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April 2015PDF

 

Melanoma

Keytruda Meets PFS, OS Endpoints in Phase III Advanced Melanoma Trial

A phase III study investigating Keytruda patients with advanced melanoma met two primary endpoints, demonstrating improvements in progression-free survival and overall survival compared to Yervoy. The study’s independent data monitoring committee recommended stopping the trial early.

In the trial, named KEYNOTE-006, Keytruda (pembrolizumab) improved PFS by 42 percent and extended overall survival by 34 percent compared to Yervoy (ipilimumab).

Investigators from 16 countries enrolled 834 patients with metastatic melanoma in the clinical trial, and patients were randomly assigned to Keytruda and Yervoy. The study was published online in the New England Journal of Medicine, and was presented at the annual meeting of the American Association for Cancer Research. The trial was sponsored by Merck.

 

Prostate Cancer

Three Xtandi Trials Show Positive Results In Castration-Resistant Prostate Cancer

Astellas Pharma Inc. and Medivation Inc. presented an updated overall survival analysis from the placebo-controlled phase III trial of Xtandi in chemotherapy-naive metastatic CRPC.

The companies also published data from two separate phase II head-to-head studies, named STRIVE and TERRAIN, comparing Xtandi (enzalutamide) to Casodex (bicalutamide).

The phase III trial, named PREVAIL, was a randomized, double-blind trial that enrolled 1,717 patients at sites in the U.S., Canada, Europe, Australia, Russia, Israel and Asia, including Japan.

 

Drugs and Targets

FDA Updates Zytiga Label To Include Chemotherapy-Naive Metastatic CRPC Data

FDA approved a label update for Zytiga (abiraterone acetate) plus prednisone to include overall survival results in chemotherapy-naive men with metastatic castration-resistant prostate cancer.

The update was based on the final analysis of the phase III, randomized, double-blind, placebo-controlled COU-AA-302 study, which showed that Zytiga plus prednisone significantly prolonged median overall survival, compared to placebo plus prednisone. 

 

Breast Cancer

Ongoing Phase II Trial Shows Correlation Between Immune Response and Recurrence

 

Lymphoma

Circulating Tumor Cells Can Be Used to Detect DLBCL Recurrence, Researchers Say

 NCI CTEP-Approved Trials for the Month of April 
  
20150430 - Apr. 30, 2015
ISSUE 16 – APRIL 24, 2015PDF

Foes Immediately Vow to Nullify Task Force Guideline on Mammography for Women 40-49

The breast cancer screening recommendations proposed by the U.S. Preventive Services Task Force earlier this week are basically unchanged from the 2009 version.

WARNING: a reader’s yawn at this juncture would be misplaced.

The recommendations proposed and put in place five years ago were so politically radioactive that they could have jeopardized the passage of the Affordable Care Act.

Indeed, the ACA specifically excluded the task force’s 2009 recommendation on mammography.

Immediately after the 2009 draft recommendation was published, then HHS Secretary Kathleen Sebelius in effect urged women between 40 and 49 to disregard the panel’s evidence-based guideline. An amendment to the ACA, called the “Women’s Preventive Health Amendment,” finished the job of invalidating the guideline. (This made the ACA politically viable.)


Mammography: When, Really, is the Right Time? And at What Cost? 

As a firestorm ignites around the U.S. Preventive Service Task Force draft recommendation on mammography, researchers and advocates are grappling with the questions at the heart of the controversy:

• Should women start screening for breast cancer at age 40 or 50?
• What is the prevalence of false-positives and overdiagnosis in these age groups?
• What are the costs of harm?

The USPSTF draft recommendation, published April 20, comes on the heels of a controversial study which estimates that the

U.S. spends $4 billion a year on unnecessary mammograms for women between the ages of 40 to 59.

Mandl: Costs of Harm from Mammography Must Be Balanced Against Benefits

The U.S. spends $4 billion on unnecessary mammograms each year, according to a study published in the April issue of Health Affairs.

Titled “National Expenditure for False-Positive Mammograms and Breast Cancer Overdiagnoses Estimated at $4 Billion a Year,” the study, by Kenneth Mandl and Mei-Sing Ong, uses expenditure data from a major U.S. health care insurer for 702,154 women in 2011 to 2013.

Of the $4 billion, $2.8 billion is attributed to false-positive mammograms, and $1.2 billion to breast cancer overdiagnosis. The study measures the rate of false positives at 11 percent and overdiagnosis at 22 percent.

Wender: Mammography Guidelines Should Balance Benefits and Risks, Not Costs

“Let me be really clear: I don’t think that article should have or will have any impact on the [US Preventive Services Task Force], and it will not have any impact on [the American Cancer Society] guidelines, either,” Wender said.

 

Four Decades of Mammography Wars

The latest draft guideline by the U.S. Preventive Services Task Force is part of nearly a four-decade war over the appropriateness of screening women between the ages of 40 and 49.

In this war, Congress usually intervened, claiming that “common sense” dictates that mammography is efficacious in younger women. This war has often engulfed NCI.

This timeline appeared in part in the Nov. 20, 2009, issue of The Cancer Letter.

AACR Annual Meeting 2015

  • Jose Baselga becomes president of AACR

  • Two Stand Up To Cancer Dream Teams launched in ovarian and lung cancer

  • Multiple award winners named

The Cancer Letter Receives Sigma Delta Chi Award

The Cancer Letter won a 2014 Sigma Delta Chi Award for Public Service in Journalism from the Society of Professional Journalists on April 23.

The Sigma Delta Chi Awards is a national competition dating back to 1932. The award recognizes Matthew Ong’s series “Power Morcellation: A Hazardous Practice” as the winner in the Newsletter category.

“This award recognizes a newsletter that renders outstanding public services through extensive coverage of an issue facing the community it serves,” the description reads.

Ong’s series, which includes an interview documentary, can be found here.

20150424 - Apr. 24, 2015
ISSUE 15 – APRIL 17, 2015PDF

Lowy: “We Need to Continually Look at the Distribution of Funds That We Allocate to the Areas of Investment”

Douglas Lowy became the NCI acting director April 1. On April 16, Lowy spoke with Paul Goldberg, editor and publisher of The Cancer Letter.

Paul Goldberg: Congratulations, first of all. How is the job treating you?

Douglas Lowy: Well, it is certainly a lot of work, but it’s an incredible opportunity—I have the opportunity of working with terrific people every day. I love it.

PG: Did you want this job?

DL: I never thought of myself as either becoming acting NCI director or the permanent NCI director, and it was not something I lobbied for.


MD Anderson Execs Get Big Raises In the Midst of Faculty Morale Woes

  

 

Two top administrators at MD Anderson Cancer Center, whose job responsibilities include maintaining harmony with the faculty, received substantial pay increases for having “excelled beyond expectation” and “effectively” directing the center’s clinical activities.

According to documents obtained by The Cancer Letter under the Texas Public Information Act, MD Anderson Provost Ethan Dmitrovsky and Physician-in-Chief Thomas Buchholz received $200,000 each in deferred compensation in 2015.

With incentive pay, supplemental annuity and deferred compensation included, the 2015 raise could boost Dmitrovsky’s total paycheck by as much as 22.9 percent compared to fiscal 2014. Buchholz’s compensation could increase by 31.4 percent.

Lawmakers Repeal Medicare SGR in Bipartisan Vote

President Barack Obama signed the Medicare Access and Children’s Health Insurance Program Reauthorization Act on April 14, permanently repealing the Medicare sustainable growth rate formula.

The bill received overwhelming bipartisan support: The House of Representatives voted 392 to 37 on April 2, and the Senate approved it with a 92 to 8 vote April 14.

In Brief

  • NCI renews Purdue’s designation as an NCI Basic Science Cancer Center

  • Joseph Gulfo named executive director of the Rothman Institute at Fairleigh Dickinson University

  • Don Gabriel joins United BioSource Corp.

  • Children’s Hospital of Wisconsin opened its MACC Fund Center clinical and Northwestern Mutual Day Hospital

  • Roche acquires CAPP Medical

Drugs and Targets

  • Health Canada approves new indication for Xtandi

  • Bayer HealthCare expands global clinical development of copanlisib

  • Immunocore and MedImmune enter into second collaboration

20150417 - Apr. 17, 2015