Use of Risk Factors for Initiation Therapy With Beacopp or Escalated Beacopp and Interim Evaluation and Modification of Therapy Based on Scintigraphy Results.
Patients were eligible if they had early unfavorable disease or patients who presented with
stage III or IV disease .Pt assigned to receive 6 cycles of Bleomycin Etoposide,
Doxorubicin, Cyclophosphamide Procarbazine, Prednisone (BEACOPP) or increased dose BEACOPP.
(IDB). Patient with Stage I or II with ³4 sites of disease, age ³50, ESR³50 “B” symptoms
lymphocyte depleted histology “E” site, or bulky disease were defined as early unfavorable
disease and were given standard BEACOPP (SB). Those with I, II B or bulky disease or Stage
III, IV were defined according the IPS. Increased dose BEACOPP (IDB) cycles of therapy was
initiated only to patients with IPS of 3 or more risk factors (high risk) Standard BEACOPP
(SB) cycles were initiated to those with a score of 0-2 (standard risk). All patients had
baseline GA67 or hybrid PET\CT scan at diagnosis and post first cycle for gallium scan or
second cycle for hybrid PET\CT. Upon the scan results therapy was planned and given for
addition of 4 cycles. Those with negative scan received cycles of SB as of the third cycle.
Dose was reduced to level I to III if patient was hospitalized due to fever and neutropenia
of 5 days or longer or pt had an episode of sepsis with unstable vital signs.
Patient with residual uptake interpreted as positive scan had additional cycles of IDB for a
total of 6 cycles
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Ron Epelbaum, ND
Rambam health care center, Bruce Rappaport Faculty of Medicine Technion
Israel: Israeli Health Ministry Pharmaceutical Administration