JANUARY 27, 2023

Welcome to Medscape's oncology briefing.

"I'm not going to let you get in the way of my patient's survival," Rebecca Shatsky,
MD, a medical oncologist at the University of California San Diego, yelled into the
phone during an appeal of a prior authorization denial.

On the other side of the peer-to-peer, a retired oncologist working for Premera Blue
Cross refused to approve Shatsky's request for pembrolizumab to treat a patient with
stage IIIc triple-negative breast cancer. He claimed the data on the drug were still
unclear.

Later, Shatsky vented her frustration on Twitter: "This denial. Will. Not. Stand," she
tweeted. "An insurance company should not get to tell me how to practice medicine
when Phase III RCT data and @NCCN + @ASCO guideline support my decision!"

Shatsky received tens of thousands of likes and hundreds of comments offering

support and advice, letting her know that she is not alone.

In fact, oncologists across the United States are fuming over prior authorization and
the barriers and delays to cancer care caused by increasingly complex requirements
and seemingly arbitrary denials.

Initially established as a cost-saving tool to push physicians away from low-value care
and toward evidence-based treatment, prior authorization has instead created a
bureaucratic juggernaut for oncologists, undermining their medical and surgical
decision-making and often putting time-sensitive care on hold. Last year, for instance,
almost 90% of oncologists said that prior authorization was a significant barrier to
prescribing new medications, and 80% said that it can negatively affect patient
outcomes.

Fundamentally, "the most important thing is the patient is getting a treatment they
need and that is consistent with established scientific guidelines," Vivek Kavadi, MD, a
radiation oncologist at Texas Oncology in Sugar Land, Texas. However, "what has
happened now is that many insurance companies have taken it upon themselves to
dictate care."

Recent federal- and state-level efforts may help curb some of these burdens, but
some of the proposals may not go far enough. Last year, for instance, Centers for
Medicare & Medicaid Services outlined changes that could help streamline and
standardize the prior authorization process, but the proposed rule excludes drugs.

As for Shatsky's patients, an executive at Premera called her a day later with news:
"We've talked again, and we'll give you the drug," Shatsky recalled the Premera
executive saying.

Although good news, oncologists should not have to vent on social media to get an
appropriate treatment authorized and their patients the care they need, experts said.

In a new regular series, Gatekeepers of Care, Medscape will explore the challenges
oncologists and patients face navigating insurance company requirements and
accessing cancer care. Please email vstern@medscape.net to share experiences.

And now, to this week's oncology news.

ONCOLOGY NEWS
Test Predicts Which CRC Patients Benefit From Adjuvant Chemo
New data provide further evidence that circulating tumor DNA (ctDNA) analysis can
identify patients with resectable colorectal cancer (CRC) who are at increased risk for
recurrence and could benefit from adjuvant chemotherapy.

An analysis of presurgical and postsurgical ctDNA from 1039 patients with stage II-IV
resectable CRC revealed that 4 weeks after surgery, ctDNA positivity was associated
with a tenfold greater risk for recurrence. ctDNA positivity was also the most
significant prognostic factor associated with recurrence risk in patients with stage II or
III CRC and identified which patients would benefit from adjuvant chemotherapy, said
researchers from the National Cancer Center Hospital East, Kashiwa, Japan.

"I believe this data further informs our use of circulating tumor DNA presence or
absence following surgical resection of colon cancer as a prognostic marker," said
Thomas J. George Jr, MD, of the GI Oncology Program at the University of Florida,
Gainesville, who was not involved in the research. However, "because the study was
not prospectively randomized to assign or withhold therapy based upon ctDNA test
results, we cannot definitively say that ctDNA can predict who will benefit from
adjuvant therapy."

READ MORE

Cervical Cancer in Women 65+ Often Deadly: So Why Not Screen?

Almost 1 in 5 women diagnosed with cervical cancer are aged 65 years or older, and
most have late-stage disease, a new study indicates.

Overall, more than 70% of older women had late-stage disease, associated with
worse survival outcomes, compared with 34%-59% of younger women, according to
an analysis of 2009-2018 data from the California Cancer Registry.

These findings represent the latest evidence calling into question national guidelines
on cervical cancer screening. The American Cancer Society, the US Preventive
Services Task Force, and the American College of Obstetricians and Gynecologists
all recommend that physicians discontinue cervical screening when women with
"adequate prior screening" reach age 65 years.

"It could be that [the guidelines] are perfectly fine if women were properly screened
before they hit 65, so that's one of our big questions," noted study co-author Frances
Maguire, PhD, an epidemiologist at the University of California, Davis.
 READ MORE

Is It Time for a More Personalized Approach to CRC Screening?

A new study confirms that the 10-year screening colonoscopy interval is safe in
asymptomatic patients with a negative baseline screening colonoscopy.

In fact, researchers at the German Cancer Research Center in Heidelberg suggest

that sex and age could potentially guide a "risk-adapted extension" of the 10-year
screening interval in these patients.

An analysis of data from 120,000 patients aged 65 years or older who underwent
repeat screening colonoscopy 10 years after a negative baseline screening
colonoscopy showed that the prevalence of CRC was 75%-85% lower compared with
all screening colonoscopies in average-risk adults aged 65 years or older. Even 11-16
years after a negative screening colonoscopy, the prevalence of CRC remained
62%-82% lower compared with that in average-risk adults, particularly women and
younger adults.

Although the data are "reassuring, I don't think that this is enough evidence to change
the recommendations," said Peter Stanich, MD, president of the Collaborative Group
of the Americas on Inherited Gastrointestinal Cancer.

READ MORE

Blood Test 24 Hours After Starting Chemo Predicts AML Survival

In patients with acute myeloid leukemia (AML), protein changes in peripheral blood
cells that take place shortly after chemotherapy begins may predict 5-year overall
survival and could be used to identify patients who need a treatment change, new
research suggests.

After comparing peripheral blood samples from patients with AML and healthy
controls, the authors found that one cell type expanded only in AML samples. Patients
with high levels of extracellular signal-regulated kinase 1/2 one day after starting
chemotherapy had worse overall survival at both 2 and 5 years, the researchers
reported in Nature Communications.

"We believe that this protein is responsible for the cancer cells' resistance to
chemotherapy and can be used to distinguish responders from nonresponders," said
first author Benedicte Sjo Tislevoll, PhD candidate, Centre for Cancer Biomarkers,
University of Bergen. "Our aim is to use this information to change treatment early for
patients who are not responding to therapy."

READ MORE

3D-Printed Tumors Could Advance New Cancer Therapies

The use of 3D bioprinting technology to develop cancer tumor models promises to
shed new light on treatment response and speed up cancer research, researchers
say.

First developed in 1988, bioprinting is primarily used in regenerative medicine

research. The technology's potential for use in cancer research has yet to be fully
realized, but a bioprinting technique developed at Penn State University could move
matters forward.

The technique, called aspiration-assisted bioprinting, was recently used to bioprint 3D

models of breast cancer tumors and recreate the microenvironment integral to
disease progression. The models were successfully treated with chemotherapy and
immunotherapy.
"We hope that in the future, this technique can be adapted in the hospital, which
would speed up the course of cancer treatment," said study leader Madhuri Dey, a
PhD candidate and researcher at Penn State.

READ MORE

Ultralow Dose of Nivolumab Offers Huge Cost Savings

In India, the high cost of immunotherapy means fewer than 5% of patients with cancer
receive full-dose therapy.

But researchers recently found that using just 6% of the recommended dose of
nivolumab in patients with advanced head and neck cancer improved 1-year overall
survival by 25%. This dose reduction also lowered treatment costs to 5%-9% of the
typical price of full-dose immunotherapy regimens.

If these findings can be extrapolated to other immune checkpoint inhibitors and tumor
types, switching to lower doses could save healthcare systems billions of dollars, said
Aaron Mitchell, MD, of Memorial Sloan Kettering Cancer Center, New York City, and
Daniel Goldstein, MD, of Tel Aviv University, Israel, in an accompanying editorial.

READ MORE
CONFERENCE NEWS

SUNLIGHT Shows New Standard of Care in Refractory Metastatic CRC: The phase 3
SUNLIGHT trial, presented at the recent American Society of Clinical Oncology
Gastrointestinal Cancers Symposium 2023, showed that overall survival was
significantly improved in patients with refractory metastatic CRC when bevacizumab
was added to trifluridine-tipiracil.

Adding SBRT to Sorafenib Boosts Survival in Liver Cancer: In patients with

hepatocellular cancer, the addition of stereotactic body radiation therapy (SBRT) to
sorafenib chemotherapy significantly improved median overall survival compared with
sorafenib alone (15.8 months vs 12.3 months) with no reported increase in adverse
events.

New Standard of Care for Early dMMR/MSI-H Colorectal Cancer?: A retrospective

review of 73 patients with localized mismatch repair-deficient or microsatellite
instability-high CRC treated with any programmed cell death 1 inhibitor prior to
surgery revealed that 2-year overall and disease-free survival rates were 100%,
suggesting a potential new standard of care.

Longest Overall Survival Ever Seen in Advanced Gastric Cancer: A phase 3 trial
revealed that combining an experimental monoclonal antibody with mFOLFOX6
chemotherapy significantly improved median overall survival in patients with
claudin-18.2+/HER2???advanced gastric or gastroesophageal junction
adenocarcinoma (18.2 vs 15.5 months), one of the longest survival outcomes
observed for these patients.

PERSPECTIVES
Oncologists May Be Too Quick to Refer Patients to Palliative Care
Not every patient with advanced cancer requires the time and skill of a palliative care
team, explained Sarah F. D'Ambruoso, NP, a hospice and palliative care nurse
practitioner for UCLA Health Cancer Care, Santa Monica.

"But don't get me wrong. I'm not discouraging referrals to palliative care, instead I'm
suggesting the careful triage of patients," she noted in a recent commentary for
Medscape.

For instance, D'Ambrosio recommends a referral to palliative care when multiple

comorbid conditions affect prognosis, treatment can no longer be tolerated,
symptoms have become unmanageable, or challenging family dynamics are
interfering with the goals of care.

But in many cases, oncology clinicians can provide basic palliative care services
without consulting a specialist. "By continuously honing and implementing primary
palliative care skills, oncology teams can feel empowered to meet the needs of their
patients themselves," she said.

READ MORE

Doctors in Film: Which Movies Are Most Inspirational to You?

What films depicting medicine have touched you?

In a recent commentary for Medscape, David Kerr, MD, posed the question to his
colleagues and shared his own favorites.

"I was always very fond of Doctor Zhivago," said Kerr, professor of cancer medicine at
University of Oxford, United Kingdom.

But the movie that moved him most as a child was The Citadel. The film, about "an
idealistic, young Glaswegian doctor," inspired Kerr when he first saw it. "Clearly,
there's a large amount of self-identification going on here. If you read the book, you
read my life story in some ways."

READ MORE

TOP TRENDING

Paxlovid Prescribing Concerns Seen in Practitioner Survey: A new Medscape

survey has revealed that physicians are hesitating to prescribe Paxlovid in older
adults because of concerns about drug interactions, existing health conditions, and
risk for rebound.

Is It Time for Yet Another COVID Booster? It's Complicated: For those who have
received a two-dose primary series of COVID-19 vaccines and all the recommended
boosters, new guidance from the US Food and Drug Administration may signal
whether a sixth shot is needed.

Possible Bivalent Vaccine Link to Strokes in People Over 65: A potential link
between the Pfizer/BioNTech bivalent COVID-19 booster and an increased risk for
ischemic stroke in people older than 65 years has been identified but may not
represent a true clinical risk, experts say.

WHAT ELSE IS HAPPENING

The Washington Post: The diagnosis of non-Hodgkin lymphoma in 9 military officers
has prompted an investigation into a possible link with work at a nuclear missile base
in Montana up to 25 years ago.

The New York Times : "I blurted out the question we all ask - how long have I got?"
wrote retired UK neurosurgeon Henry March in his most recent book, "AND FINALLY:
Matters of Life and Death," which explores his transition to patient after being
diagnosed with advanced prostate cancer.

Thanks for reading. See you next week.

Have a suggestion for coverage or a comment on this newsletter? Contact the editor
of Medscape Oncology at OncologyEditor@medscape.net.

For more cancer news, visit Medscape Oncology.

And to read the latest COVID-19 developments, visit Medscape's
Coronavirus Resource Center .

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