Originally published as JCO Early Release 10.1200/JCO.2004.06.088 on June 21 2004

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Chemotherapy With or Without Radiotherapy in Limited-Stage Diffuse Aggressive Non-Hodgkin's Lymphoma: Eastern Cooperative Oncology Group Study 1484

From Stanford University, Stanford, CA; Dana-Farber Cancer Center, New York, NY; University of Wisconsin-Madison, Madison, WI; Mayo Clinic, Rochester, MN; Allegheny Cancer Center, Pittsburgh, PA; and Abramson Cancer Center of the University of Pennsylvania, Pennsylvania, PA

Address reprint requests to Sandra J. Horning, MD, Stanford University, 875 Blake Wilbur Dr, Suite 2338, Stanford, CA 94305-5821; e-mail: sandra.horning{at}stanford.edu

PURPOSE: To compare low-dose (30 Gy) radiotherapy (RT) with observation (OBS) in limited-stage aggressive lymphoma patients achieving complete remission (CR) after chemotherapy, and to measure conversion from partial response (PR) to CR with high-dose (40 Gy) RT.

PATIENTS AND METHODS: From 1984 to 1992, stage I (with risk factors) and II adults with diffuse aggressive lymphoma in CR after eight cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) were randomly assigned to 30 Gy involved-field RT or OBS. PR patients received 40 Gy RT.

RESULTS: Among 172 CR patients, the 6-year disease-free survival (DFS) was 73% for low-dose RT versus 56% for OBS (two-sided P = .05). Failure-free survival (two-sided P = .06), and time to progression (two-sided P = .06) also favored RT. Intent-to-treat analyses yielded similar results. No survival differences were observed. Three RT versus 15 OBS patients relapsed in initial disease sites. At 6 years, failure-free survival was 63% in PR patients; conversion to CR did not significantly influence clinical outcome.

CONCLUSION: For patients in CR after CHOP, low-dose RT prolonged DFS and provided local control, but no survival benefit was observed. The majority of PR patients were event-free at 6 years despite residual radiographic abnormalities. Future efforts should be directed toward improved imaging and more effective systemic therapies.

Supported by grants CA-23318, CA-46592, CA-15488, CA-13650, CA-66636, and CA-21115 from the National Cancer Institute.

Presented in part at the Annual Meeting of the American Society of Hematology, Orlando, FL, December 7-11, 2001.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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