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

被引:30
作者
Casasnovas, Rene-Olivier [1 ]
Bouabdallah, Reda [2 ,3 ]
Brice, Pauline [4 ]
Lazarovici, Julien [5 ]
Ghesquieres, Herve [6 ]
Stamatoullas, Aspasia [7 ]
Dupuis, Jehan [8 ]
Gac, Anne-Claire [9 ]
Gastinne, Thomas [10 ]
Joly, Bertrand [11 ]
Bouabdallah, Krimo [12 ]
Nicolas-Virelizier, Emmanuelle [13 ]
Feugier, Pierre [14 ]
Morschhauser, Franck [15 ]
Sibon, David [16 ]
Bonnet, Christophe [17 ]
Berriolo-Riedinger, Alina [18 ]
Edeline, Veronique [19 ]
Parrens, Marie [20 ]
Damotte, Diane [2 ,21 ]
Coso, Diane
Andre, Marc [22 ,23 ]
Meignan, Michel [24 ]
Rossi, Cedric [1 ]
机构
[1] Univ Hosp, F Mitterrand & Inserm UMR, Dept Hematol, Dijon, France
[2] Inst P Calmette, Dept Hematol, Marseille, France
[3] Hop Priv Provence, Dept Hematol, Aix En Provence, France
[4] Hop St Louis, APHP, Dept Hematol, Paris, France
[5] Inst G Roussy, Dept Hematol, Villejuif, France
[6] Univ Claude Bernard Lyon 1, Hosp Civils Lyon, Dept Hematol, Ctr Hosp Lyon Sud, Pierre Benite, France
[7] Ctr H Becquerel, Dept Hematol, Rouen, France
[8] Henri Mondor Univ Hosp, Lymphoid Malignancies Unit, Creteil, France
[9] Inst Hematol Basse Normandie, Dept Hematol, Caen, France
[10] Univ Hosp Nantes, Dept Hematol, Nantes, France
[11] Hosp Sud Francilien, Dept Hematol, Corbeille Essonnes, France
[12] Univ Hosp Bordeaux, Dept Hematol, Bordeaux, France
[13] Ctr L Berard, Dept Hematol, Lyon, France
[14] Univ Hosp Nancy, Dept Hematol, Vandoeuvre Les Nancy, France
[15] Univ Lille 2, Unit GRITA, Dept Hematol, CHU Lille, Lille, France
[16] Hop Necker Enfants Malad, Dept Hematol, Paris, France
[17] Univ Hosp Liege, Dept Hematol, Liege, Belgium
[18] Ctr GF Leclerc, Dept Nucl Med, Dijon, France
[19] Hop R Huguenin, Inst Curie, Dept Nucl Med, St Cloud, France
[20] Univ Hosp Bordeaux & Inserm UMR, Dept Pathol, Bordeaux, France
[21] Univ Paris & GH Paris Ctr APHP, Dept Pathol, Paris, France
[22] Catholic Univ Louvain, Dept Hematol, CHU UCL Namur, Yvoir, Belgium
[23] Catholic Univ Louvain, Inst Rech Expt & Clin, Pole Mont, Brussels, Belgium
[24] Univ Hosp H Mondor, Dept Nucl Med, Creteil, France
关键词
STEM-CELL TRANSPLANTATION; EVENT-FREE SURVIVAL; OPEN-LABEL; FDG-PET; EARLY INTERIM; TRIAL; CHEMOTHERAPY; RISK; MULTICENTER; SUPERIOR;
D O I
10.1200/JCO.21.01777
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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 x BEACOPP and a PET-driven arm after 2 x BEACOPP delivering 4 x ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) in PET2-and 4 x 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% v86.7%; 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. (C) 2022 by American Society of Clinical Oncology
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页码:1091 / +
页数:12
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