TY - JOUR

T1 - Comparison of outcomes between Hodgkin's lymphoma patients treated in and outside clinical trials

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.

KW - clinical trials

KW - data linkage

KW - EORTC

KW - Hodgkin lymphoma

KW - late effects

U2 - 10.1111/ejh.13899

DO - 10.1111/ejh.13899

M3 - Journal article

C2 - 36369842

AN - SCOPUS:85143129495

VL - 110

SP - 243

EP - 252

JO - Scandinavian Journal of Haematology

JF - Scandinavian Journal of Haematology

SN - 0902-4441

IS - 3

ER -