Real-world evidence for immunotherapy in the first line setting in small cell lung cancer

Sagie, Shira; Maixner, Nitzan; Stemmer, Amos; Lobachov, Anastasiya; Bar, Jair; Urban, Damien

doi:10.1016/j.lungcan.2022.08.015

Cited by 22 publications

(18 citation statements)

References 30 publications

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“…The results showed that adding ICIs to ES-SCLC first-line chemotherapy significantly improved patients’ OS, PFS, and ORR compared to chemotherapy alone, but patients would experience more AEs. Such results are consistent with the observed application of ICIs in the real world ( 32 ). Patients treated with ICIs combined with chemotherapy exhibit higher ORR, indicating that immunotherapy can effectively mobilize the body’s anti-tumor system in ES-SCLC patients, and that can benefit patients more, making ICIs combined with chemotherapy a promising therapeutic strategy for SCLC.…”

Section: Discussionsupporting

confidence: 92%

Efficacy and safety of immune checkpoint inhibitors combined with chemotherapy in patients with extensive-stage small cell lung cancer: a systematic review and meta-analysis of randomized controlled trials

et al. 2023

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ObjectiveMany clinical trials of immune checkpoint inhibitors (ICIs) in combination with chemotherapy in the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) have been initiated, but the conclusions of these trials are not identical. This meta-analysis aimed to comprehensively collect these randomized clinical controlled trials (RCTs) to evaluate the efficacy and safety of ICIs combined with chemotherapy in the first-line treatment of ES-SCLC.MethodsWe systematically searched PubMed, Embase, and ClinicalTrials databases, to find relevant studies published until October 2022.RevMan 5.4 software was used for statistical analysis. The Cochrane Risk of Bias Tool was adopted to evaluate the risk of bias in the included studies. The primary outcome of this study was overall survival (OS), while the secondary outcomes were progression-free survival (PFS), objective response rate (ORR), all grand AEs (AEs), and ≥ 3 grand adverse events (≥ 3 AEs).ResultsA total of 780 articles were obtained in the initial examination, which was screened by layer and finally included 8 studies including 3367 patients. Six studies evaluated the efficacy of PD-1/PD-L1 inhibitors (Pembrolizumab, Nivolumab, Atezolizumab, Durvalumab, Adebrelimab, Serpulimab) combined with chemotherapy, and two studies evaluated the efficacy of CTLA-4 inhibitors (Ipilimumab) in combination with chemotherapy. The results showed that compared to chemotherapy alone, ICIs combined with chemotherapy significantly improved patients’ OS (HR=0.8, 95% CI (0.72-0.85), P<0.05), PFS (HR = 0.72, 95% CI (0.63-0.83), P < 0.05), and ORR(RR=1.08, 95% CI: 1.03-1.13, P<0.05), but patients would experience more any grand AEs and ≥3 grand AEs. Subgroup analysis showed that the PD-1/PD-L1 group performed better than the CTLA-4 group in both efficacy and safety. And ICIs plus chemotherapy significantly improved OS and PFS in patients regardless of age, gender, and performance status.ConclusionThe addition of ICIs to chemotherapy resulted in significant improvements in both PFS and OS for patients with ES-SCLC, but patients would experience more AEs.

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Section: Discussionsupporting

confidence: 92%

Efficacy and safety of immune checkpoint inhibitors combined with chemotherapy in patients with extensive-stage small cell lung cancer: a systematic review and meta-analysis of randomized controlled trials

et al. 2023

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“…A Canadian real-world study did not find significant differences in survival between patients with ECOG PS 2 treated with immunotherapy plus chemotherapy and those treated with chemotherapy alone (mOS = 5.9 vs. 6.3 months, respectively, p = 0.97). 27 Similarly, Sagie et al and Agarwal et al 28,29 in Israeli and American real-world cohorts, respectively, reported a PFS advantage without statistically significant differences in OS between PS 2/3 patients treated with immune-based therapy and those treated with chemotherapy alone. Further studies are needed to establish the real utility of adding immunotherapy in this setting while avoiding immunerelated adverse effects in patients who would not benefit from the addition of ICIs to chemotherapy.…”

Section: Discussionmentioning

confidence: 95%

Safety evaluation of immune checkpoint inhibitors combined with chemotherapy for the treatment of small cell lung cancer: A meta‐analysis of randomized controlled trials

et al. 2023

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Background The addition of immune checkpoint inhibitors (ICIs) to chemotherapy is the new standard of care in the first‐line treatment of small cell lung cancer (SCLC). However, although the concomitant use of immunotherapy and chemotherapy can increase the antitumor efficacy, it can also increase toxicity. The present study evaluated the tolerability of immune‐based combinations in the first‐line treatment of SCLC. Methods Relevant trials were identified by searching electronic databases and conference meetings. Seven phase II and III randomized controlled trials and 3766 SCLC patients were included in the meta‐analysis (immune‐based combinations = 2133; chemotherapy = 1633). Outcomes of interest included treatment‐related adverse events (TRAEs) and the rate of discontinuation due to TRAEs. Results Immune‐based combination treatment was associated with a higher risk of grade 3–5 TRAEs (odds ratio [OR], 1.16; 95% confidence interval [CI]: 1.01–1.35). Immune‐based combinations were associated with a higher risk of TRAEs leading to discontinuation (OR, 2.30; 95% CI: 1.17–4.54). No differences were observed in grade 5 TRAEs (OR, 1.56; 95% CI: 0.93–2.63). Conclusion This meta‐analysis indicates that the addition of immunotherapy to chemotherapy in SCLC patients is associated with a higher risk of toxicity and probably of treatment discontinuation. Tools for identifying SCLC patients that would not benefit from immune‐based therapy are urgently needed.

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“…Classical features proposed as favorable outcome characteristics in SCLC include disease in earlier stages and a good response to initial therapy [12]. Histology may also determine prognosis, and combined SCLC findings may result in a less favorable outcome [13]. In our case, other than histopathological findings not demonstrating combined SCLC or neuroendocrine differentiation, the patient's clinical staging of ES-SCLC and response to initial therapy, not resulting in size reduction of the tumor, would not indicate a better prognosis.…”

Section: Discussionmentioning

confidence: 99%

Prolonged Survival in a Patient With Extensive-Stage Small Cell Lung Cancer in Spite of Discontinued Immunotherapy With Atezolizumab

Konishi¹,

Kuwahara²,

Morita³

et al. 2023

Cureus

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A 64-year-old man was referred from a local clinic with a chief complaint of cough. Computed tomography (CT) revealed a mass comprising a tumor in the right lower lobe and enlarged mediastinal lymph nodes, and a whole-body workup with positron emission tomography-CT showed bilateral lymph node enlargement and cancerous pericarditis. Biopsy with bronchoscopy of the right lower lobe tumor and mediastinal lymph node confirmed the histological findings of small cell lung carcinoma. The clinical diagnosis of extensive-stage small cell lung cancer (ES-SCLC) was confirmed, and first-line treatment with carboplatin, etoposide, and atezolizumab was initiated, followed by tri-weekly atezolizumab thrice. The patient experienced worsening pleural effusion treated with thoracentesis, pleural drainage, and pleurodesis. He also experienced several recurrences, which were managed with second and third-line chemotherapy with nogitecan and amrubicin. He has been receiving third-line therapy for over 30 months since his initial visit and remains stable as of today. The patient experienced an exceptional treatment outcome considering that the prognosis of ES-SCLC remains poor, with a median survival of approximately 10 months with conventional chemotherapies using cytotoxic agents. The use of immune checkpoint inhibitors (ICI) for ES-SCLC as first-line treatment may demonstrate a persistent antitumor effect, and result in improved survival following discontinuation. In conclusion, therapy including ICI for patients with ES-SCLC is a treatment option that shows possibilities in improving survival even after discontinuation.

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Real-world evidence for immunotherapy in the first line setting in small cell lung cancer

Cited by 22 publications

References 30 publications

Efficacy and safety of immune checkpoint inhibitors combined with chemotherapy in patients with extensive-stage small cell lung cancer: a systematic review and meta-analysis of randomized controlled trials

Efficacy and safety of immune checkpoint inhibitors combined with chemotherapy in patients with extensive-stage small cell lung cancer: a systematic review and meta-analysis of randomized controlled trials

Safety evaluation of immune checkpoint inhibitors combined with chemotherapy for the treatment of small cell lung cancer: A meta‐analysis of randomized controlled trials

Prolonged Survival in a Patient With Extensive-Stage Small Cell Lung Cancer in Spite of Discontinued Immunotherapy With Atezolizumab

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