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・Integration of data form electronic medical record data and receipts data from eight medical institutions, led by the Kobe Minimally Invasive Cancer Center
・Data on treatment outcomes, such as efficacy and safety, including overall survival (OS), were obtained from electronic medical records, and data on medical costs during the treatment period were obtained from medical receipt data to create a dataset that is uniquely linked on a patient basis.
・Clinical efficacy of the immune checkpoint inhibitors atezolizumab and durvalumab in subpopulations with and without brain, bone, and liver metastases
・Atezolizumab and durvalumab have comparable efficacy against brain, bone, and liver metastases; bone metastases may be an important prognostic factor for poor overall survival (OS).
・The results of this study were presented as a poster at the 2024 Asia Conference on Lung Cancer (ACLC 2024) in October 2024.
HCC, a group company of CareNet, Inc., is engaged in solving issues related to health and medical care by analyzing medical big data and the Kobe Minimally Invasive Cancer Center Clinical Trials and Clinical Research Support Center (Location: Kobe, Hyogo; Director-General: Dr. Masahiro Nakamura), a joint venture between HCC and the Kobe Center for Minimally Invasive Cancer Treatment (Location: Kobe, Hyogo). A research team from eight medical institutions, led by the Kobe Minimally Invasive Cancer Center, Clinical Research Support Center (Location: Kobe, Hyogo; Director: Akito Hata; hereafter, KMCC), constructed a dataset that uniquely links electronic medical record data and receipts data of patients with small cell lung cancer on a patient basis and promotes cost-effectiveness and clinical efficacy analyses in various subpopulations. This project is currently underway.
The results of this study, which analyzed the clinical efficacy of immune checkpoint inhibitors (ICIs) in subpopulations focusing on the presence of brain, bone, and liver metastases, were presented in a poster at the 2024 Asia Conference on Lung Cancer (ACLC, 2024) held from October 17 to 19, 2024.
Duration (place): 17–19 Oct 2024 (Hong Kong, China and online)
Summary of research
Background/aim:
Combination regimens of chemotherapy and ICIs (atezolizumab and durvalumab) are the standard of care for the first-line treatment of advanced small cell lung cancer (ED-SCLC). Although the efficacy of atezolizumab and durvalumab combination regimens appears to be comparable, the clinical efficacy in patients with brain, bone, or liver metastases remains unclear. This study examined the clinical efficacy in patients with brain, bone, and liver metastases. Prior to this study, analyses in the overall population (including non-elderly patients) and in a subpopulation of elderly patients aged 71 years and above were published, which reported no difference in efficacy between the regimens in terms of OS, but atezolizumab was more economical in terms of healthcare costs. The study was conducted in the United States. This was a subpopulation analysis of the clinical efficacy of both regimens, focusing on the presence or absence of brain, bone, or liver metastases.
Methods:
This study was a retrospective analysis of real-world clinical data from a total of eight medical institutions: the Kobe Minimally Invasive Cancer Medical Center and the participating institutions in the study (Osaka International Cancer Center, Hakodate Goryokaku Hospital, Takarazuka City Hospital, Kobe City Medical Center Central Municipal Hospital, Kansai Medical University Hospital, JA Onomichi Hospital, and Fujita Medical University Hospital). This was a retrospective study.
Patients diagnosed with small cell lung cancer who started PD-L1 inhibitor combination chemotherapy (CDBCA + ETP + atezolizumab or CDDP/CBDCA + ETP + durvalumab) by the end of December 2022 were included in the analysis.
OS was assessed as a measure of efficacy.
Data on patient background and treatment outcomes, including efficacy and safety, were obtained from the electronic medical records of each institution. Patients were divided into 2 groups: atezolizumab combined with durvalumab (ATZ-G) and durvalumab combined with atezolizumab (DUR-G). Propensity score matching was performed based on pre-treatment information. The population with comparable backgrounds in both groups was redrawn and compared according to the presence of brain, bone, and liver metastases in the respective subpopulations.
RESULTS:
From August 2018 to December 2022, 274 cases (ATZ-G/DUR-G = 176 / 98) were extracted from 8 medical centers. In total, 128 cases (ATZ-G/DUR-G = 64 / 64) were selected as a patient population with comparable backgrounds in terms of propensity score matching. The median OS of ATZ-G (n = 22) versus DUR-G (n = 20) in patients with brain metastases was 13.9 months (95% confidence interval [CI]: 8.3-18.5) versus 12.3 months (95% CI: 8.9- not reached [NR]) respectively, with no significant difference (P = 0. 930). Median OS for ATZ-G (n = 21) versus DUR-G (n = 20) in patients with bone metastases was 11.7 months (95% confidence interval [CI]: 10.6-NR) versus 7.7 months (95% CI: 6.0-15.2), respectively, with no significant difference (P = 0.117). The median OS of ATZ-G (n = 19) versus DUR-G (n = 21) in patients with liver metastases was 12.0 months (95% confidence interval [CI]: 8.3-18.5) versus 15.2 months (95% CI: 7.8-NR), respectively, with no significant difference (P = 0.521).
Analysis using the Cox proportional hazards model showed no significant difference between ATZ and DUR in terms of OS (hazard ratio, 1.05; p=0.852); however, bone metastases were identified as a significant factor for shorter OS (hazard ratio, 1.84; p=0.029).
CONCLUSIONS:
These results suggested that ATZ and DUR are equally effective in treating patients with brain, bone, and liver metastases. Bone metastasis is also an important prognostic factor for poor OS, and this trend may be more pronounced in patients with DUR.
■ Future developments
The HCC and KMCC plan to present the results of this study at the 2024 Asia Conference on Lung Cancer (ACLC, 2024), followed by a publication. Through these studies, the HCC and KMCC can contribute to the selection of appropriate patient-specific treatments for small cell lung cancer.
The study used a dataset that uniquely linked electronic medical record data and receipt data on a patient-by-patient basis to test the clinical efficacy of combination chemotherapy and ICIs for patients with brain, bone and liver metastases from small cell lung cancer. The HCC will use the methodology of this study as a model case. It intends to use the methodology of this study as a model case for other types of cancer, including non-small cell lung cancer, and for further validation in non-cancer diseases, and to collaborate with various medical institutions. We will make use of our experience in analyzing a wide variety of data and generating evidence to contribute to the extension of healthy life expectancy and the realization of a sustainable society.
1 PS: Performance status
2 CDDP: Cisplatin
3 ETP: Etoposide
4 CBDCA: Carboplatin
About Healthcare Consulting Inc.
Head office: Sumitomo Fudosan Chiyoda Fujimi Building, 8–19, Fujimi 1-chome, Chiyoda-ku, Tokyo
Start of business: November 2021
Representative director: Kinya Kokubo
Business description: Healthcare consulting, data science for healthcare-related information, evidence-based marketing, ROI verification, and so on.
Official website: https://www.hc-c.co.jp/
Enquiries from the press regarding this matter
Healthcare Consulting Inc. Public Relations: Katsuhiko Iwasaki
Email address: k-iwasaki@hc-c.co.jp
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