Skip to main content
Top
Gepubliceerd in:

06-09-2018

Quality-adjusted survival of nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone among treatment-naive patients with advanced melanoma: a quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis

Auteurs: David F. McDermott, Ruchit Shah, Komal Gupte-Singh, Javier Sabater, Linlin Luo, Marc Botteman, Sumati Rao, Meredith M. Regan, Michael Atkins

Gepubliceerd in: Quality of Life Research | Uitgave 1/2019

Log in om toegang te krijgen
share
DELEN

Deel dit onderdeel of sectie (kopieer de link)

  • Optie A:
    Klik op de rechtermuisknop op de link en selecteer de optie “linkadres kopiëren”
  • Optie B:
    Deel de link per e-mail

Abstract

Purpose

To compare the quality-adjusted survival of nivolumab plus ipilimumab combination and nivolumab alone versus ipilimumab alone among treatment-naive patients with advanced melanoma based on a minimum 36-month follow-up from the CheckMate 067 trial.

Methods

Overall survival was partitioned into time without symptoms of progression or toxicity (TWiST), time with treatment-related grade ≥ 3 adverse events after randomization but before progression (TOX), and time from progression until end of follow-up or death (REL). Mean quality-adjusted TWiST (Q-TWiST) was calculated by multiplying the mean time spent in each health state by a utility of 1.0 for TWiST and 0.5 for TOX and REL. Sensitivity analyses included varying utilities of TOX and REL; Q-TWiST gains at different follow-up times were calculated using EQ-5D-3L utilities from the trial. Relative Q-TWiST gain of ≥ 10% was considered clinically important.

Results

Compared with ipilimumab-treated patients, those who received nivolumab + ipilimumab combination had significantly longer TWiST and TOX but shorter REL; nivolumab-treated patients had significantly longer TWiST, shorter REL, and shorter but statistically nonsignificant TOX. Mean Q-TWiST was highest for nivolumab + ipilimumab (23.5 months; 95% CI 21.9–25.2), followed by nivolumab (21.8 months; 95% CI 20.2–23.4) and ipilimumab (15.3 months; 95% CI 13.9–16.6). Relative Q-TWiST gains were favorable and clinically important for nivolumab + ipilimumab combination (+ 36.81%) and nivolumab alone (+ 29.18%) versus ipilimumab alone. Relative gains increased with follow-up from 3 to 40 months for all comparisons. These gains remained consistent in magnitude and direction in the different sensitivity analyses.

Conclusions

Nivolumab + ipilimumab combination and nivolumab alone resulted in a statistically significant and clinically important improvement in quality-adjusted survival compared with ipilimumab alone.
Bijlagen
Alleen toegankelijk voor geautoriseerde gebruikers
Literatuur
1.
go back to reference Siegel, R. L., Miller, K. D., & Jemal, A. (2017). Cancer statistics. CA: A Cancer Journal for Clinicians, 67, 7–30. Siegel, R. L., Miller, K. D., & Jemal, A. (2017). Cancer statistics. CA: A Cancer Journal for Clinicians, 67, 7–30.
2.
go back to reference American Cancer Society. (2018). Cancer facts & figs. 2018. Atlanta: American Cancer Society. American Cancer Society. (2018). Cancer facts & figs. 2018. Atlanta: American Cancer Society.
13.
go back to reference Postmus, D., Mavris, M., Hillege, H. L., Salmonson, T., Ryll, B., Plate, A., et al. (2016). Incorporating patient preferences into drug development and regulatory decision making: Results from a quantitative pilot study with cancer patients, carers, and regulators. Clinical Pharmacology and Therapeutics, 99(5), 548–554. https://doi.org/10.1002/cpt.332.CrossRefPubMed Postmus, D., Mavris, M., Hillege, H. L., Salmonson, T., Ryll, B., Plate, A., et al. (2016). Incorporating patient preferences into drug development and regulatory decision making: Results from a quantitative pilot study with cancer patients, carers, and regulators. Clinical Pharmacology and Therapeutics, 99(5), 548–554. https://​doi.​org/​10.​1002/​cpt.​332.CrossRefPubMed
15.
go back to reference Cherny, N. I., Sullivan, R., Dafni, U., Kerst, J. M., Sobrero, A., Zielinski, C., de Vries, E. G., et al. (2015). A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Annals of Oncology, 26(8), 1547–1573.CrossRefPubMed Cherny, N. I., Sullivan, R., Dafni, U., Kerst, J. M., Sobrero, A., Zielinski, C., de Vries, E. G., et al. (2015). A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Annals of Oncology, 26(8), 1547–1573.CrossRefPubMed
20.
go back to reference Chung, H. C., Bang, Y., Van Cutsem, E., Kang, Y., Hamamoto, Y., Moiseyenko, V., et al. (2010). (Q)-TWiST analysis of trastuzumab plus fluoropyrimidine/cisplatin(T-XP/FP) versus XP/FP alone as first-line therapy for advanced HER2-positive gastric cancer. Journal of Clinical Oncology, 28, 4048.CrossRef Chung, H. C., Bang, Y., Van Cutsem, E., Kang, Y., Hamamoto, Y., Moiseyenko, V., et al. (2010). (Q)-TWiST analysis of trastuzumab plus fluoropyrimidine/cisplatin(T-XP/FP) versus XP/FP alone as first-line therapy for advanced HER2-positive gastric cancer. Journal of Clinical Oncology, 28, 4048.CrossRef
22.
25.
go back to reference Sloan, J. A., Sargent, D. J., Lindman, J., Allmer, C., Vargas-Chanes, D., Creagan, E. T., et al. (2002). A new graphic for quality adjusted life years (Q-TWiST) survival analysis: The Q-TWiST plot. Quality of Life Research, 11(1), 37–45.CrossRefPubMed Sloan, J. A., Sargent, D. J., Lindman, J., Allmer, C., Vargas-Chanes, D., Creagan, E. T., et al. (2002). A new graphic for quality adjusted life years (Q-TWiST) survival analysis: The Q-TWiST plot. Quality of Life Research, 11(1), 37–45.CrossRefPubMed
28.
go back to reference Lafuma, A., Dreno, B., Delaunay, M., Emery, C., Fagnani, F., Hieke, K., et al. (2001). Economic analysis of adjuvant therapy with interferon alpha-2a in stage II malignant melanoma. European Journal of Cancer, 37(3), 369–375.CrossRefPubMed Lafuma, A., Dreno, B., Delaunay, M., Emery, C., Fagnani, F., Hieke, K., et al. (2001). Economic analysis of adjuvant therapy with interferon alpha-2a in stage II malignant melanoma. European Journal of Cancer, 37(3), 369–375.CrossRefPubMed
29.
31.
go back to reference Gelber, R. D., Cole, B., Gelber, S., & Goldhirsch, A. (1995). Comparing treatments using quality-adjusted survival: The Q-TWiST method. The American Statistician, 49, 161–169. Gelber, R. D., Cole, B., Gelber, S., & Goldhirsch, A. (1995). Comparing treatments using quality-adjusted survival: The Q-TWiST method. The American Statistician, 49, 161–169.
32.
go back to reference Shaw, J. W., Johnson, J. A., & Coons, S. J. (2005). US valuation of the EQ-5D health states: Development and testing of the D1 valuation model. Medical Care, 43(3), 203–220.CrossRefPubMed Shaw, J. W., Johnson, J. A., & Coons, S. J. (2005). US valuation of the EQ-5D health states: Development and testing of the D1 valuation model. Medical Care, 43(3), 203–220.CrossRefPubMed
36.
go back to reference Wolchok, J. D., Hoos, A., O’Day, S., Weber, J. S., Hamid, O., Lebbé, C., et al. (2009). Guidelines for the evaluation of immune therapy activity in solid tumors: Immune-related response criteria. Clinical Cancer Research, 15, 7412–7420.CrossRefPubMed Wolchok, J. D., Hoos, A., O’Day, S., Weber, J. S., Hamid, O., Lebbé, C., et al. (2009). Guidelines for the evaluation of immune therapy activity in solid tumors: Immune-related response criteria. Clinical Cancer Research, 15, 7412–7420.CrossRefPubMed
Metagegevens
Titel
Quality-adjusted survival of nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone among treatment-naive patients with advanced melanoma: a quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis
Auteurs
David F. McDermott
Ruchit Shah
Komal Gupte-Singh
Javier Sabater
Linlin Luo
Marc Botteman
Sumati Rao
Meredith M. Regan
Michael Atkins
Publicatiedatum
06-09-2018
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 1/2019
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-018-1984-3