Lapatinib (Tyverb) Combined With Paclitaxel Shows Clinical Activity In HER2+ Late-Stage Breast Cancer
Editor's ChoiceMain Category: Breast Cancer
Also Included In: Cancer / Oncology; Clinical Trials / Drug Trials
Article Date: 25 Sep 2007 - 8:00 PDT
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Lapatinib used in tandem with paclitaxel demonstrates significant clinical activity in HER2-overexpressing (HER2+) patients with metastatic breast cancer, according to results released today at the 14th European Cancer Conference (ECCO).
Lapatinib is an oral tyrosine kinase inhibitor of EGFR/HER2 that was recently approved in the U.S., Switzerland, and several other countries worldwide for use in combination with capecitabine for HER2+ advanced/metastastic breast cancer pretreated with taxanes, anthracyclines, and trastuzumab-based therapy.
The taxane paclitaxel has shown activity alone and in combination in HER2+ breast cancer.
Dr. Richard Finn, MD, assistant professor of hematology/oncology at the Geffen School of Medicine at UCLA in Los Angeles, California, and colleagues elsewhere analyzed biomarkers in 580 women whose HER2 status was unknown at the time they enrolled in a phase III trial comparing lapatinib with pacelitaxel versus paclitaxel plus placebo as first-line treatment for metastatic breast cancer.
Initial results from the trial, known as EGF30001, documented a direct correlation between lapatinib efficacy and HER2+ overexpression.
Importantly, the new analysis revealed that biomarkers correlated with clinical efficacy in 579 patients.
Specifically, the data showed that in a subset of 91 patients determined to be HER2+, lapatinib plus paclitaxel demonstrated significant superiority over the paclitaxel plus placebo group in key measures of clinical activity. The median progression-free survival was 34.4 weeks in the lapatinib/paclitaxel group versus 22.6 weeks in the paclitaxel plus placebo group (p=0.007), and the median time to disease progression was 35.1 versus 25.1 weeks for the two groups, respectively, p=0.0107. A complete or partial response was documented in 60% versus 36% of the two groups, respectively, p=0.027.
The lapatinib/paclitaxel combination did not confer additional benefit in patients with HER2- disease.
"The study bolsters evidence in support of lapatinib's potential to improve the clinical management of HER2+ metastatic breast cancer," Professor John Crown, consultant medical oncologist at St. Vincent's University Hospital in Dublin, Ireland, said.
There are approximately 430,000 new cases of breast cancer per year in Europe. In 2006, breast cancer accounted for one in seven (13.5%) of all newly diagnosed cancers, with 132,000 deaths due to the disease. Roughly a third of breast tumors are HER2+, which is a recognized marker for poor prognosis. Up to 40% of HER2+ patients are unresponsive to trastuzumab therapy.
-- http://www.lapatinib.org
By Jill Stein
Jill Stein is a Paris based medical writer
Jillstein03 at cs.com
Copyright: Medical News Today
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Feeding The Cancer Machine Or The Smart-Pill Solution
posted by Gregory D. Pawelski on 25 Sep 2007 at 11:56 amTykerb (lapatinib) is one of the first oral agents with the potential to compete directly with the IV drugs which is both a high-volume and high-revenue part of office-based practices. Early use of Tykerb will likely be limited to patients whose breast cancer is refractory to Herceptin (trastuzumab). In the longer term, it could supplant or perhaps find a place in combination with Herceptin.
Of course, will patients be able to afford the cost of these drugs? Herceptin's wholesale price on an annualized basis is approximately $45,000 per year. Tarceva, $40,000 per year. Nexavar, $60,000 per year. Avastin, $47,000 per year. Will the price of Tykerb approximate these novel agents or exceed their costs? The problem is not unique to these drugs, but also to all of the new molecularly-targeted agents.
Lee Newcomer, former chief medical officer and currently an executive with United Health Group, stated at the 12th annual conference of the National Comprehensive Cancer Network, that "Avastin improves outcomes in about 20% of patients, but we have no idea which cancer patients will benefit from a course of treatment. Because Avastin is included with numerous drug cocktails, it costs $354,000 per year of life extended with Avastin because of today's 'cookie-cutter' approach to chemotherapy. You don't know in advance who is going to respond."
Everyone is scared to death (and rightly so) at what is going to happen to the healthcare economic system with the introduction of increasingly expensive new drugs that benefit only a small percentage of patients who receive them, hence the headlong rush to develop tests to identify molecular predisposing mechanisms whose presence still does not guarantee that a drug will be effective for an individual patient. Nor can they, for any patient or even large group of patients, discriminate the potential for clinical activity among different agents of the same class.
Profit is a powerful motivating force. Among medical benefit payors, the profit motive is entirely consistent with the goal of developing a molecular test, which is to identify efficacious therapies irrespective of drug mark-up rates.
The FDA finds themselves under increasing pressure to allow new drugs into the marketplace, while at the same time protecting the safety of potential recipients of those drugs and also the financial interests of those who will have to pay for them. The pressure is so great that companion molecular diagnostics approved often have been mostly or totally ineffective at identifying clinical responders (durable and otherwise) to the various therapies.
It should be in the FDA's interest in saving the healthcare system perhaps billions of dollars a year (and thereby the healthcare system itself) by ensuring that expensive treatments are used appropriately. It should serve their interest not only in discovering new cancer treatments, but also using currently-available cell culture assay technologies to improve the effectiveness of existing drugs and save lives today by administering the right drug to the right patient at the right time.
We have the biomarkers for who will respond so we don't give these powerful and expensive medicines to those who won't. Just look at the Iressa/Tarceva story. A total failure of huge clinical trials because the proper patients were not selected. We should be able to detect cancer pathways with biomarkers and choose patients for a trial based on who responds very quickly to a drug. The ordinary trial system will not suffice if we are to encourage new drugs for restricted numbers of patients.
The methods of cancer medicine during the last thirty some years are coming to haunt the "one-size-fits-all" establishment. Technologies, developed over the last twenty years by private researchers, hold the key to solving some of the problems confronting a healthcare system that is seeking ways to best allocate available resources while accomplishing the critical task of matching individual patients with the treatments most likely to benefit them.
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