PET-guided eBEACOPP treatment of advanced-stage Hodgkin lymphoma (HD18): follow-up analysis of an international, open-label, randomised, phase 3 trial

Kreissl, Stefanie; Goergen, Helen; Buehnen, Ina; Kobe, Carsten; Moccia, Alden A.; Greil, Richard; Eichenauer, Dennis A.; Zijlstra, Josée M.; Marková, Jana; Meißner, Julia; Feuring‐Buske, Michaela; Soekler, Martin; Beck, Hans-Joachim; Willenbacher, Wolfgang; Ludwig, Wolf‐Dieter; Pabst, Thomas; Topp, Max S.; Hitz, Felicitas; Bentz, Martin; Keller, Ulrich; Kühnhardt, Dagmar; Ostermann, Helmut; Hertenstein, Bernd; Aulitzky, Walter E.; Maschmeyer, Georg; Vieler, Tom; Eich, Hans Theodor; Baues, Christian; Stein, Harald; Fuchs, Michael; Diehl, Volker; Dietlein, Markus; Engert, Andreas; Borchmann, Peter

doi:10.1016/s2352-3026(21)00101-0

Cited by 46 publications

(22 citation statements)

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“…These results compare favorably with other PET-driven strategies using either upfront BEACOPP reducing the number of BEACOPP to four cycles 4 in PET2-negative patients or upfront ABVD escalating PET2-positive patients to BEACOPP, [1][2][3] in terms of disease control, safety, and costeffectiveness. 8 Indeed, in the PET-driven arms, PET2-negative patients age , 60 years receiving 6 3 ABVD have an 82.1% (95% CI, 76.5 to 86.5) 3-year PFS in the RATHL study 2 and 87% (95% CI, 84 to 89) in the GITIL/FIL study, 3 those receiving 4 3 BEACOPP in HD18 a 5-year PFS of 93% (95% CI, 90.6 to 95.4), 9 and those included in AHL2011 receiving 2 3 BEACOPP plus 4 3 ABVD 90.5% (95% CI, 86.9 to 93.2). In the PET2-positive group, the 3-year PFS were 63.9% (95% CI, 52.9 to 72.9) and 60% (95% CI, 51 to 68) in RATHL and GITIL/FIL studies, respectively, and the 5-year PFS were 90.1% (95% CI, 87.2 to 92.9) and 68.2% (95% CI, 53.4 to 79.2) in patients who received 6 3 BEACOPP in HD18 and AHL2011, respectively.…”

Section: Discussionmentioning

confidence: 99%

Positron Emission Tomography–Driven Strategy in Advanced Hodgkin Lymphoma: Prolonged Follow-Up of the AHL2011 Phase III Lymphoma Study Association Study

Casasnovas

Bouabdallah

Brice

et al. 2022

JCO

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PURPOSE The AHL2011 study (ClinicalTrials.gov identifier: NCT01358747 ) demonstrated that a positron emission tomography (PET)-driven de-escalation strategy after two cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP) provides similar progression-free survival (PFS) and overall survival (OS) and reduces early toxicity compared with a nonmonitored standard treatment. Here, we report, with a prolonged follow-up, the final study results. METHODS Patients with advanced Hodgkin lymphoma (stage III, IV, or IIB with mediastinum/thorax ratio > 0.33 or extranodal involvement) age 16-60 years were prospectively randomly assigned between 6 × BEACOPP and a PET-driven arm after 2 × BEACOPP delivering 4 × ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) in PET2– and 4 × BEACOPP in PET2+ patients. PET performed after four cycles of chemotherapy had to be negative to complete the planned treatment. RESULTS In total, 823 patients were enrolled including 413 in the standard arm and 410 in the PET-driven arm. With a 67.2-month median follow-up, 5-year PFS (87.5% v 86.7%; hazard ratio [HR] = 1.07; 95% CI, 0.74 to 1.57; P = .67) and OS (97.7% in both arms; HR = 1.012; 95% CI, 0.50 to 2.10; P = .53) were similar in both randomization arms. In the whole cohort, full interim PET assessment predicted patients' 5-year PFS (92.3% in PET2–/PET4–, 75.4% [HR = 3.26; 95% CI, 18.3 to 5.77] in PET2+/PET4– and 46.5% [HR = 12.4; 95% CI, 7.31 to 19.51] in PET4+ patients, respectively; P < .0001) independent of international prognosis score. Five-year OS was also affected by interim PET results, and PET2+/PET4– patients (93.5%; HR = 3.3; 95% CI, 1.07 to 10.1; P = .036) and PET4+ patients (91.9%; HR = 3.756; 95% CI, 1.07 to 13.18; P = .038) had a significant lower OS than PET2–/PET4– patients (98.2%). Twenty-two patients (2.7%) developed a second primary malignancy, 13 (3.2%) and 9 (2.2%) in the standard and experimental arms, respectively. CONCLUSION The extended follow-up confirms the continued efficacy and favorable safety of AHL2011 PET-driven strategy, which is noninferior to standard six cycles of BEACOPP. PET4 provides additional prognostic information to PET2 and allows identifying patients with particularly poor prognosis.

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Section: Discussionmentioning

confidence: 99%

Positron Emission Tomography–Driven Strategy in Advanced Hodgkin Lymphoma: Prolonged Follow-Up of the AHL2011 Phase III Lymphoma Study Association Study

Casasnovas

Bouabdallah

Brice

et al. 2022

JCO

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“…26,34 With a median follow-up of five years, the cumulative incidence of MDS/AML is 0.4% (2/501 patients) for patients who received four cycles of eBEACOPP. 35 In HD15 with 6-8 cycles of eBEA-COPP, 82% of women aged <30 regained regular menstrual cycles compared with 45% of those aged >30. [36][37][38] In HD14 with four cycles of ABVD, 100% of women aged <30 and 94% of those aged >30 regained regular menstrual cycles.…”

Section: Choosi Ng Fir St-li N E Tr E Atm E N T a Pproach I N A Dva N...mentioning

confidence: 98%

“…ABVD has a better toxicity profile than eBEACOPP with respect to infectious complications, blood‐product requirements, fertility preservation and secondary myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML) 26,34 . With a median follow‐up of five years, the cumulative incidence of MDS/AML is 0.4% (2/501 patients) for patients who received four cycles of eBEACOPP 35 . In HD15 with 6–8 cycles of eBEACOPP, 82% of women aged <30 regained regular menstrual cycles compared with 45% of those aged >30 36‐38 .…”

Section: Choosing First‐line Treatment Approach In Advanced‐stage Dis...mentioning

confidence: 99%

Guideline for the first‐line management of Classical Hodgkin Lymphoma — A British Society for Haematology guideline

et al. 2022

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This guideline was compiled according to the British Society for Haematology (BSH) process at BSH Guidelines Process 2016 (b-s-h.org.uk). The Grading of Recommendations Assessment, Development and Evaluation (GRADE) nomenclature was used to evaluate levels of evidence and to assess the strength of recommendations. The GRADE criteria can be found at http://www.grade worki nggro up.org. Recommendations are based on a review of the literature using Medline, PubMed/ Medline and Cochrane searches beginning from 2013 up to January 2021. The following search terms were used: [Hodgkin lymphoma OR Hodgkin disease] NOT non-Hodgkin; AND [chemotherapy OR radiotherapy]; AND [elderly]; AND [teenage OR adolescent OR young adult]; AND [pregnancy]. Filters were applied to include only publications written in English, studies carried out in humans, clinical conferences, congresses, clinical trials, clinical studies, meta-analyses, multicentre studies and randomised controlled trials. References pre-2013 were taken from the previous version of this guideline. 1 Review of the manuscript was performed by the British Society for Haematology (BSH) Guidelines Committee Haematology Oncology Taskforce, the BSH Guidelines Committee and the Haematology Oncology sounding board of BSH.

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“…1,2 With response-adapted treatment comprising four or six cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP) in escalated dose (eBEACOPP), outstanding cure rates are achieved through a comparatively short and safe treatment approach. 3,4 Around 5 to 15% of HL patients present with bone marrow (BM) involvement, as assessed by conventional biopsy. [5][6][7] According to the Ann Arbor classification, BM involvement reflects a high tumour burden and therefore defines stage IV disease.…”

Section: Impact Of Bone Marrow Involvement On Early Positron Emission...mentioning

confidence: 99%

“…Conrad-Amadeus Voltin 2 Helen Kaul 1 Ina Bühnen 1 Jasmin Mettler 2 Thomas Pabst 3,4 Dennis A. Eichenauer 1 Michael Fuchs 1 Volker Diehl 1 Markus Dietlein 2 Andreas Engert 1 Peter Borchmann 1 Carsten Kobe 2…”

Section: Stefanie Kreisslunclassified

Impact of bone marrow involvement on early positron emission tomography response and progression‐free survival in the HD18 trial for patients with advanced‐stage Hodgkin lymphoma

et al. 2021

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PET-guided eBEACOPP treatment of advanced-stage Hodgkin lymphoma (HD18): follow-up analysis of an international, open-label, randomised, phase 3 trial

Cited by 46 publications

References 27 publications

Positron Emission Tomography–Driven Strategy in Advanced Hodgkin Lymphoma: Prolonged Follow-Up of the AHL2011 Phase III Lymphoma Study Association Study

Positron Emission Tomography–Driven Strategy in Advanced Hodgkin Lymphoma: Prolonged Follow-Up of the AHL2011 Phase III Lymphoma Study Association Study

Guideline for the first‐line management of Classical Hodgkin Lymphoma — A British Society for Haematology guideline

Impact of bone marrow involvement on early positron emission tomography response and progression‐free survival in the HD18 trial for patients with advanced‐stage Hodgkin lymphoma

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