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ISSUE 28 – JULY 11, 2014PDF



NCI to Implement More Transparent Formula
For Calculating Cancer Center Support Grants

NCI took another step toward adopting a new formula for determining the size of cancer center support grants, with the National Cancer Advisory Board accepting a report from a working group that has been working on the problem since the fall of 2012. 

The schema proposed by the working group was accepted by the advisory board at its meeting June 23. It recommends broad organizing principles rather than specific numbers. 

After the Plenary
Don Berry: In NeoALTTO & ALTTO Trials, Neoadjuvant Response Predicts Adjuvant

An article in the June 6 issue of The Cancer Letter described plenary presentations at ASCO 2014. One presentation was the adjuvant breast cancer clinical trial ALTTO in HER2-positive disease, which “was chosen [for the plenary session] because it addressed the reliability of pathological complete response as a surrogate for patient benefit.”  

photoCounterpoint
George Sledge Responds To Berry’s Letter: Neoadjuvant Doesn’t Predict Adjuvant In Breast Cancer

As always, I both enjoyed and learned something interesting from Dr. Don Berry, one of the great biostatisticians of our era. I find, reading his analysis of ALTTO and NeoALTTO, much that I agree with. I am certainly no statistician, and must bow to his statistical analysis of ALTTO and NeoALTTO. And yet at the same time I think it misses the point. So I will beg to differ.

Also: Don Berry’s Rejoinder

photoAACR Changes Its Logo— For the Fifth Time Since 2000

The American Association for Cancer Research ushered in the year 2000 with a round logo that combined the lamp of knowledge with a map of the Americas and an aspirational slogan in Latin.

The 26-year-old logo gave way to one that looked more corporate. However, AACR didn’t stop at just one redesign. It changed the logo four more times. 

photoNIH Funding Opportunity
Outstanding Investigator Award In Cancer Research Available

The NIH has published a funding opportunity announcement for the Outstanding Investigator Award in any area of cancer research.

photoIn Brief

  • Three appointed to leadership positions at St. Jude

  • Duke’s Amy Abernethy named chief medical officer at Flatiron Health

  • William Hogan joins University of Florida as director of bioinformatics

  • J. Alan Diehl named associate director of basic sciences at MUSC

  • Vincent O’Neill named chief medical officer of Exosome Diagnostics

  • Joseph Haywood named president of FASEB

  • Thomas Jefferson University receives $110 million gift

  • Stand Up to Cancer Canada launched

  • Bristol-Myers Squibb announces collaboration with Duke University

  • Pew Charitable Trusts announce class of cancer research scholars

  • Steven Bangert named CEO of the Year by the American Cancer Society

photoDrug Development

  • Breakthrough Therapy designation granted to CTL019 in ALL

  • European Commission approves Halaven for metastatic breast cancer

  • Breakthrough Therapy designation granted to blinatumomab in Ph- ALL

  • Mylan launches generic Carboplatin Injection in multi-dose vials

20140711 - Jul. 11, 2014
ISSUE 27 – JULY 4, 2014PDF



Harvard Physician, Whose Cancer Was Spread Through Morcellation, Seeks to Revamp FDA Regulation of Medical Devices

On Oct. 17, 2013, a surgical instrument called a power morcellator tore into the uterus of Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center, pulverizing what were believed to be benign fibroids.

Reed’s “minimally invasive” hysterectomy, a routine procedure, was performed at the Brigham and Women’s Hospital, a teaching hospital of Harvard Medical School.

Alas, Reed’s uterus contained an occult sarcoma, which the morcellator proceeded to spread through her abdominal pelvic cavity. Over ensuing months, as Reed battled to stay alive, her husband, Hooman Noorchashm, a cardiothoracic surgeon and, at the time, a lecturer at Harvard, waged a national campaign to put an end to the practice of power morcellation.

Conversation with The Cancer Letter
Challoner: We Recommended FDA Replace 510(k) Clearance

The Cancer Letter asked David Challoner, emeritus vice president for health affairs at the University of Florida, to discuss FDA’s 510(k) medical device clearance process.

The process has come under scrutiny after laparoscopic power morcellation procedures were found to spread previously undetected sarcomas inside benign fibroids.

Challoner chaired an Institute of Medicine committee tasked by FDA and Congress in 2009 to review the 510(k) approval process. 

photoBertagnolli: Why Brigham Stopped Making Morcellation Available Outside of a Registry Trial

“We know that this improves patient care,” Bertagnolli said in an interview with Matthew Bin Han Ong, a reporter with The Cancer Letter.

“In a case such as this one, close communication between the oncology and general gynecology communities is a key requirement for reducing morbidity and deaths due to uterine sarcomas.”

photoBSA Approves Trial of Carbon Ion Therapy, Extends EDRN and Provocative Questions

Question: What’s more expensive than proton beam radiation therapy?

Answer: Carbon ion radiation therapy.

With CIRT centers costing about $300 million to construct—about twice as much as proton beam centers—the potential adoption of this technology threatens to further inflate health spending worldwide.

photoIn Brief

  • Li Ma and Jeffrey Tyner receive Wachter Award from AAAS

  • John Cleveland named associate director of basic science at Moffitt Cancer Center

  • The Community Oncology Alliance appoints new officers

  • Roswell Park Cancer Institute receives “outstanding” distinction from NCI

  • The American Society for Radiation Oncology names 30 new fellows

20140704 - Jul. 3, 2014
June 2014PDF

Non-Small Cell Lung Cancer

Pooled Analysis of Two LUX-Lung Trials Shows Prolonged Survival with Afatinib

New overall survival data of two phase III clinical trials, LUX-Lung 3 and LUX-Lung 6, demonstrated that patients with advanced non-small cell lung cancer whose tumors have the most common epidermal growth factor receptor mutation lived longer if treated with first-line afatinib compared to chemotherapy. 

In the pooled analysis, afatinib (Gilotrif) prolonged survival of lung cancer patients whose tumors have common EGFR mutations compared with standard chemotherapy by a median of 3 months (27.3 to 24.3 months) and significantly reduced the risk of death by 19 percent (HR=0.81, p=0.037). 

Also:
Prostate Cancer 
Enzalutamide Reduced Risk of Progression By 81 Percent in Metastatic Prostate Cancer

A drug used to treat men with late-stage prostate cancer proved effective in stemming progression of the disease in research participants who had not yet received chemotherapy and extended their survival, according to results from a multi-national phase III clinical trial 

An analysis of the study’s results, published in the New England Journal of Medicine and presented at the American Society of Clinical Oncology annual meeting in Chicago, found that participants treated with enzalutamide saw an 81 percent reduction in the risk the cancer would progress and a 29 percent reduction in the risk of death. 

Pancreatic Cancer
Vaccine and LDCT Pretreatment Can Help PDACs Become Vulnerable to Immunotherapy

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).

Leukemia
Ibrutinib Increases OS, PFS Versus Ofatumumab in Phase III
Multiple Myeloma
Phase III PANORAMA-1 Trial Meets PFS Primary Endpoint
Thyroid Cancer
Phase III Trial Data: Lenvatinib Extends PFS by Over 14 Months
Glioblastoma
Vaccine Increases PFS by 4 Months In Phase II Per-Protocol Analysis
NCI Approved Trials for the Month of June
FDA Approvals

  • Lymphoseek label updated to include head and neck squamous cell carcinoma

  • Aloxi injection approved for preventing chemotherapy-related nausea in children as young as one month old

  • Orphan drug designation granted to mocetinostat for myelodysplastic syndrome

  • Invenia ABUS breast imaging technology approved 

20140630 - Jun. 30, 2014