All News

Cancer drugs and indications newly approved by the US Food and Drug Administration, May 2007 – February 2009

Celator Pharmaceuticals and the Leukemia & Lymphoma Society have partnered for the phase II development of CPX-351 (cytarabine:daunorubicin), a liposome injection for treatment of adults with acute myeloid leukemia.

The Food and Drug Administration has kicked off a voluntary pilot program to help promote the safety of drugs, and active drug ingredients, produced outside the U.S. The FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot program.

The American Society for Therapeutic Radiology and Oncology (ASTRO) has changed its name to the American Society for Radiation Oncology, but will continue to use the “T’ in its logo as part of its tagline “Targeting Cancer Care.”

Varian Medical Systems, of Palo Alto, Calif., has installed new radiotherapy units at multiple sites worldwide:

SAN FRANCISCO-Adding thalidomide to a regimen of bortezomib (Velcade), melphalan, and prednisone nearly doubled the rate of complete responses and improved the overall response rate in elderly patients with newly diagnosed multiple myeloma, according to the results of a phase III trial.

SAN FRANCISCO-Mismatched cord blood can be a suitable alternative for stem cell transplants for patients with acute leukemia, especially in emergency situations, according to research presented at ASH 2008.

This study shows that in patients with acute leukemia, cord blood can be a good alternative,” said Dr. Keating, director of the division of hematology at the University of Toronto.

In a subset of 2,366 patients from NSABP B-30 with menstrual history available at follow-up, amenorrheic patients (≥ six months) had significantly improved overall and diseasefree survival across treatment arms. Mortality was significantly reduced by 24% and recurrence by 30%.

WASHINGTON, DC- In much of the developing world, exposure to mycotoxins, which are generated by various types of fungus that grow on food, is ubiquitous. Th e most well-known mycotoxin, aflatoxin, is commonly found on nuts and is a known carcinogen, according to the International Agency for Research on Cancer (IARC).

A study of Pittsburgh-area cancer patients suggests that many are opting out of clinical trials because, as members of Medicare HMO plans, they cannot afford the additional expense such trials entail.

STOCKHOLM-Published data overwhelmingly support the use of trastuzumab (Herceptin) concurrently with chemotherapy, according to John Crown, MD, a consultant oncologist at St. Vincent’s Hospital in Dublin, Ireland. On the other hand, there is no evidence that sequential delivery is less effective than concurrent therapy, and it is definitely less toxic, commented Ian E. Smith, MD, head of the Breast Unit at Royal Marsden Hospital in London.

The studies presented at SABCS 2008 regarding adjuvant taxane schedules are well designed and add to a growing body of data on how best to use these drugs, although they leave some questions unresolved. NSABP B-30 nicely controlled for number of cycles of treatment. All patients received four cycles of doxorubicin and four of docetaxel (Taxotere), and some got four cycles of cyclophosphamide, so there was some control over the duration of exposure and total number of doses for each drug.

The optimal use of taxanes in the adjuvant treatment of breast cancer continues to inspire debate. Questions remain regarding the relative efficacy of sequential vs concurrent treatment, the most effective doses and schedules, and the best combinations of agents. Key studies presented at SABCS 2008 offered insight into these issues, but no definitive resolutions. In fact, two studies designed to establish optimal scheduling reached conflicting conclusions.

Adult patients with low-grade glioma had better survival if they received chemotherapy in addition to radiotherapy, according to the results of a Radiation Th erapy Oncology Group (RTOG) study. The data were presented at the 2008 Society for Neuro-Oncology meeting in Lake Las Vegas, Nev.

Cancer patients in England will no longer have to pay prescription charges for medicines that treat their side effects, starting in April. Drugs that will be exempt include those that address pain, nausea, chronic diarrhea, fatigue, and mouth ulcers. Tamoxifen and other long-term hormone treatments are also currently subject to this charge.

There is strong rationale for both the octreotide LAR and everolimus studies in NET”, said Dr. Siu, associate professor of medicine at the University of Toronto and Princess Margaret Hospital. “And I applaud both sets of authors for conducting trials in rare tumors.”

This is one of a number of studies that show that adding novel drugs to conventional treatments can achieve higher response rates in multiple myeloma,” said Dr. Anderson, who is the Kraft Family Professor of Medicine at the Dana-Farber Cancer Institute in Boston.

CHICAGO-Serious and fatal drug reactions tripled between 1998 and 2005, according to a 2007 FDA analysis. In that time period, the total number of serious adverse drug events multiplied 4 times faster than the number of prescriptions written. The number of serious drug reactions for biotechnology agents rose nearly 18-fold (T Moore et al: Analysis of FDA reported post marketing ADR database, Arch Intern Med 167:1752-1759, 2007).

Jimmie C. Holland, MD, widely recognized as the founder of “psychooncology,” grew up in a rural part of Texas with fertile black soil, known as the Blackland Bible Belt. It was a time when cotton was king and little girls were named Bobbi and Jimmie. Back then, the gender line was clearly demarcated; girls became teachers and nurses and homemakers. Interested in medicine as a youngster, Jimmie thought about nursing, but decided instead to buck the old-boy tradition and become a doctor. Her family and teachers supported her dream, and she never looked back.

In the first of what will become an annual review process, the nation’s largest cancer-care payer has added three new formularies to its drug coverage policy, giving oncologists even greater ability to prescribe off -label cancer drugs.

Recent results from prospective, controlled trials, specifically evaluating strategies for preventing or reducing the severity of the dermatologic effects of EGFR inhibitors, represent the first step toward an evidence-based approach to the prevention and management of these important effects.

The review by LoRusso is a critical update to what could be considered the most significant dermatologic toxicity in modern oncology. This increased importance of dermatologic toxicities to epidermal growth factor receptor (EGFR) inhibitors can be attributed to several factors: 45% to 100% of patients will develop a papulopustular rash; the rash occurs in cosmetically sensitive areas (the face and upper trunk); it is associated with symptoms of pain and pruritus; and superinfections occur in approximately 30% of patients receiving these agents-all of which lead to dose modification by 76% and discontinuation by 32% of oncologists.

Epidermal growth factor receptor (EGFR) inhibitors have emerged as important drugs in cancer therapy, providing a proven survival advantage for some patients with non–small-cell lung cancer, colorectal cancer, head and neck cancer, and pancreas cancer.

States population will be over 65 years old, with 2% of the population over 84. The corresponding projections for 2050 are 21% and 5%, respectively.[1] These projections underscore the aging of the population, with most recent estimates of life expectancy hitting a record high of 78.1 years.[2] With Americans living longer than ever before, physicians are already seeing larger numbers of elderly patients with cancers whose incidence increases with age, including colon cancer.

The Hippocratic principle of not harming the patient has remained up to this day an undisputed dogma in medicine. It reminds the physician of the possible detrimental, if not lethal, outcome of the treatment he prescribes and implicitly enforces good medical practice, although the true impact will unlikely be known. Oncology is one subspecialty of Medicine where this dilemma-ie, the pros and cons of treatment-is continuously put to the test, as the physician must decide on treatment for an often life-threatening illness while taking into account individual factors such as the patient’s will, performance status, available standard treatment options, and possible experimental approaches.

Acai demonstrated antioxidant and apoptotic effects in in vitro and in vivo studies, but no human studies have been conducted. Despite the lack of supportive data, acai, like many herbal products, is promoted to cancer patients on the ­Internet, often with false claims of cure.

In their informative article, Richard O’Hara and Diane Blum touch on several key challenges of cancer survivorship. Looking at cancer through the lens of social concerns and developmental issues, they have brought important psychosocial aspects of survivorship to the forefront of our attention, with a particular focus on the domain of social well-being within the parameters of interpersonal relationships, and financial, employment, insurance, and legal issues.

When my doctor told me that I would have to put my life on hold at age 25 because tests confirmed that I had Hodgkin’s disease-cancer!-my life changed totally. I had to quit my job, move back in with my parents, and wonder about the quantity and quality of the rest of my life.