ASH Annual Meeting
SAN DIEGO —
Patients assigned to six cycles of BEACOPPescalated chemotherapy had superior
outcomes with less toxicity compared with those assigned to eight cycles of
BEACOPPescalated or eight cycles of BEACOPP14.
Andreas Engert, MD, with the University Hospital of Cologne in
Cologne, Germany, presented final results from the GHSG HD15 trial Monday at
the 2011 ASH Annual Meeting and Exposition. Six cycles of BEACOPPescalated
improved OS while reducing critical toxicities compared with the other two
regimens, he said.
“Based on these results from this large randomized
trial, six cycles are more effective and less toxic, and thus can become our
new standard for advanced Hodgkin’s patients,” he said.
From January 2003 to April 2008, researchers enrolled
patients with newly diagnosed Hodgkin’s lymphoma at 408 centers in five
Patients in Ann Arbor stage IIB with large mediastinal
mass or extranodal lesions, or those in stage III or IV, were randomly assigned
to receive either eight cycles of BEACOPPescalated (8Besc), six cycles of
BEACOPPescalated (6Besc) or eight cycles of BEACOPP14 (8B14). Patients in
partial response with a persistent mass measuring 2.5 cm or more after
completion of chemotherapy were assessed by PET. Only those with positive PET
scan results received an additional 30 Gy of radiotherapy.
The full analysis included 705 patients in the 8Besc
group, 711 in the 6Besc group and 710 in the 8B14 group. Researchers hoped to
show that 6Besc was equivalent to eight cycles of therapy for the primary
endpoint of freedom from treatment failure.
“For six cycles of BEACOPPescalated at five years,
the tumor control is 89.3%, whereas the other two arms are around 84%,”
Engert said. “We did not only show equivalence, we were able to show
superiority for six cycles of BEACOPPescalated. Also, in OS, there is a
significant difference between six and eight cycles.”
Researchers observed 53 deaths (7.5%) in the 8Besc
group, 33 (4.6%) in the 6Besc group and 37 (5.2%) in the 8B14 group at 48
months of follow-up. OS at five years was 91.9% for 8Besc, 95.3% for 6Besc and
94.5% for 8B14. OS was superior for the 6Besc group compared with 8Besc (97.5%
Slightly more than 90% of patients in the 8Besc group
had complete response compared with 94.2% for 6Besc and 92.4% for 8B14.
Hematological toxicities occurred in 92.4% of patients
in the 8Besc group, 91.7% in the 6Besc group and 79.7% in the 8B14 group. The
higher number of deaths in the 8Besc group was primarily due to acute toxicity
of the chemotherapy and secondary neoplasms, Engert said. Overall, researchers
observed 72 secondary cancers, including 29 secondary acute myeloid leukemias
and myelodysplastic syndromes (2.7% in the 8Besc group, 0.3% in the 6Besc group
and 1.1% in the 8B14 group). – by Jason Harris
Engert reports no relevant financial disclosures.
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