PMID- 35299287
OWN - NLM
STAT- MEDLINE
DCOM- 20221215
LR  - 20221215
IS  - 1099-1069 (Electronic)
IS  - 0278-0232 (Linking)
VI  - 40
IP  - 5
DP  - 2022 Dec
TI  - Finding a consensus on time-to-event endpoints definitions in marginal zone 
      lymphoma: A Delphi method.
PG  - 1086-1089
LID - 10.1002/hon.2988 [doi]
AB  - A recent systematic review reported that trials involving patients with marginal 
      zone lymphoma (MZL) show marked heterogeneity both in the choice and definitions 
      of primary and secondary endpoints, thus hampering comparability between trials. 
      The main objective of this study was to reach consensus, through a Delphi 
      process, on the definitions of four time-to-event endpoints in MZL trials, by 
      surveying clinicians and methodologists involved in the conduct of clinical 
      trials including patients with MZL. We polled a panel of leading international 
      experts involved in MZL trials by means of self-administered sequential 
      questionnaires in 2021. Of these 105 experts, 62 responded to the Round 1 
      questionnaire regarding the definitions of progression-free survival (PFS), 
      event-free survival (EFS), time-to-failure (TTF), and time-to-next-treatment 
      (TTNT). Afterward, we therefore focused the Round 2 and 3 questionnaires among 
      principal investigators, coinvestigators, and trial methodologists. Consensus was 
      reached when there was a >80% agreement on all potential events (11 choices) of 
      each endpoint. Participants in our survey reached consensus on three of the four 
      time-to-event endpoints definitions. Consensus was reached on the definitions of 
      PFS and TTNT after Round 1, of TTF after Round 2, and was not reached for EFS 
      after Round 3. The disagreement concerned the event "treatment discontinuation" 
      in EFS definition. The main interest of our study was to elicit investigator's 
      interest in the importance of consistently defining endpoints in MZL trials and 
      to highlight that composite endpoints should not be encouraged. Fifteen years 
      after the last consensus statement on time-to-event endpoints definitions issued 
      in Lugano (2007), both the review of literature and survey of international 
      investigators agree on the inconsistency of endpoints definitions used within the 
      MZL community. Hopefully, revised standardized definitions of endpoints shall be 
      provided at the upcoming International Conference on Malignant Lymphoma in 2023.
CI  - (c) 2022 John Wiley & Sons Ltd.
FAU - Bommier, Come
AU  - Bommier C
AUID- ORCID: 0000-0002-5695-911X
AD  - Inserm U1153, Saint Louis Hospital, Paris, France.
AD  - Universite Paris Cite, Paris, France.
AD  - Biostatistics and Medical Information Department, Saint Louis Hospital, Paris, 
      France.
FAU - Lambert, Jerome
AU  - Lambert J
AD  - Inserm U1153, Saint Louis Hospital, Paris, France.
AD  - Universite Paris Cite, Paris, France.
AD  - Biostatistics and Medical Information Department, Saint Louis Hospital, Paris, 
      France.
FAU - Nowakowski, Grzegorz
AU  - Nowakowski G
AD  - Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, 
      Minnesota, USA.
FAU - Zucca, Emanuele
AU  - Zucca E
AUID- ORCID: 0000-0002-5522-6109
AD  - Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.
FAU - Thieblemont, Catherine
AU  - Thieblemont C
AD  - Universite Paris Cite, Paris, France.
AD  - APHP, Haemato-Oncology Department, Saint Louis Hospital, Paris, France.
LA  - eng
GR  - Institut National de la Sante et de la Recherche Medicale/
PT  - Letter
DEP - 20220402
PL  - England
TA  - Hematol Oncol
JT  - Hematological oncology
JID - 8307268
SB  - IM
MH  - Humans
MH  - Delphi Technique
MH  - *Lymphoma
OTO - NOTNLM
OT  - Delphi
OT  - event-free survival
OT  - progression-free survival
OT  - time-to-event endpoints
OT  - time-to-failure
OT  - time-to-next-treatment
EDAT- 2022/03/18 06:00
MHDA- 2022/12/15 06:00
CRDT- 2022/03/17 20:18
PHST- 2022/03/18 06:00 [pubmed]
PHST- 2022/12/15 06:00 [medline]
PHST- 2022/03/17 20:18 [entrez]
AID - 10.1002/hon.2988 [doi]
PST - ppublish
SO  - Hematol Oncol. 2022 Dec;40(5):1086-1089. doi: 10.1002/hon.2988. Epub 2022 Apr 2.