Past Issues – Page 110 – The Cancer Letter

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May 2014

	Lung Cancer Screening Model Projects 54,900 New Lung Cancer Cases In Five Years with Nationwide LDCT Screening A model projecting outcomes for nationwide low-dose CT screening for lung cancer estimated that gradual implementation of the program would detect roughly 54,900 more cases over five years in a high-risk Medicare population. The large majority of new cases would be early-stage disease. The model assumes that over a five-year period, an additional 20 percent of high risk patients are offered screening each year. Investigators considered three different screening use scenarios for the implementation: an expected-use scenario based on historic experience with mammography (50 percent of patients offered screening undergo screening every year), a low-use scenario (25 percent), and a high-use scenario (75 percent).
	Breast Cancer ASCO Publishes Two Clinical Guidelines For Treating HER2-Positive Breast Cancer The American Society of Clinical Oncology published two clinical practice guidelines on treating women with advanced, HER2-positive breast cancer. The first guideline lists appropriate systemic therapies for women newly-diagnosed with advanced disease and those whose early-stage disease progressed to advanced cancer. The second provides recommendations for treating brain metastases. Both guidelines were published in the Journal of Clinical Oncology. Also: Researchers Link Obesity With 34% Higher Death Risk In Pre-Menopausal Women
	Prostate Cancer Study: Delaying ADT Until Symptoms Appear Can Be Safe in Men with a PSA-based Relapse A study found that it may be safe to postpone androgen deprivation therapy in men with a PSA-only based relapse after prostate surgery or radiation therapy. Delaying ADT until the onset of symptoms or appearance of cancer on a scan does not substantially compromise long-term survival, according to the population-based observational study. “Rising PSA levels trigger a lot of anxiety, and many men want to start treatment as soon as possible,” said lead study author Xabier Garcia-Albeniz, a research associate at Harvard University School of Public Health. “These findings suggest that there may be no need to rush to ADT.” Also: Targeted Biopsy More Effective at Selecting Men For Active Surveillance, Study Says
	Non-Small Cell Lung Cancer Two Phase III Afatinib Trials Demonstrate Prolonged Survival EGFR Inhibitor Shrinks Tumors In Phase I Study of Patients With Treatment-Resistant Mutation VeriStrat Biomarker Test Predicts Treatment Outcomes In Phase III NSCLC Trial
	Colorectal Cancer New Biomarker Findings Show Improvement in KRAS Subtype In Phase III Erbitux Trial
	Childhood Neuroblastoma Immunotherapy Shrinks Tumors In Phase I Study at St. Jude
	Chemotherapy Anti-Nausea Drug Successful In Phase III Trial in Highly Emetogenic Chemotherapy
	NCI Approved Trials for the Month of May
	Drug Development FDA grants orphan drug designation to Advaxis HPV immunotherapy EMA Committee for Medicinal Products for Human Use issues positive opinion for Gardasil

20140529 - May. 29, 2014

ISSUE 20 – MAY 16, 2014

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Over $20 Million Carved Out
From Statistical, Operations Centers

The budgets of operations and statistical centers of adult clinical trials groups were cut by about $20.4 million, group chairs say.

The cuts make it difficult for the groups to continue to support ongoing trials and raise questions about the prospects for starting a new generation of trials.

NCI officials say that, overall, the budget for the groups is staying flat, in part because some of the money is being channeled into 30 sites that received the Lead Academic Participating Site designation.

LAPS, which are run by cancer centers, will be allowed to charge more for putting patients on studies.

So where are the cuts?

	No Justification Provided AAUP Demands Reinstatement of Faculty Denied Tenure Renewal at MD Anderson The American Association of University Professors sent a letter to Ronald DePinho, president of MD Anderson Cancer Center, urging the reinstatement of two faculty members who were denied tenure renewal without stated reasons. The letter is a part of AAUP’s response to a request for an investigation, which was triggered by the administration’s refusal to provide justification for denying tenure renewals to faculty who received unanimous votes for renewal from the Faculty Senate Promotions & Tenure Committee.
	Report: Rising Treatment Costs Due to 340B Discounts The 340B drug discount program is causing a rise in the costs of treating cancer patients, according to a new report. Published by the IMS Institute for Healthcare Informatics, the report, “Innovations in Cancer Care and Implications for Health Systems,” showed that marketplace behaviors, triggered by a lack of eligibility integrity, are a major reason for increasing costs of cancer care, said the Alliance for Integrity and Reform of 340B in a statement.
	TGen and George Mason Form Precision Medicine Alliance The Translational Genomics Research Institute and George Mason University announced a strategic research alliance May 6. Called the TGen-George Mason Molecular Medicine Alliance, the effort is designed to recommend medications and treatments to clinicians based on each patient’s molecular profile.
	In Brief Oncology Nursing Society names board of directors American College of Radiology names new officers Bristol-Myers Squibb and Celldex Therapeutics Inc. enter agreement Moffitt Cancer Center collaborates with Vermillion Inc. Children’s Oncology Drug Alliance helps form international collaborative

20140516 - May. 16, 2014

ISSUE 19 – MAY 9, 2014

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Oregon Center Launching $1 Billion Program To Identify Lethal Cancers Before They Kill

Brian Druker has some awesome jobs to fill.

As many as 30 scientists and their teams will get to focus on cancer research without having to worry about applying for grants.

“It’s about bringing 20 to 30 people together, giving them sufficient funding—almost like [Howard Hughes Medical Institute] level funding,” Druker said to The Cancer Letter. “If you have 20 to 30 people who are focused on science, working as a team to solve a problem, judged on progress toward the goal, as opposed to how many grants and publications do you have, we think we can make a more rapid contribution in this area.

	CMS Advisors Express Low Confidence In Low-Dose CT Screening for Lung Cancer An advisory panel for the Centers for Medicare and Medicaid Services expressed low confidence in low-dose computed tomography as a method for screening for lung cancer in the Medicare population. Evidence is inadequate to ensure that benefits of the procedure would outweigh harms, the Medicare Evidence Development & Coverage Advisory Committee said at the hearing April 30.
	Bach: LCA Center Certification Untrustworthy; CISNET Models Don’t Match When it appeared that CT screening for lung cancer was a shoo-in for Medicare coverage, the Lung Cancer Alliance, an advocacy group, started to certify “screening centers of excellence.” Centers all over the country received this designation from LCA and were listed on the group’s website. However, as he prepared for a recent Medicare advisory committee meeting, Peter Bach, a pulmonologist and health systems researcher at the Memorial Sloan-Kettering Cancer Center, checked the list of LCA-certified centers.
	Steven Woolf: Why CMS Should Not Cover LDCT National coverage for low-dose computed tomography may result in more harm than benefit to the Medicare population at this time, said Steven Woolf, a member of the Medicare Evidence Development & Coverage Advisory Committee. Speaking at the April 30 MEDCAC hearing, Woolf said coverage would run into many implementation challenges and adherence problems—it would be unlikely that all practices would observe the strict criteria set by the U.S. Preventive Services Task Force and the National Lung Screening Trial, he said.
	Growth of the Cost of Drugs Slows to 5.4 Percent per Year; 21 Therapies Launched in 2 Years The growth of global spending on oncology medicines has slowed over the past five years, according to a report by the IMS Institute for Healthcare Informatics. Spending on cancer drugs, including those used for supportive care, increased at a compound annual growth rate of 5.4 percent during the past five years, reaching $91 billion in 2013, compared with 14.2 percent from 2003 to 2008.
	Women’s Health Initiative Trial Produced $37.1 Billion in Returns The overall economic return from the Women’s Health Initiative estrogen plus progestin trial indicates that the changes in practice it produced provided a net economic return of $37.1 billion over 10 years.
	FDA Oncology Unit Fastest in Approvals Despite Having Highest Workload A study by a conservative think tank found large differences in performance of the FDA divisions, with oncology demonstrating the agency’s fastest time from application submission to approval. Paradoxically, the Manhattan Institute found that the oncology division’s staff members had the agency’s highest workload—measured in INDs per staff member at the division.
	In Brief David Cole named president of The Medical University of South Carolina Peter Bach’s account of his wife’s death from breast cancer MD Anderson honors 16 junior faculty members US Oncology and Community Oncology Alliance speak to Congress Athena Breast Health Network adopts ASCO’s HL7 Guide for EMRs Eli Lilly & Co. sign agreement with Prasco Laboratories Johns Hopkins receives $10 million from Under Armour Melanoma Research Alliance and L’Oreal Paris begin campaign Kristin Darby named chief information officer of Cancer Treatment Centers of America
	Drug Approvals Zykadia granted accelerated approval for ALK+ NSCLC ADXS-HPV grated orphan drug designation

20140509 - May. 9, 2014

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Model Projects 54,900 New Lung Cancer Cases In Five Years with Nationwide LDCT Screening