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followed by an exploratory PET-CT scan. Patients
then received four to six cycles of BV + AVD, depending on PET–CT results. At baseline, 62 percent
of patients had favorable risk, and 38 percent had
unfavorable risk.
After the BV monotherapy lead-in, 18 of 34 patients (53%) achieved a complete response (CR) and
16 (47%) patients achieved a partial response (PR).
Following two cycles of BV + AVD, the rate of CR
jumped to 97 percent (33 patients), but one patient
was removed from the study due to toxicity. Thirtyone patients ultimately completed treatment – one
patient had experienced progressive disease and another patient was removed due to toxicity. However,
Dr. Abramson noted, the patients removed from the
study had achieved CR in their last treatment cycle.
At the end of treatment, eight subjects had PET–
CT scans interpreted as positive. Dr. Abramson
and colleagues later confirmed six of the eight were
false-positive scans, a common enough occurrence to
“warrant further attention,” they wrote. At a median
follow-up of 14 months, one-year progression-free
survival (PFS) and overall survival (OS) rates were 90
percent and 97 percent, respectively.
While the addition of BV to AVD was associated with high response rates, it was associated with
treatment-related adverse events, including peripheral
neuropathy (74%), fatigue (71%), neutropenia (68%),
and anemia (56%). One older patient died of neutropenic sepsis in the first AVD cycle, while another
patient was removed from the study after experiencing grade 2 hypersensitivity, despite premedication.
Reductions in BV were required in 38 percent of patients – mostly due to peripheral neuropathy. Neutropenia and febrile neutropenia were the most common
grade 3 and 4 toxicities; however, altering the protocol
to include GCSF support, Dr. Abramson noted, dramatically reduced neutropenic episodes.
Frontline BV + R-CHOP in DLBCL
In the second trial, adding BV to the standard RCHOP (rituximab/cyclophosphamide/doxorubicin
hydrochloride/vincristine sulfate/prednisone) regimen led to “encouraging” response rates in patients
with intermediate or high-risk DLBCL (defined as
International Prognostic Index [IPI] scores of 3-5, or
age-adjusted IPI scores of 2-3 for patients younger
than 60) – a patient group with typically suboptimal
outcomes with R-CHOP alone – according to presenter Nancy Bartlett, MD.2
Dr. Bartlett, from Washington University School
of Medicine in St. Louis, Missouri, and colleagues
have previously demonstrated that single-agent BV
resulted in responses in relapsed DLBCL patients.3
With the current study, they posited that the combination of BV and R-CHOP could improve outcomes
in the frontline setting.
Fifty-three patients were enrolled in the study, 51 of
whom received treatment