Abstract
BACKGROUND
This Phase II study was performed in patients with advanced or bulky Hodgkin disease (HD) to evaluate the results of a 7‐drug chemotherapy (CT) regimen that was administered over 12 weeks according to 2 randomized modalities followed by high‐dose lymph node irradiation.
METHODS
From 1990 to 1996, 162 patients with HD at clinical stages (CS) I–III with bulky disease (mediastinal mass ratio ≥ 0.45 and/or unilateral or bilateral pelvic plus lumboaortic disease; 86 patients) or CS IV (76 patients) were randomized to receive the same cumulated dose of a CT regimen consisting of epirubicin (240 mg/m^2^), bleomycin (60 mg/m^2^), vinblastine (20 mg/m^2^), vincristine (4 mg/m^2^), cyclophosphamide (4000 mg/m^2^), etoposide (900 mg/m^2^), and methotrexate (180 mg/m^2^) plus methylprednisolone (1500 mg/m^2^) over 12 weeks either every 4 weeks (Arm Y, 79 patients) or every 3 weeks (Arm Z, 83 patients). Patients with disease in complete remission (CR) or partial remission after CT received extended‐field lymph node irradiation (involved areas, 40 grays [Gy]; noninvolved areas, 30 Gy).
RESULTS
Forty‐two percent of patients achieved a post‐CT CR, and 86% of patients achieved a CR after the completion of irradiation (there was no difference between Arm Y and Arm Z). Thirty‐five patients developed recurrent disease; most of those patients were in post‐CT partial remission. The 10‐year freedom from first progression rate was 63.9% (there was no difference between Arm Y and Arm Z). Thirty‐eight patients died: 24 patients from HD, 3 patients from CT‐related early sepsis, 1 patient from radiation‐induced pneumonitis, 6 patients from a second malignancy, and 4 patients from causes unrelated to treatment. The overall 10‐year survival rate was 76.7%. Survival was slightly higher among patients in Arm Y (83.3%) compared with patients in Arm Z (70.2%; P = 0.12).
CONCLUSIONS
No differences were found when the same amount of CT was delivered in three courses or in four courses. In 1997, because most recurrences of the H90‐A/B trial occurred in patients who achieved a post‐CT partial remission, the authors decided to reinforce the intensity of the initial CT and designed a new randomized study comparing two modalities of more intensive CT plus consolidative radiotherapy (H97‐LM trial). Cancer 2002;95:2169–79. © 2002 American Cancer Society.
DOI 10.1002/cncr.10932