title: Combined therapy in advanced stages (III and IV) of follicular lymphoma increases the possibility of cure: results of a large controlled clinical trial.
abstract: OBJECTIVE
  We evaluate the long-term results of a randomized clinical trial in patients with advanced stages (III and IV) of follicular lymphoma using chemotherapy or combined therapy (chemotherapy following by adjuvant radiotherapy in patients with nodal bulky disease).
  
  
  METHODS
  Between 1981 and 1995, patients with follicular lymphoma were treated with combined chemotherapy, mostly anthracycline-based regimens; patients who achieved complete response were randomly assigned either to receive adjuvant radiotherapy to sites or to nodal bulky disease or not (control group).
  
  
  RESULTS
  Four hundred and sixty-nine patients were randomized; in an intent-to-treat analysis all were evaluable for efficacy and toxicity. Actuarial curves at 20yr showed that event-free survival (EFS) and overall survival (OS) in the control group were 41% [95% confidence interval (CI) 36-56%) and 71% (95% CI 65-78%), respectively; these were statistically different from results for the patients who received adjuvant radiotherapy: 68% (95% CI 62-72%) and 89% (95% CI 79-96%), respectively (P<0.01). Acute and late toxicity were minimal; only four patients (<1%) developed myelodysplastic syndrome/acute leukemia. Cardiac toxicity was 2%, but one case was lethal. Thirty-six patients (8%) died secondary to unrelated causes, in complete remission.
  
  
  CONCLUSIONS
  The use of adjuvant radiotherapy in patients with poor-prognosis follicular lymphoma increases EFS and OS with minimal toxicity. We feel that follicular lymphoma should be treated curatively because <80% of patients will be in first complete response at <20yr. The use of adjuvant radiotherapy will be considered in the first line of treatment in this set of patients.
authors.affiliation: Research Unit in Oncological Diseases, Oncology Hospital, National Medical Center, IMSS, México D.F., Mexico. agaviles@avatel.net
authors.forename: Agustin
authors.initials: A
authors.lastname: Avilés
authors.forename: Serafin
authors.initials: S
authors.lastname: Delgado
authors.forename: Raúl
authors.initials: R
authors.lastname: Fernández
authors.forename: Alejandra
authors.initials: A
authors.lastname: Talavera
authors.forename: Natividad
authors.initials: N
authors.lastname: Neri
authors.forename: Judith
authors.initials: J
authors.lastname: Huerta-Guzmán
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D002423:Cause of Death; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D006331:Heart Diseases / Q000139:chemically induced; D006801:Humans; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000139:chemically induced; D009367:Neoplasm Staging; D011379:Prognosis; D012008:Recurrence; D012074:Remission Induction; D015996:Survival Rate