Skip to main content
Top
Gepubliceerd in: Quality of Life Research 4/2020

27-11-2019 | Review

Time to deterioration in cancer randomized clinical trials for patient-reported outcomes data: a systematic review

Auteurs: E. Charton, B. Cuer, F. Cottone, F. Efficace, C. Touraine, Z. Hamidou, F. Fiteni, F. Bonnetain, M.-C. Woronoff-Lemsi, C. Bascoul-Mollevi, A. Anota

Gepubliceerd in: Quality of Life Research | Uitgave 4/2020

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

The time to deterioration (TTD) approach has been proposed as a modality of longitudinal analysis of patient-reported outcomes (PROs) in cancer randomized clinical trials (RCTs). The objective of this study was to perform a systematic review of how the TTD approach has been used in phase III RCTs to analyze longitudinal PRO data.

Methods

A systematic literature search was conducted in PubMed/MEDLINE, the Cochrane Library and through manual search to identify studies published between January 2014 and June 2018. All phase III cancer RCTs including a PRO endpoint using the TTD approach were considered. We collected general information about the study, PRO assessment and the TTD approach, such as the event definition, the choice of reference score and whether the deterioration was definitive or not.

Results

A total of 1549 articles were screened, and 39 studies were finally identified as relevant according to predefined criteria. Among these 39 studies, 36 (92.3%) were in advanced and/or metastatic cancer. Several different deterioration definitions were used in RCTs, 10 studies (25.6%) defined the deterioration as “definitive”, corresponding to a deterioration maintained over time until the last PRO assessment available for each patient. The baseline score was explicitly stated as the reference score to qualify the deterioration for most studies (n = 31, 79.5%).

Conclusion

This review highlights the lack of standardization of the TTD approach for the analysis of PRO data in RCTs. Special attention should be paid to the definition of “deterioration”, and this should be based on the specific cancer setting.
Bijlagen
Alleen toegankelijk voor geautoriseerde gebruikers
Literatuur
4.
go back to reference Cnaan, A., Laird, N. M., & Slasor, P. (1997). Using the general linear mixed model to analyse unbalanced repeated measures and longitudinal data. Statistics in Medicine,16(20), 2349–2380.CrossRef Cnaan, A., Laird, N. M., & Slasor, P. (1997). Using the general linear mixed model to analyse unbalanced repeated measures and longitudinal data. Statistics in Medicine,16(20), 2349–2380.CrossRef
5.
go back to reference Fairclough, D. L. (2010). Design and analysis of quality of life studies in clinical trials. London: Chapman and Hall/CRC.CrossRef Fairclough, D. L. (2010). Design and analysis of quality of life studies in clinical trials. London: Chapman and Hall/CRC.CrossRef
6.
go back to reference Anota, A., Hamidou, Z., Paget-Bailly, S., Chibaudel, B., Bascoul-Mollevi, C., Auquier, P., et al. (2015). Time to health-related quality of life score deterioration as a modality of longitudinal analysis for health-related quality of life studies in oncology: Do we need RECIST for quality of life to achieve standardization? Quality of Life Research,24(1), 5–18. https://doi.org/10.1007/s11136-013-0583-6.CrossRefPubMed Anota, A., Hamidou, Z., Paget-Bailly, S., Chibaudel, B., Bascoul-Mollevi, C., Auquier, P., et al. (2015). Time to health-related quality of life score deterioration as a modality of longitudinal analysis for health-related quality of life studies in oncology: Do we need RECIST for quality of life to achieve standardization? Quality of Life Research,24(1), 5–18. https://​doi.​org/​10.​1007/​s11136-013-0583-6.CrossRefPubMed
10.
go back to reference Verma, S., O’Shaughnessy, J., Burris, H. A., Campone, M., Alba, E., Chandiwana, D., et al. (2018). Health-related quality of life of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer treated with ribociclib + letrozole: Results from MONALEESA-2. Breast Cancer Research and Treatment,170(3), 535–545. https://doi.org/10.1007/s10549-018-4769-z.CrossRefPubMedPubMedCentral Verma, S., O’Shaughnessy, J., Burris, H. A., Campone, M., Alba, E., Chandiwana, D., et al. (2018). Health-related quality of life of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer treated with ribociclib + letrozole: Results from MONALEESA-2. Breast Cancer Research and Treatment,170(3), 535–545. https://​doi.​org/​10.​1007/​s10549-018-4769-z.CrossRefPubMedPubMedCentral
12.
go back to reference Higgins, J., & Green, S. (2014). Cochrane handbook for systematic reviews of interventions Version 5.1. 0 [updated March 2011]. 2011. The Cochrane Collaboration. Higgins, J., & Green, S. (2014). Cochrane handbook for systematic reviews of interventions Version 5.1. 0 [updated March 2011]. 2011. The Cochrane Collaboration.
13.
go back to reference Al-Batran, S. E., Van Cutsem, E., Oh, S. C., Bodoky, G., Shimada, Y., Hironaka, S., et al. (2016). Quality-of-life and performance status results from the phase III RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma. Annals of Oncology,27(4), 673–679. https://doi.org/10.1093/annonc/mdv625.CrossRefPubMedPubMedCentral Al-Batran, S. E., Van Cutsem, E., Oh, S. C., Bodoky, G., Shimada, Y., Hironaka, S., et al. (2016). Quality-of-life and performance status results from the phase III RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma. Annals of Oncology,27(4), 673–679. https://​doi.​org/​10.​1093/​annonc/​mdv625.CrossRefPubMedPubMedCentral
14.
go back to reference Bang, Y.-J., Xu, R.-H., Chin, K., Lee, K.-W., Park, S. H., Rha, S. Y., et al. (2017). Olaparib in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy (GOLD): A double-blind, randomised, placebo-controlled, phase 3 trial. The Lancet Oncology,18(12), 1637–1651. https://doi.org/10.1016/S1470-2045(17)30682-4.CrossRefPubMed Bang, Y.-J., Xu, R.-H., Chin, K., Lee, K.-W., Park, S. H., Rha, S. Y., et al. (2017). Olaparib in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy (GOLD): A double-blind, randomised, placebo-controlled, phase 3 trial. The Lancet Oncology,18(12), 1637–1651. https://​doi.​org/​10.​1016/​S1470-2045(17)30682-4.CrossRefPubMed
16.
go back to reference Bodoky, G., Scheulen, M. E., Rivera, F., Jassem, J., Carrato, A., Moiseyenko, V., et al. (2015). Clinical benefit and health-related quality of life assessment in patients treated with cisplatin/S-1 versus cisplatin/5-FU: Secondary end point results from the First-Line Advanced Gastric Cancer Study (FLAGS). Journal of Gastrointestinal Cancer,46(2), 109–117. https://doi.org/10.1007/s12029-014-9680-1.CrossRefPubMed Bodoky, G., Scheulen, M. E., Rivera, F., Jassem, J., Carrato, A., Moiseyenko, V., et al. (2015). Clinical benefit and health-related quality of life assessment in patients treated with cisplatin/S-1 versus cisplatin/5-FU: Secondary end point results from the First-Line Advanced Gastric Cancer Study (FLAGS). Journal of Gastrointestinal Cancer,46(2), 109–117. https://​doi.​org/​10.​1007/​s12029-014-9680-1.CrossRefPubMed
17.
go back to reference Boye, M., Wang, X., Srimuninnimit, V., Kang, J. H., Tsai, C.-M., Orlando, M., et al. (2016). First-line pemetrexed plus cisplatin followed by gefitinib maintenance therapy versus gefitinib monotherapy in East Asian never-smoker patients with locally advanced or metastatic nonsquamous non-small-cell lung cancer: Quality of life results from a randomized phase III trial. Clinical Lung Cancer,17(2), 150–160. https://doi.org/10.1016/j.cllc.2015.12.004.CrossRefPubMed Boye, M., Wang, X., Srimuninnimit, V., Kang, J. H., Tsai, C.-M., Orlando, M., et al. (2016). First-line pemetrexed plus cisplatin followed by gefitinib maintenance therapy versus gefitinib monotherapy in East Asian never-smoker patients with locally advanced or metastatic nonsquamous non-small-cell lung cancer: Quality of life results from a randomized phase III trial. Clinical Lung Cancer,17(2), 150–160. https://​doi.​org/​10.​1016/​j.​cllc.​2015.​12.​004.CrossRefPubMed
18.
go back to reference Brahmer, J. R., Rodríguez-Abreu, D., Robinson, A. G., Hui, R., Csőszi, T., Fülöp, A., et al. (2017). Health-related quality-of-life results for pembrolizumab versus chemotherapy in advanced, PD-L1-positive NSCLC (KEYNOTE-024): A multicentre, international, randomised, open-label phase 3 trial. The Lancet Oncology,18(12), 1600–1609. https://doi.org/10.1016/S1470-2045(17)30690-3.CrossRefPubMed Brahmer, J. R., Rodríguez-Abreu, D., Robinson, A. G., Hui, R., Csőszi, T., Fülöp, A., et al. (2017). Health-related quality-of-life results for pembrolizumab versus chemotherapy in advanced, PD-L1-positive NSCLC (KEYNOTE-024): A multicentre, international, randomised, open-label phase 3 trial. The Lancet Oncology,18(12), 1600–1609. https://​doi.​org/​10.​1016/​S1470-2045(17)30690-3.CrossRefPubMed
20.
go back to reference Chi, K. N., Protheroe, A., Rodríguez-Antolín, A., Facchini, G., Suttman, H., Matsubara, N., et al. (2018). Patient-reported outcomes following abiraterone acetate plus prednisone added to androgen deprivation therapy in patients with newly diagnosed metastatic castration-naive prostate cancer (LATITUDE): An international, randomised phase 3 trial. The Lancet Oncology,19(2), 194–206. https://doi.org/10.1016/S1470-2045(17)30911-7.CrossRefPubMed Chi, K. N., Protheroe, A., Rodríguez-Antolín, A., Facchini, G., Suttman, H., Matsubara, N., et al. (2018). Patient-reported outcomes following abiraterone acetate plus prednisone added to androgen deprivation therapy in patients with newly diagnosed metastatic castration-naive prostate cancer (LATITUDE): An international, randomised phase 3 trial. The Lancet Oncology,19(2), 194–206. https://​doi.​org/​10.​1016/​S1470-2045(17)30911-7.CrossRefPubMed
21.
go back to reference Ellis, P. M., Shepherd, F. A., Millward, M., Perrone, F., Seymour, L., Liu, G., et al. (2014). Dacomitinib compared with placebo in pretreated patients with advanced or metastatic non-small-cell lung cancer (NCIC CTG BR.26): A double-blind, randomised, phase 3 trial. The Lancet Oncology,15(12), 1379–1388. https://doi.org/10.1016/s1470-2045(14)70472-3.CrossRefPubMed Ellis, P. M., Shepherd, F. A., Millward, M., Perrone, F., Seymour, L., Liu, G., et al. (2014). Dacomitinib compared with placebo in pretreated patients with advanced or metastatic non-small-cell lung cancer (NCIC CTG BR.26): A double-blind, randomised, phase 3 trial. The Lancet Oncology,15(12), 1379–1388. https://​doi.​org/​10.​1016/​s1470-2045(14)70472-3.CrossRefPubMed
22.
go back to reference Felip, E., Hirsh, V., Popat, S., Cobo, M., Fülöp, A., Dayen, C., et al. (2018). Symptom and quality of life improvement in LUX-Lung 8, an open-label phase III study of second-line afatinib versus erlotinib in patients with advanced Squamous Cell carcinoma of the lung after first-line platinum-based chemotherapy. Clinical Lung Cancer,19(1), 74–83.e11. https://doi.org/10.1016/j.cllc.2017.06.002.CrossRefPubMed Felip, E., Hirsh, V., Popat, S., Cobo, M., Fülöp, A., Dayen, C., et al. (2018). Symptom and quality of life improvement in LUX-Lung 8, an open-label phase III study of second-line afatinib versus erlotinib in patients with advanced Squamous Cell carcinoma of the lung after first-line platinum-based chemotherapy. Clinical Lung Cancer,19(1), 74–83.e11. https://​doi.​org/​10.​1016/​j.​cllc.​2017.​06.​002.CrossRefPubMed
23.
go back to reference Fiteni, F., Anota, A., Bonnetain, F., Oster, J.-P., Pichon, E., Wislez, M., et al. (2016). Health-related quality of life in elderly patients with advanced non-small cell lung cancer comparing carboplatin and weekly paclitaxel doublet chemotherapy with monotherapy. The European Respiratory Journal,48(3), 861–872. https://doi.org/10.1183/13993003.01695-2015.CrossRefPubMed Fiteni, F., Anota, A., Bonnetain, F., Oster, J.-P., Pichon, E., Wislez, M., et al. (2016). Health-related quality of life in elderly patients with advanced non-small cell lung cancer comparing carboplatin and weekly paclitaxel doublet chemotherapy with monotherapy. The European Respiratory Journal,48(3), 861–872. https://​doi.​org/​10.​1183/​13993003.​01695-2015.CrossRefPubMed
24.
go back to reference Fizazi, K., Scher, H. I., Miller, K., Basch, E., Sternberg, C. N., Cella, D., et al. (2014). Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: Results from the randomised, phase 3 AFFIRM trial. The Lancet Oncology,15(10), 1147–1156. https://doi.org/10.1016/S1470-2045(14)70303-1.CrossRefPubMed Fizazi, K., Scher, H. I., Miller, K., Basch, E., Sternberg, C. N., Cella, D., et al. (2014). Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: Results from the randomised, phase 3 AFFIRM trial. The Lancet Oncology,15(10), 1147–1156. https://​doi.​org/​10.​1016/​S1470-2045(14)70303-1.CrossRefPubMed
25.
go back to reference Geater, S. L., Xu, C. R., Zhou, C., Hu, C. P., Feng, J., Lu, S., et al. (2015). Symptom and quality of life improvement in LUX-Lung 6: An open-label phase III study of afatinib versus cisplatin/gemcitabine in asian patients with EGFR mutation-positive advanced non-small-cell lung cancer. Journal of Thoracic Oncology,10(6), 883–889. https://doi.org/10.1097/JTO.0000000000000517.CrossRefPubMed Geater, S. L., Xu, C. R., Zhou, C., Hu, C. P., Feng, J., Lu, S., et al. (2015). Symptom and quality of life improvement in LUX-Lung 6: An open-label phase III study of afatinib versus cisplatin/gemcitabine in asian patients with EGFR mutation-positive advanced non-small-cell lung cancer. Journal of Thoracic Oncology,10(6), 883–889. https://​doi.​org/​10.​1097/​JTO.​0000000000000517​.CrossRefPubMed
26.
go back to reference Gill, S., Ko, Y. J., Cripps, C., Beaudoin, A., Dhesy-Thind, S., Zulfiqar, M., et al. (2016). PANCREOX: A randomized phase III study of fluorouracil/leucovorin with or without oxaliplatin for second-line advanced pancreatic cancer in patients who have received gemcitabine-based chemotherapy. Journal of Clinical Oncology,34(32), 3914–3920. https://doi.org/10.1200/JCO.2016.68.5776.CrossRefPubMed Gill, S., Ko, Y. J., Cripps, C., Beaudoin, A., Dhesy-Thind, S., Zulfiqar, M., et al. (2016). PANCREOX: A randomized phase III study of fluorouracil/leucovorin with or without oxaliplatin for second-line advanced pancreatic cancer in patients who have received gemcitabine-based chemotherapy. Journal of Clinical Oncology,34(32), 3914–3920. https://​doi.​org/​10.​1200/​JCO.​2016.​68.​5776.CrossRefPubMed
27.
go back to reference Guimbaud, R., Louvet, C., Ries, P., Ychou, M., Maillard, E., Andre, T., et al. (2014). Prospective, randomized, multicenter, phase III study of fluorouracil, leucovorin, and irinotecan versus epirubicin, cisplatin, and capecitabine in advanced gastric adenocarcinoma: A French intergroup (Federation Francophone de Cancerologie Digestive, Federation Nationale des Centres de Lutte Contre le Cancer, and Groupe Cooperateur Multidisciplinaire en Oncologie) study. Journal of Clinical Oncology,32(31), 3520–3526. https://doi.org/10.1200/JCO.2013.54.1011.CrossRefPubMed Guimbaud, R., Louvet, C., Ries, P., Ychou, M., Maillard, E., Andre, T., et al. (2014). Prospective, randomized, multicenter, phase III study of fluorouracil, leucovorin, and irinotecan versus epirubicin, cisplatin, and capecitabine in advanced gastric adenocarcinoma: A French intergroup (Federation Francophone de Cancerologie Digestive, Federation Nationale des Centres de Lutte Contre le Cancer, and Groupe Cooperateur Multidisciplinaire en Oncologie) study. Journal of Clinical Oncology,32(31), 3520–3526. https://​doi.​org/​10.​1200/​JCO.​2013.​54.​1011.CrossRefPubMed
29.
go back to reference Hamidou, Z., Chibaudel, B., Hebbar, M., Hug de Larauze, M., André, T., Louvet, C., et al. (2016). Time to definitive health-related quality of life score deterioration in patients with resectable metastatic colorectal cancer treated with FOLFOX4 versus sequential dose-dense FOLFOX7 followed by FOLFIRI: The MIROX randomized phase III trial. PLoS ONE,11(6), e0157067. https://doi.org/10.1371/journal.pone.0157067.CrossRefPubMedPubMedCentral Hamidou, Z., Chibaudel, B., Hebbar, M., Hug de Larauze, M., André, T., Louvet, C., et al. (2016). Time to definitive health-related quality of life score deterioration in patients with resectable metastatic colorectal cancer treated with FOLFOX4 versus sequential dose-dense FOLFOX7 followed by FOLFIRI: The MIROX randomized phase III trial. PLoS ONE,11(6), e0157067. https://​doi.​org/​10.​1371/​journal.​pone.​0157067.CrossRefPubMedPubMedCentral
31.
go back to reference Harrington, K. J., Ferris, R. L., Blumenschein, G., Colevas, A. D., Fayette, J., Licitra, L., et al. (2017). Nivolumab versus standard, single-agent therapy of investigator’s choice in recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141): Health-related quality-of-life results from a randomised, phase 3 trial. The Lancet Oncology,18(8), 1104–1115. https://doi.org/10.1016/S1470-2045(17)30421-7.CrossRefPubMedPubMedCentral Harrington, K. J., Ferris, R. L., Blumenschein, G., Colevas, A. D., Fayette, J., Licitra, L., et al. (2017). Nivolumab versus standard, single-agent therapy of investigator’s choice in recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141): Health-related quality-of-life results from a randomised, phase 3 trial. The Lancet Oncology,18(8), 1104–1115. https://​doi.​org/​10.​1016/​S1470-2045(17)30421-7.CrossRefPubMedPubMedCentral
34.
go back to reference Loriot, Y., Miller, K., Sternberg, C. N., Fizazi, K., De Bono, J. S., Chowdhury, S., et al. (2015). Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): Results from a randomised, phase 3 trial. The Lancet Oncology,16(5), 509–521. https://doi.org/10.1016/S1470-2045(15)70113-0.CrossRefPubMed Loriot, Y., Miller, K., Sternberg, C. N., Fizazi, K., De Bono, J. S., Chowdhury, S., et al. (2015). Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): Results from a randomised, phase 3 trial. The Lancet Oncology,16(5), 509–521. https://​doi.​org/​10.​1016/​S1470-2045(15)70113-0.CrossRefPubMed
35.
go back to reference Machiels, J.-P. H., Haddad, R. I., Fayette, J., Licitra, L. F., Tahara, M., Vermorken, J. B., et al. (2015). Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): An open-label, randomised phase 3 trial. The Lancet Oncology,16(5), 583–594. https://doi.org/10.1016/S1470-2045(15)70124-5.CrossRefPubMed Machiels, J.-P. H., Haddad, R. I., Fayette, J., Licitra, L. F., Tahara, M., Vermorken, J. B., et al. (2015). Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): An open-label, randomised phase 3 trial. The Lancet Oncology,16(5), 583–594. https://​doi.​org/​10.​1016/​S1470-2045(15)70124-5.CrossRefPubMed
37.
go back to reference Novello, S., Kaiser, R., Mellemgaard, A., Douillard, J. Y., Orlov, S., Krzakowski, M., et al. (2015). Analysis of patient-reported outcomes from the LUME-Lung 1 trial: A randomised, double-blind, placebo-controlled, Phase III study of second-line nintedanib in patients with advanced non-small cell lung cancer. European Journal of Cancer,51(3), 317–326. https://doi.org/10.1016/j.ejca.2014.11.015.CrossRefPubMed Novello, S., Kaiser, R., Mellemgaard, A., Douillard, J. Y., Orlov, S., Krzakowski, M., et al. (2015). Analysis of patient-reported outcomes from the LUME-Lung 1 trial: A randomised, double-blind, placebo-controlled, Phase III study of second-line nintedanib in patients with advanced non-small cell lung cancer. European Journal of Cancer,51(3), 317–326. https://​doi.​org/​10.​1016/​j.​ejca.​2014.​11.​015.CrossRefPubMed
38.
go back to reference Pavel, M. E., Singh, S., Strosberg, J. R., Bubuteishvili-Pacaud, L., Degtyarev, E., Neary, M. P., et al. (2017). Health-related quality of life for everolimus versus placebo in patients with advanced, non-functional, well-differentiated gastrointestinal or lung neuroendocrine tumours (RADIANT-4): A multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet Oncology,18(10), 1411–1422. https://doi.org/10.1016/S1470-2045(17)30471-0.CrossRefPubMed Pavel, M. E., Singh, S., Strosberg, J. R., Bubuteishvili-Pacaud, L., Degtyarev, E., Neary, M. P., et al. (2017). Health-related quality of life for everolimus versus placebo in patients with advanced, non-functional, well-differentiated gastrointestinal or lung neuroendocrine tumours (RADIANT-4): A multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet Oncology,18(10), 1411–1422. https://​doi.​org/​10.​1016/​S1470-2045(17)30471-0.CrossRefPubMed
39.
go back to reference Perol, M., Ciuleanu, T. E., Arrieta, O., Prabhash, K., Syrigos, K. N., Goksel, T., et al. (2016). Quality of life results from the phase 3 REVEL randomized clinical trial of ramucirumab-plus-docetaxel versus placebo-plus-docetaxel in advanced/metastatic non-small cell lung cancer patients with progression after platinum-based chemotherapy. Lung Cancer,93, 95–103. https://doi.org/10.1016/j.lungcan.2016.01.007.CrossRefPubMed Perol, M., Ciuleanu, T. E., Arrieta, O., Prabhash, K., Syrigos, K. N., Goksel, T., et al. (2016). Quality of life results from the phase 3 REVEL randomized clinical trial of ramucirumab-plus-docetaxel versus placebo-plus-docetaxel in advanced/metastatic non-small cell lung cancer patients with progression after platinum-based chemotherapy. Lung Cancer,93, 95–103. https://​doi.​org/​10.​1016/​j.​lungcan.​2016.​01.​007.CrossRefPubMed
42.
go back to reference Reck, M., Taylor, F., Penrod, J. R., DeRosa, M., Morrissey, L., Dastani, H., et al. (2018). Impact of nivolumab versus docetaxel on health-related quality of life and symptoms in patients with advanced squamous non-small cell lung cancer: results from the CheckMate 017 study. Journal of Thoracic Oncology,13(2), 194–204. https://doi.org/10.1016/j.jtho.2017.10.029.CrossRefPubMed Reck, M., Taylor, F., Penrod, J. R., DeRosa, M., Morrissey, L., Dastani, H., et al. (2018). Impact of nivolumab versus docetaxel on health-related quality of life and symptoms in patients with advanced squamous non-small cell lung cancer: results from the CheckMate 017 study. Journal of Thoracic Oncology,13(2), 194–204. https://​doi.​org/​10.​1016/​j.​jtho.​2017.​10.​029.CrossRefPubMed
43.
go back to reference Saad, F., Fizazi, K., Jinga, V., Efstathiou, E., Fong, P. C., Hart, L. L., et al. (2015). Orteronel plus prednisone in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (ELM-PC 4): A double-blind, multicentre, phase 3, randomised, placebo-controlled trial. The Lancet Oncology,16(3), 338–348. https://doi.org/10.1016/S1470-2045(15)70027-6.CrossRefPubMed Saad, F., Fizazi, K., Jinga, V., Efstathiou, E., Fong, P. C., Hart, L. L., et al. (2015). Orteronel plus prednisone in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (ELM-PC 4): A double-blind, multicentre, phase 3, randomised, placebo-controlled trial. The Lancet Oncology,16(3), 338–348. https://​doi.​org/​10.​1016/​S1470-2045(15)70027-6.CrossRefPubMed
45.
go back to reference Shiroiwa, T., Fukuda, T., Shimozuma, K., Mouri, M., Hagiwara, Y., Doihara, H., et al. (2017). Long-term health status as measured by EQ-5D among patients with metastatic breast cancer: Comparison of first-line oral S-1 and taxane therapies in the randomized phase III SELECT BC trial. Quality of Life Research,26(2), 445–453. https://doi.org/10.1007/s11136-016-1388-1.CrossRefPubMed Shiroiwa, T., Fukuda, T., Shimozuma, K., Mouri, M., Hagiwara, Y., Doihara, H., et al. (2017). Long-term health status as measured by EQ-5D among patients with metastatic breast cancer: Comparison of first-line oral S-1 and taxane therapies in the randomized phase III SELECT BC trial. Quality of Life Research,26(2), 445–453. https://​doi.​org/​10.​1007/​s11136-016-1388-1.CrossRefPubMed
46.
47.
go back to reference Vaughn, D. J., Bellmunt, J., Fradet, Y., Lee, J. L., Fong, L., Vogelzang, N. J., et al. (2018). Health-related quality-of-life analysis from KEYNOTE-045: A phase III study of pembrolizumab versus chemotherapy for previously treated advanced urothelial cancer. Journal of Clinical Oncology,36(16), 1579–1587. https://doi.org/10.1200/JCO.2017.76.9562.CrossRefPubMed Vaughn, D. J., Bellmunt, J., Fradet, Y., Lee, J. L., Fong, L., Vogelzang, N. J., et al. (2018). Health-related quality-of-life analysis from KEYNOTE-045: A phase III study of pembrolizumab versus chemotherapy for previously treated advanced urothelial cancer. Journal of Clinical Oncology,36(16), 1579–1587. https://​doi.​org/​10.​1200/​JCO.​2017.​76.​9562.CrossRefPubMed
48.
go back to reference Vinik, A., Bottomley, A., Korytowsky, B., Bang, Y.-J., Raoul, J.-L., Valle, J. W., et al. (2016). Patient-reported outcomes and quality of life with sunitinib versus placebo for pancreatic neuroendocrine tumors: Results from an international phase III trial. Targeted Oncology,11(6), 815–824. https://doi.org/10.1007/s11523-016-0462-5.CrossRefPubMed Vinik, A., Bottomley, A., Korytowsky, B., Bang, Y.-J., Raoul, J.-L., Valle, J. W., et al. (2016). Patient-reported outcomes and quality of life with sunitinib versus placebo for pancreatic neuroendocrine tumors: Results from an international phase III trial. Targeted Oncology,11(6), 815–824. https://​doi.​org/​10.​1007/​s11523-016-0462-5.CrossRefPubMed
50.
go back to reference Fiteni, F., Westeel, V., Pivot, X., Borg, C., Vernerey, D., & Bonnetain, F. (2014). Endpoints in cancer clinical trials. Journal of Visceral Surgery,151(1), 17–22.CrossRef Fiteni, F., Westeel, V., Pivot, X., Borg, C., Vernerey, D., & Bonnetain, F. (2014). Endpoints in cancer clinical trials. Journal of Visceral Surgery,151(1), 17–22.CrossRef
53.
go back to reference Anota, A., Savina, M., Bascoul-Mollevi, C., & Bonnetain, F. (2017). Qolr: An r package for the longitudinal analysis of health-related quality of life in oncology. Journal of Statistical Software, Articles,77(12), 1–30. Anota, A., Savina, M., Bascoul-Mollevi, C., & Bonnetain, F. (2017). Qolr: An r package for the longitudinal analysis of health-related quality of life in oncology. Journal of Statistical Software, Articles,77(12), 1–30.
55.
go back to reference Ajani, J. A., Moiseyenko, V. M., Tjulandin, S., Majlis, A., Constenla, M., Boni, C., et al. (2007). Quality of life with docetaxel plus cisplatin and fluorouracil compared with cisplatin and fluorouracil from a phase III trial for advanced gastric or gastroesophageal adenocarcinoma: The V-325 Study Group. Journal of Clinical Oncology,25(22), 3210–3216. https://doi.org/10.1200/JCO.2006.08.3956.CrossRefPubMed Ajani, J. A., Moiseyenko, V. M., Tjulandin, S., Majlis, A., Constenla, M., Boni, C., et al. (2007). Quality of life with docetaxel plus cisplatin and fluorouracil compared with cisplatin and fluorouracil from a phase III trial for advanced gastric or gastroesophageal adenocarcinoma: The V-325 Study Group. Journal of Clinical Oncology,25(22), 3210–3216. https://​doi.​org/​10.​1200/​JCO.​2006.​08.​3956.CrossRefPubMed
57.
go back to reference Kiebert, G. M., Curran, D., & Aaronson, N. K. (1998). Quality of life as an endpoint in EORTC clinical trials. European Organization for Research and Treatment for Cancer. Statistics in Medicine,17(5–7), 561–569.CrossRef Kiebert, G. M., Curran, D., & Aaronson, N. K. (1998). Quality of life as an endpoint in EORTC clinical trials. European Organization for Research and Treatment for Cancer. Statistics in Medicine,17(5–7), 561–569.CrossRef
58.
go back to reference Fiteni, F., Pam, A., Anota, A., Vernerey, D., Paget-Bailly, S., Westeel, V., et al. (2015). Health-related quality-of-life as co-primary endpoint in randomized clinical trials in oncology. Expert Review of Anticancer Therapy,15(8), 885–891.CrossRef Fiteni, F., Pam, A., Anota, A., Vernerey, D., Paget-Bailly, S., Westeel, V., et al. (2015). Health-related quality-of-life as co-primary endpoint in randomized clinical trials in oncology. Expert Review of Anticancer Therapy,15(8), 885–891.CrossRef
Metagegevens
Titel
Time to deterioration in cancer randomized clinical trials for patient-reported outcomes data: a systematic review
Auteurs
E. Charton
B. Cuer
F. Cottone
F. Efficace
C. Touraine
Z. Hamidou
F. Fiteni
F. Bonnetain
M.-C. Woronoff-Lemsi
C. Bascoul-Mollevi
A. Anota
Publicatiedatum
27-11-2019
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 4/2020
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-019-02367-7

Andere artikelen Uitgave 4/2020

Quality of Life Research 4/2020 Naar de uitgave