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Breast cancer survival improved by dense’ dosing
Compressing chemotherapy into a two-week "dose-dense" schedule rather than the standard of dosing every three weeks leads to a significant improvement in survival with no increase in toxicity in women with node-positive breast cancer, according to new research.
The study, coordinated by Cancer and Leukemia Group B on behalf of the Breast Intergroup and sponsored by the National Cancer Institute, found a 31% decrease in the death rate with dose-dense chemotherapy administration. The first results of the study were announced at the annual San Antonio Breast Cancer Symposium in December.
"These findings are significant because all the women received the same individual and cumulative dosage of each drug — the only difference was the interval between chemotherapy treatments — and that one difference is shown to have a positive impact on survival," says Marc L. Citron, MD, clinical professor of medicine at Albert Einstein College of Medicine in Bronx, NY, and principal investigator of the study.
The study enrolled 2,005 women with primary breast cancer that had spread to the lymph nodes, with no other metastases. They were randomized postoperatively to one of four treatments. Patients received either a biweekly dose-dense regimen of the adjuvant agent paclitaxel and the chemotherapeutic agents doxorubicin and cyclophosphamide in combination or sequentially, or they received a standard three-weekly moderate-dose regimen of the drugs in combination or sequentially. All patients received equal cumulative doses of the three agents. Tamoxifen was administered post-chemotherapy. Patients in the two-week arm also received filgrastim (Neupogen) to boost their production of infection-fighting white blood cells and combat neutropenia.
After follow-up, researchers found that the dose-dense regimens, either sequential or concurrent, were significantly better than the three-week regimens in improving both disease-free survival and overall survival. Researchers also found that side effects were no more severe among patients on dose-dense regimens than among those on the conventional treatments, and that patients on the dose-dense regimens suffered fewer cases of neutropenia.
Adoption of medication-use technology slow
Adoption of technology into the medication-use system of hospitals and health systems has been slow, even though it could improve patient safety and free pharmacists for more clinical duties, according to the latest installment from the ASHP (American Society of Health-System Pharmacists) National Survey of Pharmacy Practice in Hospital Settings.
Only a small number of survey respondents report having proven safeguards available in their facilities, such as computerized prescriber order entry systems (7%) and bar code technology at the patient’s beside (1.5%). Bar codes are used to a greater extent (10%) to verify doses before dispensing. Robotic distribution systems are used in only 8% of hospitals.
A majority of institutions report using point-of-use dispensing devices (58%) in decentralized distribution systems. More than 70% of those devices are linked to the pharmacy computer system.
The survey also found that pharmacists are required to review and approve all medication orders prior to administration in 79% of hospitals. One-fourth of hospitals require pharmacist review and approval of orders written for medical procedures in areas such as labor and delivery, surgery, and radiology.
This entire survey is available in the Jan. 1, 2003, issue of the American Journal of Health-System Pharmacy. A summary report containing graphs and charts of the survey data also may be obtained from Eli Lilly by calling (800) 874-2778.
Bush will seek pediatric drug testing legislation
Health and Human Services (HHS) Secretary Tommy G. Thompson has announced that HHS will pursue rapid passage of legislation giving the Food and Drug Administration (FDA) authority to require pharmaceutical manufacturers to conduct appropriate pediatric clinical trials on drugs and biologics.
The announcement came as the federal government decided not to appeal an October decision in the U.S. District Court for the District of Columbia, which held that FDA lacks the legal authority to impose certain requirements for pediatric testing on drug manufacturers. That decision has prevented the FDA from enforcing such requirements, which were mandated in final regulations published in 1998 and known as the "pediatric rule." FDA Commissioner Mark B. McClellan, MD, says it is better to work with committees in Congress to enact new legislation than to continue with litigation that could take years to reach an uncertain outcome.
Thompson also announced further steps in the implementation of the Best Pharmaceuticals for Children Act (BPCA), which President Bush signed into law in early 2002, including an announcement of the first products to be named for testing under this Act. The first two drugs to be studied in clinical trials under BPCA will be nitroprusside (Nipride), for the controlled reduction of blood pressure, and lorazepam (Ativan), for the treatment of status epilepticus and for sedation in the pediatric intensive care unit.
FDA cracks down on drug importation
The Food and Drug Administration (FDA) has announced that it is strengthening the controls designed to protect patients by restricting imports of certain prescription drugs that can be used safely only with specified controls in place.
The FDA’s action involves adding the drugs to an existing FDA Import Alert, which alerts FDA field personnel to the possible importation of these drugs, provides guidance regarding their detention and refusal of admission into the United States, and advises United States Customs personnel to refer any attempted importation to the local FDA field office.
The drugs added to the Import Alert are:
- Isotretinoin (Accutane) — indicated for the treatment of severe recalcitrant nodular acne.
- Fentanyl citrate (Actiq) — indicated for the management of severe cancer pain in patients who are tolerant to opioid therapy.
- Clozapine (Clozaril) — indicated for the management of severe schizophrenia in patients who fail to respond to standard drug treatments for schizophrenia.
- Alosetron hydrochloride (Lotronex) — indicated for the treatment of severe irritable bowel syndrome in women.
- Mifepristone or RU-486 (Mifiprex) — indicated for the medical termination of early intrauterine pregnancy.
- Thalidomide (Thalomid) — indicated for the acute treatment of the cutaneous manifestations of moderate-to-severe erythema nodosum leprosum.
- Dofetilide (Tikosyn) — indicated for the maintenance of normal sinus rhythm in patients with certain cardiac arrhythmias.
- Bosentan (Tracleer) — indicated for the treatment of severe pulmonary arterial hypertension.
- Trovafloxacin mesylate or alatrofloxacin mesylate injection (Trovan) — an antibiotic administered in inpatient health care settings for the treatment of severe, life-threatening infections.
- Sodium oxybate (Xyrem) — indicated for the treatment of cataplexy in patients with narcolepsy.
The FDA also alerted consumers not to buy these drugs over the Internet, because drugs obtained via web sites usually are not accompanied by these safety controls.
Because of the higher risk of these drugs to patients, the FDA took action to curtail further the products’ availability from foreign sources, which generally are not FDA-approved. Controls on these drugs include limiting their distribution to specific facilities (such as hospitals), limiting their distribution to physicians with special training or expertise, or requiring certain medical procedures (such as pregnancy testing or blood testing) with their use.
Breast cancer survival improved by dense dosing; Adoption of medication-use technology slow; Bush will seek pediatric drug testing legislation; FDA cracks down on drug importation
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