosery V, Frost N, Alt J, Waller CF, Reinmuth N, Rohde G, Saalfeld FC, von Rose AB, Acker F, Aspacher L, Möller M, and Sebastian M
Objectives: Small-cell lung cancer (SCLC) is a lung malignancy with high relapse rates and poor survival outcomes. Treatment-resistant disease relapse occurs frequently and effective salvage therapies are urgently needed., Materials and Methods: We aimed to define efficacy and safety of checkpoint inhibitors (CPIs) in a heterogeneous population of relapsed and refractory SCLC patients in a large retrospective multicentric real-world cohort across German tertiary care centers., Results: A total of 111 patients from 11 treatment centers were included. Median age of all patients was 64 years, and 63% were male. Approximately one-third of all patients had poor performance status [Eastern Cooperative Oncology Group (ECOG) ⩾ 2], and 37% had known brain metastases. Patients were heavily pretreated with a median number of prior therapy lines of 2 (range, 1-8). Median follow-up of the entire cohort was 21.7 months. Nivolumab and Nivolumab/Ipilimumab were the most common regimens. Overall disease control rate was 27.2% in all patients and was numerically higher in CPI combination regimens compared with single-agent CPI (31.8% versus 23.8%; p = 0.16). Median overall survival (OS) was 5.8 months [95% confidence interval (CI), 1.7-9.9 months]. The 12- and 24-month survival rates were 31.8% and 12.7%, respectively. The 12-week death rate was 27.9%. Disease control and response rate were significantly lower in patients with liver metastases. Platinum sensitivity (to first-line treatment), metastatic burden, and lactate dehydrogenase (LDH) showed prognostic impact on survival in univariate analysis. Neutrophil-to-lymphocyte ratio (NLR) was a significant and independent predictor of survival in univariate ( p = 0.01) and multivariate analyses [hazard ratio (HR), 2.1; 95% CI = 1.1-4.1; p = 0.03]., Conclusion: CPI in patients with relapsed or refractory (R/R) SCLC is of limited value in an overall patient cohort; however, long-term survival, in particular with CPI combination strategies, is possible. Clinical characteristics allow a more differentiated subgroup selection, in particular patients with low NLR showed less benefit from CPI in R/R SCLC., Competing Interests: Conflict of interest statement: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: J.A.S. reports personal fees from Boehringer Ingelheim, personal fees from AstraZeneca, personal fees from Roche, personal fees from BMS, personal fees from Amgen, personal fees from LEO pharma, personal fees from Novartis, personal fees from Takeda, outside of the submitted work; R.T. has nothing to disclose; A.A. reports grants and personal fees from BMS, outside the submitted work; V.R. has nothing to disclose; N.F. has nothing to disclose; J.A. reports personal fees and non-financial support from BMS, outside the submitted work; C.F.W. has nothing to disclose; N.R. reports honoraria or consultation fees from Amgen, AstraZeneca, Bristol-Myers Squibb, Boehringer-Ingelheim, Daiichi Sankyo, Hoffmann-La Roche, Lilly, MSD, Merck, Pfizer, and Takeda, outside the submitted work; G.R. has nothing to disclose; F.C.S. reports grants from Roche, non-financial support from Lilly, personal fees from Takeda, personal fees from Pfizer, outside the submitted work; A.B.v.R. has nothing to disclose; F.A. has nothing to disclose; L.A. has nothing to disclose; M.M. has nothing to disclose; M.S. reports personal fees from Lilly, personal fees from AstraZeneca, personal fees from Bristol-Myers & Squibb, personal fees from Merck Sharp & Dohme, personal fees from Pfizer, personal fees from Takeda, personal fees from Roche, personal fees from AbbVie, personal fees from Boehringer-Ingelheim, personal fees from Celgene, personal fees from Novartis, outside the submitted work, (© The Author(s), 2022.)