Abstract
Purpose
The TORG0503 study was undertaken to select a preferred platinum-based third-generation regimen for patients with completely resected non-small cell lung cancer (NSCLC). This study aimed to describe the quality of life (QOL) analysis of that study.
Methods
Patients with completely resected NSCLC were randomized to receive three cycles of docetaxel plus cisplatin (DC) or paclitaxel plus carboplatin (PC) on day 1 every 3 weeks. QOL was assessed at three time points (baseline, after two cycles, and after three cycles) using the Functional Assessment of Cancer Therapy–taxane (FACT-Taxane). The adjusted odds ratio (OR) and 95% confidence interval (CI) were calculated by logistic regression analysis that was adjusted for the baseline score in the FACT-Taxane total score and each subscale to evaluate treatment (PC vs. DC) effectiveness.
Results
QOL data from 104 patients (DC, n = 56 patients; PC, n = 48) were analyzed. In the FACT-Taxane total score, the baseline-adjusted OR (95% CI) of not worse QOL for the DC group was 3.3 (1.4–8.3) compared with the PC group. In the taxane subscale, the baseline-adjusted OR (95% CI) was 6.2 (2.6–16.0).
Conclusion
Total QOL was maintained better in the DC group than in the PC group, especially the taxane subscale that consists of neurotoxicity and taxane components in spite of no treatment-related death in both arms between DC and PC. We might recommend DC as the control regimen for the next clinical trial from the viewpoint of QOL, similar to the primary outcomes in TORG0503.
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Data availability
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Acknowledgements
We thank the participants in this trial and Hiroyuki Kashiro for the administrative support.
Funding
This work was supported by TORG. The research fund was provided to TORG by Sanofi Pharmaceutical Co. Ltd under the research contract. The funders did not have any involvement in the design of the study; collection, analysis, and interpretation of the data; writing of the article; or decision to submit the article for publication. Additionally, this study was supported by the Ministry of Education, Culture, Sports, Science and Technology in Japan Grant-in-Aid for Scientific Research Grant C in 2020 (Grant No. 20K07835).
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Conceptualization: KK, HK, HO, and AM. Data curation: HK, TS, MT, TO, RM, HO, and KK. Formal analysis: AM. Funding acquisition: AM and KK. Methodology: AM, KK, HK, and KY. Project administration: KK. Software and Validation: AM. Supervision: KK. Visualization: KK, KY. Roles/Writing—original draft: AM. Writing—review & editing: KK, KY, HK, TS, MT, TO, RM, HO, and KK.
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Professor Kaoru Kubota reports grants and personal fees from Boehringer Ingelheim and Ono and personal fees from Chugai MSD, AstraZeneca, Eli Lilly, Daiichi Sankyo, and Bristol Myers Squibb, outside the submitted work. The authors report no other conflicts of interest in this work.
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This study was conducted in accordance with the declaration of Helsinki and was approved by the Ethics Committee of all participating institutes in agreement for medical research involving human subjects.
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Matsuda, A., Yamaoka, K., Kunitoh, H. et al. Quality of life with docetaxel plus cisplatin versus paclitaxel plus carboplatin in patients with completely resected non-small cell lung cancer: quality of life analysis of TORG 0503. Qual Life Res 32, 2629–2637 (2023). https://doi.org/10.1007/s11136-023-03424-y
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DOI: https://doi.org/10.1007/s11136-023-03424-y