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Evidence-Based Oncology December 2017
EHR Documentation and the Patient–Physician Visit
Sheree Starrett, MD, MS
How Technology, Social Media Are Changing the Way Clinical Trials Connect With Patients
Mary Caffrey
Halt and Catch Fire: Can the Digital Revolution Empower the Move Toward Value-Based Cancer Care?
Joseph Alvarnas, MD
Q&A With Dr Thomas LeBlanc: The Value of ePROs in Oncology
Surabhi Dangi-Garimella, PhD
High-Impact Workflow Changes for Value-Based Care Success
Charles Saunders, MD; Charles Alcorn, MS; Catherine Cowan, MSN, RN; and Maria Fabbiano
Lending the Patient Voice to Oncology Quality Measurement
Surabhi Dangi-Garimella, PhD
Navigating the Quality Landscape in Oncology: Pitfalls and Lessons Learned
Surabhi Dangi-Garimella, PhD
Stakeholders Weigh in on Payment Reform in Cancer Care
Surabhi Dangi-Garimella, PhD
The Commercial Payer OCM Experience: Year 1
Surabhi Dangi-Garimella, PhD
Will 2-Sided Risk Be a Reality in the OCM?
Kelly Davio
How Has the OCM Evolved? Year 1 Provider Updates
Surabhi Dangi-Garimella, PhD
AJMC®tv Interviews, December 2017
Produced by Laura Joszt and The Center for Biosimilars®
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Medical World News®, December 2017
AJMC Staff

Medical World News®, December 2017

AJMC Staff
Key drug approvals; alcohol cancer link.
Roche Gets Drug Approvals for First Treatment for a Rare Blood Disorder and NSCLC

AJMC Staff

ROCHE HAD 2 DRUGS approved by the FDA—one for a rare blood disease and the other for first-line treatment for lung cancer.

Vemurafenib (Zelboraf ) is the first FDA-approved drug for Erdheim-Chester disease (ECD), a rare blood disorder. Already approved for the treatment of people with unresectable or metastatic melanoma with the BRAF V600E mutation, the new indication includes patients with ECD who harbor the BRAF V600 mutation. Characterized by an abnormal multiplication of histiocytes, these white blood cells can invade normal tissues and organs.

The drug was approved based on data from the phase 2 VE-BASKET study, which used an innovative clinical trial design that matched a disease’s underlying genetic profile to the mechanism of action of the medicine. For the 22 people with ECD, the trial showed a best overall response rate of 54.5%.

“This FDA decision means people living with Erdheim-Chester disease will now, for the first time, have an FDA-approved treatment option,” Sandra Horning, MD, Roche’s chief medical officer and head of global product development, said in a statement.1 “We are committed to finding new ways to bring medicines to patients with high unmet need, and we are pleased that this innovative clinical trial helped identify Zelboraf for treatment of this rare disease.”

The second drug approved was alectinib (Alecensa) as a first-line treatment for people with anaplastic lymphoma kinase (ALK )-positive metastatic non–small cell lung cancer (NSCLC). The FDA approved the drug based on results from the phase 3 ALEX study, which showed the drug reduced the risk of disease worsening or death by 47% compared with crizotinib. Median progression-free survival was 25.7 months for people on alectinib, compared with 10.4 months for those on crizotinib.

Alectinib has been recommended in the National Comprehensive Cancer Network guidelines as a treatment option for first-line ALK -positive metastatic NSCLC. “Our goal is to develop medicines that have the potential to significantly improve upon the standard of care,” Horning said in a separate statement.2 “In our pivotal study, Alecensa significantly extended the time that people lived without their disease worsening compared to crizotinib and also showed a marked reduction in the risk of their cancer spreading to the brain.”


1. FDA approves Zelboraf (vemurafenib) for Erdheim-Chester disease with BRAF V600 mutation [press release]. Basel, Switzerland: Roche; November 7, 2017. Accessed November 7, 2017.

2. FDA approves Roche’s Alecensa (alectinib) as first-line treatment for people with specific type of lung cancer [press release]. Basel, Switzerland: Roche; November 7, 2017. Accessed November 7, 2017.

ASCO: Alcohol Linked to Several Types of Cancer

Jaime Rosenberg

ALCOHOL CONSUMPTION, whether light, medium, or heavy, is linked to higher risks of several leading cancers, according to findings released by the American Society of Clinical Oncology (ASCO).1

ASCO has listed alcohol as a definite risk factor for cancer, saying that it contributed to 5% to 6% of new cancers and cancer deaths globally. The evidence linked alcohol consumption with breast, colon, esophagus, and head and neck cancers.

“People don’t typically associate drinking beer, wine, and hard liquor with increasing their risk of developing cancer in their lifetimes,” said ASCO President Bruce Johnson, MD, FASCO, in the statement. “However, the link between increased alcohol consumption and cancer has been rmly established and gives the medical community guidance on how to help their patients reduce their risk of cancer.”

According to the National Cancer Opinion Survey conducted by ASCO earlier this year,2 70% of Americans do not identify alcohol as a risk factor for cancer, and only 38% are limiting their alcohol intake as a way to reduce the risk of cancer.

In addition to raising awareness of the correlation between alcohol consumption and cancer, ASCO also put emphasis on implementing evidence-based policy recommendations to reduce excessive alcohol consumption:
  • Provide alcohol screening and brief interventions in clinical settings
  • Regulate alcohol outlet density
  • Increase alcohol taxes and prices
  • Maintain limits on days and hours of sale
  • Enhance enforcement of laws prohibiting sales to minors
  • Restrict youth exposure to advertising of alcoholic beverages
  • Include alcohol control strategies in comprehensive cancer control plans
  • Support efforts to eliminate the use of “pinkwashing” to market alcoholic beverages.
For example, discouraging alcoholic beverage companies from exploiting the color pink or pink ribbons to show a commitment to nding a cure for breast cancer given the evidence that alcohol consumption is linked to an increased risk of breast cancer.

According to ASCO, excessive alcohol consumption can also delay or negatively affect cancer treatment. Oncologists have the ability to identify strategies to help patients reduce their alcohol intake; address racial, ethnic, gender, and sexual orientation disparities that may place these populations at increased cancer risk; and serve as community advisers and leaders to raise awareness of alcohol as a cancer risk behavior.

“ASCO joins a growing number of cancer care and public health organizations in recognizing that even moderate alcohol use can cause cancer,” said Noelle K. LoConte, MD, lead author of the statement and associate professor of medicine at the University of Wisconsin, in the ASCO statement. “Therefore, limiting alcohol intake is a means to prevent cancer. The good news is that just like people wear sunscreen to limit their risk of skin cancer, limiting alcohol intake is one more thing people can do to reduce their overall risk of developing cancer.”


1. Alcohol linked to cancer according to major oncology organization: ASCO cites evidence and calls for reduced alcohol consumption [press release]. Alexandria, VA: American Society of Clinical Oncology; November 7, 2017. Accessed November 7, 2017.

2. National survey reveals most Americans are unaware of key cancer risk factors. American Society of Clinical Oncology website. key-cancer-risk?et_cid=39746367&et_rid=789325918&linkid=National+Cancer+Opinion+Survey.

Published October 24, 2017. Accessed November 7, 2017.

FDA Action on MSK Tumor Profiling Assay Breaks Ground on Multiple Fronts

Mary Caffrey

THE FDA HAS AUTHORIZED a faster approval path for a next-generation sequencing (NGS) assay developed at Memorial Sloan Kettering (MSK) Cancer Center, which represents both a scientific and regulatory breakthrough at the agency.

The diagnostic test, known as IMPACT, identifies more genetic mutations, or biomarkers, for cancer “than any test previously reviewed by the agency,” according to an FDA statement issued November 15.1 What’s more, the FDA simultaneously announced that it was granting accreditation to the New York State Department of Health (NYSDOH) to act on its behalf, and that tests that passed muster with that agency would not need a separate FDA clearance.

IMPACT, which stands for Integrated Mutation Profiling of Actionable Cancer Targets, allows clinicians to look beyond the mutations in solid tumor cancers—lung, colon, breast, and melanoma—to aid patients with less common solid tumors.2 Because NGS casts a wider net than conventional genetic testing, it allows researchers in phase I “basket studies” to find out quickly if cancer therapies can be used in rarer cancers beyond those for which they are already approved.

The test had been submitted through the FDA’s de novo premarket review pathway, reserved for low- to moderate-risk devices. It had previously been reviewed by NY state health regulators, who had cleared it for use. The FDA’s action on November 15 created a Class II pathway for these types of tests, allowing them to be cleared either through the FDA or by an accredited third party.

Third-party accreditation allows the FDA to keep up with the pace of innovation and encourage test develop- ers to voluntary seek 510(k) clearance, FDA Commission- er Scott Gottlieb, MD, said in the statement.

“This is another example of where the FDA is working to nd creative and exible approaches to regulation that spurs development and efficient delivery of innovative technology,” he said. “We’ll continue to look for opportunities to create regulatory efficiencies where possible to drive broader access to tools that improve American health, while maintaining the safety and e cacy standards that patients should expect from their FDA-reviewed products.”1

“NGS technologies can examine hundreds, if not millions, of DNA variants at a time; and we are only at the beginning of realizing the true potential for these devices to assist patients and their health care providers in learning about the genetic underpinnings of their disease,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, in the statement.

“Recognizing the significant effect information about an individual’s biomarkers can have on their care planning and outcomes, the FDA worked closely with NYSDOH and MSK to help ensure that the IMPACT test is accurate, reliable and clinically meaningful. This collaboration is an excellent example of how the FDA can partner with the medical and development communities to review innovative tests as quickly as possible.”


1. FDA unveils a streamlined path for the authorization of tumor profiling tests alongside its latest product action [press release]. Silver Spring, MD: FDA Newsroom; November 15, 2017. NewsEvents/Newsroom/PressAn- nouncements/ucm585347.htm. Accessed November 29, 2017.

2. MSK researchers develop targeted test for mutations in both rare and common cancers. Memorial Sloan Kettering Cancer Center website. Accessed November 15, 2017.

ASCO’s TAPUR Study Expands to Enroll Patients Receiving Immunotherapy

AJMC Staff

WITH AN EXPANSION THAT includes immunotherapy combination treatments, the American Society of Clinical Oncology (ASCO)’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study has now grown to 500 participants and 16 therapies.

“This study just reached a key milestone and we’re excited to explore these treatments further,” said ASCO chief medical officer Richard L. Schilsky, MD, FACP, FASCO. “While no conclusions about drug efficacy should be drawn at this point, we are very pleased with the growth and expansion of the TAPUR Study.”

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