Involved-Field Radiotherapy in Patients with Stage III/IV Hodgkin's Lymphoma: First Results of the Randomized EORTC Trial # 20884
William Levin, MD
University of Pennsylvania Cancer Center
Ultima Vez Modificado: 5 de noviembre del 2001
Presenter: B.M. Aleman Presenter's Affiliation: EORTC Lymphoma Group, Brussels, Belgium Type of Session: Plenary
Background While the role of radiation therapy in the treatment of early stage Hodgkins Disease is well established, its utility in advanced disease is not as clear.
736 patients were enrolled in a phase-III randomized trial comparing involved field radiotherapy (IFRT) versus no further treatment (no-RT) in patients with stage III/IV HL, who reached CR after standard MOPP/ABV chemotherapy.
Patients in early CR (after 4 cycles) received a total of 6 cycles while those in late CR (after 6 cycles) were given 8 courses.
Patients were randomized after the last chemotherapy cycle.
IFRT was performed as follows: 24 Gy to all initially involved nodal areas and 16-24 Gy to all initially involved extranodal areas, in fractions of 1.5-2.0 Gy, 5 fractions a week.
Partial responders (PR) after 6 cycles of MOPP/ABV were treated with IFRT to all initially involved lymph node areas and all initially involved organs.
The dose delivered to nodal areas and initially involved organs depended on their clinical status.
In case of CR after chemotherapy, the dose was the same as in CR patients.
In case of PR, 30 Gy were delivered to nodal areas and 18-24 Gy to extranodal sites with localized boost of 4-10 Gy where necessary.
The dose per fraction was 1.5-2.0 Gy on nodal areas.
The main endpoints were relapse-free survival (RFS), event-free survival (EFS) and overall survival (OS).
The mean age was 36 years; 80% had mediastinal involvement (of whom 35% bulky); 42% had stage IV disease.
After chemotherapy 60% reached a CR, 35% a PR, <1 % had no change, 2% had progressive disease (PD) and 2 % have died.
From the 418 patients who reached a CR, 161 patients were randomized to receive no RT and 172 patients to IFRT.
After a median follow-up of 6 years, no significant differences were observed in the randomized patients.
The 5-year RFS, 5-year EFS and 5-year OS rates were 85%, 82%, and 89%, respectively, for the no-RT group and 87%, 79% and 85%, respectively, for the IFRT group.
Among the 243 PR patients after chemotherapy, the 5-year EFS and 5-year OS rates were 80% and 87%.
IFRT does not improve the treatment results in patients with stage III/IV HL who reach CR after standard MOPP/ABV chemotherapy.
In partial responders after 6 cycles of MOPP/ABV the addition of IFRT induces similar overall survival and event-free survival rates as those of CR patients after chemotherapy.
Clinical/Scientific Implications The results of this study suggest that there is no role for involved field radiation therapy in patients with stage III/IV Hodgkins disease who achieve a complete response after full dose chemotherapy. Partial responders benefit from the addition of IFRT, and can achieve survival rates similar to complete responders.
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