2024-SABCS-Takeaways - 2

MEDICAL ONCOLOGY SPOTLIGHT
Medical oncologists must
consider tolerability, quality of
life in treatment decisions
I
n recent years, the U.S. Food
and Drug Administration (FDA)
decision-making process for
new drug approvals
has shifted from
focusing on maximumtolerated
dose - the
familiar MTD - in
favor of a more
complex optimal
dose. The optimal
dose balances
pharmacodynamics,
pharmacokinetics, acute
and long-term toxicities,
and patient-reported outcomes,
as well as clinical activity of the
drug. MTD remains an upper
limit on dosing but is no longer a
guide to recommended dosing,
as the adverse events and even
intolerability associated with a
drug at MTD can make patient
adherence a challenge.
The FDA has recommended
dose reductions for fulvestrant,
capecitabine, and other familiar
agents based on reported
widespread dose reductions
during clinical trials and
in real-world practice.
Mounting evidence
of asymmetrical
and bell-shaped
dose-response
curves for many
newly developed
agents underline
Stacey Tinianov,
MPH, BCPA
the reality that lower
doses may offer better
clinical results and
lower toxicity rates or severity
compared to the MTD.
Adverse events, even at lower
grades, can take huge tolls on
patients' quality of life. The rightsizing
of therapeutic doses improves
adherence and, ultimately, a
patient's overall outcome.
" I would ask you to have that
conversation about grade 2
adverse events and not minimize
it, " said patient advocate Stacey
Tinianov, MPH, BCPA, Executive
Director of Advocates for
Collaborative Education, during
the View from the Trenches
session. " And, as you're doing
that, think about where you
would add your four to six loose,
watery stools above baseline
during your day. "
There is also a growing
recognition that treatment-related
toxicities may not be confined to
acute events, such as diarrhea or
stomatitis. Breast cancer therapy
also may be responsible for less
obvious effects on quality of life,
long-term health events, and
sexual health for both male and
female patients. An FDA draft
guidance is being developed
regarding evaluation of ovarian
function in premenopausal
women in clinical trial design,
and in the context of toxicities
associated with novel therapies. 
Sex, Drugs, Rock and Roll session
2
2024 SABCS®
| Takeaways

https://events.hubilo.com/sabcs2024/session/252172 https://events.hubilo.com/sabcs2024/session/252172 https://events.hubilo.com/sabcs2024/session/252192

2024-SABCS-Takeaways

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