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BY KATHERINE LAGOMARSINO | FEBRUARY 14, 2012
I recently joined CURE as managing editor of books and special projects. While I have been in journalism for many years now, this is my first foray, as an editor, into the complex world of cancer. But as a daughter--well, that's a different story.
During one of my first staff meetings here, someone brought up the often-used analogies to describe the cancer experience: a battle, a journey, a roller coaster. But when I think of cancer, I always envision it as a marathon, admittedly, another well-worn metaphor. Perhaps that's because my father was an avid runner. He finished seven marathons in his lifetime, counted Chariots of Fire as one of his favorite movies (the theme song was one of his favorite songs), and he even founded a nine-mile running race in our hometown.
But in April 2000, my father's real marathon began when he was diagnosed with metastatic melanoma. The doctors figured it was from a large malignant mole he had removed from his leg 15 years prior, but that was only a guess. Melanoma can lie dormant for years before it resurfaces in places like lymph nodes, which is where my father's recurred. A small, seemingly innocuous lump on his groin.
My father was a doctor himself--an ophthalmologist--so he knew that his prognosis would not be good. And it wasn't; it was of the "get-your-affairs-in-order" variety. But, being a stubborn man, a first-generation Italian from Newark and the son of a steeplejack, Dr. Bill, as his patients called him, was just warming up. He had only begun preparing for what was going to be a grueling six-year run filled with fatigue, dehydration, pain and emotional exhaustion.
There were runner's highs, like when a limb perfusion appeared to work, followed by extreme lows, when the brain mets appeared. And then there were the second, third and fourth winds when promising new studies came out. On he went, plodding from surgery to chemo to radiation. From clinical trial to clinical trial. Along the course, family and friend had lined up to cheer him on, give him water and food or tend to his injuries. In June 2006, my father hit the wall. His melanoma could no longer be controlled. He was spent, and he wanted to enjoy the final leg of the race at a slow amble, absorbing the sights and sounds of the course and the gathering crowd. On November 11, 2006, he crossed the finish line at peace--surrounded by his biggest fans.
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BY ELIZABETH WHITTINGTON | FEBRUARY 1, 2012
Prostate cancer has seen its share of progress over the past few years, including several new drugs that have been approved for patients with metastatic disease. On Tuesday, results of two clinical studies were announced that foreshadow additional therapies that will help further extend survival and improve quality of life.
While prostate cancer is one of the most common cancers, it has a 99 percent five-year survival rate, with most patients diagnosed at an early stage. But for more than 28,000 men this year, prostate cancer will be fatal. For many of these patients, those with metastatic prostate cancer to the bones or men whose cancer doesn't respond to standard hormonal treatment, Alpharadin and MDV3100 could be very useful.
Alpharadin (radium-223) is an intravenous drug that uses alpha particles (a type of ionizing radiation) to kill cancer cells. MDV3100, a new form of hormone therapy, is a pill that works by preventing the tumor cells from using testosterone that can spur cancer growth. The two drugs work very differently and both improve survival, which led some researchers to suggest that combining these agents with other therapies could produce a synergistic response.
In the Alpharadin trial (called ALSYMPCA), 922 prostate cancer patients with bone metastases were randomized two to one to Alpharadin or placebo, with all patients receiving best supportive care. Because the most common site of prostate cancer metastasis is typically bone tissue, targeting a drug to delay or attack cancer at the bone seems like a smart idea. That's what Alpharadin does--it targets the cancer cells that have invaded the bone tissue. It's not a cure, but it did prolong survival by 30 percent (14 months versus 11.2 months) and delayed the time to a patient's first skeletal-related event, such as a spinal cord compression or bone fracture by a median of 5.2 months (13.6 months versus 8.4 months). The side effects of the drug are surprisingly minimal--a slight increase in neutropenia and diarrhea.
The AFFIRM trial, which involved MDV3100, also randomized patients two to one with the experimental treatment versus placebo. The trial included 1,199 patients with metastatic prostate cancer that had progressed after treatment with docetaxel and other hormonal therapies.
The drug increased survival by a median of 4.8 months over placebo (18.4 months versus 13.6 months). Howard Scher, MD, chief of genitourinary oncology at Memorial Sloan-Kettering Cancer Center in New York and co-lead investigator of the AFFIRM study, also noted that more patients treated with the drug experienced tumor shrinkage and more than a 50 percent decline in PSA levels. The drug also delayed cancer growth by five months. Side effects, which included diarrhea, fatigue and hot flashes, were well-tolerated and had similar rates of toxicity to the placebo arm.
Nicholas Vogelzang, MD, chair and medical director of the Developmental Therapeutics Committee of US Oncology, who moderated the press briefing on Tuesday, called the results unprecedented. "This will definitely change the way we take care of patients every day in the office."
He may not have to wait long. MDV3100 has been submitted to the Food and Drug Administration. And both MDV3100 and Alpharadin have been granted fast-track status, which means they will likely have a quicker-than-usual review by the agency.
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BY ELIZABETH WHITTINGTON | APRIL 28, 2011
Today the FDA approved Zytiga (abiraterone) to treat metastatic hormone-resistant prostate cancer. The approval is for patients who have received prior Taxotere (docetaxel).
We wrote on Zytiga back in the Winter issue with "Promise for Prostate" when we covered up-and-coming treatments for prostate cancer. Provenge (sipuleucel-T), a vaccine that stimulates a patient's own immune system to fight cancer, had just been approved and another therapy, Jevtana (cabazitaxel), had been approved at near record speed by the FDA.
For a disease that hasn't had many new treatment options in nearly 10 years, it is impressive that prostate cancer patients with advanced disease now have three new treatment options. And even more interesting, they all work differently.
Provenge is a vaccine--the first therapeutic cancer vaccine to have been approved. Jevtana is a form of chemotherapy called a taxane, the same class as Taxol (paclitaxel) and Taxotere. Zytiga is a hormone therapy that inhibits a protein called CYP17A1, which helps in producing testosterone.
Results of a phase 3 study were presented this past October at the annual meeting of the European Society of Medical Oncology in Milan. The international trial randomly assigned 1,195 men to receive either Zytiga and prednisone or prednisone alone. The addition of Zytiga improved median survival from 10.9 months to 14.8 months--a 36 percent increase. The drug also slowed time to disease progression from 6.6 months to 10.2 months. About 38 percent of patients experienced a drop in prostate-specific antigen (PSA) of at least 50 percent from baseline compared with 10 percent on prednisone alone. Side effects included fluid retention, low potassium levels, liver function abnormalities and cardiac disorders.
Zytiga had been granted priority review back in late December, which means the FDA would review within six months. The FDA approved Zytiga well before the June 20 deadline.
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