PMID- 37967311
OWN - NLM
STAT- MEDLINE
DCOM- 20240221
LR  - 20240221
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 42
IP  - 1
DP  - 2024 Jan 1
TI  - Long-Term Follow-Up of the Response-Adapted Intergroup EORTC/LYSA/FIL H10 Trial 
      for Localized Hodgkin Lymphoma.
PG  - 19-25
LID - 10.1200/JCO.23.01745 [doi]
AB  - Clinical trials frequently include multiple end points that mature at different 
      times. The initial report, typically based on the primary end point, may be 
      published when key planned co-primary or secondary analyses are not yet 
      available. Clinical Trial Updates provide an opportunity to disseminate 
      additional results from studies, published in JCO or elsewhere, for which the 
      primary end point has already been reported.The primary analysis of the Early 
      positron emission tomography (ePET) Response-Adapted Treatment in localized 
      Hodgkin Lymphoma H10 Trial demonstrated that in ePET-negative patients, the risk 
      of relapse increased when involved-node radiotherapy (INRT) was omitted and that 
      in ePET-positive patients, switching from doxorubicin, bleomycin, vinblastine, 
      and dacarbazine (ABVD) to bleomycin, etoposide, doxorubicin, cyclophosphamide, 
      vincristine, procarbazine, and prednisone (BEACOPPesc) significantly improved 
      5-year progression-free survival (PFS). Here, we report the final results of a 
      preplanned analysis at a 10-year follow-up. In the favorable (F) ePET-negative 
      group, the 10-year PFS rates were 98.8% versus 85.4% (hazard ratio [HR], 13.2; 
      95% CI, 3.1 to 55.8; P value for noninferiority = .9735; difference test P < 
      .0001) in favor of ABVD + INRT; in the unfavorable (U) ePET-negative group, the 
      10-year PFS rates were 91.4% and 86.5% (HR, 1.52; 95% CI, 0.84 to 2.75; P value 
      for noninferiority = .8577; difference test P = .1628). In ePET-positive 
      patients, the difference in terms of PFS between standard ABVD and intensified 
      BEACOPPesc was no longer statistically significant (HR, 0.67; 95% CI, 0.37 to 
      1.20; P = .1777). In conclusion, the present long-term analysis confirms that in 
      ePET-negative patients, the omission of INRT is associated with lower 10-year 
      PFS. Instead, in ePET-positive patients, no significant difference between 
      standard and experimental arms emerged although intensification with BEACOPPesc 
      was safe, with no increase in late adverse events, namely, second malignancies.
FAU - Federico, Massimo
AU  - Federico M
AUID- ORCID: 0000-0002-9889-3796
AD  - University of Modena and Reggio Emilia, Modena, Italy.
FAU - Fortpied, Catherine
AU  - Fortpied C
AD  - EORTC Headquarters, Brussels, Belgium.
FAU - Stepanishyna, Yana
AU  - Stepanishyna Y
AUID- ORCID: 0000-0002-7884-193X
AD  - National Cancer Institute, Kyiv, Ukraine.
FAU - Gotti, Manuel
AU  - Gotti M
AD  - Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
FAU - van der Maazen, Richard
AU  - van der Maazen R
AUID- ORCID: 0000-0003-0360-9172
AD  - Radboud University Medical Center Nijmegen, Nijmegen, the Netherlands.
FAU - Cristinelli, Caterina
AU  - Cristinelli C
AUID- ORCID: 0000-0002-5757-3569
AD  - Hopital Saint-Louis, Paris, France.
FAU - Re, Alessandro
AU  - Re A
AUID- ORCID: 0000-0003-1156-6395
AD  - Spedali Civili Hospital, Brescia, Italy.
FAU - Plattel, Wouter
AU  - Plattel W
AUID- ORCID: 0000-0001-9828-9460
AD  - University Medical Center Groningen, Groningen, the Netherlands.
FAU - Lazarovici, Julien
AU  - Lazarovici J
AUID- ORCID: 0009-0000-3496-7445
AD  - Institut Goustave-Roussy, Paris, France.
FAU - Merli, Francesco
AU  - Merli F
AUID- ORCID: 0000-0002-0979-7883
AD  - Azienda Unita Sanitaria Locale- IRCCS di Reggio Emilia, Reggio Emilia, Italy.
FAU - Specht, Lena
AU  - Specht L
AUID- ORCID: 0000-0002-6902-2190
AD  - Rigshospitalet, Copenhagen, Denmark.
FAU - Schiano de Colella, Jean-Marc
AU  - Schiano de Colella JM
AUID- ORCID: 0000-0001-9923-4808
AD  - Institut Paoli-Calmette, Marseille, France.
FAU - Hutchings, Martin
AU  - Hutchings M
AUID- ORCID: 0000-0003-3873-1741
AD  - Rigshospitalet, Copenhagen, Denmark.
FAU - Versari, Annibale
AU  - Versari A
AUID- ORCID: 0000-0002-8675-2435
AD  - Azienda Unita Sanitaria Locale- IRCCS di Reggio Emilia, Reggio Emilia, Italy.
FAU - Edeline, Veronique
AU  - Edeline V
AD  - Institut Curie, Paris, France.
FAU - Stamatoulas, Aspasia
AU  - Stamatoulas A
AUID- ORCID: 0000-0001-7321-5254
AD  - Centre Henri Becquerel, Rouen, France.
FAU - Girinsky, Theodore
AU  - Girinsky T
AD  - Institut Gustave Roussy, Villejuif, France.
FAU - Ricardi, Umberto
AU  - Ricardi U
AUID- ORCID: 0000-0003-4406-7621
AD  - University of Turin, Turin, Italy.
FAU - Aleman, Berthe
AU  - Aleman B
AUID- ORCID: 0000-0003-2306-6590
AD  - The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam, the 
      Netherlands.
FAU - Meulemans, Bart
AU  - Meulemans B
AD  - EORTC Headquarters, Brussels, Belgium.
FAU - Tonino, Sanne
AU  - Tonino S
AD  - Amsterdam University Medical Center, Amsterdam, the Netherlands.
FAU - Raemaekers, John
AU  - Raemaekers J
AD  - Radboud University Medical Center Nijmegen, Nijmegen, the Netherlands.
FAU - Andre, Marc
AU  - Andre M
AUID- ORCID: 0000-0001-7101-810X
AD  - CHU UCL Namur, Yvoir, Belgium.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20231115
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 11056-06-7 (Bleomycin)
RN  - 7GR28W0FJI (Dacarbazine)
RN  - 80168379AG (Doxorubicin)
RN  - VB0R961HZT (Prednisone)
RN  - 35S93Y190K (Procarbazine)
RN  - 5V9KLZ54CY (Vinblastine)
RN  - 5J49Q6B70F (Vincristine)
SB  - IM
MH  - Humans
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Bleomycin
MH  - Dacarbazine
MH  - Disease-Free Survival
MH  - Doxorubicin
MH  - Follow-Up Studies
MH  - *Hodgkin Disease/diagnostic imaging/drug therapy/pathology
MH  - Neoplasm Recurrence, Local/drug therapy
MH  - Prednisone
MH  - Procarbazine/adverse effects
MH  - Vinblastine
MH  - Vincristine
PMC - PMC10730029
COIS- The following represents disclosure information provided by authors of this 
      manuscript. All relationships are considered compensated unless otherwise noted. 
      Relationships are self-held unless noted. I = Immediate Family Member, Inst = My 
      Institution. Relationships may not relate to the subject matter of this 
      manuscript. For more information about ASCO's conflict of interest policy, please 
      refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center. Open 
      Payments is a public database containing information reported by companies about 
      payments made to US-licensed physicians (Open Payments). Marc Andre Consulting or 
      Advisory Role: Takeda, BMSi, Roche, AbbVie, Novartis, Eli Lilly Benelux Research 
      Funding: Takeda (Inst), Roche (Inst) Travel, Accommodations, Expenses: Gilead 
      Sciences, AstraZeneca, Takeda No other potential conflicts of interest were 
      reported.
EDAT- 2023/11/15 18:41
MHDA- 2023/12/25 06:41
PMCR- 2025/01/01
CRDT- 2023/11/15 16:13
PHST- 2025/01/01 00:00 [pmc-release]
PHST- 2023/12/25 06:41 [medline]
PHST- 2023/11/15 18:41 [pubmed]
PHST- 2023/11/15 16:13 [entrez]
AID - JCO.23.01745 [pii]
AID - 10.1200/JCO.23.01745 [doi]
PST - ppublish
SO  - J Clin Oncol. 2024 Jan 1;42(1):19-25. doi: 10.1200/JCO.23.01745. Epub 2023 Nov 
      15.