CLINICAL NEWS
Written in Blood
that male respondents reported a higher
median number of published articles
(median = 3 vs. 2; p=0.0092) and a higher
median percent effort in research (50% vs.
40%; p=0.0029) compared with females.
“This gender disparity is important to
emphasize in program planning,” the
authors wrote. “With 50 percent of faculty
being female, many of whom are working
mothers, we should encourage discussions
about approaches that have been helpful
to academic success from more senior
female faculty.”
Responses on the pre- and postsurveys, which were distributed to 41
participants and returned by 38 (93% response rate), echoed the responses on the
cross-sectional survey. After participating
in the program, doctors were more likely
to express feeling confident in their skills
as researchers, presenters, and team leaders. For example, comparing the pre- and
post-workshop responses, more doctors
reported that they “strongly agreed” with
the following statements:
• I am able to develop a sound,
scientific hypothesis (0 vs. 85;
p=0.0005).
• I feel I have a comprehension of the
principles of clinical research design
and execution (11 vs. 71; p<0.001).
• I am confident in my knowledge to
identify the regulatory requirements
of clinical research (9 vs. 49;
p=0.0005).
• I feel confident in my current
strategies for pursuing and
developing a successful career in
clinical research (6 vs. 60; p<0.0001).
• I feel confident in my skills to
formulate, develop, and sustain a
multidisciplinary clinical research
team (9 vs. 54; p=0.0003).
• I am confident in my skills in
preparing research results and
presenting the work to varied
audiences (9 vs. 69; p<0.0001).
The mentorship survey was distributed
to 40 participants; 38 responded (95%
response rate). About th ree-quarters
(n=28; 74%) reported that “mentorship
resulted in increased knowledge or skills
in conduct of research.” Other benefits
attributable to CRTI mentorship, including promotions and publications, are
presented in TABLE 3.
Limitations of the study include the
use of non-standardized assessments, as
well as the potential for responder bias.
“Respondents may have been biased to
report positive feelings or gratitude for a
program that was provided at no cost to
them,” Dr. King said. “Given the duration
of time between CRTI participation and
the 2014 cross-sectional survey, we anticipate that most of the ‘honeymoon period’
positivity would have subsided.” The study
also lacked a control group, and CRTI
respondents may have been more destined
to be successful in the field, as they were
selected as the most promising applicants
for the program.
Based on their findings, Dr. King and
authors made several recommendations
for future CRTI programs, including:
Bortezomib, Dexamethasone, and
Rituximab Combination Is Effective
for Newly Diagnosed Waldenström
Macroglobulinemia
In a report of long-term follow-up from a phase II trial of patients with
newly diagnosed Waldenström macroglobulinemia (WM), the combination of bortezomib, dexamethasone, and rituximab (BDR) led to an overall survival (OS) rate of 66 percent at seven years. These results suggest
that this regimen provides a long treatment-free interval in the frontline
setting, according to the study authors, led by Maria Gavriatopoulou,
of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine in Greece.
“Rituximab has become a key treatment component of WM, however,
it is associated with a modest response rate of about 30 percent and [a]
long time to response,” Ms. Gavriatopoulou and authors wrote, leading
them to combine rituximab with bortezomib, hypothesizing that the two
agents may lead to “synergistic, rapid activity” in patients with newly
diagnosed WM.
The authors enrolled 59 patients from 10 sites in Europe as part of the
European Myeloma Network between March 2007 and June 2010. BDR
combination therapy consisted of:
• 1.3 mg/m2 of intravenous (IV) bortezomib on days 1, 4, 8, and 11
during the first 21-day cycle
• continuing to emphasize interactions
of CRTI participants (for evaluation
and for “celebrations of success”)
through social media and newsletters
• 1.6 mg/m2 of IV bortezomib on days 1, 8, 15, and 22 during four 35day consecutive cycles (cycles 2-5)
• increasing the participation of
underrepresented minorities
• 375 mg/m2 of IV rituximab on days 1, 8, 15, and 22 during cycles 2
and 5
• standardizing the language and
timing of CRTI evaluations (at
intervals of 3 years after attendance at
the summer didactic session)
“This evaluation supports the continued efforts to mentor and train junior
academic hematologists in a structured
approach,” the authors concluded, adding,
however, that “it is difficult to know how
much CRTI directly influenced these
positive outcomes.”
REFERENCE
King AA, Vesely SK, Elwood J, et al. The American Society of Hematology
Clinical Research Training Institute is associated with high retention in
academic hematology. Blood. 2016 October 26. [Epub ahead of print]
Benefits Observed During a One-Year Mentorship
Program (n=38)
TABLE 3.
Area
N
• 40 mg of IV dexamethasone during cycles 2 and 5
Treatment lasted 23 weeks with no planned maintenance therapy.
Monoclonal immunoglobulin M levels were evaluated prior to each
treatment cycle, and computed tomography scans were performed at
three timepoints: within three months of enrollment, after BDR completion, and when disease progression was suspected.
Most patients were >65 years of age (61%) and had adverse prognostic factors (82% with a hemoglobin <11.5 g/dL; 64% with a ß2microglobulin ≥3 mg/
dL). Per the International
Prognostic Scoring System
for WM (IPSS WM), 45.5
percent were high-risk and
40 percent were intermediate-risk.
With a median followup of 86 months, 85
percent of patients in the
intent-to-treat population
responded to BDR
treatment:
• 3% had a complete
response (CR)
Mentor interaction resulted in publication.
6 (16%)
Mentor interaction resulted in a presentation.
7 (18%)
Mentor interaction resulted in a poster.
4 (11%)
Mentor interaction led to me learning new teaching method or approach.
4 (11%)
Mentor resulted in increased knowledge or skills in conduct of research.
28 (74%)
• 58% had a PR
Mentor resulted in increasing new clinical knowledge.
9 (24%)
Mentor facilitated job change or promotion.
6 (16%)
• 17% had a minor
response
Mentor facilitated involvement in a clinical trials cooperative group.
6 (16%)
• 7% had a very good
partial response
(VGPR)
Combining
rituximab with
bortezomib led
to “synergistic,
rapid activity”
in patients with
newly diagnosed
Waldenström
macroglobulinemia.
The major response rate (any response better than PR) was 68 percent.
Continued on page 50
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ASH Clinical News
December 2016