The study – the largest randomized trial of early-stage Hodgkin’s disease conducted in the U.S. in two decades – evaluated whether chemotherapy should be part of the treatment regimen for patients with early-stage Hodgkin’s disease. Earlier studies utilizing other chemotherapy combinations followed by radiation also demonstrated improved progression-free survival rates; however, patients experienced excessive toxicities.
The study also determined that staging laparotomy – a previously common abdominal surgery used to diagnose the stage of Hodgkin’s disease – could be avoided. Instead of undergoing staging laparotomy, patients in the trial were staged clinically, by examining tumor size, lymph node involvement, and where the disease has spread.
In the 10-year, phase III trial, 348 patients who had not undergone staging laparotomy were randomized to receive either a combined treatment of three cycles of doxorubicin and vinblastine followed by radiation, or radiation alone. Radiation therapy levels were the same for patients in both arms.
Of the patients who received the combined treatment, the three-year failure free survival rate was 94 percent compared to 81 percent of patients who received only radiation therapy. Patients who achieved failure free survival did not experience a recurrence of their disease or develop any other treatment-related complications during the three-year follow-up period. Because of the significant results, the study was stopped at the second interim analysis after nine years.
“Patients receiving this novel chemotherapy regimen followed by radiation achieved a marked improvement in failure free survival rates compared with patients treated with radiation therapy alone,” said Oliver Press, M.D., a Professor of Medicine in the Division of Medical Oncology at the University of Washington. “This study also showed that staging laparotomy was not necessary to obtain excellent failure free survival rates for patients with early-stage Hodgkin’s disease.”
Ten patients experienced disease progression in the combined treatment group compared to 34 on the radiation therapy group, and only one treatment-related death occurred on each arm. Because highly toxic chemotherapy drugs were not used, patients generally experienced manageable side effects.
During the last three to four years, combined treatment regimens of short course chemotherapy followed by radiation such as the one used in this trial have become the standard of care for patients with early-stage Hodgkin’s disease. Today, most physicians use even smaller radiation fields than were used in this study.
“Phase III Randomized Intergroup Trial of Subtotal Lymphoid Irradiation Versus Doxorubicin, Vinblastine, and Subtotal Lymphoid Irradiation for Stage I to IIA Hodgkin’s Disease.” Oliver W. Press, MD, et al.; Division of Medical Oncology, University of Washington, Seattle , WA. Vol 19, No 22 (November 15) 2001, pp: 4238-4244.
The Journal of Clinical Oncology is the semi-monthly peer-reviewed journal of the American Society of Clinical Oncology (ASCO), the world's leading professional society representing physicians who treat people with cancer.
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