ABSTRACT
The Annual Congress of the European Society of Medical Oncology (ESMO) is one of the world's most influential oncology forums for clinicians, researchers, patient advocates, journalists and healthcare industry representatives. The 2022 edition returned to the in-person format, as well as virtually, after 2 years of the COVID-19 pandemic and was held in Paris, France, from September 9 to 13. Under the topic "Understanding the disease to provide better care for cancer patients”, 1,913 s and 76 late-breaking s on the latest cancer research were presented. Copyright © 2022 Clarivate.
ABSTRACT
Background: To investigate the efficacy and safety of anti-PD-1 antibody plus regorafenib in refractory microsatellite stable (MSS) metastatic colorectal cancer (mCRC). Methods: We retrospectively analyzed the efficacy and safety of 103 MSS mCRC patients treated with anti -PD-1 antibodies(including nivolumab, pembrolizumab, camrelizumab, sintilimab, and toripalimab) combined with regorafenib(80 mg once daily for 21 days on/7 days off)between July 2019 and June 2021 in Hunan Cancer Hospital. Results: 103 patients had received at least one dose of regorafenib plus anti -PD-1 antibody. Due to COVID-19 pandemics, economic or other reasons, 48 patients (46.6%) did not return to hospital for second cycle of combination treatment .With a median follow-up of 5.30 months (range 0.50-22.50), the median overall survival (mOS) and progression-free survival (mPFS) were 8.40 months (95%CI:6.40-12.70) and 2.50 months (95%CI:2.27-3.47) in the entire cohort, respectively. The mOS and mPFS were significantly longer in patients who received more than 1 cycle (n = 55, 53.4%) compared to those who received just 1 cycle(n = 48, 46.6%). (16.07 vs. 4.37 months, HR 0.21;95%CI:[0.12-0.38];P<0.001;3.10 vs. 1.11 months, HR 0.12;95%CI: [0.05-0.31];P<0.001). Further analyses revealed that sintilimab (n = 66, 64.1%) significantly improved mPFS from 1.61 months to 3.30 months, compared to other anti-PD-1 antibodies (n = 37, 35.9%) (HR 0.55;95%CI:[0.31-0.99];P = 0.044). Cox multivariate regression analysis demonstrated that cycles of regorafenib plus PD-1 was a significant independent risk factor for the OS and PFS(P0.001).Patients who had previously undergone surgery were better than those who had not (P= 0.029).Sintilimab plus regorafenib had a better PFS benefit(P= 0.044.)Seven patients were diagnosed as partial response and another 16 cases were diagnosed as stable disease in the 55 patients who were evaluated, but no complete response. Thus the objective response rate was 12.7% and the disease control rate was 41.8%.Treatment-related adverse events of grade 3 or higher occurred in 13 (12.6%) patients. Conclusions: The combination of regorafenib plus anti-PD-1 antibody had a manageable safety profile and promising efficacy in MSS mCRC patients, especially in patients who received more than one cycle. Compared with the other anti-PD-1 antibodies, sintilimab may have more encouraging efficacy, which needs further prospective studies.
ABSTRACT
Background: As the first domestic PD-1 antibody approved for lung cancer in China, camrelizumab has exhibited proven effectiveness for non-small-cell lung cancer (NSCLC) patients. However, the cost-effectiveness of this new regimen remains to be investigated. Objective: To evaluate the cost-effectiveness of camrelizumab combination therapy vs. chemotherapy for previously untreated patients with advanced, non-squamous NSCLC without Alk or Egfr genomic aberrations from the perspective of China's healthcare system. Methods: Based on the CameL trial, the study developed a three-health state Markov model to evaluate the cost-effectiveness of adding camrelizumab to chemotherapy compared to chemotherapy alone in NSCLC patients. The analysis models were conducted for patients unselected by PD-L1 tumor expression (the base case) and the patient subgroup with PD-L1-expressing tumors (≥1%). Primary model outcomes included the costs in US dollars and health outcomes in quality-adjusted life-years (QALYs) as well as the incremental cost-effectiveness ratio (ICER) under a willingness-to-pay threshold of $31,500 per QALY. Additionally, a scenario analysis that adjusted within-trial crossover was employed to evaluate camrelizumab combination therapy compared to chemotherapy without subsequent use of PD1/PD-L1 antibodies. Results: Camrelizumab combination therapy was more costly and provided additional 0.11 QALYs over chemotherapy in the base case analysis (0.86 vs. 0.75 QALYs), 0.12 QALYs over chemotherapy in the subgroup analysis (0.99 vs. 0.88 QALYs), and 0.34 QALYs over chemotherapy in the scenario analysis (0.86 vs. 0.52 QALYs). Correspondingly, the ICER was $63,080 per QALY, $46,311 per QALY, and $30,591 per QALY, in the base case, the subgroup, and the scenario analysis, respectively. One-way sensitivity analyses revealed that ICERs of the base case and the subgroup analysis were most sensitive to the cost of camrelizumab, the cost of pemetrexed. Besides, the base case and subgroup analysis were more sensitive to the risk of neutrophil count decreased in the camrelizumab and the utility of stable disease, respectively. Conclusion: Although camrelizumab combination therapy is not cost-effective as first-line therapy for NSCLC patients in China in the base case, adjusting within-trial crossover would move the treatment regimen toward cost-effectiveness in the scenario analysis.