R-CHOP 14 with or without radiotherapy in non-bulky limited-stage diffuse large B-cell lymphoma (DLBCL)
Mené en France sur 334 patients atteints d'un lymphome diffus à grandes cellules B de stade limité (durée médiane de suivi : 64 mois ; taille de la tumeur : inférieure à 7cm), cet essai évalue, du point de vue de la survie sans événement, l'intérêt d'ajouter une radiothérapie à une chimiothérapie de type R-CHOP
The benefit of radiotherapy (RT) following chemotherapy in limited-stage diffuse large B-cell lymphoma (DLBCL) remains controversial. Before the Rituximab (R) era, randomized trials have reported conflicting results. We conducted a randomized trial in patients with non-bulky (tumor size <7cm) limited-stage DLBCL to evaluate the benefit of RT following R-CHOP. Patients were stratified according to the Miller modified IPI (mIPI) including LDH (normal/elevated), ECOG performance status (0-1/2-3), age (<60/>60 yrs) and disease stage (I/II). The patients received 4 or 6 consecutive cycles of R-CHOP delivered every two weeks, followed or not by RT at 40 Gy delivered 4 weeks after the last R-CHOP cycle. All patients were evaluated by FDG-PETs performed at baseline, after 4 R-CHOP cycles and at the end of treatment. The primary objective of the trial was event-free survival (EFS) from randomization. The trial randomized 165 patients in the R-CHOP arm and 169 in the R-CHOP+RT arm. In an intent to treat analysis, with a median follow-up of 64 months, five-year EFS was not statistically different between the two arms, with 89% ± 2.9 in the R-CHOP arm vs 92% ± 2.4 in the R-CHOP+RT arm (HR 0.61, 95%CI 0.3 to 1.2, p=0.18). Overall survival was also not different at 92% (95% CI: 89.5-94.5) for patients assigned to R-CHOP alone, and 96% (95% CI: 94.3-97.7) for those assigned to R-CHOP+RT, (p=ns) R-CHOP alone is not inferior to R-CHOP followed by RT in patients with non-bulky limited-stage DLBCL. (ClinicalTrials.gov number, NCT00841945).
Blood 2017