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Clinical Trial
. 2021 Oct 10;39(29):3251-3260.
doi: 10.1200/JCO.21.00068. Epub 2021 Jun 22.

Gonadal Function Recovery in Patients With Advanced Hodgkin Lymphoma Treated With a PET-Adapted Regimen: Prospective Analysis of a Randomized Phase III Trial (AHL2011)

Isabelle Demeestere  1 , Judith Racape  2 , Julie Dechene  3 , Jehan Dupuis  4 , Franck Morschhauser  5 , Virginie De Wilde  6 , Julien Lazarovici  7 , Hervé Ghesquieres  8 , Mohamed Touati  9 , David Sibon  10 , Magda Alexis  11 , Anne-Claire Gac  12 , Hannah Moatti  13 , Emmanuelle Virelizier  14 , Hervé Maisonneuve  15 , Delphine Pranger  16 , Roch Houot  17 , Luc-Matthieu Fornecker  18 , Adrian Tempescul  19 , Marc André  20 , René-Olivier Casasnovas  21
Affiliations
Clinical Trial

Gonadal Function Recovery in Patients With Advanced Hodgkin Lymphoma Treated With a PET-Adapted Regimen: Prospective Analysis of a Randomized Phase III Trial (AHL2011)

Isabelle Demeestere et al. J Clin Oncol. .

Abstract

Purpose: The prospective, randomized AHL2011 trial demonstrated that the use of the doxorubicin, bleomycin, vinblastine, and dacarbazine regimen (ABVD) after two cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPescalated) in early responders on the basis of a positron emission tomography (PET)-driven strategy was safe and minimized toxicity compared with standard 6 BEACOPPescalated cycles. This substudy investigated the benefit of this strategy in gonadal function and fertility in patients under 45 years old.

Methods: Ovarian function was assessed by serum measurement of follicle-stimulating hormone (FSH), estradiol, and anti-müllerian hormone in women, and semen analysis, FSH, and testosterone levels were used to evaluate testicular function in men at baseline, end of treatment, and during 5 years of follow-up.

Results: A total of 145 women and 424 men, enrolled between May 19, 2011, and April 29, 2014, were included. The risk of premature ovarian insufficiency (FSH > 24 IU/L) and of having a low ovarian reserve (anti-müllerian hormone < 0.5 ng/mL) was reduced after treatment in the PET-driven group (odds ratio [OR], 0.20; 95% CI, 0.08 to 0.50; P = .001 and OR, 0.15; 95% CI, 0.04 to 0.56, P = .005, respectively). Both parameters were correlated with age and dose of alkylating agents. However, no significant differences were observed in terms of pregnancy rates. Men in the PET-driven group had a higher recovery rate of sperm parameters after treatment compared with the standard BEACOPPescalated group, as well as a lower risk of severe testicular damage (OR, 0.26; 95% CI, 0.13 to 0.5; P < .0001) and a higher likelihood of achieving pregnancy (OR, 3.7; 95% CI, 1.4 to 9.3; P = .004).

Conclusion: Although both treatments affected ovarian reserve and spermatogenesis, the PET-driven strategy decreased the risk of gonadal dysfunction and infertility in advanced Hodgkin lymphoma.

Trial registration: ClinicalTrials.gov NCT01358747.

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Conflict of interest statement

Isabelle DemeestereConsulting or Advisory Role: RocheResearch Funding: Roche diagnosisTravel, Accommodations, Expenses: Ferring Jehan DupuisConsulting or Advisory Role: AstraZenecaTravel, Accommodations, Expenses: Gilead Sciences Franck MorschhauserConsulting or Advisory Role: Roche/Genentech, Gilead Sciences, Celgene, Bristol Myers Squibb, AbbVie, Epizyme, ServierSpeakers' Bureau: RocheExpert Testimony: Roche/Genentech Virginie De WildeConsulting or Advisory Role: Takeda, Janssen Oncology Julien LazaroviciTravel, Accommodations, Expenses: Roche, Novartis, Sandoz, Janssen-Cilag, Jazz Pharmaceuticals France, Daiichi Sankyo Oncology France, Mundipharma, Pfizer, AbbVie Hervé GhesquieresHonoraria: Gilead Sciences, Janssen, Celgene, RocheConsulting or Advisory Role: Gilead Sciences, Celgene, Roche, MundipharmaTravel, Accommodations, Expenses: Roche, Gilead Sciences, Celgene, Takeda Mohamed TouatiHonoraria: AmgenConsulting or Advisory Role: Janssen, Bristol Myers Squibb/Celgene David SibonConsulting or Advisory Role: Takeda, Iqone healthcare, Janssen, RocheTravel, Accommodations, Expenses: Takeda, Janssen Luc-Matthieu ForneckerConsulting or Advisory Role: Takeda, RocheTravel, Accommodations, Expenses: Takeda, Roche Marc AndréConsulting or Advisory Role: Takeda, BMSiResearch Funding: Takeda, RocheTravel, Accommodations, Expenses: Roche, Celgene, Gilead Sciences René-Olivier CasasnovasHonoraria: Roche/Genentech, Takeda, Gilead Sciences, Bristol Myers Squibb, Merck, AbbVie, Celgene, Janssen, AmgenConsulting or Advisory Role: Roche/Genentech, Takeda, Gilead Sciences, Bristol Myers Squibb, Merck, AbbVie, Celgene, Janssen, IncyteResearch Funding: Roche/Genentech, Gilead Sciences, TakedaTravel, Accommodations, Expenses: Roche/Genentech, Takeda, Gilead Sciences, JanssenNo other potential conflicts of interest were reported.

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