Abstract and Introduction
Abstract
Background: Camrelizumab plus chemotherapy have been approved as standards for the treatment of advanced non-small cell lung cancer (NSCLC) patients based on two phase III trials. However, clinical trial results may not be representative of the general population, as clinical trials often have specific inclusion and exclusion criteria. Our research aims to investigate the real-world effectiveness and safety of camrelizumab in inoperable or advanced NSCLC patients.
Methods: This multicenter retrospective observational study included inoperable or advanced pathologically confirmed NSCLC patients who received at least one dose of camrelizumab at 22 hospitals. Clinical and follow-up data of camrelizumab were collected retrospectively from the medical records. The primary outcome was the objective response rate (ORR) and secondary outcomes were disease control rate (DCR), 6-month progression-free survival (PFS), overall survival (OS), and treatment-related adverse events (TRAEs). Multivariate logistic and Cox regression analyses were applied to identify potential predictive factors of ORR and PFS, respectively.
Results: Between July 2019 and March 2021, 336 patients were included. Adenocarcinoma was seen in 58.4% and stage IV disease in 69.3%. Twenty-nine (8.6%) had liver metastasis at baseline. Most patients received camrelizumab in the first-line setting (74.1%) and in combination with chemotherapy (60.7%). The ORR was 40.2% [95% confidence interval (CI): 34.9–45.6%] and DCR was 85.1% (95% CI: 81.3–88.9%), while the 6-month PFS and OS rates were 73.0% (95% CI: 67.1–78.0%) and 93.1% (95% CI: 89.8–95.4%), respectively. In multivariate analyses, liver metastasis [odds ratio (OR), 0.324; 95% CI: 0.115–0.915; P=0.033] and increasing lines of camrelizumab treatment (vs. first line, second line: OR, 0.347; 95% CI: 0.162–0.741; P=0.006; ≥ third line: OR, 0.126; 95% CI: 0.043–0.367; P<0.001) were negatively associated, while a longer duration of camrelizumab treatment was positively associated with ORR and PFS. TRAEs were recorded in 164 (48.8%) patients, without new safety signal.
Conclusions: We conducted a comprehensive overview of the effectiveness and safety profile of camrelizumab in a broader NSCLC population in real world NSCLC patients, and subgroup analysis indicated the presence of liver metastasis was associated with worse outcomes.
Introduction
Lung cancer is the leading cause of cancer-related death worldwide, with 2.2 million new cases and 1.8 million deaths estimated in 2020.[1] Non-small cell lung cancer (NSCLC) is a common subtype (85%), and surgery has been well established as cornerstone for the treatment of early-stage disease. However, most patients are diagnosed at an advanced stage and 5-year survival is scarce (6–32%).[2,3] Immunotherapy has revolutionized the landscape of clinical cancer treatment. Immune checkpoint inhibitors (ICIs) targeting the programmed death 1 (PD-1) axis have shown better patient survival in advanced NSCLC patients treated alone or in combination with chemotherapy in first or second-line settings, when compared with chemotherapy alone.[4]
Camrelizumab, also known as SHR-1210, is a humanized monoclonal antibody against PD-1. It was first approved by the National Medical Products Administration (NMPA) for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma in May 2019 in China,[5] and has since been extensively investigated in various cancers.[6] Camrelizumab plus carboplatin and pemetrexed and plus carboplatin and paclitaxel have been successively approved as new standards for the treatment of advanced non-squamous NSCLC and squamous NSCLC in China, based on the encouraging efficacy and safety data from two pivotal phase III trials (CameL and CameL-sq).[7,8] Additionally, a phase Ib/II trial showed promising efficacy and acceptable toxicity of camrelizumab in combination with apatinib, a highly selective tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2, in patients with advanced non-squamous NSCLC previously treated with chemotherapy.[9]
However, despite the promising results observed, patients enrolled in clinical trials are generally strictly defined to generate robust evidence and translating this evidence into clinical practice can be challenging, especially given a diverse population we deal with in daily life. Clinical trial results may not be representative of the general population, as clinical trials often have specific inclusion and exclusion criteria. This means that the results may not be generalizable to people who do not meet these criteria. Clinical trials are often conducted over a relatively short period of time, which may not be long enough to fully assess the long-term safety and efficacy of a treatment. Clinical trial results may not fully reflect the real-world context in which a treatment is used, as the controlled environment of a clinical trial may not be representative of everyday practice. To better understand the effectiveness and safety profiles of camrelizumab in real-life NSCLC patients, we conducted this retrospective observational study using data collected from 22 tertiary hospitals in China. We present the following article in accordance with the STROBE reporting checklist (available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-22-852/rc).[10]
Transl Lung Cancer Res. 2023;12(1):127-140. © 2023 AME Publishing Company
