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. 2024 Oct 17;6(1):100744.
doi: 10.1016/j.jtocrr.2024.100744. eCollection 2025 Jan.

First-Line Chemo-Immunotherapy in SCLC: Outcomes of a Binational Real-World Study

Laura Moliner  1 , Núria Zellweger  2 , Sabine Schmid  3 , Martina Bertschinger  4 , Christine Waibel  5 , Ferdinando Cerciello  3 , Patrizia Froesch  6 , Michael Mark  7 , Adrienne Bettini  8 , Pirmin Häuptle  9 , Veronika Blum  10 , Lisa Holer  11 , Stefanie Hayoz  11 , Martin Früh  12 , Samreen Ahmed  13 , Shradha Bhagani  13 , Nicola Steele  14 , Hannah-Leigh Gray  14 , Stephen D Robinson  15 , Michael Davidson  16 , Samantha Cox  17 , Taha Khalid  18 , Tom R Geldart  18 , Luke Nolan  19 , Deborah C Scott  19 , Lindsay Hennah  20 , Tom Newsom-Davis  20 , Emma Rathbone  21 , Catherine Handforth  21 , Arshi Denton  22 , Shairoz Merchant  22 , Fiona Blackhall  23 , Laetitia A Mauti  4 , Raffaele Califano  23 , Sacha I Rothschild  2   5
Affiliations

First-Line Chemo-Immunotherapy in SCLC: Outcomes of a Binational Real-World Study

Laura Moliner et al. JTO Clin Res Rep. .

Abstract

Introduction: SCLC is characterized by aggressiveness and limited treatment options, especially in extensive-stage SCLC (ES-SCLC). Immunotherapy added to the platinum-etoposide combination has recently become standard in this setting. This retrospective study aims to evaluate the real-world effectiveness of chemo-immunotherapy in patients with ES-SCLC, focusing on subpopulations excluded from clinical trials.

Methods: A retrospective binational multicenter study was conducted, involving consecutive patients with ES-SCLC from 10 British and 10 Swiss institutions. Patients received platinum-etoposide chemotherapy in combination with immunotherapy (atezolizumab or durvalumab). Patient, tumor, and treatment details were collected. Overall survival (OS), progression-free survival, objective response rate, and safety outcomes were analyzed.

Results: A total of 436 patients were included. One hundred forty-two patients (32.6%) in our cohort would not have been eligible for the pivotal registrational trials owing to an Eastern Cooperative Oncology Group performance status of 2 or higher, autoimmune disease, active brain metastases, or steroid use. Most patients received carboplatin (96.8%) and atezolizumab (97.9%). The median progression-free survival was 5.5 months and the median OS was 9.3 months. The two-year OS was 14%. Patients with liver or bone metastases or an Eastern Cooperative Oncology Group performance status of 2 or higher had worse survival outcomes. Treatment-related adverse events were reported in 222 patients (51%) whereas immune-related adverse events occurred in 95 patients (22%). Three out of five grade 5 immune-related adverse events were caused by pneumonitis.

Conclusions: To our knowledge, this is the largest real-world cohort of patients treated with chemo-immunotherapy for ES-SCLC. Although one-third of patients would not have been eligible for pivotal trials, the survival outcomes in our cohort are similar to those in registrational trials. In particular, the number of long-term survivors and the safety data are comparable, supporting the use of chemo-immunotherapy as first-line treatment for ES-SCLC in daily clinical practice.

Keywords: Immunotherapy; Real-world data; SCLC; Special populations.

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Conflict of interest statement

Dr. Schmid received consulting fees and speaker invitations (payment to institution) from AstraZeneca, Bristol-Myers Squibb, Janssen, Merck, Merck Sharp & Dohme, Sanofi, and Takeda and travel support from 10.13039/100002429Amgen, 10.13039/100004337Roche, and Takeda. Dr. Bertschinger received honoraria for lectures and presentations from AstraZeneca, and Janssen and reports participation on the advisory boards of Stemline, and Sanofi. Dr. Cerciello reports participation on the advisory boards (payment to the institution) of Bristol-Myers Squibb and PharmaMar. Dr. Mark reports participation on the advisory boards of AstraZeneca, Bristol-Myers Squibb, Janssen, Merck Sharp & Dohme, Roche, and Takeda. Dr. Blum reports participation on the advisory boards of Sanofi. Dr. Früh received consulting fees (payment to the institution) from AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Janssen, Merck Sharp & Dohme, PharmaMar, Pfizer, Roche, and Takeda. Dr. Robinson is a junior representative on the British Neuro Oncology Society Council and a Member of the British Thoracic Oncology Group’s Thymic Malignancies Special Interest Group and received support for travel and accommodation from the British Thoracic Oncology Group. Dr. Cox received honoraria for lectures and presentations (personal payment) from Amgen, AstraZeneca, Bayer, Chugai Pharma, Eli Lilly, Merck Sharp & Dohme, and Pfizer and is a consultant representative of the All Wales Medicines Strategy Group (unpaid). Dr. Scott received research support from 10.13039/100002491Bristol-Myers Squibb. Dr. Davis received consulting fees (personal payment) from Abbvie, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, EQRx, Gilead, GlaxoSmithKline, Janssen, Eli Lilly, Merck, Merck Sharp & Dohme, Novartis, Novocure, Pfizer, Roche, Sanofi, and Takeda and honoraria for lectures and presentations (personal payment) from Abbvie, Amgen, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Gilead, Janssen, Eli Lilly, Merck, Merck Sharp & Dohme, Novartis, Pfizer, Roche, and Takeda and reports participation on the Data Safety Monitoring Board (personal payment) from Roche, Blueprint Medicine. Dr. Blackhall received consulting fees from Amgen, AstraZeneca, and Roche and Honoraria for lectures and presentations from Amgen, and AstraZeneca and reports participation on the advisory boards of Amgen and AstraZeneca. Dr. Mauti received consulting fees (personal payment) from Daiichi Sankyo, Janssen, and Sanofi and honoraria for lectures and presentations (personal payment) from Amgen and reports participation on the advisory boards (personal payment) of AstraZeneca, Janssen, Merck, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Roche, and Sanofi. Dr. Califano received grants from 10.13039/100004331Johnson and Johnson, 10.13039/501100013119PharmaMar, 10.13039/100004330GlaxoSmithKline, Roche, Arrivent, and Taiho Pharmaceutical, consulting fees from Merck Sharp & Dohme, Roche, Bristol-Myers Squibb, AstraZeneca, Janssen, GlaxoSmithKline, Takeda, PharmaMar, and Pfizer, honoraria for lectures from Merck Sharp & Dohme, Roche, AstraZeneca, Janssen, GlaxoSmithKline, Takeda, and Pfizer, support for travel and accommodations from Takeda, Merck Sharp & Dohme, and Johnson and Johnson and reports participation on the Data Safety Monitoring Boards of Gsk, AstraZeneca, PharmaMar, and Johnson and Johnson, Takeda and Pfizer and membership of the ESMO educational publishing working group and holds stock or stock options from Supportive Care UK and Leaders in oncology care at the Christie private care. Dr. Rothschild received consulting fees (payment to the institution) from Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Eisai, Eli Lilly, Merck Serono, Merck Sharp & Dohme, Novartis, Otsuka, Pfizer, PharmaMar, Roche Pharma, Roche Diagnostics, Sanofi Aventis, and Takeda., research support from Amgen, Astra-Zeneca, Merck, and Roche, honoraria for lectures and presentations (payment to the institution) from Amgen, AstraZeneca, Bristol-Myers Squibb, Merck Sharp & Dohme Oncology, Novartis, Roche Pharma, Roche Diagnostics, and Takeda, payment for expert testimony (payment to the institution) from AstraZeneca, Bristol-Myers Squibb, and Roche Pharma, support for travel and accommodations (payment to the institution) from Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Merck Sharp & Dohme, Roche, and Takeda and reports participation on the Data Safety Monitoring Board (payment to the institution) of Roche and membership of the Federal Drug Commission of the Federal Office of Public Health. The remaining authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Progression-free survival and overall survival. Kaplan-Meier curves of the (A) progression-free survival and (B) overall survival. The width of the line shows the confidence intervals. mOS, median overall survival; mPFS, median progression-free survival.
Figure 2
Figure 2
Progression-free survival depends on baseline characteristics. Kaplan-Meier curves of the progression-free survival depending on the presence at diagnosis of (A) brain metastases, (B) liver metastases, and (C) bone metastases. The width of the line shows the CIs. CI, confidence interval; HR, hazard ratio.
Figure 3
Figure 3
Overall survival depending on the use of prophylactic cranial irradiation (PCI) and/or consolidative thoracic radiotherapy (cTRT). Kaplan-Meier curves of the overall survival. The width of the line shows the confidence intervals.
Supplementary Figure 1A
Supplementary Figure 1A
Supplementary Figure 1B
Supplementary Figure 1B
See this image and copyright information in PMC

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