Comparison of outcomes between Hodgkin's lymphoma patients treated in and outside clinical trials: A study based on the EORTC-Dutch late effects cohort-linked data

Sidsel Jacobsen Juul; Michal Kicinski; Michael Schaapveld; Sára Rossetti; Berthe M.P. Aleman; Lifang Liu; Flora E. van Leeuwen; Paul Meijnders; Augustinus D.G. Krol; Cécile P.M. Janus; Martin Hutchings; Maja V. Maraldo

doi:10.1111/ejh.13899

Comparison of outcomes between Hodgkin's lymphoma patients treated in and outside clinical trials: A study based on the EORTC-Dutch late effects cohort-linked data

Sidsel Jacobsen Juul^*, Michal Kicinski, Michael Schaapveld, Sára Rossetti, Berthe M.P. Aleman, Lifang Liu, Flora E. van Leeuwen, Paul Meijnders, Augustinus D.G. Krol, Cécile P.M. Janus, Martin Hutchings, Maja V. Maraldo

^*Corresponding author for this work

Department of Clinical Medicine

Research output: Contribution to journal › Journal article › Research › peer-review

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Abstract

Studies have shown higher survival rates for patients with Hodgkin lymphoma (HL) treated within clinical trials compared to patients treated outside clinical trials. However, endpoints are often limited to overall survival (OS). In this retrospective cohort study, we investigated the effect of trial participation on OS, the incidence of relapse, second cancer, and cardiovascular disease (CVD). The study population consisted of patients with HL, aged between 14 and 51 years at diagnosis, who started their treatment between 1962 and 2002 at three Dutch cancer centres. Patients were either included in the EORTC Lymphoma Group trials (H1–H9) or treated according to standard guidelines at the time. After adjusting for differences in baseline characteristics, trial participation was associated with longer OS (median OS: 29.4 years [95%CI: 27.0–31.6] for treatment inside trials versus 27.4 years [95%CI: 26.0–28.5] for treatment outside trials, p =.046), a lower incidence of relapse (HR = 0.79, 95%CI: 0.63–0.98, p =.036) and a higher incidence of CVD (HR = 1.49, 95%CI: 1.23–1.79, p <.001). The trial effect for CVD was present only for patients treated before 1983. No evidence of differences in the incidence of second cancer was found. Consequently, essential results from clinical trials should be implemented into standard practice without undue delay.

Original language	English
Book series	European Journal of Haematology
Volume	110
Issue number	3
Pages (from-to)	243-252
Number of pages	10
ISSN	0902-4441
DOIs	https://doi.org/10.1111/ejh.13899
Publication status	Published - 2023

Bibliographical note

Funding Information:
The work leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking (under grant agreement no. 115546), resources that are composed of a financial contribution from the European Union's Seventh Framework Programme (FP7/2007/2013) and in‐kind contribution from EFPIA companies. This publication reflects the authors' view, and neither IMI nor the EU nor EFPIA are responsible for any use that may be made of the information contained therein. Also, this publication was supported by a donation from the Danish Cancer Society in Denmark.

Funding Information:
Innovative Medicines Initiative Joint Undertaking, Grant/Award Number: 115546; European Union's Seventh Framework Programme, Grant/Award Number: FP7/2007/2013; The Danish Cancer Society Funding information

Publisher Copyright:
© 2022 The Authors. European Journal of Haematology published by John Wiley & Sons Ltd.

Keywords

clinical trials
data linkage
EORTC
Hodgkin lymphoma
late effects

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Cite this

Juul, S. J., Kicinski, M., Schaapveld, M., Rossetti, S., Aleman, B. M. P., Liu, L., van Leeuwen, F. E., Meijnders, P., Krol, A. D. G., Janus, C. P. M., Hutchings, M., & Maraldo, M. V. (2023). Comparison of outcomes between Hodgkin's lymphoma patients treated in and outside clinical trials: A study based on the EORTC-Dutch late effects cohort-linked data. European Journal of Haematology, 110(3), 243-252. https://doi.org/10.1111/ejh.13899

Comparison of outcomes between Hodgkin's lymphoma patients treated in and outside clinical trials : A study based on the EORTC-Dutch late effects cohort-linked data. / Juul, Sidsel Jacobsen; Kicinski, Michal; Schaapveld, Michael; Rossetti, Sára; Aleman, Berthe M.P.; Liu, Lifang; van Leeuwen, Flora E.; Meijnders, Paul; Krol, Augustinus D.G.; Janus, Cécile P.M.; Hutchings, Martin; Maraldo, Maja V.

In: European Journal of Haematology, Vol. 110, No. 3, 2023, p. 243-252.

Research output: Contribution to journal › Journal article › Research › peer-review

Juul, SJ, Kicinski, M, Schaapveld, M, Rossetti, S, Aleman, BMP, Liu, L, van Leeuwen, FE, Meijnders, P, Krol, ADG, Janus, CPM, Hutchings, M & Maraldo, MV 2023, 'Comparison of outcomes between Hodgkin's lymphoma patients treated in and outside clinical trials: A study based on the EORTC-Dutch late effects cohort-linked data', European Journal of Haematology, vol. 110, no. 3, pp. 243-252. https://doi.org/10.1111/ejh.13899

Juul, Sidsel Jacobsen ; Kicinski, Michal ; Schaapveld, Michael ; Rossetti, Sára ; Aleman, Berthe M.P. ; Liu, Lifang ; van Leeuwen, Flora E. ; Meijnders, Paul ; Krol, Augustinus D.G. ; Janus, Cécile P.M. ; Hutchings, Martin ; Maraldo, Maja V. / Comparison of outcomes between Hodgkin's lymphoma patients treated in and outside clinical trials : A study based on the EORTC-Dutch late effects cohort-linked data. In: European Journal of Haematology. 2023 ; Vol. 110, No. 3. pp. 243-252.

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title = "Comparison of outcomes between Hodgkin's lymphoma patients treated in and outside clinical trials: A study based on the EORTC-Dutch late effects cohort-linked data",

abstract = "Studies have shown higher survival rates for patients with Hodgkin lymphoma (HL) treated within clinical trials compared to patients treated outside clinical trials. However, endpoints are often limited to overall survival (OS). In this retrospective cohort study, we investigated the effect of trial participation on OS, the incidence of relapse, second cancer, and cardiovascular disease (CVD). The study population consisted of patients with HL, aged between 14 and 51 years at diagnosis, who started their treatment between 1962 and 2002 at three Dutch cancer centres. Patients were either included in the EORTC Lymphoma Group trials (H1–H9) or treated according to standard guidelines at the time. After adjusting for differences in baseline characteristics, trial participation was associated with longer OS (median OS: 29.4 years [95%CI: 27.0–31.6] for treatment inside trials versus 27.4 years [95%CI: 26.0–28.5] for treatment outside trials, p =.046), a lower incidence of relapse (HR = 0.79, 95%CI: 0.63–0.98, p =.036) and a higher incidence of CVD (HR = 1.49, 95%CI: 1.23–1.79, p <.001). The trial effect for CVD was present only for patients treated before 1983. No evidence of differences in the incidence of second cancer was found. Consequently, essential results from clinical trials should be implemented into standard practice without undue delay.",

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author = "Juul, {Sidsel Jacobsen} and Michal Kicinski and Michael Schaapveld and S{\'a}ra Rossetti and Aleman, {Berthe M.P.} and Lifang Liu and {van Leeuwen}, {Flora E.} and Paul Meijnders and Krol, {Augustinus D.G.} and Janus, {C{\'e}cile P.M.} and Martin Hutchings and Maraldo, {Maja V.}",

note = "Funding Information: The work leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking (under grant agreement no. 115546), resources that are composed of a financial contribution from the European Union's Seventh Framework Programme (FP7/2007/2013) and in‐kind contribution from EFPIA companies. This publication reflects the authors' view, and neither IMI nor the EU nor EFPIA are responsible for any use that may be made of the information contained therein. Also, this publication was supported by a donation from the Danish Cancer Society in Denmark. Funding Information: Innovative Medicines Initiative Joint Undertaking, Grant/Award Number: 115546; European Union's Seventh Framework Programme, Grant/Award Number: FP7/2007/2013; The Danish Cancer Society Funding information Publisher Copyright: {\textcopyright} 2022 The Authors. European Journal of Haematology published by John Wiley & Sons Ltd.",

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doi = "10.1111/ejh.13899",

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T2 - A study based on the EORTC-Dutch late effects cohort-linked data

AU - Juul, Sidsel Jacobsen

AU - Kicinski, Michal

AU - Schaapveld, Michael

AU - Rossetti, Sára

AU - Aleman, Berthe M.P.

AU - Liu, Lifang

AU - van Leeuwen, Flora E.

AU - Meijnders, Paul

AU - Krol, Augustinus D.G.

AU - Janus, Cécile P.M.

AU - Hutchings, Martin

AU - Maraldo, Maja V.

N1 - Funding Information: The work leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking (under grant agreement no. 115546), resources that are composed of a financial contribution from the European Union's Seventh Framework Programme (FP7/2007/2013) and in‐kind contribution from EFPIA companies. This publication reflects the authors' view, and neither IMI nor the EU nor EFPIA are responsible for any use that may be made of the information contained therein. Also, this publication was supported by a donation from the Danish Cancer Society in Denmark. Funding Information: Innovative Medicines Initiative Joint Undertaking, Grant/Award Number: 115546; European Union's Seventh Framework Programme, Grant/Award Number: FP7/2007/2013; The Danish Cancer Society Funding information Publisher Copyright: © 2022 The Authors. European Journal of Haematology published by John Wiley & Sons Ltd.

PY - 2023

Y1 - 2023

N2 - Studies have shown higher survival rates for patients with Hodgkin lymphoma (HL) treated within clinical trials compared to patients treated outside clinical trials. However, endpoints are often limited to overall survival (OS). In this retrospective cohort study, we investigated the effect of trial participation on OS, the incidence of relapse, second cancer, and cardiovascular disease (CVD). The study population consisted of patients with HL, aged between 14 and 51 years at diagnosis, who started their treatment between 1962 and 2002 at three Dutch cancer centres. Patients were either included in the EORTC Lymphoma Group trials (H1–H9) or treated according to standard guidelines at the time. After adjusting for differences in baseline characteristics, trial participation was associated with longer OS (median OS: 29.4 years [95%CI: 27.0–31.6] for treatment inside trials versus 27.4 years [95%CI: 26.0–28.5] for treatment outside trials, p =.046), a lower incidence of relapse (HR = 0.79, 95%CI: 0.63–0.98, p =.036) and a higher incidence of CVD (HR = 1.49, 95%CI: 1.23–1.79, p <.001). The trial effect for CVD was present only for patients treated before 1983. No evidence of differences in the incidence of second cancer was found. Consequently, essential results from clinical trials should be implemented into standard practice without undue delay.

AB - Studies have shown higher survival rates for patients with Hodgkin lymphoma (HL) treated within clinical trials compared to patients treated outside clinical trials. However, endpoints are often limited to overall survival (OS). In this retrospective cohort study, we investigated the effect of trial participation on OS, the incidence of relapse, second cancer, and cardiovascular disease (CVD). The study population consisted of patients with HL, aged between 14 and 51 years at diagnosis, who started their treatment between 1962 and 2002 at three Dutch cancer centres. Patients were either included in the EORTC Lymphoma Group trials (H1–H9) or treated according to standard guidelines at the time. After adjusting for differences in baseline characteristics, trial participation was associated with longer OS (median OS: 29.4 years [95%CI: 27.0–31.6] for treatment inside trials versus 27.4 years [95%CI: 26.0–28.5] for treatment outside trials, p =.046), a lower incidence of relapse (HR = 0.79, 95%CI: 0.63–0.98, p =.036) and a higher incidence of CVD (HR = 1.49, 95%CI: 1.23–1.79, p <.001). The trial effect for CVD was present only for patients treated before 1983. No evidence of differences in the incidence of second cancer was found. Consequently, essential results from clinical trials should be implemented into standard practice without undue delay.

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KW - data linkage

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KW - late effects

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DO - 10.1111/ejh.13899

M3 - Journal article

C2 - 36369842

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JO - Scandinavian Journal of Haematology

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