FDA approves Halaven (eribulin mesylate) for the treatment of metastatic breast cancer

The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.

Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer.

Halaven is marketed by Woodcliff Lakes, N.J. -based Eisai Inc.

Read more on the FDA website.

IsoFlow infusion catheter receives FDA marketing clearance

If you haven't seen this video about the IsoFlow infusion catheter, I think you'll be impressed. This is targeted drug delivery (not to be confused with targeted biologic drugs).

San Jose, Calif. – September 2, 2009 – Vascular Designs, a medical device company, today announced that its IsoFlow™ infusion catheter has secured 510(k) marketing clearance by the U.S. Food and Drug Administration (FDA) for the direct delivery of medications into highly targeted areas. An important application of IsoFlow may be in the treatment of cancer.

The IsoFlow Infusion catheter enables sideways perfusion, which allows physicians to precisely target and isolate areas within the body where the infused drugs are delivered. With IsoFlow’s unique design, medications can be delivered into areas that could not previously be treated directly, for instance, a cancerous tumor. According to numerous studies, this approach lets physicians increase drug concentrations at targeted sites while reducing systemic exposure, thereby improving efficacy and patient outcomes when treating illnesses such as cancer with chemotherapy.

To read the entire press release, visit: Vascular Designs

2009 ASCO EHR Symposium

The 2009 ASCO (American Society of Clinical Oncology) Electronic Health Record (EHR) symposium is this October in San Francisco, CA. Because of the HITECH provisions found in the ARRA, we know that EHRs will become very prevalent across all medical specialties, including oncology.

In the field of oncology, so many medications cause significant adverse reactions. Plus, combination therapy is often used to treat cancer. EHRs can help clinicians keep track of all the treatment infusions and they may also alert providers about the possible risks associated with combining certain chemotherapy agents with targeted biologics.

Interested in knowing who will be speaking? Here are just a few examples:

• Peter Yu, M.D. - Chair ASCO EHR Workgroup, Oncologist, Palo Alto Medical Foundation (PAMF)
• Barbara McAneny, M.D. - CEO, New Mexico Oncology Hematology Consultants
• Charles McKay, M.D. - CEO, Tennessee Oncology
• John Cox, D.O., M.B.A. - Editor-in-Chief, Journal of Oncology Practice
• Robert Miller, M.D. - Oncologist, Johns Hopkins Kimmel Cancer Center
• Kenneth Buetow, Ph.D. - Director, NCI's Center for Biomedical Informatics and Information Technology (CBIIT)
• Lawrence Shulman, M.D. - Chief Medical Officer, Dana- Farber Cancer Center
• William Hersh, M.D. - Chair, Department of Medical Information and Clinical Epidemiology, Oregon Health and Sciences University

If you're an oncologist (and you're not retiring anytime soon), you won't want to miss this! To get more information about the ASCO EHR symposium, visit: http://www.asco.org/ehrsymposium

New cancer drug has few side effects

There's an interesting article in the New England Journal of Medicine (NEJM) that talks about a novel new cancer agent called olaparib. In a phase 1 study, this drug was found to have few adverse effects (compared to conventional chemo) and displays antitumor activity in certain tumors. Here's the brief conclusion: Olaparib has few of the adverse effects of conventional chemotherapy, inhibits PARP, and has antitumor activity in cancer associated with the BRCA1 or BRCA2 mutation.

Technology Review has a nice article on this titled, "New Drug Kills Cancer with Few Side Effects." Sounds simple, doesn't it?

Compare that to the NEJM title: "Inhibition of Poly(ADP-Ribose) Polymerase in Tumors from BRCA Mutation Carriers." Did you catch all that? What's PARP?

Did you learn about PARP in medical school? The inhibition of poly(adenosine diphosphate [ADP]–ribose) polymerase (PARP) is a potential therapeutic strategy for the treatment of cancers with specific DNA-repair defects, including those arising in carriers of a BRCA1 or BRCA2 mutation. Olaparib (AZD2281) is an orally acting PARP inhibitor.

As cancer therapy becomes more tailored in our evolving world of personalized medicine, it's exciting to see all this research that combines molecular biology, genomics, and targeted therapies. Advances in medical technology and drug development are leading to innovative treatments in the world of oncology.

Olaparib (AZD2281), previously known as KU-0059436, began to be manufactured by AstraZeneca after the company acquired KuDOS Pharmaceuticals.

Is Breast Cancer a Different Disease in Young Women?

We often think of breast cancer as primarily being a disease that affects older individuals. However, there are many cases of young, healthy women developing breast cancer and most of them have positive genetic markers to genes like BRCA1 and BRCA2. These genes are currently implicated in the majority of inherited breast (and even ovarian) cancers.

When breast cancer hits a really young woman (say in her early 30's), is it an entirely different disease? This seems to be an area that causes confusion in the oncology community. In a recent CME-certified activity titled, "Breast Cancer in Women Under 40," Jeffrey Peppercorn, MD, MPH discusses this issue. He remarks how breast cancer in women under 40 are more likely to be:

• estrogen receptor-negative (or ER negative)
  
• higher grade
• HER2-positive

Plus, he indicates that "young African-American women are more likely to have triple-negative breast cancer (estrogen receptor–negative, progesterone receptor–negative, and HER2-negative)."

Advances in medical science are helping us understand the disease process of cancer as researchers explore different treatment options including chemotherapy, hormone therapy, radiation, and other modalities. With all these advances in medicine and technology, will we ever find a cure for breast cancer?

Speaking of breast cancer, one topic I don't think anyone really understands is the spontaneous regression of tumors (when tumors disappear by themselves). It's very rare, but it does occur. Miracle healings! One minute you're told you have a tumor, the next minute it's gone! Do modern day miracles still happen? I believe they do. Scientists have postulated various mechanisms by which tumors may disappear by themselves. One researcher lists these possible explanations: "immune mediation, tumor inhibition by growth factors and/or cytokines, induction of differentiation, hormonal mediation, elimination of a carcinogen, tumor necrosis and/or angiogenesis inhibition, psychologic factors, apoptosis and epigenetic mechanisms." The list doesn't include supernatural healings, but psychologic factors? I'm not so sure about that.

If we can gain a better understanding of why certain tumors may disappear by themselves, then this information may someday lead to a cure for cancer. I'd like to see more research on the topic of spontaneous regression.

Chemotherapy in Older Women with Early Breast Cancer

There aren't that many clinical studies that include older women with early breast cancer. Plus, older women are more likely to be treated with lower doses of chemotherapy than younger women. So, it becomes difficult to know how they should be treated if they present with early breast cancer.

Fortunately, the NEJM has an interesting article about the use of "Adjuvant Chemotherapy in Older Women with Early-Stage Breast Cancer." Here's the conclusion: Standard adjuvant chemotherapy is superior to capecitabine in patients with early-stage breast cancer who are 65 years of age or older. In this study, standard chemotherapy was either cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide plus doxorubicin. Capecitabine is marketed by Roche under the trade name Xeloda.

So what does all this mean? Here are some of the highlights from the discussion section of the article:

The authors note that "the choice of chemotherapeutic agents, dose, schedule, and dose modification should be based on the treatment plans in published reports." There are significant toxicities associated with certain chemotherapy agents and many older patients are unable to tolerate such regimens.

The authors also write that "patients in this trial had an excellent performance status and no major organ dysfunction. The toxicity of these regimens in vulnerable or frail patients is probably greater than the toxicity observed in the patients in this study, and they should be administered with caution or not at all in such patients."