Litigation Change Ahead – Pleural Mesotheliomas, Lung Cancers in Non/Light Smokers, and Other

The future continues to arrive with increasing analysis of tumor-specific mutations for various types of cancer that increasingly end up in litigation. Over time, analyses of this sort will influence litigation outcomes.

The latest example is an August 21, 2013 Cleveland Clinic press release about a new study that will entail use of next gen sequencing of tumors to make treatment decision for persons with one or more of 15 solid tumors. The tumors included in the study include some pleural mesotheliomas and some lung cancers in persons with little or no smoking history, plus other tumors that are ending up in litigation, including bladder cancers.

Interestingly, the study also includes uveal melanomas. Those tumors – and mesotheliomas – are more common in persons with the BAP1 mutation. The impact of the BAP1 mutation was identified by a group lead by Joseph Testa, and a group led by Michele Carbone, with both groups including a wide group of other excellent researchers.

Testing will utilize tests developed by Foundation Medicine. That entity intends to transform the world of cancer treatment. Foundation explains its mission as follows:

"Foundation Medicine is a commercial-stage company focused on fundamentally changing the way patients with cancer are treated. Our proprietary molecular information platform generates actionable genomic information about a patient’s individual cancer, enabling physicians to optimize treatments in clinical practice and enabling biopharmaceutical companies to develop targeted oncology therapies more effectively. The Company’s first clinical product, FoundationOne, is the only commercially available comprehensive molecular information product designed for use in the routine care of patients with cancer.

Molecular subtypes of cancer

As the molecular drivers of cancer are better understood and more targeted therapies are developed against those drivers, there is an ever-growing need to perform comprehensive molecular analysis of tumors to determine the optimal treatment strategy for each patient. Foundation Medicine is pioneering the development of a comprehensive cancer diagnostic test that represents this critical step toward individualized cancer care by helping physicians recommend treatment options for each patient based on the molecular subtype of their cancer.

A new, cutting edge diagnostic approach

By utilizing next-generation sequencing on small amounts of cancer tissue, relevant genomic information that will help doctors make the most informed treatment recommendations will be captured in one test with greater than 99% sensitivity and specificity for alterations within all relevant cancer genes. Test results will be uniquely reported within the context of publicly available scientific and medical literature and clinical trials, integrating complex genomic research in a coordinated and easily accessible way for physicians to inform treatment recommendations.

Rock solid Foundation, positioned for success

Foundation Medicine was founded by world leaders in genome technology, cancer biology and medical oncology from the Broad Institute, the Dana-Farber Cancer Institute, Harvard Medical School and the Massachusetts Institute of Technology."

Pasted below are the Cleveland Clinic press release and a study outline listing the 15 tumors.

"Cleveland Clinic to Study Feasibility and Clinical Impact of Next Generation Genomic Sequencing

Study Targets Solid Tumor Cancer Patients with Poor Prognosis or Limited Treatment Options

August 21, 2013

As modern cancer treatments become more personalized, Cleveland Clinic is now offering select cancer patients the opportunity to have their tumors analyzed for genetic mutations that could influence their treatments.

For the next year, cancer patients with one of 15 specific solid tumors with historically poor prognosis or limited treatment options will have the opportunity to participate in a study where their tissue samples will be sent for targeted genetic sequencing to Foundation Medicine, a molecular information company specializing in comprehensive genomic analysis of tumors.

Participating patients’ tissue samples will be analyzed with a test that examines more than 230 cancer-related genes to provide information on the tumor’s genomic composition and identifies genomic alterations that could guide treatment. Once the analysis is complete, an independent team of Taussig Cancer Institute oncologists will review the results and recommend a personalized treatment plan which could include chemotherapy, radiation, targeted therapies and/or participation in a clinical trial that may benefit the patient.

“Personalized medicine is changing the way we treat cancer,” says Davendra Sohal, MD, MPH, staff physician in the department of Solid Tumor Oncology at Cleveland Clinic’s Taussig Cancer Institute and principal investigator. “Knowing the specific genomic composition of a tumor may allow us to create precise, individual treatment plans for patients rather than relying on standard treatments that may be ineffective and may result in unnecessary treatment costs.”

Since its inception, Cleveland Clinic has been at the forefront of cancer breakthroughs. Cleveland Clinic physicians and scientists have developed new surgical techniques, discovered new treatments and uncovered new information about cancer cells that have changed the way patients are screened, diagnosed and treated. Advancements in cancer genomics are the next step.

“This is a very exciting time in cancer research,” says Brian J. Bolwell, MD, FACP, chairman of Cleveland Clinic’s Taussig Cancer Institute. “This type of personalized cancer medicine can help patients with recurrent cancers or with cancers that do not respond well to current treatment protocols. Through this collaboration, we can give patients more treatment options than ever before.”

For more information on Cleveland Clinic cancer services, call the Cancer Answer Line at 1.866.223.8100 or visithttp://clevelandclinic.org/cancer.

http://www.twitter.com/ClevelandClinic.

Media Contact

Stephanie Jansky, 216.636.5869, janskys@ccf.org

__________________________________________________________________________

Inclusion Criteria


1. Solid tumor with a confirmed histopathologic diagnosis falling into one of the following categories and without a known curative therapeutic option:

i. Metastatic/locally-advanced carcinoma of unknown primary- this includes tumors in which the pathology reads poorly differentiated (adeno)carcinoma in which the primary organ site cannot be discerned with certainty despite adequate clinical, laboratory and radiologic investigations

ii. Metastatic/locally-advanced bladder cancer after failure of at least one platinum-based systemic chemotherapy

iii. Metastatic/locally-advanced adrenocortical cancer

iv. Metastatic/locally-advanced non-clear cell renal cell carcinoma

v. Metastatic/locally-advanced non-small cell lung cancer in a non/light/distant smoker without known EGFR or EML4-ALK mutation in the tumor

vi. Unresectable pancreatobiliary cancer

vii. Head and neck squamous cell carcinoma, after failure of primary therapy

viii. Metastatic/unresectable pleural mesothelioma

ix. Metastatic triple-negative- defined as ER-negative (<5%), PR-negative (<5%), HER2 non-amplified (FISH ratio <2.0)- breast cancer who have received 0-1 prior regimens for advanced disease

x. Anaplastic and atypical meningioma

xi. Metastatic uveal melanoma

xii. Metastatic castrate-resistant prostate adenocarcinoma

xiii. Grade III Gliomas (anaplastic oligodendroglioma, anaplastic astrocytoma and mixed anaplastic glioma)

xiv. Glioblastoma

xv. Metastatic colorectal cancer

2. Age ≥18 years

3. ECOG performance status 0, 1 or 2

4. Measurable and/or evaluable disease per RECIST version 1.1

5. Patient not currently enrolled or being enrolled in another clinical trial of cancer-specific therapeutic agent(s)

6. Prior therapies (e.g. chemotherapy, targeted therapy, surgery, radiation) are permitted but not required

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About Kirk

Since becoming a lawyer in 1983, Kirk’s over 30 years of practice have focused on advising a wide range of corporations, associations, and individuals (as both plaintiffs and defendants) on both tort and commercial law issues centered around “mass torts.”

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