The HTML2 The study included in this report was published on researchsquare.com as a preprint, and has not yet been peer examined.
The Most Important Takeaway
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Combining the immunotherapy sintilimab with paclitaxel/nab-paclitaxel and platinum-based chemotherapy appears to be as effective as when adding it to a gemcitabine-based regimen in squamous cell non-small cell lung cancer (sqNSCLC), suggests a real-world analysis.
Why this is important
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Numerous studies have demonstrated the antitumor efficacy of immune checkpoint inhibitors in combination with paclitaxel/nab-paclitaxel and platinum-based chemotherapy in the first-line treatment of sqNSCLC.
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While the anti-programmed death (PD)-1 monoclonal antibody sintilimab was shown to have a powerful antitumor response, the ORIENT-12 randomized controlled trial combined it only with gemcitabine and platinum-based chemotherapy.
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The current results suggest that combining sintilimab with paclitaxel/nab-paclitaxel and platinum-based chemotherapy could be a novel option for the treatment of sqNSCLC.
Study Design
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Researchers looked over medical records of patients diagnosed with stage IIIB-IV of sqNSCLC or without EGFR and ALK mutations, who started treatment in January 2019 and continued until January 2021.
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Patients were treated with first-line sintilimab plus paclitaxel/nab-paclitaxel (sintilimab-TP) or sintilimab plus gemcitabine (sintilimab-GP), plus platinum-based chemotherapy.
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Information on demographics of patients and performance status, PD-ligand1 expression, tumor response, and adverse events was gathered as well as the progression-free and overall survival were calculated by using the Kaplan-Meier method.
Key Results
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Patients in the sintilimab TP arm received a median dose of four doses, while patients in the sintilimab GP arm received six doses.
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After a median follow-up of 12.1 months the median survival rate without progression was 10.9 months for the sintilimab-TP group and 7.7 months for sintilimab GP ( P =.24). Median overall survival was 20.1 months and 16.3 months and 16.3 months, respectively ( P = .46).
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The overall response rate was 59.4% in patients given sintilimab TP vs. 40% in in the sintilimab GP arm. The disease control rate was 93% and 95.0 percent, respectively.
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Grade 3 or higher adverse events were noted in 37.5 percent of patients receiving sintilimab-TP and 55.0% of those treated with sintilimab-GP. The most frequent were anemia and decreased white blood cell count.
Limitations
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The study was limited due to its observational and retrospective design, as well as its small sample size, the authors note. The follow-up time was also short.
Study Disclosures
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The study was supported by State Key Laboratory of Respiratory Disease-The Open Project, Fundamental and Applied Fundamental Research Project of City-School (Institute) Joint Funding Project, Guangzhou Science and Technology Bureau, and Zhongnanshan Medical Foundation of Guangdong Province.
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No relevant financial relationships declared.
This is a synopsis of a preprint research study “Sintilimab with Chemotherapy: The First-Line Treatment For Locally Advanced Or Metastatic Squamous Small-Cell Lung Cancer: Real World Data Study,” published online by Medscape on October 25. The study was led by Chengzhi Zhou, PhD, professor, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. The study has not yet been peer reviewed. The complete text is available at researchsquare.com.
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