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・Integration of electronic medical record data and receipt data from eight medical institutions centered on the Kobe Minimally Invasive Cancer Center.
・Data on treatment outcomes, including Overall Survival(OS) and other efficacy and safety data from electronic medical record data and medical cost data during the treatment period from receipt data, were obtained to build a dataset that is uniquely linked on a patient basis.
Comparison of the clinical benefit of regimens containing the immune checkpoint inhibitors atezolizumab and durvalumab in terms of efficacy and safety in patients with advanced small-cell lung cancer
・Showed that CBDCA+ETP+ATZ and CDDP+ETP+DUR have similar benefits in patients with good general condition and renal function (PS≤1 and CCr≥60 mL/min) who are considered eligible for CDDP (CDDP-compliant patients).
・Poster presentation of the study results at ESMO-Asia 2024 in December 2024
Healthcare Consulting Inc. (HCC; Head office: Tokyo; President: Kinya Kokubo), which is a group company of CareNet Inc., and a research team of eight medical institutions led by the Kobe Minimally Invasive Cancer Center Clinical Trials and Clinical Research Support Center (KMCC; Kobe, Hyogo; Director: Akito Hata) have established a dataset that uniquely links electronic medical record data and receipt data of small-cell lung cancer patients electronic medical record data and receipt data of patients with small-cell lung cancer on a patient-by-patient basis. The Research Support Center is promoting cost-effectiveness analysis and clinical utility analysis in various subpopulations.
The results of the study, which compared the clinical benefit of regimens including the immune checkpoint inhibitors atezolizumab or durvalumab in patients with good general health and renal function (PS ≤ 1 and CCr ≥ 60 mL/min) who were considered CDDP-eligible (CDDP-compliant patients), in terms of both efficacies. The results of a study comparing both efficacy and safety aspects of regimens containing the immune checkpoint inhibitors atezolizumab or durvalumab in patients considered eligible for CDDP (CDDP-compliant patients) will be presented in a poster at ESMO-Asia 2024 from 6 to December 8, 2024.
■ Presentation
Cisplatin (CDDP)+Etoposide (ETP)+Durvalumab (DUR) vs. Carboplatin (CBDCA)+ ETP + Atezolizumab (ATZ): propensity score matching (PSM) real-world data (RWD) on CDDP-fit extensive disease (ED)-small cell lung cancer (SCLC)
Kosuke Hamai; Katsuya Hirano; Akito Hata; Yuta Yamanaka; Toshiyuki Sumi; Motohiro Tamiya; Yuki Sato; Yuko Oya; Nobuyuki Katakami; Katsuhiko Iwasaki; Tatsuhiro Uenishi; Kinya Kokubo
European Society for Medical Oncology Asia Congress 2024 (ESMO-Asia 2024)
6 – 8 December 2024 (Singapore)
■ Summary of the study
BACKGROUND/AIMS
Combination regimens of chemotherapy and immune checkpoint inhibitors (atezolizumab or durvalumab) are standard first-line treatments for advanced small-cell lung cancer. The efficacies of atezolizumab and durvalumab combination regimens are comparable; however, durvalumab can be combined with either CDDP or CBDCA, whereas atezolizumab can only be combined with CBDCA. Traditionally, CDDP has been considered more effective in CDDP-compliant patients; however, little is known about its use in combination with immune checkpoint inhibitors. This study aimed to compare the efficacy and safety of patients treated with CDDP+ETP+DUR with those treated with CBDCA+ETP+ATZ in patients considered eligible for CDDP.
Prior to this study, the results of analyses in the overall population (including non-elderly patients) and in a subpopulation of patients aged 71 years and older were published, which reported no difference in efficacy between the regimens in terms of OS, but that atezolizumab was more economical in terms of healthcare costs. The comparable efficacy of atezolizumab and durvalumab in patients with brain, bone, and liver metastases has also been reported. This study is a subpopulation analysis of the clinical benefit of both regimens, focusing on patients who received CDDP + ETP + DUR and those who received CBDCA + ETP + ATZ and were considered eligible for CDDP. This study provides insight into the implications of choosing CBDCA + ETP + ATZ for patients considered eligible for CDDP.
METHODS
This study analyzed real-world clinical data from a total of eight medical institutions: the Kobe Minimally Invasive CancerCenter and the participating institutions (Osaka International Cancer Institute, Hakodate Goryokaku Hospital, Takarazuka City Hospital, Kobe City Medical Center General Hospital, Kansai Medical University Hospital, JA Onomichi General Hospital and Fujita Health University Hospital). This is a retrospective study.
Patients diagnosed with small-cell lung cancer who started PD-L1 inhibitor combination chemotherapy (CDBCA+ETP+ATZ or CDDP/CBDCA+ETP+DUR) by the end of December 2022 were included in the analysis.
OS and PFS were evaluated as measures of efficacy. In addition, the incidence of immune-related adverse events (grade 2 or higher), interstitial lung disease, febrile neutropenia, serious adverse events, and number of hospital admissions were evaluated as safety measures.
Data on patient background and treatment outcomes, including efficacy and safety, were obtained from the electronic medical record data of each medical institution.
Patients were divided into two groups: atezolizumab combination therapy group (ATZ-G) and durvalumab combination therapy group (DUR-G), with CDDP-compliant patients (PS≤1 and CCr≥60 mL/min) selected from the ATZ-G and CDDP-using patients from the DUR-G, and propensity score matching was performed, and the population was redrawn with comparable backgrounds in both groups.
RESULTS
Between August 2018 and December 2022, 274 patients (ATZ-G/DUR-G = 176 / 98) were selected from eight medical centers; 98 were CDDP-compliant, and among DUR-G, 31 were on CDDP. Fifty patients (ATZ-G/DUR-G = 25 / 25) were then selected as a population of patients with comparable backgrounds by propensity score matching.
Response rates were 76.0% for ATZ-G and 88.0% for DUR-G (P=0.463); median OS for ATZ-G and DUR-G was 19.8 months (95% CI: 12.2- Not Reached [NR]) and 21.4 months (95% confidence interval [CI]: 14.0-NR) respectively (P=0.490) The median PFS for ATZ-G and DUR-G was 4.7 (95% CI: 4.3-6.5) and 5.6 (95% CI: 5.1-7.5) months respectively (P=0.500). There were no significant differences in safety, with ATZ-G and DUR-G respectively reporting 2% and 20% (P=0.702) of immune-related adverse events (AEs) grade 2 or above, 4% and 8% (P=1.000) of interstitial lung disease of any grade, 8% and 8% (P=1.000) of febrile neutropenia, 8% and 16% (P=0.667) of serious adverse events and median/mean hospital admissions were 1/1.7 and 2/2.3 (P=0.331).
CONCLUSIONS
These results suggest that CBDCA + ETP + ATZ and CDDP + ETP + DUR have similar benefits in patients with advanced small-cell lung cancer who are considered eligible for CDDP.
■ Future developments
HCC and KMCC plan to present the results of this study at the 2024 Asia Conference on Lung Cancer (ACLC 2024), which a publication will follow. Through these research activities, we will contribute to the selection of appropriate patient-specific treatment options for small-cell lung cancer.
This study utilized a dataset that uniquely linked electronic medical record and receipt data on a patient-by-patient basis to investigate the clinical utility of regimens that included immune checkpoint inhibitors in patients with advanced small-cell lung cancer who were considered eligible for CDDP. As a model case, HCC intends to use the methodology of this study in collaboration with various medical institutions with the aim of validating it in other types of cancer, including non-small-cell lung cancer, as well as non-cancer diseases. 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 ESMO-Asia 2024: European Society for Medical Oncology Asia Congress 2024
2 ICI: Immune checkpoint inhibitor
3 ATZ: Atesolizumab
4 DUR: durvalumab
5 CDDP: cisplatin
6 CBDCA: Carboplatin
7 ETP: Etoposide
8 OS: overall survival
9 PFS: Progression-free survival
10 PS: Performance status
11 CCr: Creatinine clearance
12 NR: Not Reached
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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