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.

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.

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.

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.

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.

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 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.

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.

As can be seen from the figure, the AC>TH arm has a lower risk of annual recurrence that begins during the first year (the time the treatment with trastuzumab is given), and that benefit continues, when compared to patients treated with chemotherapy alone (AC>T).  However, the risk for recurrence does rise in the trastuzumab-treated patients after the therapy is completed at one year, and that risk remains increased for another 2 or 3 years, at approximately 4.9% per year. 

To address that continued risk, studies testing the extension of anti-her-2 therapy are being conducted.  The Wyeth study at CORT tests the oral anti-her-2 drug neratinib (HKI-272).  The study is a randomized comparison of neratinib versus a neratinib placebo, given daily by mouth for one year.  Neratinib may reduce cardiac function (similar to other her-2 blockers), so function must be monitored.  Other risks include rash, diarrhea, and nausea.  Based on experience with the drug to date, these risks can be managed with supportive care medication and/or dose reduction in most circumstances. 

Patients who have completed one year of adjuvant therapy with trastuzumab (Herceptin), and who are within 2 years of completion of that therapy are eligbile for the Wyeth study at CORT. 

For more information about this study, or to schedule a consultation about management of breast cancer, call 972-566-5588, and ask to speak with a Patient Care Coordinator.   Additional information about this study, and directions to the office are located at: www.CORTPA.com.