Ruling may impact FDA’s authority

2/19/2007 Springfield, MA Robert Cohen The Republican (www.masslive.com) Abigail Burroughs fought head and neck cancer for 18 months, desperately seeking access to promising experimental drugs after chemotherapy and radiation therapy failed. She was unable to get into a clinical trial for ImClone's now widely available Erbitux, because it was for colon cancer patients only, and she failed to meet the clinical trial inclusion criteria for Iressa, an AstraZeneca cancer drug that later proved largely unsuccessful. At the end of May 2001, Burroughs was finally accepted into a clinical trial for OSI Pharmaceutical's subsequently approved cancer drug Tarceva, but she was too ill to travel from Virginia to the Texas testing site. She died two weeks later at age 21. "It was a horrible, horrible nightmare. When your child is terminally ill, you want to do everything you can," said her father, Frank Burroughs of Fredericksburg, Va. "People just want a chance to live when they are facing death." Burroughs soon formed the Abigail Alliance, an organization dedicated to helping cancer patients and others with life-threatening illnesses break down barriers imposed by the Food and Drug Administration and the pharmaceutical industry to obtaining potentially helpful experimental drugs outside the clinical trial setting. His relentless campaign has resulted in a court ruling that threatens to shake the foundations of the FDA's regulatory authority covering pharmaceuticals and lead to greatly expanded use of unapproved medications that haven't been fully tested for safety or effectiveness. The legal battle, ironically, comes as medical experts, members [...]

2009-04-14T11:32:56-07:00February, 2007|Archive|

Oral Cancer Cases to Increase 11 Percent This Year

2/13/2007 Phoenix, AZ press release Yahoo News (news.yahoo.com) Zila, Inc. noted with dismay that while the American Cancer Society (ACS) celebrated new data with a headline "Cancer Deaths Down for Second Year", the same data showed a marked increase in the number of expected new cases and deaths due to oral cancer. "The ACS data, published in 'Cancer Facts & Figures 2007', projects 34,360 new cases of Oral Cavity & Pharynx Cancer - a remarkable 11 percent increase over the 30,990 cases that ACS projected for 2006, and a 20 percent increase among males," notes Frank Bellizzi, president of Zila Pharmaceuticals, Inc., marketer of the ViziLite® Plus with TBlue630 system for the early detection of oral abnormalities that could lead to cancer. Nearly as many women will be diagnosed with oral cancer as with cervical cancer this year. ACS projects that total deaths due to oral cancer will rise nearly two percent to 7,550 in 2007, from 7,430 in 2006. "As the ACS celebrates a decline in many cancers," Dr. Bellizzi added, "it is critical to note that oral cancer remains a common cancer type in men, and a critical threat to women. Early detection is the key to reducing death and minimizing the quality-of-life impact of this insidious disease. As the ACS reports, the 5-year survival rate when oral cancer is detected early is 81.3 percent, but late detection results in a survival rate of only 26 percent. "Dentists across America are moving rapidly to adopt the three-minute, non-invasive, [...]

2009-04-14T11:32:17-07:00February, 2007|Archive|

Precision Targeting Lowers Risk While Directing Higher Dose Of Radiation At Tumors

2/13/2007 United Kingdom press release Medical News Today (ww.medicalnewstoday.com) A new radiation treatment system at Rush University Medical Center addresses two important aspects of cancer treatment simultaneously with one device: confirming the exact location of a tumor during each treatment session and then delivering treatment. This approach is known as image guide radiation therapy (IGRT). The TomoTherapy Hi-Art System combines 3-D imaging from computerized tomography (CT scanning) with precisely targeted radiation beams. Because of the remarkable accuracy of the system it is possible to direct a higher dose of radiation at a tumor with a lower risk of affecting surrounding tissues and organs. Precise patient positioning is crucial for effective radiation treatment. With the TomoTherapy system, CT scan slices are taken through the area being treated as the patient lies on the treatment table. These slices are used to image the location of the tumor and to make immediate adjustments, if needed, to make sure the radiation is directed exactly to where it should be. "This is extremely useful since a patient's tumor position may change slightly from session to session," said Dr. Ross Abrams, chairman, department of Radiation Oncology at Rush. Immediately after determining the correct position, the TomoTherapy system delivers a very sophisticated form of intensity modulated radiation therapy (IMRT). As the patient slowly moves continuously through a rotating ring, the radiation beam makes a spiral pattern around the patient. Each time the linear accelerator, the mechanism that creates the radiation beam, comes around it is directing the [...]

2009-04-14T11:31:48-07:00February, 2007|Archive|

Efficacy of radiologic screening for distant metastases and second primaries in newly diagnosed patients with head and neck cancer

2/13/2007 MC Jackel et al. Laryngoscope, February 1, 2007; 117(2): 242-7 Objectives: Detection of distant metastases and second primary tumors in newly diagnosed patients with head and neck cancer has usually a major effect on prognosis but does not always influence clinical management. This must be considered when radiologic screening investigations are used. The present study particularly evaluates how often additional neoplastic lesions detected by screening had an impact on therapy. Study Design: The authors conducted a single-institution retrospective analysis. Methods: The medical records of 260 patients with newly diagnosed squamous cell carcinoma of the head and neck treated between 1999 and 2002 were retrospectively analyzed. Before therapy, all patients had undergone screening by computed tomography scan of the chest, abdominal ultrasound, and bone scintigraphy. Results: Screening investigations identified 16 patients (6.2%) with distant metastases and six patients (2.3%) with simultaneous second primaries. Chest computed tomography scan detected 20 neoplastic lesions; abdominal ultrasound and bone scintigraphy each detected 2. Three findings of distant metastases proved to be false-positive during follow up. Of the 22 patients with positive screening results, clinical management was affected in 13 (59.1%). Twelve were originally scheduled for curative surgery and 10 had chest abnormalities. Conclusion: Chest computed tomography scan was the most effective screening investigation, which should be routinely used whenever curative surgery of head and neck cancer is planned. Abdominal ultrasound and bone scintigraphy may sometimes be valuable before extensive surgical treatment of far advanced disease. In patients scheduled for primary radiotherapy, radiologic screening had [...]

2009-04-14T11:31:20-07:00February, 2007|Archive|

TAX 324 Phase III Study Shows Docetaxel Increases Survival in Head, Neck Cancer

2/13/2007 Boston, MA web-based article - no attribution CancerFocus.net Marshall R. Posner, MD, medical director of the Head and Neck Oncology Program at the Dana-Farber Cancer Institute in Boston reported at the 2006 annual meeting of the American Society of Clinical Oncology (ASCO) on the randomized Phase III TAX 324 Study Group. 501 patients with locally advanced squamous cell carcinomaterm of the head and neck (SCCHN) (oral cavity, oropharynx, larynx and hypopharynx) were the focus of the study. In the study, patients receiving docetaxel in combination with cisplatin and 5-FUterm as induction (neoadjuvant) therapy, followed by chemoradiotherapy and surgery were compared to those not receiving docetaxel. The results showed an impressive 70.6 months median overall survival in patients who took docetaxel compared to 30.1 months for those not receiving docetaxel in their treatment. There was a 30% reduction in mortality rate for those patients receiving docetaxel. There was an absolute three-year survival improvement of 14% in the docetaxel group as well. Progression-free survival (PFS) was also significantly greater with the docetaxel regimen with two-year PFS at 53% compared to 42%. Grade 3/4 neutropenia occurred in 85% of the docetaxel group and 56% in the non-docetaxel group. However, there was no other significant increase in toxicity, and other trials are continuing in conjunction with other targeted molecular agents for treatment of SCCHN.

2009-04-14T11:30:52-07:00February, 2007|Archive|

Recovery involves adjusting to changed life – Part 4

2/12/2007 California, USA Daniel Borenstein ContraCostaTimes.com (Note: This is the fourth of a four part series) About 9:45 each morning for six weeks, I walked past the warning sign ("Caution, High Radiation Area") in the basement of Berkeley's Herrick Hospital, propped myself up on the table and laid down. Technicians placed a preformed mesh mask over my face and shoulders and snapped it to the table. My head was locked in place as the staff members carefully nudged my body to the left or right a bit to ensure I was perfectly aligned. Then everyone left. It was just me on that table. The X-ray beams were turned on from next door. For each of my 15 daily blasts, the machine sounded like the tone from the emergency broadcast signal. ("Had this been a real emergency ...") It drowned out the classical music on the boom box in the corner -- and it killed the tranquil effect of the idyllic birch trees and spring flowers painted on the ceiling tiles overhead. This was the latest radiation technology for cancer treatment. The intensity of the beams could be regulated and the computer-controlled equipment programmed in three dimensions. During the 15-minute cycle, the emitting disk swept 180 degrees, from my left side to overhead to my right side. It radiated my mouth, throat and neck. The daily treatment was combined with weekly IV chemotherapy drugs. My mouth and throat were so raw that I couldn't eat solid foods. Mashed potatoes were too [...]

2009-04-14T11:29:58-07:00February, 2007|Archive|

Fear and uncertainty cloud every decision – Part 3

2/12/2007 California, USA Daniel Borenstein ContraCosta Times (www.contracostatimes.com) (Note: this is the third of a four part series) Setting the boundaries for the next phase of my cancer therapy was all about balancing long-term risk -- weighing the chances of the disease recurring against the permanent side effects of extra radiation. No matter which way I went, there was no certainty. The data were sketchy and the doctors disagreed on the best option. They had one consistent message: I needed to pick my path. As one doctor put it: "Ultimately, you have to decide. You have to do what feels most comfortable to you." I didn't think I would ever feel comfortable with the decision. I felt totally unqualified to make it. For guidance, I visited physicians in the East Bay, as well as the UC San Francisco medical school and the Dana-Farber Cancer Institute in Boston. The East Coast doctors endorsed the cutting-edge chemotherapy I had received. That was something I needed to hear after a UCSF doctor suggested it had been a waste of time. It enabled me to put that issue behind me and move on to the big decision: Whether to irradiate one or both sides of my head and neck, and whether to include the nasal passages above my palate. I had what was broadly called head-and-neck cancer, usually found in smokers or heavy drinkers. I was never much of a drinker, and none of the doctors thought that my teenage smoking for less than [...]

2009-04-14T11:29:27-07:00February, 2007|Archive|

Learning to decipher language of treatment – Part 2

2/12/2007 California, USA Daniel Borenstein ContraCosta Times (www.contracostatimes.com) (Note: This is the second of a four part series.) When I began my cancer therapy, I didn't understand the differences among the doctors who would be caring for me. I didn't appreciate that when a patient receives cutting-edge treatment, he must be ready for changes in plans along the way. And I didn't understand that, in the end, I was going to have to make the tough decisions even though I started my treatment without a basic understanding of cancer treatments. I quickly learned that a "primary" is the site where the cancer originates, and that cancer can migrate, or "metastasize," to other parts of the body. In my case, the "metastasis," the site of the migration, was obvious. There was a bulge, a cyst, on the right side of my neck. But the microscopic primary was never located. The doctors didn't know where my cancer began. As a result, they disagreed on my treatment. My wife was a doctor who could explain the medicine to me in simple terms. And my oncologist, Randy Oyer, was a good friend who wasn't put off by my flurry of inquisitive e-mails. Randy planned to hit me with a heavy dose of chemotherapy and then follow with radiation to mop up bad cells in key areas of my mouth and neck. The regimen of starting with three potent chemo drugs for head-and-neck cancers like mine was new. It had been tried only for a [...]

2009-04-14T11:28:48-07:00February, 2007|Archive|

Diagnosis sets harrowing journey in motion – Part 1

2/12/2007 California, USA Daniel Borenstein Contra Costa Times (www.contracostatimes.com) This is the first of a four part series. "I think you are cured," my oncologist told me April 24. It was just about a year after I had been diagnosed with cancer. I had endured chemotherapy and radiation treatment. I had traveled across the country for expert opinions to ensure I was making the right treatment decisions. I had nearly died and was hospitalized for 12 days when things went awry. But I had made it through. This story has a happy ending. I'm going to live. As I've come to fully appreciate, we all have to go someday. But the cancer probably won't kill me. I was lucky. I had a type of cancer that could be cured with intense doses of chemotherapy and radiation. I had health insurance to pay hundreds of thousands of dollars of medical bills. I was married to a doctor who could educate me and assist me in making critical decisions. And I was personal friends with one of my oncologists, who was willing to use the latest treatments. Nevertheless, it was a terrifying journey. I've never been so sick, so weak or so scared. I've never had to make so many difficult decisions. I'm hardly alone. This year, an estimated 1.4 million new cancer cases will be diagnosed in this country, according to the American Cancer Society. The five-year survival rate for all cancers diagnosed from 1996 to 2002 was 66 percent. Many [...]

2009-04-14T11:28:18-07:00February, 2007|Archive|

Slashing NCI’s Budget Would Hurt Industry Too, Critics Say

2/10/2007 Washington, D.C. Aaron Lorenzo BioWorld News (www.bioworld.com) The National Cancer Institute faces a funding cut in the coming fiscal year, per President Bush's proposed budget, and oncology drug developers are in for a pinch. Cancer study cooperative groups, which include researchers, cancer centers and community doctors who evaluate investigational and approved therapies, are expected to pare back their work significantly. The Coalition of Cancer Cooperative Groups, comprised of the 10 U.S. groups whose research is sponsored by the NCI, says up to 95 of their trials may have to be closed or delayed this year. That's nearly half of the studies they conduct annually, and such cuts would affect up to 3,000 patients. That's a sizable chunk of the 20,000 enrolled in their trials each year for access to investigational drugs, newer frontline treatment modalities and quality care. Such reductions, said Richard Schilsky, chairman of a study cooperative called Cancer and Leukemia Group B, "can trickle down" to biotech companies "in a fairly negative way." Because these groups enroll nearly half the patients in the U.S. who participate in cancer trials, there will be a direct impact on drug development firms. That's especially true of smaller firms with limited finances that make their investigational products available to the NCI for use in cooperative group testing. "Oftentimes these are Phase II, but also occasionally even Phase III studies," he told BioWorld Today, though he noted that Phase II trials are most likely to absorb the cuts. That translates to less [...]

2009-04-14T11:27:46-07:00February, 2007|Archive|
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