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Randomized Comparison of Low-Dose Involved-Field Radiotherapy and No Radiotherapy for Children With Hodgkin’s Disease Who Achieve a Complete Response to Chemotherapy

From the Section of Pediatric Hematology-Oncology, University of Chicago, Chicago, IL; Department of Preventive Medicine, Keck School of Medicine, University of Southern California, and Department of Pathology/Research, Children’s Hospital Los Angeles, Los Angeles, CA; Group Health Cooperative of Puget Sound, Department of Pediatric Hematology-Oncology, Redmond, WA; Mayo Clinic and Foundation, Rochester, MN; Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY; Departments of Radiotherapy and Pediatric Medical Imaging, Primary Children’s Medical Center, Salt Lake City, UT; Department of Pathology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; Department of Hematology-Oncology, Children’s Healthcare of Atlanta at Scottish Rite Hospital, Atlanta, GA; and Division of Pediatric Hematology-Oncology, C.S. Mott Children’s Hospital, Ann Arbor, MI.

Address reprint requests to James B. Nachman, MD, Children’s Oncology Group, PO Box 60012, Arcadia, CA 91066-6012; email: jnachman{at}peds.bsd.uchicago.edu

PURPOSE: Current standard therapy for children and adolescents with Hodgkin’s disease includes combination chemotherapy and low-dose involved-field radiation (LD-IFRT). Because radiation may be associated with adverse late effects, the Children’s Cancer Group (CCG) investigated whether radiation could be omitted in patients achieving a complete response to initial chemotherapy without jeopardizing the excellent outcome obtained with combined-modality therapy.

PATIENTS AND METHODS: Between January 1995 and December 1998, 829 eligible patients were enrolled onto CCG 5942. A total of 501 patients who achieved an initial complete response after risk-adapted combination chemotherapy were randomized to receive LD-IFRT or no further treatment. Event-free survival (EFS) and overall survival were assessed from the date of study entry or the date of randomization, as appropriate.

RESULTS: The projected 3-year EFS from study entry for the entire cohort was 87% ± 1.2%. Among patients who achieved a complete response to initial chemotherapy, 92% ± 1.9% of those randomized to receive LD-IFRT were alive and disease free 3 years after randomization, versus 87% ± 2.2% for patients randomized to receive no further therapy (stratified log-rank test; P = .057). With an "as-treated" analysis, 3-year EFS after randomization for the radiation cohort was 93% ± 1.7% versus 85% ± 2.3% for patients receiving no further therapy (stratified log-rank test; P = .0024). Three-year survival estimates for patients treated with and without LD-IFRT were 98% ± 1.1% for patients who received radiation and 99% ± 0.5% for patients who did not receive radiation.

CONCLUSION: LD-IFRT after an initial complete response to risk-adapted chemotherapy improved EFS. At this time, there is no survival advantage for LD-IFRT, but follow-up remains short.

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