Early positron emission tomography response‑adapted treatment in low‑risk diffuse large B‑cell lymphoma: an open‑label, multicenter, randomized, noninferiority phase III trial
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.
This phase III, randomized, noninferiority, multicenter trial evaluated whether early positron emission tomography (PET) after two cycles of R‑CHOP could safely reduce treatment duration in patients with low‑risk diffuse large B‑cell lymphoma (DLBCL) (aaIPI=0). 650 patients were randomized to a PET‑adapted arm, wherein patients with a negative PET after two cycles received a total of four cycles of R‑CHOP, versus a standard arm of six cycles regardless of PET findings. At 3‑year progression‑free survival, the PET‑adapted arm achieved 92.0% compared with 89.2% for the standard arm (HR 0.72, 95% CI 0.47–1.12, p < 0.0001). PET‑adapted therapy also yielded lower toxicity (grade ≥ 3 adverse events 54.7% vs 62.7%, serious adverse events 9.5% vs 14.2%). The study demonstrates that early PET can safely reduce treatment intensity in low‑risk DLBCL without compromising efficacy.
Optimizing therapy intensity in low‑risk DLBCL can reduce treatment‑related toxicity and improve patient quality of life while maintaining cure rates. This trial establishes that early PET imaging is an effective tool for de‑escalating therapy safely, potentially informing guidelines and improving standard of care.
Bizonyítékszint: Állatkísérletes. Állatmodellben vizsgálták.
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