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Dear Subscriber,
Robert A Nagourney MD
As we prepare this edition of our newsletter we are pleased to report that our Phase II clinical trial in advanced lung cancer has been submitted and is under review for publication.

As the field of laboratory-directed therapies has confronted resistance from investigators who call for controlled clinical trials to validate this approach, it is important to continue providing prospective documentation of the efficacy and clinical utility of assay-directed therapy. While there are many excellent retrospective analyses constituting almost 2,000 patients, directed trials that use assay selection for the upfront choice of chemotherapy are more compelling yet fewer in number.

It is with a sense of satisfaction and accomplishment that we submit this study in which previously untreated patients with metastatic lung cancer received assay-directed therapy selected from among drugs that are FDA approved, commercially available and in wide use for this disease.  

In our report, we succeeded in doubling the response rate from an historical experience of 30 percent to 64 percent and achieved strong statistical significance (p=. 00015). In addition, the median survival for patients in our study of 21.3 months nearly doubled the best available results in the literature of 12.5 months. As several of our patients remain alive close to seven years at this writing, we believe that this approach to therapy has the capacity to alter the natural history of lung cancer - the leading cause of cancer death in America.

The results of our lung cancer study, in which only conventional chemotherapeutics were used, strongly supports our belief that this laboratory platform could offer even greater opportunities to streamline the introduction of the newest classes of targeted agents. We have initiated discussions with a pharmaceutical firm to implement directed studies with some of the newest signal inhibitors. It is our hope that patients with refractory malignancies, those who may not benefit from conventional therapies, will soon be able to avail themselves of these new classes of targeted agents based upon laboratory selection, all under the auspices of IRB approved protocols. (IRB is the acronym for Institutional Review Board for Human Participants. Any institution that receives federal funding to conduct research is required to establish an IRB to review investigations which directly or indirectly involve human participants.)

It is important to remember that new drugs aren't always better drugs. In this context, the remarkable success of one our kidney cancer patients who had shown no response to the newest targeted VEGF inhibitors, has now achieved a complete remission using assay-directed  conventional cytotoxics, represents the advantage of drug selection over the random introduction of new drugs. His normal PET/CT scan is a monumental success for directed therapies and reaffirms the dictum at Rational Therapeutics that all patients should receive "whatever works best."

Dr. Nagourney Signature
Dr. Robert Nagourney
Rational Therapeutics

P.S. Last month I was honored to present at the TedXSoCal conference here in Long Beach, California. It was a most rewarding experience. You can view the video on You Tube.


Close Call - A Physician's  

Personal Encounter With Cancer    

There are some things we can only experience for ourselves.

Very few who have not had cancer would believe how little is known about treatment and how ineffective most of it is. As this becomes evident, we are dying. It is too late for most.

 

In my case, my chest was ravaged by metastatic kidney cancer. My red blood cells were mysteriously gone, while the chemotherapy I had obediently taken for three months had done nothing. I was not expected to live.

 

Good fortune led me to Robert Nagourney, MD, an oncologist who does chemosensitivity testing on samples of patients' tumors. Just in the nick of time I made a "pilgrimage" to his office in Long Beach, California. The test, or "functional profile" of my tumor, led to a recommendation for a combination of three conventional anti-cancer drugs. However, none are drugs of choice for kidney cancer; none of them would have been used as "standard" therapy.

 

 

Within two weeks, my chest x-ray was clearing and my blood count was improving. I was feeling better. Five months after diagnosis and two months on the new treatment, my chest metastases were "melting away."

I had no assurance that the army of kidney cancer cells wouldn't be coming back tomorrow.  I may have been living on borrowed time. So I chose to use it to begin telling my story.

Because even though I'm a physician, I suspect my encounter with cancer is not that different from the experience of others.

Except, perhaps, for the outcome.

John FreidbergTwo months ago, I underwent a nephrectomy/tumorectomy (consisting of a six hour procedure to remove my huge tumor and right kidney). Followed by one week of recovery.  Two weeks ago, on July 2011, my follow-up CT/PET was entirely negative - tumor gone, nodes gone, chest clear. It put a smile on everyone's face: the surgeon, my local oncologist Gary Cecchi, MD, the oncology nurses and me, of course.

It's hard to believe that one year ago, I was on the brink of death with a diagnosis of Stage 4 renal cell cancer, a diagnosis carrying a 5 percent chance of a 5-year survival. Dr. Cecchi, has now declared me "in remission." I'm almost back to normal, building muscles back, swimming and even taking an Aikido Martial Arts class.

The public needs to know about the chemosensitivity tests I had and about the handful of physicians, like Dr. Nagourney, who are saving lives with personalized cancer therapy every day.

My story is here to give hope to patients who are almost certainly demoralized by the conventional attitudes toward renal clear cell carcinoma: chemo doesn't work!? When it's done right it does. And Dr. Nagourney made sure it was done right on me.

Read more about Dr. Freidberg and others patients, in their own words, on the

Rational Therapeutics website.


In This Issue
Close Call
Sasha Vujacic Visits RT
Save the Date
Submit Your Questions


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A Recent Visitor  

Recently, two-time NBA champion Sasha Vujacic visited Rational Therapeutics and presented a check for The Nagourney Institute to conduct research based on the principles of assay-directed therapy.

Click here for Sasha's story. 

 

 

Rational Therapeutics website   

Using Maintenance Therapies

Many of our patients receive ongoing therapy, extending their treatment for much longer than other centers typically employ. But there are compelling reasons to consider this methodology.   

 

There is a long tradition of maintenance therapy in pediatric oncology. Children with acute lymphoblastic leukemia uniformly receive three stages of therapy: induction, consolidation, and finally maintenance. The maintenance stage consists of weekly, or even daily therapies.

 

The historical experiences of relapse in this population lead investigators to consistently expose these patients to drugs for a period of years. Despite the apparent success of this approach in childhood cancers, long-term maintenance therapy did not gain popularity in adult oncology. Why?

 

Click here for the answer.

Back by
Popular Demand

Cancer is Not Contagious,
But Laughter Is!

Follow these three easy steps to experience true belly laughs while supporting a great cause - The Vanguard Cancer Foundation.

  1. Save the Date -
    October 1, 2011
  2. Make a reservation by clicking the link below
  3. Bring cash, checkbook or credit card to out bid your friends for some great auction items.

For more information or to register, click here. 

 

Submit Questions

We work hard to bring the most recent and relevant information to patients and colleagues. It is our quest to partner with you and answer any questions you might have about assay-directed therapy.

If you have a question that we have not yet addressed, please submit it to: sburt@rational-t.com and we will add it to our newsletter or blog.  

Our Blogs 

Hope Practiced Here 
Read patient stories and learn about the advances at Rational Therapeutics.
 
Dr. Nagourney's Blog 
Written by Robert Nagourney, MD, this blog is for physicians and scientists.