Long-term Tamoxifen Use Linked To Second Breast Cancer

{Tamoxifen 3D - photo left}

Long-term tamoxifen use linked to second breast cancer:
http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20090825/tamoxifen_risk_090825/20090825?hub=Health
From The Canadian Press, “A new study suggests long-term use of tamoxifen is linked to an increased risk of a second type of breast cancer…another rare subtype of the disease increased by more than 400 per cent.”

Adjuvant Hormonal Therapy for Breast Cancer and Risk of Hormone Receptor–Specific Subtypes of Contralateral Breast Cancer
http://cancerres.aacrjournals.org/cgi/content/abstract/0008-5472.CAN-09-1355v1
From Cancer Res 2009;69(17):6865–70, “Compared with the breast cancer risk women in the general population have, breast cancer survivors have a substantially higher risk of developing a second primary contralateral breast cancer. Adjuvant hormonal therapy reduces this risk, but preliminary data indicate that it may also increase risk of hormone receptor–negative contralateral tumors…Compared with women not treated with hormonal therapy, users of adjuvant tamoxifen for 5 years had a reduced risk of ER+ contralateral breast cancer [odds ratio, 0.4; 95% confidence interval (CI), 0.3–0.7], but a 4.4-fold (95% CI, 1.03–19.0) increased risk of ER- contralateral breast cancer. Tamoxifen use for <5>

From U.S. News (HealthBuzz):
http://health.usnews.com/articles/health/2009/08/26/health-buzz-rare-risk-of-cancer-after-taking-tamoxifen-and-other-health-news.html
“The study's lead author (Dr. Christopher Li ) told HealthDay News he does not think women should be afraid to take the drug, stating that its benefits outweigh its risks. Tamoxifen is customarily given only for five years because there's no evidence that longer-term use has additional benefits.”

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Aspirin Use After Colorectal Cancer Diagnosis Associated With Improved Survival

A study published in JAMA August 12th, 2009 concludes:

Regular aspirin use after the diagnosis of colorectal cancer is associated with lower risk of colorectal cancer–specific and overall mortality, especially among individuals with tumors that overexpress COX-2.

The researchers explained:
"These results suggest that aspirin may influence the biology of established colorectal tumors in addition to preventing their occurrence. Our data also highlight the potential for using COX-2 or related markers to tailor aspirin use among patients with newly diagnosed colorectal cancer. Nonetheless, because our data are observational, routine use of aspirin or related agents as cancer therapy cannot be recommended, especially in light of concerns over their related toxicities, such as gastrointestinal bleeding."

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PharmQD: Pharmacist Social Network With Continuing Education and more

This is the link to the CE portion and they are grouped by topic - a lot of FREE ones, but some have associated costs:
http://www.pharmqd.com/ce

PharmQD promotes:

"Become a member of our interactive community. Collaborate and network with
your colleagues and trusted peers. Membership is free!"

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FDA issues final rules to help patients access investigational drugs

As HemOnctoday reported August 13th/09:
The FDA has published two new final rules explaining how critically ill patients can get access to investigational therapies when they are ineligible for clinical trials and do not have other treatment options.

The first rule, “Expanded access to investigational drugs for treatment use,”
clarifies procedures and standards with the aim of making investigational drugs
more widely available. It clarifies existing regulations and adds new types of
expanded access for treatment use. Under the final rule, expanded access to
investigational drugs for treatment use will be available to:

- Individual patients, including in emergencies.

- Intermediate-size patient populations.

- Larger populations under a treatment protocol or treatment investigational
new drug application (IND).

The second rule, “Charging for investigational drugs under an investigational
new drug application,” spells out the specific circumstances and costs for which
a manufacturer can charge patients for an investigational drug. The rule revises
the charging regulation to:

- Clarify the circumstances under which charging for an investigational drug
in a clinical trial is appropriate.

- Set forth criteria for charging for an investigational drug for the
different types of expanded access for treatment use described in FDA’s final
rule on expanded access for treatment use of investigational drugs.

- Clarify what costs can be recovered.

The agency has also launched a website for patients and physicians seeking more information about their options with regard to these investigational drugs. It includes information on treatment with an FDA-approved drug, treatment with an investigational drug as part of a clinical trial or obtaining access to an investigational drug outside of a clinical trial.
“With these initiatives, patients will have the information they need to help them decide whether to seek investigational products,” Margaret A. Hamburg, MD, commissioner of food and drugs, said in a press release. “For patients seeking expanded access to investigational drugs and biologics, the new rules make the process easier to understand.”

This is the direct link to the FDA post:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm176526.htm

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A Glimpse At The History Of The Pharmacist Profession

{Photo: The Sibiu Pharmacy Museum in Sibiu, in the Transylvania region of Romania, is housed in a 1569 Gothic townhouse where the oldest pharmacy in Romania operated for over 150 years. The pharmacy was known as La Ursul Negru (The Black Bear), and likely looked nothing like this. While the museum has a vast collection of chemistry instruments ranging from the 15th century to the 19th, this beautiful pharmacy reconstruction dates from the 18th century.}

While not quite specific to the realm of oncology pharmacy I thought pharmacists from all fields would enjoy a look back at the roots of our profession. I stumbled upon this intriguing piece on pharmacist history whilst searching for something in WIkipedia. The last statment below is very interesting and amusing indeed.

In Japan, at the end of the Asuka period (538-710) and
the early Nara period (710-794), the
men who fulfilled roles similar to those of modern pharamacists were highly
respected. The place of pharmacists in society was expressly defined in the Taihō Code (701) and re-stated in the Yōrō Code (718). Ranked
positions in the pre-Heian Imperial court were
established; and this organizational structure remained largely intact until the Meiji Restoration
(1868). In this highly stable hierarchy, the pharmacists -- and even pharmacist
assistants -- were assigned status superior to all others in health-related
fields such as physicians and acupuncturists. In the Imperial household, the pharmacist was even ranked above the two personal physicians of the Emperor.

Of course, as Bob Dylan sang: "The Times They Are A-Changing."

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FDA Approves Bevacizumab To Treat Advanced Renal Cell Carcinoma

As Reported by The Associated Press. 2009 Aug 2:

Avastin (bevacizumab) received approval from the Food and Drug Administration
(FDA) for a new indication to treat advanced renal cell carcinoma. This is the
most common form of kidney cancer. The FDA approval adds kidney cancer
indication to the 5 others for this drug, which include treatment of breast,
colon, and lung cancers. Bevacizumab, a targeted therapy for cancer, is an
angiogenesis inhibitor. Genentech, the manufacturer of Avastin, announced
approval for the new indication on August 2.

From Medscape, Aug 4:

The US Food and Drug Administration (FDA) has approved a new indication for
bevacizumab intravenous infusion (Avastin, Genentech, Inc) for the treatment of
metastatic renal cell carcinoma. The recommended dose is 10 mg/kg every 2 weeks
in combination with interferon α-2a (9 MIU subcutaneously 3 times weekly).

Bevacizumab is a monoclonal antibody that works by binding to vascular
endothelial growth factor and preventing its role in angiogenesis, which
deprives tumors of blood, oxygen, and other nutrients necessary to support their
growth and metastasis.

Approval of the indication was based on data from a global, randomized,
double-blind, placebo-controlled phase 3 study — the Avastin in Renal (AVOREN)
study — of 649 patients with newly diagnosed metastatic renal cell carcinoma,
showing that the addition of bevacizumab to interferon α-2a significantly
increased progression-free survival by 67% compared with interferon α-2a alone
(10.2 months vs 5.4 months; hazard ratio [HR], 0.60; 95% confidence interval
[CI], 0.49 – 0.72).

Results also showed that the combination therapy significantly
decreased tumor size by 30% compared with 12% for interferon α-2a alone.
However, no improvements were observed in median overall survival on the final
analysis after 444 deaths (survival, 23 months vs 21 months; HR, 0.86; 95% CI,
0.72 – 1.04).

Adverse events reported in the study were consistent with the safety
profiles for bevacizumab and interferon α-2a, with fatigue (13%), weakness
(10%), proteinuria (7%), hypertension (6%), and bleeding (3%) most often
reported.

Bevacizumab previously was approved for the treatment of metastatic
colorectal cancer, nonsquamous non-small cell lung cancer, metastatic breast
cancer, and glioblastoma.

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