Saturday, December 29, 2012

This type of thing is more common than one might think. Click-on the headline link below to watch the ABC News report or to read all about it:

Cancer Drug Shortage Leads to Less-Effective Substitute Drugs, Study Finds

Abby Alonzo was eight weeks into treatment for Hodgkin lymphoma and doing great when her doctor informed the 9-year-old's parents that one ingredient in the cocktail of chemo drugs she was receiving was no longer available, and they would have to use a substitution.

"It's scary, and I was alarmed but I didn't really have a sense of how critical this drug was," said Katie Alonzo, Abby's mother. "When something like this happens, you have to put your faith in the doctors."
But by 12 weeks into treatment, Abby relapsed. Rather than receiving a planned break from treatment, she was rushed into emergency "salvage therapy," which involved more chemo, a bone marrow transplant and radiation.

The doctors at St. Jude Children's Research Hospital in Memphis, Tenn., who treated Abby, attribute her relapse to the shortage of the drug mechlorethamine, also known as nitrogen mustard. In today's New England Journal of Medicine, the St. Jude doctors, along with colleagues from the Dana-Farber cancer institute in Boston and the Lucile Packard Children's Hospital in Stanford, Calif., highlight how the scarcity of this medication has been linked to a higher rate of relapse among children, teenagers and young adults with Hodgkin lymphoma.

The 40 patients in the study who received the substitute drug cyclophosphamide experienced complications at about twice the rate of the 181 patients studied who didn't have to switch drugs. This is the first randomized study to compare the differences in treatment outcomes between the two medications.
None of the patients died, but the authors emphasize that they're only 18 months out from treatment and could still be hit with adverse effects...

Click-on the headline link above to read more.

Feel good and keep smiling!  Pat 

Friday, December 28, 2012

Indianapolis coach back on sidelines following 3 months of chemotherapy

Pagano Back to Coach Colts After Cancer Treatment

Monday, December 10, 2012

BREAKING NEWS: New combo therapy gives hope to older acute myeloid leukemia (AML). Here's the press release announcing data from here in Atlanta at ASH. I have been here since Thursday, mostly focusing on multiple meyloma. But this is an example of the type of incremental progress researchers are making with blood cancers

REVLIMID® AND VIDAZA® COMBINATION THERAPY ACHIEVES NEARLY 30 PERCENT COMPLETE RESPONSE IN UNTREATED ELDERLY PATIENTS WITH ACUTE MYELOID LEUKEMIA
 
BOUDRY, SWITZERLAND – (Dec. 10, 2012) – Celgene International Sàrl (NASDAQ: CELG) today announced that results from a study evaluating the combination of REVLIMID (lenalidomide) plus VIDAZA (azacitidine) in patients 60 years or older with untreated acute myeloid leukemia (AML) were presented at the American Society of Hematology annual meeting in Atlanta, GA.

In the phase II investigator-initiated study, patients received azacitidine 75 mg/m2/day, days 1-7 followed by lenalidomide 50 mg/day, days 8-28 of 42-day cycles. Treatment was continued until disease progression, unacceptable adverse event or completion of 12 cycles.

With 42 patients enrolled in the study, the overall response rate was 41%, with 28% of patients achieving a complete response (CR/CRi). The median time to CR and CRi was 12 and 6 weeks, respectively; the median duration of response (CR/CRi/PR) was 28 weeks (range 6 to >104 weeks). Median overall survival for all patients in the study was 20 weeks (range 1 to >121 weeks) and 69 weeks (range 10 to >121 weeks) for patients who responded to therapy. Additionally, median overall survival for responders was superior to non-responders (69 vs. 15 weeks p<0.01).

Most common adverse events were grade 1-2 and gastrointestinal in nature. There was one case each of grade 3 fever, sepsis, hyponatremia, pneumonitis and SIRS syndrome.

A three-arm phase II study in elderly AML patients is currently underway evaluating azacitidine monotherapy, azacitidine followed by lenalidomide (50 mg), and lenalidomide monotherapy.

These data are from an investigational study. REVLIMID® plus VIDAZA® is not approved for the treatment of acute myeloid leukemia.

Monday, December 3, 2012

This could be big, big news in the world of cancer research...

Supreme Court to decide if human genes patentable

November 30, 2012|Jonathan Stempel | Reuters
 
(Reuters) - The Supreme Court on Friday agreed to decide whether human genes can be patented, a hotly contested issue with broad practical and ethical consequences for the future of gene-based medicine for millions of people worldwide.
  The nation's highest court in a brief order agreed to review a case over whether Myriad Genetics Inc may patent two genes linked to hereditary breast and ovarian cancer.

In a 2-1 ruling on August 16, a panel of the U.S. Federal Circuit Court of Appeals in Washington, D.C., upheld the biotechnology company's right to patent "isolated" genes that account for most inherited forms of the two cancers.

That ruling also denied Myriad's effort to patent methods of "comparing" or "analyzing" DNA sequences.
The appeal against Myriad and the University of Utah Research Foundation was being pursued by a variety of medical associations and doctors, led by the Association for Molecular Pathology. Their case is being handled by lawyers for the American Civil Liberties Union.

Myriad shares fell as much as 9 percent after the Supreme Court agreed to hear the appeal and ended the trading session down $1.13, or 3.8 percent, at $28.72 on the Nasdaq.

PLANNING OF MEDICAL CARE
Sandra Park, a lawyer for the ACLU Women's Rights Project who worked on the appeal, in a phone interview called Friday's decision to take the case a "huge step" toward ensuring the provision of needed medical care and research and that patients can access their own genetic information.

She estimated that more than 4,000 of the roughly 22,000 genes in the human genome have U.S. patents.
"For many people, understanding their genetic risk of disease is crucial to planning medical care," she said. "People need to understand that risk so they can plan for screening and other major medical decisions with their doctors."

Supporters of Salt Lake City-based Myriad, in contrast, have said denying patent protection could slow advances in personalized medicine, which uses genetic tests to identify specific therapies for individual patients.

Peter Meldrum, Myriad's chief executive, said in a statement that the Supreme Court's ultimate decision could affect the providing of medical treatment to hundreds of millions of people. He said Myriad's own diagnostic test has helped nearly 1 million people learn about their risk of hereditary cancer.

"The discovery and development of pioneering diagnostics and therapeutics require a huge investment and our U.S. patent system is the engine that drives this innovation," he said.

Many outside groups supported the petitioners, including the AARP, the American Medical Association, the American Society of Human Genetics, the March of Dimes Foundation, the National Breast Cancer Foundation and several women's health groups.

"Some critics say it is unjust to give a company a monopoly over something as intrinsic to people's health as their genes," said Josephine Johnston, a research scholar at The Hastings Center, a independent bioethics research institute in Garrison, New York, who is not involved in the Myriad case.