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
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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.
I: European Journal of Haematology, Bind 110, Nr. 3, 2023, s. 243-252.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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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 -
ID: 395871973