E1484 – Trial Results Summary for Patients

Title

Using Chemotherapy Alone or with Radiation Therapy to Treat Aggressive Non-Hodgkin’s Lymphoma

Sponsor

Eastern Cooperative Oncology Group through the NCI-sponsored Cancer Cooperative Group Program

Purpose of the Study

The purpose of this study was to compare lower-dose radiation therapy versus observation alone in patients who had complete responses (no detectable disease) after eight cycles of chemotherapy with a combination of cyclophosphamide, doxorubicin, vincristine and prednisone. The study also looked at the effectiveness of high-dose radiation therapy in patients who had partial responses (cancer that got smaller) to this chemotherapy treatment.

Results

An improvement in six-year, disease-free survival (the time to return of disease or death) was observed in 73 percent of patients who had achieved a complete response with combination chemotherapy followed by low-dose radiation therapy. Of the patients who received combination chemotherapy followed by observation alone, 56 percent were still free of disease after six years. This study showed that while radiation provided control of the tumors, relapses occurring in other areas of the body were the major cause of treatment failure. This study did not detect differences in overall survival in the two treatment arms.

Conclusion

This study, initiated more than 20 years ago, sets a standard for local control with radiation therapy for future comparisons with newer systemic approaches incorporating rituximab, alternate chemotherapy, or radioimmunotherapy.

Start Date

October 1984

Stop Date

August 1992

Number of Participating Patients

399

Eligibility Requirements

Participants in this study had limited-stage aggressive lymphoma and had no detectable cancer (complete remission) after chemotherapy with cyclophosphamide, doxorubicin, vincristine and prednisone. Patients had no prior chemotherapy or radiation therapy.

Study Design

Patients received eight cycles of chemotherapy delivered through a vein. Those who had complete responses to treatment were randomly selected to receive either observation or low-dose radiation therapy (30Gy). Patients who had partial responses to treatment were all given a higher dose of radiation treatment (40Gy). Four weeks following radiation therapy, patient’s disease was again evaluated for response.

Side Effects

Treatment with low-dose and high-dose radiation therapy was tolerated well. Three severe side effects included cardiac problems and lowered blood counts.