Randomized Controlled Trial

. 2018 Jan 11;131(2):174-181.

doi: 10.1182/blood-2017-07-793984. Epub 2017 Oct 23.

R-CHOP 14 with or without radiotherapy in nonbulky limited-stage diffuse large B-cell lymphoma

Thierry Lamy¹, Gandhi Damaj², Pierre Soubeyran³, Emmanuel Gyan⁴, Guillaume Cartron⁵, Krimo Bouabdallah⁶, Rémy Gressin⁷, Jérôme Cornillon⁸, Anne Banos⁹, Katell Le Du¹⁰, Mohamed Benchalal¹¹, Marie-Pierre Moles¹², Steven Le Gouill¹³, Joel Fleury¹⁴, Pascal Godmer¹⁵, Hervé Maisonneuve¹⁶, Eric Deconinck¹⁷, Roch Houot¹⁸, Kamel Laribi¹⁹, Jean Pierre Marolleau²⁰, Olivier Tournilhac²¹, Bernard Branger²², Anne Devillers²³, Jean Philippe Vuillez²⁴, Thierry Fest²⁵, Philippe Colombat²⁶, Valérie Costes²⁷, Vanessa Szablewski²⁷, Marie C Béné²⁸, Vincent Delwail²⁹; LYSA Group

Affiliations

¹ Hematology Department, Rennes University Hospital, INSERM Research Unit 1236, Rennes, France.
² Hematology Department, Centre Hospitalier Universitaire (CHU) d'Amiens, INSERM U1245, Amiens, France.
³ Bergonié Bordeaux Institute and Bordeaux University, Bordeaux, France.
⁴ Hematology and Cell Therapy Department, Clinical Investigation Center (CIC) INSERM U1415, CHU de Tours, Université François Rabelais, Tours, France.
⁵ Hematology Department, CHU Montpellier, Centre National de la Recherche Scientifique (CNRS) Unité Mixte de Recherche (UMR) 5235, Montpellier, France.
⁶ Hematology and Cell Therapy Department, University Hospital of Bordeaux, Bordeaux, France.
⁷ Onco Hematology Department, Hospital University Grenoble, INSERM U1209, CNRS UMR 5309, Université Grenoble Alpes, Site Santé, La Tronche, Grenoble, France.
⁸ Hematology Department, Cancer Institute Lucien Neuwirth, Saint-Priest-en-Jarez, France.
⁹ Hematology Department, Centre Hospitalier de la Côte Basque, Bayonne, France.
¹⁰ Hematology Department, Clinique Victor Hugo, Le Mans, France.
¹¹ Radiotherapy Department, Centre Eugène Marquis, Rennes, France.
¹² Hematology Department, CHU d'Angers, Angers, France.
¹³ Hematology Department, CHU de Nantes, University of Nantes, INSERM team 10 UMR 892, Institut de Recherche en Santé de l'Université de Nantes, CIC Hospital Hôtel Dieu, Nantes, France.
¹⁴ Oncology Department, Médicale-Pôle Santé République, Clermont-Ferrand, France.
¹⁵ Hematology Department, Centre Hospitalier de Vannes, Vannes, France.
¹⁶ Hematology Department, Centre Hospitalier Départemental de Vendée, La Roche-Sur-Yon, France.
¹⁷ Hematology Department, Centre Hospitalier Regional Universitaire Besançon, INSERM UMR 1098, Université de Franche-Comté, Besançon, France.
¹⁸ Hematology Department, Rennes University Hospital, INSERM UMR 1236, Rennes, France.
¹⁹ Hematology Department, Centre Hospitalier du Mans, Le Mans, France.
²⁰ Hematology and Cell Therapy Department, CIC U1415, Department EA4666, CHU Amiens, Amiens, France.
²¹ Hematology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.
²² Health Network of Pays de Loire, Nantes, France.
²³ Nuclear Medicine Department, Centre Eugène Marquis, Rennes, France.
²⁴ Imaging Nuclear Medicine Department and Radiopharmaceutical and Bioclinical Department, CHU de Grenoble, INSERM U1039, Grenoble University, Grenoble, France.
²⁵ INSERM UMR 1236, Rennes University, Etablissement Français du Sang and Laboratoire d'Hématologie, CHU de Rennes, Rennes, France.
²⁶ Hematology and Cell Therapy Department, CIC INSERM U1415, CHU de Tours, Université François Rabelais, Tours, France.
²⁷ Pathology Department, CHU Montpellier, Montpellier, France.
²⁸ Hematology Biology, Nantes University Hospital, Nantes, France; and.
²⁹ Hematology and Cell Therapy Department, CIC INSERM U1415, CHU de Poitiers, and CIC INSERM 1402, Université de Poitiers, Poitiers, France.

PMID: 29061568
PMCID: PMC5757680
DOI: 10.1182/blood-2017-07-793984

Randomized Controlled Trial

R-CHOP 14 with or without radiotherapy in nonbulky limited-stage diffuse large B-cell lymphoma

Thierry Lamy et al. Blood. 2018.

. 2018 Jan 11;131(2):174-181.

doi: 10.1182/blood-2017-07-793984. Epub 2017 Oct 23.

Authors

Affiliations

¹ Hematology Department, Rennes University Hospital, INSERM Research Unit 1236, Rennes, France.
² Hematology Department, Centre Hospitalier Universitaire (CHU) d'Amiens, INSERM U1245, Amiens, France.
³ Bergonié Bordeaux Institute and Bordeaux University, Bordeaux, France.
⁴ Hematology and Cell Therapy Department, Clinical Investigation Center (CIC) INSERM U1415, CHU de Tours, Université François Rabelais, Tours, France.
⁵ Hematology Department, CHU Montpellier, Centre National de la Recherche Scientifique (CNRS) Unité Mixte de Recherche (UMR) 5235, Montpellier, France.
⁶ Hematology and Cell Therapy Department, University Hospital of Bordeaux, Bordeaux, France.
⁷ Onco Hematology Department, Hospital University Grenoble, INSERM U1209, CNRS UMR 5309, Université Grenoble Alpes, Site Santé, La Tronche, Grenoble, France.
⁸ Hematology Department, Cancer Institute Lucien Neuwirth, Saint-Priest-en-Jarez, France.
⁹ Hematology Department, Centre Hospitalier de la Côte Basque, Bayonne, France.
¹⁰ Hematology Department, Clinique Victor Hugo, Le Mans, France.
¹¹ Radiotherapy Department, Centre Eugène Marquis, Rennes, France.
¹² Hematology Department, CHU d'Angers, Angers, France.
¹³ Hematology Department, CHU de Nantes, University of Nantes, INSERM team 10 UMR 892, Institut de Recherche en Santé de l'Université de Nantes, CIC Hospital Hôtel Dieu, Nantes, France.
¹⁴ Oncology Department, Médicale-Pôle Santé République, Clermont-Ferrand, France.
¹⁵ Hematology Department, Centre Hospitalier de Vannes, Vannes, France.
¹⁶ Hematology Department, Centre Hospitalier Départemental de Vendée, La Roche-Sur-Yon, France.
¹⁷ Hematology Department, Centre Hospitalier Regional Universitaire Besançon, INSERM UMR 1098, Université de Franche-Comté, Besançon, France.
¹⁸ Hematology Department, Rennes University Hospital, INSERM UMR 1236, Rennes, France.
¹⁹ Hematology Department, Centre Hospitalier du Mans, Le Mans, France.
²⁰ Hematology and Cell Therapy Department, CIC U1415, Department EA4666, CHU Amiens, Amiens, France.
²¹ Hematology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.
²² Health Network of Pays de Loire, Nantes, France.
²³ Nuclear Medicine Department, Centre Eugène Marquis, Rennes, France.
²⁴ Imaging Nuclear Medicine Department and Radiopharmaceutical and Bioclinical Department, CHU de Grenoble, INSERM U1039, Grenoble University, Grenoble, France.
²⁵ INSERM UMR 1236, Rennes University, Etablissement Français du Sang and Laboratoire d'Hématologie, CHU de Rennes, Rennes, France.
²⁶ Hematology and Cell Therapy Department, CIC INSERM U1415, CHU de Tours, Université François Rabelais, Tours, France.
²⁷ Pathology Department, CHU Montpellier, Montpellier, France.
²⁸ Hematology Biology, Nantes University Hospital, Nantes, France; and.
²⁹ Hematology and Cell Therapy Department, CIC INSERM U1415, CHU de Poitiers, and CIC INSERM 1402, Université de Poitiers, Poitiers, France.

PMID: 29061568
PMCID: PMC5757680
DOI: 10.1182/blood-2017-07-793984

Abstract

The benefit of radiotherapy (RT) after chemotherapy in limited-stage diffuse large B-cell lymphoma (DLBCL) remains controversial. We conducted a randomized trial in patients with nonbulky limited-stage DLBCL to evaluate the benefit of RT after rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Patients were stratified according to the modified International Prognostic Index, including lactate dehydrogenase, Eastern Cooperative Oncology Group performance status, age, and disease stage. The patients received 4 or 6 consecutive cycles of R-CHOP delivered once every 2 weeks, followed or not by RT at 40 Gy delivered 4 weeks after the last R-CHOP cycle. All patients were evaluated by fluorodeoxyglucose-positron emission tomography scans performed at baseline, after 4 cycles of R-CHOP, and at the end of treatment. The primary objective of the trial was event-free survival (EFS) from randomization. The trial randomly assigned 165 patients in the R-CHOP arm and 169 in the R-CHOP plus RT arm. In an intent-to-treat analysis with a median follow-up of 64 months, 5-year EFS was not statistically significantly different between the 2 arms, with 89% ± 2.9% in the R-CHOP arm vs 92% ± 2.4% in the R-CHOP plus RT arm (hazard ratio, 0.61; 95% confidence interval [CI], 0.3-1.2; P = .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 plus RT (P = not significant). R-CHOP alone is not inferior to R-CHOP followed by RT in patients with nonbulky limited-stage DLBCL. This trial was registered at www.clinicaltrials.gov as #NCT00841945.

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Figures

**Figure 2.**
**Kaplan-Meier analysis of survival calculated from time of inclusion.** (A) Event-free survival and (B) overall survival. Solid line, R-CHOP; dotted line, R-CHOP plus RT.

**Figure 3.**
**Kaplan-Meier analysis of overall survival for patients in CR at cycle 4 according to randomization.** Solid line, R-CHOP; dotted line, R-CHOP plus RT.

**Figure 4.**
**Incidence of relapse according to treatment arm.** Solid line, R-CHOP; dotted line, R-CHOP plus RT.

See this image and copyright information in PMC

Comment in

Limited-stage DLBCL: it's patient selection.
Persky DO. Persky DO. Blood. 2018 Jan 11;131(2):155-156. doi: 10.1182/blood-2017-11-813915. Blood. 2018. PMID: 29326347 Free PMC article.
Balancing the Therapeutic Ratio in DLBCL Requires Appropriate, Individualized Patient Selection Rather Than Broad Elimination of Radiation Therapy.
Campbell BA, Bakst RL, Milgrom SA, Seymour JF. Campbell BA, et al. Int J Radiat Oncol Biol Phys. 2022 Jul 1;113(3):479-488. doi: 10.1016/j.ijrobp.2022.02.017. Int J Radiat Oncol Biol Phys. 2022. PMID: 35777387 No abstract available.
Diffuse large B-cell lymphoma of the Waldeyer's ring: A U.S. population-based survival analysis.
Florindez JA, Lossos IS, Alderuccio JP. Florindez JA, et al. Hematol Oncol. 2023 Feb;41(1):192-195. doi: 10.1002/hon.3059. Epub 2022 Aug 22. Hematol Oncol. 2023. PMID: 35942538 No abstract available.

References

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1. Persky DO, Unger JM, Spier CM, et al. ; Southwest Oncology Group. Phase II study of rituximab plus three cycles of CHOP and involved-field radiotherapy for patients with limited-stage aggressive B-cell lymphoma: Southwest Oncology Group study 0014. J Clin Oncol. 2008;26(14):2258-2263. - PubMed
1. Miller TP. The limits of limited stage lymphoma. J Clin Oncol. 2004;22(15):2982-2984. - PubMed
1. Zelenetz AD, Abramson JS, Advani RH, et al. . NCCN Clinical Practice Guidelines in Oncology: non-Hodgkin’s lymphomas. J Natl Compr Canc Netw. 2010;8(3):288-334. - PubMed
1. Bonnet C, Fillet G, Mounier N, et al. ; Groupe d’Etude des Lymphomes de l’Adulte. CHOP alone compared with CHOP plus radiotherapy for localized aggressive lymphoma in elderly patients: a study by the Groupe d’Etude des Lymphomes de l’Adulte. J Clin Oncol. 2007;25(7):787-792. - PubMed

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R-CHOP 14 with or without radiotherapy in nonbulky limited-stage diffuse large B-cell lymphoma

Affiliations

R-CHOP 14 with or without radiotherapy in nonbulky limited-stage diffuse large B-cell lymphoma

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