Advocacy News Watch May/June 2003 Sub Nav

Approval of Iressa

On May 5, 2003, the US Food and Drug Administration announced it had granted approval for Iressa (gefitinib) for the treatment of advanced non-small cell lung cancer (NSCLC), the most common form of lung cancer. The first in a new class of anticancer drugs known as epidermal growth factor receptor inhibitors, Iressa was approved under the FDA’s accelerated approval process for drug therapies designed to treat conditions for which no approved treatment exists. Iressa is indicated as monotherapy for the treatment of patients with locally advanced or metastatic NSCLC who failed to respond to prior treatment with both platinum- based and docetaxel chemotherapies. According to the FDA, "The mechanism by which Iressa exerts its clinical benefit is not fully understood. However, Iressa was developed to block growth stimulatory signals in cancer cells. These signals are mediated in part by enzymes called tyrosine kinases. Iressa blocks several of these tyrosine kinases, including the one associated with Epidermal Growth Factor Receptor (EGFR)." As per the terms of accelerated approval, further Phase IV studies will be conducted to satisfy FDA requirements for full approval, especially in light of concerns over patient’s deaths from interstitial lung disease (ILD) during studies conducted in Japan. Although these developments have resulted in some groups questioning the approval of this drug, researchers note that the incidence of ILD was roughly 2% in the Japanese experiments yet only 0.3% in studies conducted in the US. The FDA "believes that this rare but serious toxicity of Iressa does not outweigh the benefits demonstrated in patients with advanced NCSLC." The continuing studies will, according to the FDA, evaluate Iressa "in patients with lung cancer resistant to two previous chemotherapy regimens and will determine whether Iressa prolongs survival compared to best supportive care," compare the effects of treatment with Iressa to those of docetaxel in patients with lung cancer that has proven to be resistant to previous treatment, and determine whether Iressa reduces cancer symptoms in patients with lung cancer resistant to all available chemotherapy.

FDA Commissioner Mark McClellan, MD, PhD, stated the "FDA believes it is crucial for cancer patients to have many safe and effective treatment options available to them in their battle against this disease. With the approval of Iressa, thousands of patients with lung cancer will now have access to an additional treatment after others haven't worked to stop the progression of their disease." Others have not been so sanguine. The nonprofit group Public Citizen maintains the drug should not have been approved, citing the failure of trials to demonstrate the benefits of the drug and the aforementioned deaths from ILD. Still, representatives from some patient advocacy groups remain optimistic; Peggy McCarthy, founder of the Alliance for Lung Cancer Advocacy, Support, and Education, believes that "unfortunately, most people that are diagnosed with lung cancer cannot be cured by surgery. New treatments like IRESSA are desperately needed to give these patients and their families an alternative when chemotherapy fails."

IRESSA LINKS

 

Nursing Resources
Medsites
HemoSurf: An Interactive Hematology Atlas
This online resource offers “the chance to learn about Morphological Hematology by using over 3,000 pictures of blood and bone marrow films.” The program provides “fundamental theoretical knowledge” on demand while visitors are examing the films and cases.

Urology Nurses Online
This site, the “peer-reviewed, on-line nursing section of the Digital Urology Journal, employs the technology of the Internet to facilitate education, collaboration, and exchange of information among nurses practicing in urology.” Visitors will find an extensive collection of topical articles and reports, links to adult and pediatric uroradiology rounds and cases, a “Patient Information” section, a calendar of upcoming meetings and conferences, and links to other informative medical websites.

PDA Resources
RnNDH (Nursing Drug Handbook)
Download this collection of monographs that contain all of the basic sections that appear in the print version of the Nursing 2003 Drug Handbook. You’ll find information on each drug’s available forms, actions and interactions, indications and dosages, possible adverse reactions, effects on lab test results, contraindications, administration routes, and more. Various appendices cover infusion rates, therapeutic drug monitoring guidelines, normal laboratory test values, dialyzable drugs, and other topics.

OncoRN: The 2003 Oncology Nursing Drug Handbook for Your PDA
This PDA resource “contains all the information nurses need at their fingertips and includes the latest chemotherapy drugs, symptom management drugs, and antibiotics.” Compatible with all major operating systems, this resource is updated on a quarterly basis. Visit this site to take an interactive tour of this product.

eAbstracts
 Quality of Living Among Ovarian Germ Cell Cancer Survivors: A Narrative Analysis
 The Experience of Lower Limb Lymphedema for Women After Treatment for Gynecologic Cancer


Press Releases

In each issue of Oncology Net Guide you’ll find links to recent press releases from major pharmaceutical manufacturers, cancer advocacy groups, oncology professional organizations, and other newsmakers.

Clinical trials from years ago may not hold up to today's standards, according to the March 1, 2003, issue of the International Journal of Radiation Oncology, Biology and Physics, the official journal of ASTRO, the American Society for Therapeutic Radiology and Oncology. Because older trials are still sometimes used to help determine the best treatment for a patient, it is important for physicians and patients to make sure that only high-quality trials are used when deciding on treatment plan.
Data presented at the 2003 annual meeting of the American Urological Association shows that “a percent reduction in urinary incontinence (UI) episodes and not absolute change from baseline is the better correlate of patient’s perception of UI improvement as indicated by changes in quality of life (QOL) measures.”
Data presented during the annual meeting of the American Urological Association show that treatment with Zometa injection in “patients with prostate cancer that has spread to bone significantly lowers the risk of debilitating bone complications and delays their onset by a median time of more than five months. In addition, increases in pain scores were consistently lower for patients on Zometa than for those on placebo.”
Data presented at the American Urological Association Annual Meeting showed that “out to four years of therapy, men taking the drug for symptomatic benign prostatic hyperplasia” showed a “sustained improvement in urinary symptoms, urinary flow rates and prostate volume reduction. Additionally, long-term treatment resulted in a low incidence of drug-related side effects. The incidence of most drug-related side effects decreased with duration of treatment.”
Emend is the first in a new class of medicines in more than a decade to help prevent the nausea and vomiting triggered by highly emetogenic cancer chemotherapy. Emend will be used in combination with other anti-vomiting medicines and is the first medicine indicated for the prevention of delayed symptoms, including the nausea and vomiting that can go on for several days following highly emetogenic chemotherapy. In two clinical studies, 42% fewer patients treated with Emend vomited or required rescue medication compared to standard anti-vomiting treatment.
The April 2003 issue of the International Journal of Radiation Oncology, Biology and Physics, the official journal of ASTRO, the American Society for Therapeutic Radiology and Oncology, reported on a study that found that women with breast cancer are less likely to conserve their breasts if there is no radiation therapy facility located nearby.

Regulatory and Legislative News

In each issue, this corner of Oncology Net Guide will feature links to news and information on important legislative and regulatory developments, on a state and national level, which may affect how oncologists practice medicine. We’ll post links from medical societies and organizations, patient’s advocacy groups, official government agencies and departments, and outlets of the professional and lay media. We’ll also strive to provide you with the right tools and information you’ll need to transform this knowledge into action. Additionally, we’ll focus our attention on Medicare/Medicaid reimbursement, coding changes, malpractice, HIPAA, and other important issues. Obviously, this is a lot to cover, so we’re asking for your help: if something comes to your attention that you think could benefit your colleagues and fellow readers, send it to us at oncologynetguide@mdnetguide.com.

The Centers for Disease Control and Prevention’s Division of Cancer Prevention and Control (DCPC) “works with partners in the government, private, and nonprofit sectors to develop, implement, and promote effective cancer prevention and control practices nationwide.” This DCPC-provided site allows visitors to access a searchable database of pending and enacted state and federal cancer legislation, organized by topic, year, word, and bill number. The site also provides summaries and analyses of specific cancer legislation, and links to legislators and others making decisions related to public health and cancer.
The FDA’s has approved Iressa, under its accelerated approval program, as monotherapy for advanced NSCLC in patients whose cancer has continued to progress despite treatment with platinum-based and docetaxel chemotherapy. In light of “substantial differences in response rates in subsets of patients,” AstraZeneca has agreed to conduct additional studies of Iressa’s clinical benefits. The FDA also determined that the incidence of “serious and sometimes fatal interstitial lung disease,” a side effect sometimes observed in patients treated with this medication, is low enough that it “does not outweigh the benefits demonstrated in patients with advanced NCSLC.”
The measure seeks to encourage voluntary reporting of health care errors by creating "Patient Safety Organizations" (which may include such preexisting groups as the Joint Commission on Accreditation of Healthcare Organizations) to collect voluntary, confidential provider reports of medical errors and store them in a national database. This data would be analyzed to better learn the causes of medical errors and facilitate the implementation of systems and procedures to prevent these errors from occurring in the future.
This article from canceractionnow.org addresses the issues of public participation in the new drug approval process and the beneficial role of expanded access programs for experimental cancer drugs.
The American Society of Clinical Oncology provides this database to assist members in handling Medicare coverage issues. Physicians can “locate information on their Carrier, CAC representatives, and their local state society. Viewers will also be able to research oncology- and hematology-related Local Medical Review Policies (LMRPs) by state and subject. Final policies, as well as draft LMRPs and pertinent correspondence to and from Carriers, are available.”

 


Departments
Internet Listings