Heard in the Blogosphere
Continued from page 162
Is There a Mental-
Health Crisis in
Academia?
As part of a series on mental health and
well-being among graduate students,
Nature asked several researchers on the
front lines of science for their insights on
mental health in academia and for their
opinions on the cultural shifts that
need to occur.
“Graduate students are suffering,
and they need help. We have
fantastic mental-health services on
this campus, but a lot of students
are hesitant to use them. … Some
students might not want to raise
concerns about their adviser or their
department out of fear of retaliation.
I’ve been warned not to bite the hand
that feeds me.”
—Robbie Hable, PhD-candidate, from
the University of Kansas
“Last year, I had a paper come out
[that] was well received. … It was the
first time I felt like I was actually doing
science, not just playing a part. But
then, everything died down. … I feel
like I’m shouting into the void. When
I see a paper that I find interesting,
I make sure to send the author an
e-mail or message them on Twitter.
… It lets people know that they have
worth. That sort of support doesn’t
have to come from superiors.”
—Vince Butitta, PhD-candidate, from the
University of Wisconsin–Madison
“We need to do more to map and
monitor the situation. The few studies
that have addressed mental-health
issues among graduate students had
alarming results, but the message
isn’t getting out. … For me and for a
lot of people I work with, the whole
point of science is to make the world
better in some sense. … We want
people to do good research, and we
need them to be healthy.”
—Mattias Björnmalm, MSc, PhD, from Imperial
College London, U.K.
“Unless you get published in a very
prestigious journal or get a lot of
citations, it can feel like a downer,
even though you accomplished what
you were supposed to accomplish.
… I would encourage other students
to think about what they really
want from a PhD. Sort things out
for yourself. Talk to people who
are important in your personal and
professional life, and don’t forget to
work out. And try to have a life outside
the lab.”
“When the mental-health
charity Student Minds started in
2009, many universities denied
that they had a mental-health
problem on their campus. But
the conversation has changed.
Now, universities say, ‘We know
we need to do something, but’s
what the right thing to do?’”
—Rachel Piper, policy manager at
Student Minds in Oxford, U.K.
Kd
Mary Jo
Lechowicz, MD
@MaryJoLechowicz
Great group! I learned
a lot. Wonderful talent…
looking forward to hearing
about how the projects
have evolved over our time
together. #ASH #MedEd
#ASHMEI18
Once-Weekly Dosing Is Now FDA Approved
The FDA granted Priority Review to KYPROLIS ® , which was the fi rst hematology product approved under the FDA Oncology
Center of Excellence Real-Time Oncology Review Pilot Program. 1
SUPERIOR OUTCOMES
SUPERIOR PFS KYPROLIS ® once-weekly 70 mg/m 2 with dexamethasone (Kd) vs
KYPROLIS ® twice-weekly 27 mg/m 2 with dexamethasone* (Kd):
• EXTENDED PFS by 47%: 11.2 months in once-weekly arm vs 7.6 months in twice-weekly arm; HR = 0.69
(95% CI: 0.54-0.88); P = 0.0014 2
*Kd27 is not an FDA-approved dose for KYPROLIS ® .
INCREASED DEPTH OF RESPONSE:
• 4x AS MANY PATIENTS ACHIEVED ≥ CR: 7.1% in once-weekly arm (n = 17) vs 1.7% in twice-weekly arm (n = 4) 2,†
A subgroup analysis of ORR.
†
COMPARABLE SAFETY: Overall safety was comparable between the once-weekly and twice-weekly groups 2
Select adverse events of interest:
• The incidence of cardiac failure was 3.8% in the once-weekly arm (n = 9) vs 5.1% in the twice-weekly arm (n = 12) 2,3
• The incidence of pulmonary hypertension was 1.7% in the once-weekly arm (n = 4) vs 1.3% in the twice-weekly arm (n = 3) 3
PATIENTS WERE ABLE TO STAY ON THERAPY LONGER: Patients stayed on treatment for 31% longer
in the once-weekly arm (median 38 weeks) vs the twice-weekly arm (median 29.1 weeks) 2
CI = confi dence interval; CR = complete response; HR = hazard ratio; Kd = KYPROLIS ® and dexamethasone; ORR = overall response rate;
PFS = progression-free survival.
Kd once-weekly vs twice-weekly study design: Phase 3, randomized, multicenter, open-label study (N = 478) in patients with relapsed and refractory
multiple myeloma who had received 2 to 3 lines of therapy, KYPROLIS ® and dexamethasone 70 mg/m 2 once weekly (n = 240) versus KYPROLIS ® and
dexamethasone 27 mg/m 2 twice weekly (n = 238). The primary endpoint was PFS. Secondary endpoints included ORR and safety. 2
INDICATION AND IMPORTANT SAFETY INFORMATION FOR KYPROLIS
INDICATION
Tumor Lysis Syndrome
KYPROLIS ® (carfi lzomib) is indicated in combination with dexamethasone or
• Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes, have
with lenalidomide plus dexamethasone for the treatment of patients with
occurred. Patients with a high tumor burden should be considered at
relapsed or refractory multiple myeloma who have received one to three
greater risk for TLS. Adequate hydration is required prior to each dose in
Cycle 1, and in subsequent cycles as needed. Consider uric acid lowering
lines of therapy.
drugs in patients at risk for TLS. Monitor for evidence of TLS during
IMPORTANT SAFETY INFORMATION FOR KYPROLIS
treatment and manage promptly, and withhold until resolved.
Cardiac Toxicities
• New onset or worsening of pre-existing cardiac failure (e.g., congestive
heart failure, pulmonary edema, decreased ejection fraction), restrictive
cardiomyopathy, myocardial ischemia, and myocardial infarction including
fatalities have occurred following administration of KYPROLIS. Some
events occurred in patients with normal baseline ventricular function.
Death due to cardiac arrest has occurred within one day of administration.
• Monitor patients for signs or symptoms of cardiac failure or ischemia.
Evaluate promptly if cardiac toxicity is suspected. Withhold KYPROLIS for
Grade 3 or 4 cardiac adverse events until recovery, and consider whether
to restart at 1 dose level reduction based on a benefi t/risk assessment.
• While adequate hydration is required prior to each dose in Cycle 1, monitor
all patients for evidence of volume overload, especially patients at risk for
cardiac failure. Adjust total fl uid intake as clinically appropriate.
• For patients ≥ 75 years, the risk of cardiac failure is increased. Patients
with New York Heart Association Class III and IV heart failure, recent
myocardial infarction, conduction abnormalities, angina, or arrhythmias
may be at greater risk for cardiac complications and should have a
comprehensive medical assessment prior to starting treatment with
KYPROLIS and remain under close follow-up with fl uid management.
Acute Renal Failure
• Cases of acute renal failure, including some fatal renal failure events, and
renal insuffi ciency adverse events (including renal failure) have occurred.
Acute renal failure was reported more frequently in patients with advanced
relapsed and refractory multiple myeloma who received KYPROLIS
monotherapy. Monitor renal function with regular measurement of the
serum creatinine and/or estimated creatinine clearance. Reduce or
withhold dose as appropriate.
—Franziska Frank, PhD, environmental researcher from
Umeå University, Sweden
Learn more at KYPROLIS-HCP.com
164
ASH Clinical News
Pulmonary Toxicity
• Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure,
and acute diffuse infi ltrative pulmonary disease such as pneumonitis and
interstitial lung disease have occurred. Some events have been fatal. In
the event of drug-induced pulmonary toxicity, discontinue KYPROLIS.
Pulmonary Hypertension
• Pulmonary arterial hypertension (PAH) was reported. Evaluate with cardiac
imaging and/or other tests as indicated. Withhold KYPROLIS for PAH until
resolved or returned to baseline and consider whether to restart based on
a benefi t/risk assessment.
Dyspnea
• Dyspnea was reported in patients treated with KYPROLIS. Evaluate
dyspnea to exclude cardiopulmonary conditions including cardiac failure
and pulmonary syndromes. Stop KYPROLIS for Grade 3 or 4 dyspnea until
resolved or returned to baseline. Consider whether to restart based on a
benefi t/risk assessment.
Hypertension
• Hypertension, including hypertensive crisis and hypertensive emergency,
has been observed, some fatal. Control hypertension prior to starting
KYPROLIS. Monitor blood pressure regularly in all patients. If hypertension
cannot be adequately controlled, withhold KYPROLIS and evaluate.
Consider whether to restart based on a benefi t/risk assessment.
Venous Thrombosis
• Venous thromboembolic events (including deep venous thrombosis
and pulmonary embolism) have been observed. Thromboprophylaxis
is recommended for patients being treated with the combination of
KYPROLIS with dexamethasone or with lenalidomide plus dexamethasone.
The thromboprophylaxis regimen should be based on an assessment of
the patient’s underlying risks.