Low-Dose Radiation Is Sufficient for the Noninvolved Extended-Field Treatment in Favorable Early-Stage Hodgkin’s Disease: Long-Term Results of a Randomized Trial of Radiotherapy Alone

Author:

Dühmke Eckhart1,Franklin Jeremy1,Pfreundschuh Michael1,Sehlen Susanne1,Willich Norman1,Rühl Ursula1,Müller Rolf-Peter1,Lukas Peter1,Atzinger Anton1,Paulus Ursula1,Lathan Bernd1,Rüffer Ulrich1,Sieber Markus1,Wolf Jürgen1,Engert Andreas1,Georgii Axel1,Staar Susanne1,Herrmann Richard1,Beykirch Maria1,Kirchner Hartmut1,Emminger Adelheid1,Greil Richard1,Fritsch Esther1,Koch Peter1,Drochtert Angelika1,Brosteanu Oana1,Hasenclever Dirk1,Loeffler Markus1,Diehl Volker1

Affiliation:

1. From the Canton Hospital, Basel, Switzerland; Radiotherapy and Internal Medicine Departments, Münich University, Münich; Biometry, Radiotherapy, and Internal Medicine Departments, Cologne University, Cologne; Munster University, Munster; Moabit Hospital, Berlin; Innsbruck University, Innsbruck; Klinikum Passau, Passau; and Pathology Department, Hannover Medical School, Hannover, Germany.

Abstract

PURPOSE: To show that radiotherapy (RT) dose to the noninvolved extended field (EF) can be reduced without loss of efficacy in patients with early-stage Hodgkin’s disease (HD). PATIENTS AND METHODS: During 1988 to 1994, pathologically staged patients with stage I or II disease who were without risk factors (large mediastinal mass, extranodal lesions, massive splenic disease, elevated erythrocyte sedimentation rate, or three or more involved areas) were recruited from various centers. All patients received 40 Gy total fractionated dose to the involved field areas but were randomly assigned to receive either 40 Gy (arm A) or 30 Gy (arm B) total fractionated dose for the clinically noninvolved EF. No chemotherapy was given. RT films were prospectively reviewed for protocol violations and recurrences retrospectively related to the applied RT. RESULTS: Of 382 recruited patients, 376 were eligible for randomized comparison, 190 in arm A and 186 in arm B. Complete remission was attained in 98% of patients in each arm. With a median follow-up of 86 months, 7-year relapse-free survival (RFS) rates were 78% (arm A) and 83% (arm B) (P = .093). The upper 95% confidence limit for the possible inferiority of arm B in RFS was 4%. Corresponding overall survival rates were 91% (arm A) and 96% (arm B) (P = .16). The most common causes of death (n = 27) were cardiorespiratory disease/pulmonary embolisms (seven), second malignancy (six), and HD (five). Protocol violation was associated with significantly poorer RFS. Nonirradiated nodes were involved in 42 of 52 reviewed relapses, infield areas in 18, marginal areas in 17, and extranodal sites in 16. CONCLUSION: EF-RT alone attains good survival rates in favorable early-stage HD. The 30-Gy dose is adequate for clinically noninvolved areas. Protocol violation worsens the subsequent prognosis. Relapse patterns suggest that systemic therapy can reduce the 20% long-term relapse rate.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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