CORT, P.A. will close on 8-31-2013: Why? What’s Next?

July 18, 2013

Research activities at CORT, P.A. closed a couple of years ago as a result of poor reimbursement for conduct of clinical trials from both government and private pharmaceutical sources.  The costs of extensive physical and human infrastructure that are necessary for conduct of oncology clinical trials were not met.  In addition, both government and private pharmaceutical trial sources often tracked study milestone payments poorly, if at all.  Despite careful tracking and invoicing for study milestone achievement, payments were almost always delayed.  In the case of one government-sponsored study for breast cancer, payments were not received for several years after the study actually closed.  Another government study mailed payments to the hospital rather than the investigator’s study research office resulting in hours of lost time in retrieval of funds from the hospital, which had deposited the funds to its account, even though it had no involvement in the conduct of the research at our private office research site.  In discussing the inadequate reimbursement for trial conduct, one contract research organization trial manager visiting my office told me that the CRO routinely offered per-subject research reimbursement at levels below what they knew the trials costs.  It was the duty of the investigator/research manager to discover the true cost and request a higher payment, and that increased level of payment would be routinely granted if requested.  The true costs are often difficult to quantify, and many hidden expenses do not materialize until the trial is already under way at the site.  Many other issues could be cited, but my point is that both government and private research sponsors understand these issues well, but fail to address them because they (and the CRO intermediaries that they employ) benefit financially by suppressing payment to the sites conducting the trials.  This is why so few private practices participate in the conduct of clinical trials: they lose money, but learn this only too late.  Because the overhead costs of State Universities or other government-owned entities are covered by the taxpayers, they can “afford” to conduct research studies that are not profitable, but my suspicion is that they do not even know that they lose money in the conduct of many of the clinical trials they perform. 

Subsequent to research closure at CORT, the local single-specialty oncology provider that holds a virtual monopoly in the Texas region has continued with its anti-competitive practices, buying the clinical practices of physicians who might refer patients to oncologists (breast surgeons, colorectal surgeons, urologists, surgical oncologists).  That practice is a form of vertical human supply-chain management, which consolidates oncology patients into a stream that only flows into that giant oncology provider’s practice locations.  The small practices are left with dwindling numbers of patients and reduced income, but the same (or usually increasing) overhead.  It is no wonder that a survey of private oncology practices showed that in the past year 20% have closed and another 20% have folded to become part of hospital or other entities (yes, some are swallowed by the giant oncology monopoly player mentioned above). 

(See report: http://glacialblog.com/userfiles/76/Community_Oncology_Practice_Impact_Report_6-25-13F(1).pdf )

In addition to competitive pressures of unfair trade practices, increased demands of ICD-10 integration, electronic health record “meaningful use” documentation, HIPPA law updates, oncology drug shortages, drug/treatment/radiology authorization requirements, electronic immunization registry requirements for adults, and frequently delayed or denied payments for oncology drugs provided by the office have continued to be major problems for private oncology practice.  Such issues lead to hundreds of hours of unpaid managerial time spent in the practice each year, despite lower take-home for the physician-manager.

Advertisements

Everolimus (Afinitor) Approved for Advanced Unresectable or Metastatic Pancreatic Neuroendocrine Tumors (PNET)

May 7, 2011

On May 5, 2011, the FDA approved everolimus (Afinitor) for treatment of advanced unresectable or metastatic progressive neuroendocrine tumors of pancreatic origin.   

The approval was based on a randomized comparison of everolimus at 10 mg orally/day versus placebo.  The median progression-free survival (PFS) was 11.0 versus 4.6 months, respectively (p<0.001).  This respresents a major advance for patients with this aggressive form of cancer, for which there were few treatment options.

Abiraterone (Zytiga) Approved for Metastatic Hormone-Resistant Prostate Cancer

May 4, 2011

The FDA approved abiraterone (Zytiga) for treatment of castrate-resistant (androgen-independent) metastatic prostate cancer for patients who have received prior chemotherapy containing docetaxel (Taxotere).  The approval was based on an interim analysis of overall survival (OS) in a placebo-controlled randomized trial, each arm receiving prednisone at 5 mg 2x/day orally.  The median OS was 14.8 months in the abiraterone/prednisone group, compared to 10.9 months in the placebo/prednisone group (p<0.0001). 

The most common adverse reactions (>5%) were joint swelling or discomfort, low potassium, edema, muscle discomfort, hot flashes, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, dyspepsia, nocturia, and upper respiratory tract infection.  Abnormal liver function tests were seen in <1% of patients. 

Abiraterone blood levels were substantially higher when the drug was taken with food (compared to a fasting state).  The recommended dose and schedule for abiraterone is 1000 mg orally once/day, in combination with prednisone 5 mg orally 2x/day.  Abiraterone should be taken on an empty stomach.  No food should be consumed for at least two hours before the dose and for at least one hour after the dose.

CORT Implements Electronic Health Records

July 14, 2010

CORT is pleased to announce our implementation of the OmniMD electronic health record system.  Our implementation will be occurring over the next 4-8 weeks.   This system was selected after a review of over 30 systems.  This web-based system will provide access to patient records for our physicians and providers from any point of care.  The system is full-featured, with electronic medication prescribing, encounter documentation, chemotherapy documentation, and lab integration.  In our next phase of integration, we will be opening our Patient Portal, which will allow patients to go online through a secure password-protected portal to view their records, lab, request appointments and prescriptions, and send messages to clinic providers.  We believe this will facilitate better care delivery and rapid communication with patients and referring physicians.

CORT Moves Focus to Personalized Cancer Therapy, Away from Research Trials

July 14, 2010

With regrets to past, present, and future patients and referring physicians, CORT has terminated participation in many research trials over the past few months. As many of you may have followed this blog site, or linked to it from others, you might have noticed there has been a decline in our acceptance of and participation in new trial program offerings. Providing research opportunities, in addition to standard therapy options has been an expensive endeavor, with high overhead costs for research personnel and facilities. CORT is not and has not been supported by governmental grants. Trials funded by both National Caner Institute and private Pharma sponsors have been woefully underfunded, not meeting costs of conducting these trials. I will continue to support research participation even if it does not occur through my practice directly, but by my referral of patients to participate at other sites.

The long term commitment that CORT has had to providing access to innovative and high-quality cancer drug therapy continues without interruption. As can be seen in the history of our many posts, CORT has years of experience in providing cutting-edge therapies. That experience spills over to all therapy selections (not just study treatment), management of treatment side effects, and probably most importantly, in the commitment to comprehensive planning of individualized treatment approaches for each patient.  As treatment evolves to therapy selection based on genetic and molecular profiling of individual tumor specimens, CORT will remain a leader.

Future posts will focus on some of the fantastic new developments occurring with ever accelerating speed in our field.  My interest is how these developments can be translated rapidly to the patients, and how selection of the therapy can be tailored individually whenever possible.

XRP6258 (Cabazitaxel) Increased Survival for Patients with Advanced Hormone Refractory Prostate Cancer

March 10, 2010

Data from the TROPIC clinical trial was announced at the American Society of Clinical Oncology (ASCO) 2010 Genitourinary Cancer Symposium. This phase III study was conducted at 146 sites in 26 countries. CORT was the study site in Dallas, TX. The study included 755 men patients with hormone refractory prostate cancer whose disease had progressed despite previous docetaxel (Taxotere) chemotherapy.

The primary endpoint of the study was overall survival. Patients were randomly assigned to receive XRP6258 (Cabazitaxel) plus prednisone/prednisolone or mitoxantrone plus prednisone/prednisolone, the latter being an existing stardard-of-care therapy for second-line chemotherapy in such patients.

The results showed that the combination of cabazitaxel plus prednisone/prednisolone signficantly reduced the risk of death by 30% (hazard ratio (HR)=0.70; CI: 0.59-0.83; p<0.0001) with a clinically meaningful improvement in median overall survival of 15.1 months in the cabazitaxel combination arm versus 12.7 months in the mitoxantrone combination arm.

CORT wishes to thank the patients who participated in this clinical trial. Their courage and generosity of spirit enabled such critical reseach to be done.

Based on important clinical trial information such as was obtained in this study, cabazitaxel recently received fast track designation from the US FDA.

New Treatment for Her-2+ Metastatic Breast Cancer Opens at CORT

September 4, 2009

CORT has opened the Wyeth 3144A2 3005 WW Study testing the oral her-2 inhibitor, neratinib, in combination with paclitaxel (Taxol), versus standard therapy with trastuzumab (Herceptin) in combination with paclitaxel, for first-line treatment of her-2+ metastatic breast cancer. 

Neratinib is an oral anti-her-1/her-2 drug with demonstrated efficacy in metastatic her-2 positive breast cancer.  The safety studies have demonstrated acceptable and manageable toxicity of neratinib, including rash and occasional loose stools or diarrhea being most common.  As with other her-2 inhibiting drugs, neratinib may lower the cardiac ejection fraction, so serial monitoring of cardiac function is routine.  The Phase III study will compare the efficacy and tolerability of paclitaxel with either oral neratinib or trastuzumab (a monoclonal antibody against her-2 protein, given IV).

The potential advantages of neratinib include improved convenience (and possibly improved safety).  The drug is given orally.  

For more information about this study, visit our website at www.CORTPA.com, or contact a Research Coordinator at 972-566-5588.  

Patients with her-2+ breast cancer may also be eligible for other studies and treatment at CORT, including non-study therapy.  The principle investigator at CORT is Dr. Barry Mirtsching.  He has personally conducted over 200 trials in cancer therapy over 16 years, many in breast cancer management.  Experience in both trial and non-trial breast cancer management benefits patients by producing better treatment outcomes.  Care at CORT is individual and personal, with adequate time for problem-solving and direct contact with the physician.

STRIDE Breast Cancer Study Testing Stimuvax Cancer Vaccine Open at CORT

September 4, 2009

CORT has opened the STRIDE study for first-line treatment of metastatic, hormone-receptor positive breast cancer.  The study will test standard anti-estrogen therapy in combination with a vaccine placebo, versus standard anti-estrogen therapy with the Stimuvax cancer vaccine.  The press release regarding this study is posted below.

For more information about this study, or to schedule appointments for evaluation and treatment of metastatic breast cancer, visit the CORT website at www.CORTPA.com, or call 972-566-5588 and ask to speak with a Patient Care Coordinator or CORT Research Nurse. 

STRIDE Press Announcement:

24 Jun 2009 – Merck KGaA announced the initiation of its global Phase III clinical study of the therapeutic cancer vaccine Stimuvax® (BLP25 liposome vaccine, L-BLP25) in patients with advanced, inoperable breast cancer. The STRIDEa study will determine if Stimuvax can extend progression-free survival in patients treated with hormonal therapy who have hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer. Overall survival, quality of life, tumor response and safety will also be assessed in this study. The STRIDE study will be supervised by an expert Steering Committee and is sponsored by Merck, which is leading the development of Stimuvax.
STRIDE will enroll more than 900 patients with advanced breast cancer at an estimated 180 sites in over 30 countries – within North America, Europe, Asia and Australia; the Principal Investigator is Dr Lawrence Shulman, Chief Medical Officer and Senior Vice President for Medical Affairs, Dana-Farber Cancer Institute, Boston, USA.
 
Stimuvax is an investigational therapeutic cancer vaccine designed to stimulate the body’s immune system to identify and target cancer cells that express MUC1, an antigen commonly expressed in breast cancer as well as in other common cancer types such as non-small cell lung cancer (NSCLC), multiple myeloma, and colorectal, prostate and ovarian cancers.
 
The Phase III program for Stimuvax was initiated following results from a randomized Phase IIb study of 171 patients with inoperable stage IIIb NSCLC, in which Stimuvax showed a trend towards extending median overall survival from 13.3 months for patients receiving best supportive care (BSC) to 30.6 months for patients receiving Stimuvax plus BSC. Reported side effects included mild-to-moderate flu-like symptoms, gastrointestinal disturbances and mild injection-site reactions. A further long-term safety analysis in 16 patients receiving prolonged treatment with Stimuvax from 2 to 8.2 years showed the most common treatment-related adverse events were injection-site reactions (ISRs) with no evidence of autoimmune reactions. These data also show that the occurrence of ISRs decreased with long-term therapy (>1 year).

CORT Raising Funds for Susan Komen in Race-for-the-Cure

August 8, 2009

Dear Friends,

CORT has recently accepted the challenge to raise funds to support the 2009 Komen Dallas Race for the Cure®  on October 17th. 

Please join us in the fight by donating in support of my participation in the Race.  Your tax-deductible contribution will fund local outreach and awareness programs for underserved communities in the Dallas County area and national breast cancer research.

Donating is quick and easy.  Click here to visit my personal page and pledge your support.  If you would prefer you can mail a check or money order to my attention to the address below.  No donation is too small.  I truly appreciate your support.

Sincerely,

Barry Mirtsching
7777 Forest Land B242

Dallas, TX 75230-2525
 

To sponsor my participation online, click here.

Proleukin (Interleukin-2) Therapy for Renal Cell Carcinoma: Treatment Option for Select Patients

August 6, 2009

Therapy options for patients with metastatic renal cell carcinoma has expanded significantly, with the FDA approval of sunitinib (Sutent), sorafenib (Nexavar), everolimus (Affinitor), temsirolimus (Torisel), and bevacizumab (Avastin).  These drugs have significant anti-tumor and anti-angiogenic effects.  Progression-free survival (PFS) is improved when compared to placebo or alpha-interferon (Intron-A) therapy.  Many patients will respond to more than one of these agents, and therefore overall outcomes for patients receiving sequential treatments may be improved.   These therapies have expected and manageable toxicities and risks, and are delivered on an outpatient basis.  Nonetheless, these new therapies do not offer curative potential to any patient when used in patients with established metastatic disease.   Patients with reduced overall health and function (performance status) can be treated with these agents.

Interleukin-2 (IL-2, Proleukin) is an FDA approved therapy for metastatic renal cancer.   It is a potent immune stimulator, and it may have anti-angiogenic activity.  Since its clinical development nearly two decades ago, it remains the only therapy with a known curative potential for patients with metastatic renal carcinoma.  Treatment with IL-2 has substantial toxicity, priniciply secondary to capillary leak syndrome and vasodilation, which can result in serious hypotension, fluid accumulation, edema, pulmonary congestion, renal dysfunction, or other organ failure.  Patient selection for this form of therapy is critical.  Only patients with good performance status and adequate kidney, heart, and lung function are potential candidates for IL-2 treatment.  Treatment is delivered on an inpatient basis, under carefully-monitored circumstances, usually in the intensive care unit.  Treatment is delivered by a specialized team of oncologists and nurses, who are familiar with the specific program of IL-2 therapy, and have experience in management and prevention of toxicities.   A critical care physician (ICU physician) is also engaged in management.  Therapy lasts for 5 days, with several additional days potentially required for resolution of treatment-related lab or clinical changes.  Most of the treatment-related side effects abate rapidly after the therapy is completed.  A second cycle of inpatient IL-2 therapy is given after the patient has had a brief period of outpatient recovery.   In studies of IL-2 in metastatic kidney cancer, the overall response rate (out of 255 patients) = 15% (7% complete, 8% partial). That is not higher than other recently-approved medications.  However, the median duration of complete response (CR*) is 6.7+ years (range 7 months – 10+ years).  Those long-term results are not achieved by other treatments for metastatic renal cancer.

Additional information about IL-2 therapy is available at www.Proleukin.com.  CORT is a provider for IL-2 therapy in the North Texas area.  Our patients are treated in Medical City Dallas Hospital.

For information about CORT, or to schedule a consultation about treatment of renal cancer, call 972-566-5588 to speak with a Patient Care Coordinator.  Additional information about CORT and directions are available at www.CORTPA.com.