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R-CHOP 14 with or without radiotherapy in non-bulky limited-stage diffuse large B-cell lymphoma (DLBCL)

Thierry Lamy, Gandhi Damaj, Pierre Soubeyran, Emmanuel Gyan, Guillaume Cartron, Krimo Bouabdallah, Rémy Gressin, Jérôme Cornillon, Anne Banos, Katell Le Du, Mohamed Benchalal, Marie-Pierre Moles, Steven Le Gouill, Joel Fleury, Pascal Godmer, Hervé Maisonneuve, Eric Deconinck, Roch Houot, Kamel Laribi, Jean Pierre Marolleau, Olivier Tournilhac, Bernard Branger, Anne Devillers, Jean Philippe Vuilliez, Thierry Fest, Philippe Colombat, Valérie Costes, Vanessa Szablewski, Marie C. Béné and Vincent Delwail

Key points

  • R-CHOP alone is not inferior to R-RCHOP followed by radiotherapy.

Abstract

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).

  • Submitted July 25, 2017.
  • Accepted October 11, 2017.