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July 2014PDF

Colorectal Cancer 
Trifluridine and Tipiracil Hydrochloride Increase OS, PFS in Phase III Trial

A phase III trial of trifluridine and tipiracil hydrochloride significantly improved both overall and progression-free survival in refractory metastatic colorectal cancer that had progressed after standard therapies. 

Data from the trial of the oral anticancer combination, also known as TAS-102, were presented at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer in Barcelona, Spain.

The global, randomized, double-blind trial, named RECOURSE, met the primary efficacy endpoint of statistically significant improvement in overall survival versus placebo (HR=0.68, p < 0.0001). TAS-102 reduced the risk of mortality by 32 percent when compared to placebo. 

Melanoma

IDMC Halts Mekinist-Tafinlar Trial Early Due to OS Benefit; Recommends Crossover

An independent data monitoring committee recommended an early stop a phase III trial of Mekinist and Tafinlar in patients with BRAF V600E or V600K mutation-positive unresectable or metastatic cutaneous melanoma, following a demonstrated overall survival benefit.

The randomized, open-label study, named COMBI-v, compared the combination of Mekinist (trametinib) and Tafinlar (dabrafenib) to vemurafenib in subjects with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma. 

Also:
Gastroenteropancreatic Neuroendocrine Tumors
Somatuline Demonstrates 65.1 Percent Of Patients Progression-Free at 96 Weeks

By priming pancreatic ductal adenocarcinomas with a therapeutic vaccine and a low-dose chemotherapy combination prior to surgery, researchers converted PDACs into cancers that may respond to immunotherapy.

Researchers pretreated PDAC patients with the vaccine GVAX and low doses of the chemotherapy cyclophosphamide, which caused the aggregation of immune cells inside the patients’ tumors, and many of these immune cells expressed proteins that may make these cancers amenable to immunotherapies such as PD-1 inhibitors.

The trial was published in Cancer Immunology Research, a journal of the American Association for Cancer Research, produced in collaboration with the Cancer Research Institute).

Acute Myeloid Leukemia
Volasertib and LDAC Doubled Response in Older Patients
Cervical Cancer
Study: Negative HPV Test More Accurate than Negative Pap Test In Predicting Cancer Risk
Proton Therapy
Phase II Study: Proton Therapy Can Have Similar Success Rate, Smaller Level of Risk in Treatment of Hodgkin Lymphoma
NCI CTEP-Approved Trials for the Month of July
FDA Approvals

  • Zydelig tablets approved for three blood cancers

  • Imbruvica approved in chronic lymphocytic leukemia

  • Avastin granted priority review in metastatic cervical cancer

  • Blinatumomab granted breakthrough therapy designation in acute lymphoblastic leukemia

  • CTL019 granted breakthrough therapy designation in adult and pedtiatric ALL

  • European Commission approves Halaven for metastatic breast cancer

  • Mylan Inc. launches generic carboplatin injection in multi-dose vials

  • FDA approves IBA Cone Beam Computed Tomography proton therapy solution

  • FDA issues drug safety communication regarding docetaxel

20140731 - Jul. 31, 2014
ISSUE 30 – JULY 25, 2014PDF



FDA Advisors Debate Ban, Black Box

And Status Quo of Power Morcellators

In a heated two-day hearing, several members of an FDA advisory panel on medical devices expressed low confidence in power morcellation as a treatment for uterine fibroids, and focused on alternative methods for performing hysterectomies and fibroid removal.

There was no formal consensus on either an outright ban on power morcellators or issuance of a “black box” warning label.

Photo: Families harmed by power morcellation pose on FDA’s White Oak campus July 11, following a two-day hearing on the controversial surgical procedure

The Numbers
GYN Group: Open Surgery Would Cost More Lives than Morcellation

More women would die from open surgery each year if the FDA decides to ban power morcellation, said Jubilee Brown, an associate professor at MD Anderson Cancer Center and a spokesperson of the American Association of Gynecologic Laparoscopists.

Capitol Hill
Sen. Harkin Introduces NIH Funding Bill That Boosts Budget to $46.2 Billion by 2021

Sen. Tom Harkin introduced a bill that would set NIH on a path to recoup the purchasing power it has lost since 2003, and make funding biomedical research a national priority.

The bill is not an appropriations bill, and does not authorize spending any money. It would, however, raise the limits set in place for NIH by the 2011 Budget Control Act and sequestration, allowing Congress to appropriate $46.2 billion by 2021—a level near where NIH funding would be, had it kept pace with inflation. 

photoAppropriations
Senate Committee Approves 4.5 Percent Cut to Defense Department Cancer Research Funding

The Department of Defense appropriations measure for the fiscal year 2015, approved by the Senate Appropriations Committee July 17, decreased overall funding for peer-reviewed cancer research programs by 4.5 percent. 

photoIn Brief

  • V. Craig Jordan to join MD Anderson Cancer Center

  • Georgetown’s Kevin FitzGerald named to Pontifical Council for Culture

  • John Birkmeyer named executive VP for enterprise support systems at Dartmouth-Hitchcock health system.

  • Ellen Miller Sonet named chief strategy and alliance officer of CancerCare

  • Rep. Henry Waxman receives lifetime achievement award from 340B Coalition

20140725 - Jul. 25, 2014
ISSUE 29 – JULY 18, 2014PDF



DePinho’s Handling of MD Anderson Tenure Dispute Triggers Formal Investigation by AAUP

The American Association of University Professors has authorized a formal investigation of MD Anderson Cancer Center, a move that could result in censure.

The investigation was triggered by refusal on the part of MD Anderson’s administration to provide justification for denying tenure renewals to two faculty members.

The faculty members in question—Kapil Mehta and Zhengxin Wang—received unanimous votes in favor of renewal from the Faculty Senate Promotions & Tenure Committee, but the institution’s president, Ronald DePinho, ultimately decided not to extend their tenure. 

Memorial Sloan Kettering Seizes Top Cancer Hospital Prize from MD Anderson in U.S. News & World Report Rankings

MD Anderson Cancer Center’s uninterrupted seven-year stretch as the top cancer hospital in the U.S. News & World Report rankings has come to an end.

Memorial Sloan Kettering Cancer Center has broken the spell of being the perpetual runner-up and moved to the lead.

The result is as close as cancer care can come to a photo finish:

• MSKCC: 100 percent.

• MD Anderson: 99.9 percent.

photoCapitol Hill 
Advocates Lobby Congress To Close Medicare Loophole For Colonoscopy Coverage

A coalition of advocacy groups focused on colorectal cancer asked Congress to fix the loophole in Medicare coverage of colonoscopies.

The group, organized by Fight CRC and the American Cancer Society Cancer Action Network, met July 16 to lobby for proposed legislation that would ensure cost is not a barrier to colon cancer screenings.

photoIn Brief

  • University of Arizona forms plan with Banner Health to build statewide health system

  • Roswell Park Cancer Institute granted approval for genome trials by New York State Department of Health

  • Medical College of Wisconsin receives $2.6 million grant from NCI

  • Dana-Farber Cancer Institute forms three-year immuno-oncology lung cancer collaboration with Johnson & Johnson and Janssen Biotech

  • Eli Lilly and Company and Immunocore Limited form collaboration

  • The Ohio State University and the University of Michigan sign agreement with Venture Therapeutics Inc.

20140718 - Jul. 18, 2014