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Updated: Aug 29, 2025

Patient-Derived Tumor Explants As a "Live" Preclinical Platform for Predicting Drug Resistance in Patients
Published on: February 7, 2021
Real-world evidence for immunotherapy in the first line setting in small cell lung cancer
Shira Sagie1, Nitzan Maixner2, Amos Stemmer2
1Institute of Oncology, Sheba Medical Center, Ramat Gan, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; The Sheba Talpiot Medical Leadership Program, Israel.
Objective:
Despite major progress over the past decade in the field of lung cancer care, only mild advances have occurred in Small Cell Lung Cancer (SCLC), with prognosis remaining poor. Based on two randomized clinical trials (RCTs), two checkpoint-inhibitors have recently been approved in extensive-SCLC with moderate improvements in median overall survival (OS). However, only limited data exist regarding the impact of immunotherapy in real-world SCLC patients. This study reports the efficacy of immunotherapy in the first-line treatment of extensive-stage SCLC patients in a real-world setting.
Methods:
a retrospective cohort study of all patients treated for extensive-SCLC with chemotherapy with or without immunotherapy, at a single center in Israel between October-2017 and July-2021. Patient characteristics, adverse-events and survival analyses were conducted.
Results:
Of 102 patients identified, 54 patients (53%) received immunotherapy in addition to chemotherapy. 34.7% of patients had a performance status (PS) of 2-4. Patients that received only chemotherapy were older, had more liver metastasis and a poorer PS. In the whole cohort, patients receiving immunotherapy had a significantly longer median OS (353 days vs 194 days, HR = 0.40p < 0.0001). After stratification by PS groups, survival analysis remained significantly longer in the PS 0-1 group (HR 0.43, p = 0.0036), with a trend for better survival in the PS 2-3 group. Multivariate analysis validated an OS advantage with immunotherapy (HR = 0.46, p = 0.004).
Conclusion:
We present evidence for the efficacy of immunotherapy in SCLC in a real-world setting. Although treatment groups differ in their baseline characteristics, it appears that even some patients not included in RCTs, such as poor PS, may benefit from the addition of immunotherapy to their treatment protocol.
Insights
Immunotherapy significantly improves overall survival for extensive-stage Small Cell Lung Cancer (SCLC) patients in real-world settings. This approach offers benefits even for patients with poor performance status, expanding treatment options beyond clinical trials.
Area of Science:
- Oncology
- Pulmonology
- Immunotherapy
Background:
- Small Cell Lung Cancer (SCLC) has a poor prognosis despite recent advances.
- Checkpoint inhibitors offer moderate survival benefits in extensive-SCLC based on clinical trials.
- Limited data exist on immunotherapy's real-world effectiveness in SCLC.
Purpose of the Study:
- To evaluate the efficacy of first-line immunotherapy in extensive-stage SCLC patients in a real-world setting.
- To compare outcomes of chemotherapy with or without immunotherapy in SCLC.
- To assess immunotherapy's impact on overall survival and adverse events.
Main Methods:
- Retrospective cohort study of 102 extensive-SCLC patients treated between October 2017 and July 2021.
- Analysis of patient characteristics, adverse events, and survival data.
- Comparison between chemotherapy alone and chemotherapy plus immunotherapy groups.
Main Results:
- Patients receiving immunotherapy had significantly longer median overall survival (353 days vs. 194 days).
- Immunotherapy benefit was observed in patients with good (PS 0-1) and a trend in poor (PS 2-3) performance status.
- Multivariate analysis confirmed an overall survival advantage with immunotherapy (HR=0.46, p=0.004).
Conclusions:
- Immunotherapy demonstrates efficacy in real-world extensive-stage SCLC treatment.
- Patients not typically included in clinical trials, such as those with poor performance status, may benefit.
- Real-world data support the addition of immunotherapy to chemotherapy for SCLC.
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