FINAL ANALYSIS OF THE AHL2011 RANDOMIZED PHASE III LYSA STUDY COMPARING AN EARLY PET DRIVEN TREATMENT DE-ESCALATION TO A NOT PET-MONITORED STRATEGY IN PATIENTS WITH ADVANCED STAGES HODGKIN LYMPHOMA
Author(s): ,
Olivier Casasnovas
Affiliations:
Hematology,CHU Le Bocage and INSERM 1231,Dijon,France
,
Pauline Brice
Affiliations:
Hematology,APHP, Hopital Saint Louis,Paris,France
,
Reda Bouabdallah
Affiliations:
Hematology,Institut P. Calmette,Marseille,France
,
Gilles Salles
Affiliations:
Hematology,Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, et Université Claude Bernard Lyon-1,Pierre Bénite,France
,
Aspasia Stamatoulas
Affiliations:
Hematology,Centre H. Becquerel, Rouen,France
,
Jehan Dupuis
Affiliations:
Hematology,Hopital H. Mondor,Creteil,France
,
Oumedaly Reman
Affiliations:
Hematology, Institut d’hématologie de basse normandie ,Caen,France
,
Thomas Gastinne
Affiliations:
Hematology,University Hospital of Nantes,Nantes,France
,
Bertrand Joly
Affiliations:
Hematology,Hospital Sud Francilien,Corbeil-Essonnes,France
,
Krimo Bouabdallah
Affiliations:
Hematology,University Hospital of Bordeaux,Bordeaux,France
,
Emmanuelle Nicolas-Virelizier
Affiliations:
Hematology,Centre L. Bérard ,Lyon,France
,
Pierre Feugier
Affiliations:
Hematology,University Hospital of Nancy ,Vandoeuvre les Nancy,France
,
Franck Morschhauser
Affiliations:
Hematology,CHU Lille, Unité GRITA, Université de Lille 2,Lille,France
,
Richard Delarue
Affiliations:
Hematology,Hopital Necker,Paris,France
,
Alina Berriolo-Riedinger
Affiliations:
Nuclear Medicine,Centre G.F. Leclerc,Dijon,France
,
Véronique Edeline
Affiliations:
Nuclear Medicine,Hopital R. Huguenin, Institut Curie ,St-Cloud,France
,
Alexandra Traverse-Glehen
Affiliations:
Pathology,Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, et Université Claude Bernard Lyon-1,Pierre Bénite,France
,
Marc André
Affiliations:
Hematology,CHU UCL Namur, Université catholique de Louvain ,Yvoir,Belgium
,
Nicolas Mounier
Affiliations:
Hematology,University Hospital of Nice,Nice,France
Michel Meignan
Affiliations:
Nuclear Medicine,LYSA IM, University Hospital H. Mondor,Creteil,France
EHA Learning Center. CASASNOVAS O. Jun 15, 2018; 214504
Dr. Olivier CASASNOVAS
Dr. Olivier CASASNOVAS

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Abstract
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Abstract: S110

Type: Oral Presentation

Presentation during EHA23: On Friday, June 15, 2018 from 11:30 - 11:45

Location: Room A2

Background
Escalated BEACOPP (BEAesc) improves PFS but not OS in pts with advanced Hodgkin Lymphoma (HL) compared to ABVD and is associated to a higher risk of hematological toxicity, secondary leukemia and infertility.

Aims
We hypothesized that PET performed after 2 cycles of upfront BEAesc (PET2) could identify early responding patients who might benefit from a strategy of dose intensity de-escalation, without impairing the disease control.

Methods
The AHL 2011 trial (NCT01358747) was designed to evaluate in 16 to 60 y old HL pts with stage III, IV or high risk IIB, a treatment strategy driven by PET after 2 BEAesc cycles, delivering 4 cycles of ABVD for PET2 negative pts and 4 cycles of BEAesc for PET2 positive pts. This PET driven strategy (arm B) was randomly compared to a standard treatment not adapted by PET delivering 6 cycles of BEAesc (arm A). The allocation of treatment in the experimental arm was based on the central review of PET2 interpreted according to Deauville criteria within 48 hours. PFS was the primary endpoint of the study with a hypothesis of non-inferiority of the PET driven arm compared to the standard arm. 

Results
From May 2011 to May 2014, 823 pts were registered including 413 and 410 pts in the arms A and B respectively. Pts characteristics were well balanced in both arms: median age was 30 y, 63% were male, 74% had nodular sclerosis HL, 11% stage IIB, 28% stage III, 60% stage IV, and 58% an IPS ≥3.
PET2 positivity rate was similar in arms A (12%) and B (13%). Based on PET2 results, 346 (84%) pts received 4 cycles of ABVD and 51 (12%) 4 additional cycles of BEAesc in the experimental arm.
The treatment toxicity was significantly higher in pts receiving 6 cycles of BEAesc compared to those who received 2 cycles of BEAesc + 4 cycles of ABVD with more frequent grade ≥3 AE (anemia (11% vs 2%), leukopenia (85% vs 74%), thrombocytopenia (44% vs 15%), and sepsis (7% vs 3%). 204 serious adverse events (SAE) related to treatment occurred in 119 (26%) patients treated with 6 cycles of BEAesc (leading to death in 6 cases), compared to 102 SAE (leading to death in 2 cases) in 62 (17%) patients treated with 2 x BEAesc + 4 x ABVD (p<0.003). In these latter patients most of SAE (66%) occurred during the 2 first cycles of chemotherapy.

With a median follow up of 50 months, the estimated 4y-PFS was similar in the standard (87.4%) and the PET driven arms (87.1%; p = 0.68). PET2 positivity was related to a significantly lower 4y-PFS compared to PET2 negative patients in the whole population (70.7% vs 90.4%; p<0.0001) and in both randomization arms (75.1% vs 94% and 70.8% vs 91.6% in the standard and PET driven arms, respectively; p<0.0001 for both). OS was similar in both arms.

Conclusion
PET performed after 2 cycles of BEAesc can be safely used to guide subsequent treatment and supports the response-adapted strategy delivering 4 cycles of ABVD for pts with negative PET2 reducing the treatment-related immediate toxicity without impairing the disease control. PET positivity after 2 cycles of BEAesc is related to a higher risk of disease progression, encouraging to develop new treatment options in patients with PET2 positive advanced stage HL.

Session topic: 17. Hodgkin lymphoma – Clinical

Keyword(s): Hodgkin's Lymphoma, PET

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