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Three cycles of MOPP/ABV hybrid and involved-field irradiation is more effective than subtotal nodal irradiation in favorable supradiaphragmatic clinical stages I-II Hodgkins disease Prelimi-nary results of the EORTC-GELA H8-F randomized trial in 543 patients



Three cycles of MOPP/ABV hybrid and involved-field irradiation is more effective than subtotal nodal irradiation in favorable supradiaphragmatic clinical stages I-II Hodgkins disease Prelimi-nary results of the EORTC-GELA H8-F randomized trial in 543 patients



Blood 96(11 Part 1): 575a, November 16



The trial aimed at reducing the incidence of late toxicity while maintaining the best possible survival. From September 1993 to March 1999, 543 adult patients with supradiaphragmatic CS I-II HD were randomized. All patients presented with the following characteristics: age < 50, and CS I-II2-3, and A + ESR < 50 or B + ESR < 30, and MT ratio < 0.35. The trial compared STNI (n = 272) with M/A hybrid X 3 cycles followed by involved field (IF 36-40 Gy) irradiation (n = 271). As per July 2000 the median follow-up time since randomization is 42 months. Chemotherapy-related hematological toxicity (mainly WBC) was developed by 85 (31%) patients while radiation-related hematological toxicity was observed in 3 (1%) STNI patients and 7 (3%) M/A patients only. No patients interrupted their treatment because of toxicity. Response rates (CR, PR, PD) were similar (94%, 3%, 3% versus 96%, 3%, 1%) in STNI and M/A groups, respectively. However, the number of patients who relapsed was much higher in STNI (n=41) than in M/A (n=1) leading to a 4-year Treatment Failure-Free Survival (TFFS) rate of 77% and 99% (p<0.001), respectively. Salvage therapy was effective yielding a 4-year Overall Survival rate of 95% and 99% (p=0.019). Causes of death included progressive disease (4 and 1 patients), treatment-related complications (2 and 0), intercurrent disease (1 and 0), and cause unspecified (1 and 0). No acute leukemia nor MDS were observed yet. In view of its higher TFFS and potentially less treatment-related morbidity and mortality, chemotherapy and IF irradiation is preferred to STNI, which is no longer used for patients with favorable supradiaphragmatic HD. To assess the optimal combined modality strategy, the current EORTC-GELA H9-F trial investigates the contribution of IF irradiation using a randomized design between three dosages: 36 Gy versus 20 Gy versus no irradiation in patients achieving CR after chemotherapy.

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