Skip to main content
Top
Published in: Quality of Life Research 10/2020

Open Access 01-10-2020 | Melanoma

Health-related quality of life (QoL) in patients with advanced melanoma receiving immunotherapies in real-world clinical practice settings

Authors: Richard W. Joseph, Frank Xiaoqing Liu, Alicia C. Shillington, Cynthia P. Macahilig, Scott J. Diede, Vaidehi Dave, Qing Harshaw, Todd L. Saretsky, Alan Simon Pickard

Published in: Quality of Life Research | Issue 10/2020

Login to get access

Abstract

Background

Pembrolizumab (PEMBRO) and ipilimumab + nivolumab (IPI + NIVO) are approved advanced melanoma (AM) immunotherapies. To address limited health-related quality of life (QoL) real-world evidence with immunotherapies in AM, we compared QoL in AM patients receiving either treatment in clinical practice.

Methods

A prospective US observational study enrolled adult AM patients initiating first-line PEMBRO or IPI + NIVO between June 2017 and March 2018. Endpoints included the QLQ-C30 global health score (GHS) and EuroQol visual analog scale (EQ-VAS) scores. Mean changes were compared using repeated measures mixed-effects models and are presented covariate adjusted.

Results

225 PEMBRO and 187 IPI + NIVO patients were enrolled. From baseline through week 24, PEMBRO was associated with 3.2 mean GHS score increase (95% CI 0.5, 5.9; p = .02), while no change was observed with IPI + NIVO; 0.2 (95% CI − 2.6, 3.0; p = 0.87). Among objective treatment-responders, GHS scores associated with PEMBRO increased 6.0 (95% CI 3.1, 8.8; p < .0001); IPI + NIVO patients increased 3.8 (95% CI 0.8, 6.9; p = .01). In treatment non-responders, IPI + NIVO was associated with GHS/QoL deterioration of − 3.7 (95% CI − 6.8, − 0.6; p = .02), PEMBRO non-responders demonstrated no change; 0.7 (95% CI − 2.3, 3.7; p = 0.6). Between treatments, PEMBRO patients increased 2.6 greater in EQ-VAS (95% CI 0.6, 4.5; p = .01) vs IPI + NIVO at 24 weeks.

Conclusions

PEMBRO was associated with better 24-week QoL compared to IPI + NIVO in actual clinical practice settings. Real-world data has known limitations, but with further confirmation these results may have implications for treatment selection.
Appendix
Available only for authorised users
Footnotes
1
Alopecia areata, Autoimmune hemolytic anemia, Autoimmune hepatitis, Dermatomyositis, Diabetes (type 1), Autoimmune juvenile idiopathic arthritis, Glomerulonephritis, Graves’ disease, Guillain-Barré syndrome, Idiopathic thrombocytopenic purpura, Myasthenia gravis, Autoimmune myocarditis, Multiple sclerosis, Pemphigus/pemphigoid, Pernicious anemia, Polyarteritis nodosa, Polymyositis, Primary biliary cirrhosis, Psoriasis, Rheumatoid arthritis, Scleroderma/systemic sclerosis, Sjögren’s syndrome, Systemic lupus erythematosus, Hashimoto’s thyroiditis, Autoimmune of uveitis, Vitiligo, Granulomatosis with polyangiitis (Wegener’s).
 
Literature
1.
go back to reference Cornish, D., Holterhues, C., van de Poll-Franse, L. V., et al. (2009). A systematic review of health-related quality of life in cutaneous melanoma. Annals of Oncology, 20(Suppl 6), 51–58.CrossRef Cornish, D., Holterhues, C., van de Poll-Franse, L. V., et al. (2009). A systematic review of health-related quality of life in cutaneous melanoma. Annals of Oncology, 20(Suppl 6), 51–58.CrossRef
2.
go back to reference Al-Shakhli, H., Harcourt, D., Kenealy, J., et al. (2006). Psychological distress surrounding diagnosis of malignant and nonmalignant skin lesions at a pigmented lesion clinic. Journal of Plastic, Reconstructive & Aesthetic Surgery, 28(2), 479–486.CrossRef Al-Shakhli, H., Harcourt, D., Kenealy, J., et al. (2006). Psychological distress surrounding diagnosis of malignant and nonmalignant skin lesions at a pigmented lesion clinic. Journal of Plastic, Reconstructive & Aesthetic Surgery, 28(2), 479–486.CrossRef
3.
go back to reference Weitman, E. S., Perez, M., Thompson, J. F., et al. (2018). Quality of life patient-reported outcomes for locally advanced cutaneous m, elanoma. Melanoma Research, 28(2), 134–142.CrossRef Weitman, E. S., Perez, M., Thompson, J. F., et al. (2018). Quality of life patient-reported outcomes for locally advanced cutaneous m, elanoma. Melanoma Research, 28(2), 134–142.CrossRef
4.
go back to reference Schadendorf, D., Larkin, J., Wolchok, J., et al. (2017). Health-related quality of life results from the phase III CheckMate 067 study. European Journal of Cancer, 82, 80–91.CrossRef Schadendorf, D., Larkin, J., Wolchok, J., et al. (2017). Health-related quality of life results from the phase III CheckMate 067 study. European Journal of Cancer, 82, 80–91.CrossRef
5.
go back to reference Petrella, T. M., Robert, C., Richtig, E., et al. (2017). Patient-reported outcomes in KEYNOTE-006, a randomised study of pembrolizumab versus ipilimumab in patients with advanced melanoma. European Journal of Cancer, 86, 115–124.CrossRef Petrella, T. M., Robert, C., Richtig, E., et al. (2017). Patient-reported outcomes in KEYNOTE-006, a randomised study of pembrolizumab versus ipilimumab in patients with advanced melanoma. European Journal of Cancer, 86, 115–124.CrossRef
6.
go back to reference Basch, E., Abernethy, A. P., Mullins, C. D., et al. (2012). Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology. Journal of Clinical Onocology, 20(34), 4249–4255.CrossRef Basch, E., Abernethy, A. P., Mullins, C. D., et al. (2012). Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology. Journal of Clinical Onocology, 20(34), 4249–4255.CrossRef
9.
go back to reference Schachter, J., Ribas, A., Long, G. V., et al. (2017). Pembrolizumab versus ipilimumab for advanced melanoma: final overall survival results of a multicentre, randomised, open-label phase 3 study (KEYNOTE-006). Lancet, 390, 1853–1862.CrossRef Schachter, J., Ribas, A., Long, G. V., et al. (2017). Pembrolizumab versus ipilimumab for advanced melanoma: final overall survival results of a multicentre, randomised, open-label phase 3 study (KEYNOTE-006). Lancet, 390, 1853–1862.CrossRef
10.
go back to reference Abernathy, A. P., Postow, M. A., Chesney, J. A., et al. (2015). Effect of nivolumab (NIVO) in combination with ipilimumab (IPI) versus IPI alone on quality of life (QoL) in patients (pts) with treatment-naïve advanced melanoma (MEL): Results of a phase II study (CheckMate 069). Journal of Clinical Oncology, 33, 9029–9029.CrossRef Abernathy, A. P., Postow, M. A., Chesney, J. A., et al. (2015). Effect of nivolumab (NIVO) in combination with ipilimumab (IPI) versus IPI alone on quality of life (QoL) in patients (pts) with treatment-naïve advanced melanoma (MEL): Results of a phase II study (CheckMate 069). Journal of Clinical Oncology, 33, 9029–9029.CrossRef
11.
go back to reference Aaronson, N. K., Ahmedzai, S., Bergman, B., et al. (1993). The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute, 85(5), 365–376.CrossRef Aaronson, N. K., Ahmedzai, S., Bergman, B., et al. (1993). The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute, 85(5), 365–376.CrossRef
12.
go back to reference The EuroQol Group. (1990). EuroQol a new facility for the measurement of health-related quality of life. Health Policy, 16(3), 199–208.CrossRef The EuroQol Group. (1990). EuroQol a new facility for the measurement of health-related quality of life. Health Policy, 16(3), 199–208.CrossRef
13.
go back to reference Cocks, K., King, M. T., Velikova, G., et al. (2012). Evidence-based guidelines for interpreting change scores for the European Organisation for the Researchand Treatment of Cancer Quality of Life Questionnaire Core 30. European Journal of Cancer., 48(11), 1713–1721.CrossRef Cocks, K., King, M. T., Velikova, G., et al. (2012). Evidence-based guidelines for interpreting change scores for the European Organisation for the Researchand Treatment of Cancer Quality of Life Questionnaire Core 30. European Journal of Cancer., 48(11), 1713–1721.CrossRef
14.
go back to reference Pickard, A. S., Neary, M. P., & Cella, D. (2010). Estimation of minimally important differences in EQ-5D utility and VAS scores in cancer. Health and Quality Life Outcomes. 2007 Dec 21;5:70. Erratum in: Health and Quality of Life Outcomes, 8(4). Pickard, A. S., Neary, M. P., & Cella, D. (2010). Estimation of minimally important differences in EQ-5D utility and VAS scores in cancer. Health and Quality Life Outcomes. 2007 Dec 21;5:70. Erratum in: Health and Quality of Life Outcomes, 8(4).
16.
go back to reference Gnanasakthy, A., Barrett, A., Evans, E., et al. (2019). A review of patient-reported outcomes labeling for oncology drugs approved by the FDA and the EMA (2012–2016). Value in Health, 22(2), 203–209.CrossRef Gnanasakthy, A., Barrett, A., Evans, E., et al. (2019). A review of patient-reported outcomes labeling for oncology drugs approved by the FDA and the EMA (2012–2016). Value in Health, 22(2), 203–209.CrossRef
17.
go back to reference Dreno, B., Ascierto, P. A., Atkinson, V., et al. (2018). Health-related quality of life impact of cobimetinib in combination with vemurafenib in patients with advanced or metastatic BRAFV600 mutation–positive melanoma. British Journal of Cancer, 118(6), 777–784.CrossRef Dreno, B., Ascierto, P. A., Atkinson, V., et al. (2018). Health-related quality of life impact of cobimetinib in combination with vemurafenib in patients with advanced or metastatic BRAFV600 mutation–positive melanoma. British Journal of Cancer, 118(6), 777–784.CrossRef
18.
go back to reference Dreno, B., Bartley, K., Ascierto, P. A., et al. (2015). Quality-of-life (QoL) assessment in patients (pts) with metastatic melanoma receiving vemurafenib (V) and cobimetinib (C). Journal of Clinical Oncology, 33(15 supplement), 9021–9021.CrossRef Dreno, B., Bartley, K., Ascierto, P. A., et al. (2015). Quality-of-life (QoL) assessment in patients (pts) with metastatic melanoma receiving vemurafenib (V) and cobimetinib (C). Journal of Clinical Oncology, 33(15 supplement), 9021–9021.CrossRef
19.
go back to reference Grob, J. J., Amonkar, M. M., Karaszewska, B., et al. (2015). Comparison of dabrafenib and trametinib combination therapy with vemurafenib monotherapy on health-related quality of life in patients with unresectable or metastatic cutaneous BRAF Val600-mutation-positive melanoma (COMBI-v): Results of a phase 3, open-label, randomised trial. Lancet Oncology, 6(13), 1389–1398.CrossRef Grob, J. J., Amonkar, M. M., Karaszewska, B., et al. (2015). Comparison of dabrafenib and trametinib combination therapy with vemurafenib monotherapy on health-related quality of life in patients with unresectable or metastatic cutaneous BRAF Val600-mutation-positive melanoma (COMBI-v): Results of a phase 3, open-label, randomised trial. Lancet Oncology, 6(13), 1389–1398.CrossRef
20.
go back to reference Long, G. V., Atkinson, V., Ascierto, P. A., et al. (2016). Effect of nivolumab on health-related quality of life in patients with treatment-naive advanced melanoma: Results from the Phase III CheckMate 066 study. Annals of Oncology, 27(10), 1940–1946.CrossRef Long, G. V., Atkinson, V., Ascierto, P. A., et al. (2016). Effect of nivolumab on health-related quality of life in patients with treatment-naive advanced melanoma: Results from the Phase III CheckMate 066 study. Annals of Oncology, 27(10), 1940–1946.CrossRef
22.
go back to reference Schadendorf, D., Amonkar, M. M., Stroyakovskiy, D., et al. (2015). Health-related quality of life impact in a randomised Phase III study of the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V600 metastatic melanoma. European Journal of Cancer, 51(7), 833–840.CrossRef Schadendorf, D., Amonkar, M. M., Stroyakovskiy, D., et al. (2015). Health-related quality of life impact in a randomised Phase III study of the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V600 metastatic melanoma. European Journal of Cancer, 51(7), 833–840.CrossRef
23.
go back to reference Schadendorf, D., Amonkar, M. M., Milhem, M., et al. (2014). Functional and symptom impact of trametinib versus chemotherapy in BRAF V600E advanced or metastatic melanoma: Quality-of-life analyses of the METRIC study. Annals of Oncology, 25(3), 700–706.CrossRef Schadendorf, D., Amonkar, M. M., Milhem, M., et al. (2014). Functional and symptom impact of trametinib versus chemotherapy in BRAF V600E advanced or metastatic melanoma: Quality-of-life analyses of the METRIC study. Annals of Oncology, 25(3), 700–706.CrossRef
24.
go back to reference Shuk, E., Shoushtari, A. N., Luke, J., et al. (2017). Patient perspectives on ipilimumab across the melanoma treatment trajectory. Supportive Care Cancer, 25(7), 2155–2167.CrossRef Shuk, E., Shoushtari, A. N., Luke, J., et al. (2017). Patient perspectives on ipilimumab across the melanoma treatment trajectory. Supportive Care Cancer, 25(7), 2155–2167.CrossRef
Metadata
Title
Health-related quality of life (QoL) in patients with advanced melanoma receiving immunotherapies in real-world clinical practice settings
Authors
Richard W. Joseph
Frank Xiaoqing Liu
Alicia C. Shillington
Cynthia P. Macahilig
Scott J. Diede
Vaidehi Dave
Qing Harshaw
Todd L. Saretsky
Alan Simon Pickard
Publication date
01-10-2020
Publisher
Springer International Publishing
Keywords
Melanoma
Melanoma
Published in
Quality of Life Research / Issue 10/2020
Print ISSN: 0962-9343
Electronic ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-020-02520-7

Other articles of this Issue 10/2020

Quality of Life Research 10/2020 Go to the issue