title: Randomized clinical trial to assess the efficacy of radiotherapy in primary mediastinal large B-lymphoma.
abstract: OBJECTIVE
  We developed a controlled clinical trial to assess the efficacy and toxicity of adjuvant-involved field radiotherapy (IFRT) in patients with primary mediastinal B-cell lymphoma that achieved complete response after the patients were treated with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP-14).
  
  
  METHODS
  Between January 2001 and June 2004, 124 consecutive patients who were in complete remission after dose dense chemotherapy and rituximab administration (R-CHOP14) were randomly assigned to received IFRT (30 Gy). Sixty-three patients received IFR, and 61 patients did not (control group).
  
  
  RESULTS
  The study aimed to include 182 patients in each arm but was closed prematurely because in a security analysis (June 2004), progression and early relapse were more frequent in patients that did not received IFRT. Patients were followed until March 2009, at which point actuarial curves at 10 years showed that progression free-survival was 72% in patients who received IFR and 20% in the control group (p < 0.001), overall survival was 72% and 31%, respectively (p < 0.001). Acute toxicity was mild and well tolerated.
  
  
  CONCLUSIONS
  Adjuvant radiotherapy to sites of bulky disease was the only difference to have an improvement in outcome in our patients; the use of rituximab during induction did not improve complete response rates and did affect overall survival; patients who received rituximab but not IFRT had a worse prognosis.
  
  
  CONCLUSIONS
  The use of IFRT in patients with primary mediastinal B-cell lymphoma who achieved complete response remain as the best treatment available, even in patients that received rituximab during induction.
authors.affiliation: Oncology Research Unit, Oncology Hospital, National Medical Center, IMSS, México, D. F., Mexico. agustin.aviles@imss.gob.mx
authors.forename: Agustin
authors.initials: A
authors.lastname: Avilés
authors.forename: Natividad
authors.initials: N
authors.lastname: Neri
authors.forename: Raúl
authors.initials: R
authors.lastname: Fernández
authors.forename: Judith
authors.initials: J
authors.lastname: Huerta-Guzmán
authors.forename: María J
authors.initials: MJ
authors.lastname: Nambo
mesh_terms: D000328:Adult; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D057239:Early Termination of Clinical Trials / Q000401:mortality; D005260:Female; D006801:Humans; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D008479:Mediastinal Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D008800:Mexico; D011241:Prednisone / Q000008:administration & dosage; D018714:Radiotherapy, Adjuvant / Q000379:methods / Q000401:mortality; D000069283:Rituximab; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; C571759:R-CHOP protocol; D000069283:Rituximab; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone