Annals of oncology : official journal of the European Society for Medical Oncology · 2025
Early positron emission tomography response-adapted treatment in low-risk diffuse large B-cell lymphoma: an open-label, multicenter, randomized, noninferiority phase III trial.
СтатьяКлиническое исследование III фазыМногоцентровое исследованиеРандомизированное исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
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Michot J-M, Bologna S, Bastie J-N, Borght T V, Brière J, Ribrag V, Bommier C, Peyrade F, Lebras L, Damaj G, Coso D, Sibon D, Bonnet C, Morschhauser F, Ghesquières H, Fruchart C, Soussain C, Becker S, Olivier P, Julian A, Molina T, Haioun C, Tilly H
Аннотация
BACKGROUND: Preliminary reports suggest interim positron emission tomography (PET) could drive treatment duration in limited-stage diffuse large B-cell lymphoma (DLBCL). This phase III randomized study in first-line therapy for DLBCL patients with adjusted-age international prognostic index (aaIPI) risk = 0, evaluates an experimental PET-response adapted approach using PET response after two cycles of R-CHOP to de-escalate treatment duration.
PATIENTS AND METHODS: LNH2009-1B study is a two-arm, open-label, multicenter, prospective, randomized phase III noninferiority trial, evaluating treatment de-escalation based on PET after two cycles of R-CHOP in previously untreated DLBCL patients aged 18-80 years, with aaIPI = 0. In the experimental PET-adapted arm, patients with a negative PET after two cycles received four cycles in total of R-CHOP, whereas those with a positive PET after two cycles received a total of six cycles. In the standard arm, treatment was six cycles regardless of PET results after two cycles. No radiotherapy was planned. The primary endpoint was 3 years progression-free survival (PFS). The primary analysis was carried out in the intention-to-treat population. The trial is registered with ClinicalTrial.gov, NCT01285765, recruitment is completed.
RESULTS: A total of 650 patients were enrolled, of whom 319 were randomly assigned to the PET-adapted arm and 331 to the standard arm. In the PET-adapted arm, 77.7% of patients had a negative PET scan after two cycles and received a total of four cycles of R-CHOP. The 3-year PFS in PET-adapted and standard arms were 92.0% [95% confidence interval (CI) 88.3% to 94.5%] and 89.2% (95% CI 85.3% to 92.2%), respectively (P value = 0.070). The noninferiority of the experimental PET-adapted arm was demonstrated (hazard ratio 0.72, 95% CI 0.47-1.12, P value < 0.0001). Patients in the PET-adapted arm had fewer adverse events of grades ≥3 (54.7% versus 62.7%, P = 0.046) and serious adverse events (9.5% versus 14.2%, P = 0.039).
CONCLUSION: A risk-adapted approach using early PET after two cycles of R-CHOP was beneficial, minimizing toxicity without compromising efficacy in patients treated in first-line therapy for low-risk DLBCL.
PATIENTS AND METHODS: LNH2009-1B study is a two-arm, open-label, multicenter, prospective, randomized phase III noninferiority trial, evaluating treatment de-escalation based on PET after two cycles of R-CHOP in previously untreated DLBCL patients aged 18-80 years, with aaIPI = 0. In the experimental PET-adapted arm, patients with a negative PET after two cycles received four cycles in total of R-CHOP, whereas those with a positive PET after two cycles received a total of six cycles. In the standard arm, treatment was six cycles regardless of PET results after two cycles. No radiotherapy was planned. The primary endpoint was 3 years progression-free survival (PFS). The primary analysis was carried out in the intention-to-treat population. The trial is registered with ClinicalTrial.gov, NCT01285765, recruitment is completed.
RESULTS: A total of 650 patients were enrolled, of whom 319 were randomly assigned to the PET-adapted arm and 331 to the standard arm. In the PET-adapted arm, 77.7% of patients had a negative PET scan after two cycles and received a total of four cycles of R-CHOP. The 3-year PFS in PET-adapted and standard arms were 92.0% [95% confidence interval (CI) 88.3% to 94.5%] and 89.2% (95% CI 85.3% to 92.2%), respectively (P value = 0.070). The noninferiority of the experimental PET-adapted arm was demonstrated (hazard ratio 0.72, 95% CI 0.47-1.12, P value < 0.0001). Patients in the PET-adapted arm had fewer adverse events of grades ≥3 (54.7% versus 62.7%, P = 0.046) and serious adverse events (9.5% versus 14.2%, P = 0.039).
CONCLUSION: A risk-adapted approach using early PET after two cycles of R-CHOP was beneficial, minimizing toxicity without compromising efficacy in patients treated in first-line therapy for low-risk DLBCL.