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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
ISSUE 26 – JUNE 27, 2014PDF



ODAC Clarifies Standards for Maintenance In Ovarian Cancer;
Nixes Olaparib in 11-2 Vote

Some of the questions that landed the AstraZeneca drug Olaparib (lynparza) before the FDA Oncologic Drugs Advisory Committee were classic:

• How much progression-free survival is enough?

• Can you make use of post-hoc analysis to identify a cohort in which the drug appears to be most effective?

Two big questions in their own right, but in the case of Olaparib, these questions were even more important because of the setting. Olaparib is intended as maintenance for relapsed ovarian cancer, where the standard of care is no cancer drugs at all.

Joint NCAB-BSA Meeting
NCI Prepares for Intramural Program Review

NCI has received some relief from sequestration, and the budget cuts will be adjusted proportionally, Director Harold Varmus said at the joint meeting of the National Cancer Advisory Board and the Board of Scientific Advisors June 23.

“The FY 14 budget is not very dissimilar from last year’s budget,” Varmus said. “We had relief from sequestration. We have correspondingly reduced the level of cuts we have imposed on both competitive and non-competitive awards. We expect to be awarding roughly the same number of RPGs, research project grants, as we did in FY 13.”

photoGroups Urge FDA to Take More Action Against Tobacco Products

On the fifth anniversary of the landmark 2009 law granting the FDA authority over tobacco products, 10 leading public health and medical organizations called on the FDA and the Obama Administration to prioritize three actions to reduce tobacco use.

photoIn Brief

  • James Downing named CEO of St. Jude Children’s Research Hospital

  • Lynda Chin receives fellowship at MD Anderson Cancer Center

  • Thomas Hansen, CEO of Seattle Children’s, to retire in 2015

  • Cornelia Ulrich and Bruce Edgar to join Huntsman Cancer Institute

photoFDA News

  • Lymphoseek label updated to include head and neck SCC

  • Aloxi injection approved to prevent chemotherapy-related nausea and vomiting in children as young as one month old

  • Fast Track status granted to DNX-2401 in glioblastoma

  • Orphan Drug status granted to mocetinostat for myelodysplastic syndrome

20140627 - Jun. 27, 2014