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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

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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.

References

  1. Sung, H., Ferlay, J., Siegel, R. L., Laversanne, M., Soerjomataram, I., Jemal, A., & Bray, F. (2021). Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 71(3), 209–249. https://doi.org/10.3322/caac.21660

    Article  PubMed  Google Scholar 

  2. Siegel, R. L., Miller, K. D., Fuchs, H. E., & Jemal, A. (2022). Cancer statistics, 2022. CA: A Cancer Journal for Clinicians, 72(1), 7–33. https://doi.org/10.3322/caac.21708

    Article  PubMed  Google Scholar 

  3. Testa, U., Castelli, G., & Pelosi, E. (2018). Lung cancers: Molecular characterisation, clonal heterogeneity and evolution, and cancer stem cells. Cancers, 10(8), 248. https://doi.org/10.3390/cancers10080248

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  4. Jones, G. S., & Baldwin, D. R. (2018). Recent advances in the management of lung cancer. Clinical Medicine, 18(Suppl 2), s41–s46. https://doi.org/10.7861/clinmedicine.18-2-s41

    Article  PubMed  PubMed Central  Google Scholar 

  5. Fossella, F., Pereira, J. R., von Pawel, J., Pluzanska, A., Gorbounova, V., Kaukel, E., Mattson, K. V., Ramlau, R., Szczesna, A., Fidias, P., Millward, M., & Belani, C. P. (2003). Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: The TAX 326 Study Group. Journal of Clinical Oncology, 21(16), 3016–3024. https://doi.org/10.1200/JCO.2003.12.046

    Article  CAS  PubMed  Google Scholar 

  6. Kubota, K., Watanabe, K., Kunitoh, H., Noda, K., Ichinose, Y., Katakami, N., Sugiura, T., Kawahara, M., Yokoyama, A., Yokota, S., Yoneda, S., Matsui, K., Kudo, S., Shibuya, M., Isobe, T., Segawa, Y., Nishiwaki, Y., Ohashi, Y., Niitani, H., et al. (2004). Phase III randomised trial of docetaxel Plus cisplatin versus vindesine plus cisplatin in patients with stage IV non-small-cell lung cancer: The Japanese Taxotere Lung Cancer study Group. Journal of Clinical Oncology, 22(2), 254–261. https://doi.org/10.1200/JCO.2004.06.114

    Article  CAS  PubMed  Google Scholar 

  7. Lim, J. U., & Yeo, C. D. (2022). Update on adjuvant therapy in completely resected NSCLC patients. Thoracic Cancer, 13(3), 277–283. https://doi.org/10.1111/1759-7714.14277

    Article  PubMed  Google Scholar 

  8. Kubota, K., Kunitoh, H., Seto, T., Shimada, N., Tsuboi, M., Ohhira, T., Okamoto, H., Masuda, N., Maruyama, R., Shibuya, M., & Watanabe, K. (2020). Randomized phase II trial of adjuvant chemotherapy with docetaxel plus cisplatin versus paclitaxel plus carboplatin in patients with completely resected non-small cell lung cancer: TORG 0503. Lung Cancer, 141, 32–36. https://doi.org/10.1016/j.lungcan.2019.11.009

    Article  PubMed  Google Scholar 

  9. Sugitani, Y., Sugitani, N., & Ono, S. (2020). Quantitative preferences for lung cancer treatment from the patients’ perspective: A systematic review. Patient, 13(5), 521–536. https://doi.org/10.1007/s40271-020-00434-7

    Article  PubMed  Google Scholar 

  10. Liao, K., Wang, T., Coomber-Moore, J., Wong, D. C., Gomes, F., Faivre-Finn, C., Sperrin, M., Yorke, J., & van der Veer, S. N. (2022). Prognostic value of patient-reported outcome measures (PROMs) in adults with non-small cell lung cancer: A scoping review. BMC Cancer, 22(1), 1076.

    Article  PubMed  PubMed Central  Google Scholar 

  11. FACIT. org. Retrived February 18, 2022, from https://www.facit.org/measures/FACT-Taxane

  12. Cella, D., Peterman, A., Hudgens, S., Webster, K., & Socinski, M. A. (2003). Measuring the side effects of taxane therapy in oncology: The functional assesment of cancer therapy-taxane (FACT-taxane). Cancer, 98(4), 822–831. https://doi.org/10.1002/cncr.11578

    Article  CAS  PubMed  Google Scholar 

  13. FACIT. org. Retrived March 1, 2022, from https://www.facit.org/measures-scoring-downloads/fact-taxane-scoring-downloads

  14. Dossing, A., Tarp, S., Furst, D. E., Gluud, C., Wells, G. A., Beyene, J., Hansen, B. B., Bliddal, H., & Christensen, R. (2016). Modified intention-to-treat analysis did not bias trial results. Journal of Clinical Epidemiology, 72, 66–74. https://doi.org/10.1016/j.jclinepi.2015.11.003

    Article  PubMed  Google Scholar 

  15. Lydersen, S. (2019). Last observation carried forward. Tidsskrift for den Norske Laegeforening: Tidsskrift for Praktisk Medicin, Ny Raekke. https://doi.org/10.4045/tidsskr.19.0061

    Article  PubMed  Google Scholar 

  16. Osoba, D., Bezjak, A., Brundage, M., Zee, B., Tu, D., Pater, J., Quality of Life Committee of the NCIC CTG. (2005). Analysis and interpretation of health-related quality-of-life data from clinical trials: Basic approach of the National Cancer Institute of Canada Clinical Trials Group. European Journal of Cancer, 41(2), 280–287. https://doi.org/10.1016/j.ejca.2004.10.017

    Article  PubMed  Google Scholar 

  17. Carpenter, J., & Kenward, M. (2013). Multiple imputation and its application. John Wiley & Sons.

    Book  Google Scholar 

  18. Barnes, S. A., Lindborg, S. R., & Seaman, J. W. (2006). Multiple imputation techniques in small sample clinical trials. Statistics in Medicine, 25(2), 233–245.

    Article  PubMed  Google Scholar 

  19. Kris, M. G., Gaspar, L. E., Chaft, J. E., Kennedy, E. B., Azzoli, C. G., Ellis, P. M., Lin, S. H., Pass, H. I., Seth, R., Shepherd, F. A., Spigel, D. R., Strawn, J. R., Ung, Y. C., & Weyant, M. (2017). Adjuvant systemic therapy and adjuvant radiation therapy for stage I to IIIA completely resected non-small-Cell lung cancers. Journal of Clinical Oncology, 35, 2960–2974. https://doi.org/10.1200/JCO.2017.72

    Article  PubMed  Google Scholar 

  20. Oizumi, S., Kobayashi, K., Inoue, A., Maemondo, M., Sugawara, S., Yoshizawa, H., Isobe, H., Harada, M., Kinoshita, I., Okinaga, S., Kato, T., Harada, T., Gemma, A., Saijo, Y., Yokomizo, Y., Morita, S., Hagiwara, K., & Nukiwa, T. (2012). Quality of life with gefitinib in patients with EGFR-mutated non-small cell lung cancer: Quality of life analysis of northeast Japan Study Group 002 trial. The Oncologist, 17(6), 863–870. https://doi.org/10.1634/theoncologist.2011-0426

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  21. Basch, E., Jia, X., Heller, G., Barz, A., Sit, L., Fruscione, M., Appawu, M., Iasonos, A., Atkinson, T., Goldfarb, S., Culkin, A., Kris, M. G., & Schrag, D. (2009). Adverse symptom reporting by patients versus clinicians: Relationships with clinical outcomes. Journal of the National Cancer Institute, 101(23), 1624–1632. https://doi.org/10.1093/jnci/djp386

    Article  PubMed  PubMed Central  Google Scholar 

  22. Basch, E. (2010). The missing voice of patients in drug-safety reporting. New England Journal of Medicine, 362(10), 865–869. https://doi.org/10.1056/NEJMp0911494

    Article  CAS  PubMed  Google Scholar 

  23. United States Food and Drug Administration (FDA). (2009). Guidance for industry. U.S. Department of Health and Human Services. Patient-reported outcome measures: Use in medical product development to support labeling claims. Retrived March 1, 2020, from https://www.fda.gov/downloads/drugs/guidances/ucm193282.pdf.

  24. Brundage, M., Bass, B., Davidson, J., Queenan, J., Bezjak, A., Ringash, J., Wilkinson, A., & Feldman-Stewart, D. (2011). Patterns of reporting health-related quality of life outcomes in randomized clinical trials: Implications for clinicians and quality of life researchers. Quality of Life Research, 20, 653–664.

    Article  PubMed  Google Scholar 

  25. Currow, D. C., Plummer, J. L., Kutner, J. S., Samsa, G. P., & Abernethy, A. P. (2012). Analyzing PHASE III studies in hospice/palliative care: A solution that sits between intention-to-treat and per protocol analyses: The palliative-modified ITT analysis. Journal of Pain and Symptom Management, 44(4), 595–603. https://doi.org/10.1016/j.jpainsymman.2011.10.028

    Article  PubMed  Google Scholar 

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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).

Author information

Authors and Affiliations

  1. Center for Health Informatics policy, National Institute of Public Health, 2-3-6 Minami, Wako-Shi, Saitama, 351-0197, Japan

    Ayako Matsuda

  2. Teikyo University Graduate School of Public Health, Tokyo, Japan

    Kazue Yamaoka

  3. Department of Internal Medicine, Japanese Red Cross Medical Center, Tokyo, Japan

    Hideo Kunitoh

  4. Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan

    Takashi Seto

  5. Department of Thoracic Surgery, National Cancer Center Hospital East, Kashiwa, Japan

    Masahiro Tsuboi

  6. Department of Surgery, Tokyo Medical University, Tokyo, Japan

    Tatsuo Ohira

  7. Nippon Steel Yawata Memorial Hospital, Kitakyushu, Japan

    Riichiroh Maruyama

  8. Yokohama Municipal Citizen’s Hospital, Yokohama, Japan

    Hiroaki Okamoto

  9. Nippon Medical School Hospital, Tokyo, Japan

    Kaoru Kubota

Authors
  1. Ayako Matsuda
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Contributions

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.

Corresponding author

Correspondence to Ayako Matsuda.

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Conflict of interest

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.

Ethical approval

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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All patients signed informed consent before any study-related procedures.

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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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