Posted by Keith Galloway on Thu, Mar 11, 2010 @ 10:05 AM
The high cost of healthcare is an ongoing concern for cancer patients and their oncologists. The price of chemotherapy medications alone can be
exorbitant, costing patients an average $1,600 for a 30-day prescription. Personalized dose management is one overlooked strategy for helping to minimize those rising costs.
Dose management involves the use of a precise diagnostic tool-individual drug blood level testing-that is both effective and inexpensive. It offers patients a range of
advantages, including more accurate chemotherapy dosing, better clinical response, and greater survival rates. Research has shown that personalized dose management has the potential to provide these benefits while also reducing the most severe, debilitating side effects. That kind of return on investment is rare in any form of medicine and especially in oncology.
By contrast, certain oral cancer medications that oncologists and patients rely on for treatment are often extremely high-priced with minimal clinical benefit. For example, the drugs Avastin (bevacizumab) and Xeloda (capecitebine) are often used in combination with other cancer drugs to enhance treatment. Bevacizumab is purported to decrease the growth of cancer cells for patients with metastatic cancer of the colon, lung, breast and other vital organs. Yet the evidence of benefit has been questioned while the list of potential side effects (high blood pressure, irregular heartbeat, vomiting) is quite long.
Simple dose adjustment to individual patient needs may lessen the need for expensive supporting medications because it helps the oncologist tailor and optimize drug dosing from the outset. With blood drug level testing, patients are more likely to get a dose that falls within the therapeutic range from the beginning and throughout the course of treatment. More appropriate dosing leads to both reduced tumor size and less toxicity. With more effective treatment patients may be less likely to require supporting medications that make up 30 percent of anti-cancer costs.
In addition to providing an alternative to high-priced drugs, the routine use of PCM Assays may also help lower medical costs by
• Reducing the need for medical interventions
• Reducing the frequency and length of hospital stays
• Lowering rates of disease relapse
Patients with any form of cancer face numerous challenges. Providing more effective treatment and lowering health care costs at the same time not only boosts patients' chance of survival but also adds to their quality of life.
Posted by Keith Galloway on Wed, Jan 27, 2010 @ 08:13 AM
One of the key benefits of personalized dose management is a reduction in chemotherapy side effects, which enhances patients' treatment and quality of life.
Dose management lessens the risk of severe toxicity and side effects in two ways. First, it enables the oncologist to more accurately prescribe the most appropriate dose to an individual patient rather than a standard dose. Second, it gives the doctor a tool to measure and adjust dosage over time to ensure that blood drug levels remain optimal but never get too high.
Research has demonstrated the impact of dose management on patient side effects. In a 2008 study, colorectal cancer patients whose treatment was based on the testing of blood drug levels had fewer severe side effects typically associated with the drug 5-fluorouracil (5-FU). Patients given adjusted rather than fixed doses were far less likely to suffer from Grade 3 / 4 (the most severe) diarrhea, one of the most common side effects of 5-FU and other chemotherapy agents. Researchers also noted a reduction in hematologic toxicity.
Dose management based on testing of blood drug levels also has the potential to lessen severe side effects of busulfan, a common chemotherapeutic agent. Busulfan is often used with patients undergoing hematopoietic stem cell transplantation for cancers of the blood and immune system. Because it is a high-dose regimen busulfan can cause veno-occlusive disease, among other serious side effects. But with timely testing and careful management of busulfan blood levels, oncologists can better manage dosing and minimize the risks of this critical treatment.
As the impact of blood drug level testing and dose management on chemotherapy side effects become more widely known and incorporated into clinical practice, oncologists can more successfully balance efficacy against those effects.
Posted by Keith Galloway on Tue, Dec 08, 2009 @ 04:05 PM
To maximize cancer treatment outcomes, oncologists administer what they believe to be the most effective chemotherapy dose tolerated by patients. Yet
research has shown that practitioners may be under-estimating the level of drug patients actually needs to achieve a positive response and improved survival rates.
New research reported in the October 2009 issue of Lung Cancer illustrates this point. Researchers at the S. Paolo Hospital in Milan, Italy studied more than 100 elderly patients diagnosed with advanced non-small cell lung cancer. Dr. A. Luciani and study co-authors compared the relative dose intensity (RDI) of chemotherapy agents administered to NSCLC patients. According to the study abstract, about one-third of patients received RDIs that were suboptimal, or less than 80 percent of the planned dose. The rest received RDIs above 80 percent. The response rate for patients receiving the higher doses was 55.2 percent compared to 33.3 percent for patients on the suboptimal doses.
Among the study authors' conclusions, it's noted that "an adequate dose intensity has a significant positive impact on both response rate and overall survival." With elderly patients oncologists may be too often erring on the side of suboptimal doses, and undertreatment, in order to avoid toxicity. But the research provides evidence that patients aged 70 and older can and should receive the optimal dose.
A second study published in the same journal compared the benefits of chemotherapy for elderly lung cancer patients versus younger patients. Mariano Provencio and associates examined treatment, toxicity, response rate, and survival in patients enrolled in six clinical trials. Their analysis found no significant differences in terms of treatment cycles or response rates. In their conclusions, study authors called for "more selective treatments, based on the genetic differences that older patients have."
Both studies support the principles of personalized medicine, and specifically personalized dose management. In the first study, individual characteristics such as body mass index, were more important than age in determining dose intensity. Even though the patients were older, the optimal dose brought about improvements both in terms of response and overall survival.
Given the fact that the number of elderly patients with cancer is on the rise, personalized chemotherapy management-with the goal of achieving optimal dosing and outcomes-merits further consideration. By incorporating optimal dose management into routine practice, oncologists can achieve greater efficacy with both elderly and young patients.
Posted by Keith Galloway on Fri, Nov 13, 2009 @ 08:25 AM
To determine the appropriate chemotherapy dose for individual patients, oncologists most often turn to the standard of body surface area (BSA). But relying on BSA alone can result in under-dosing or over-dosing because this standard measurement does not provide enough specific, personalized information about the patient. Individual patients not only absorb and metabolize drugs differently, but the rates of drug absorption and clearance in an individual change day to day, week to week.
Testing of blood drug levels, by contrast, provides the oncologist with more accurate information about how a patient's body is responding to a standard dose. It also gives the physician a tool for monitoring patient response and making any necessary adjustments over time. Blood testing greatly increases the likelihood that the oncologist prescribes the optimal dose and maintains it.
How does such personalized chemotherapy blood testing and management work? At the start of chemotherapy, the oncologist prescribes a test designed to determine the actual blood level of a specific cancer drug in his patient. After a blood draw, the blood sample is sent to a laboratory for analysis. The results, combined with clinical exams, allow the physician to draw conclusions about the efficacy and safety of the initial dose. If the dose is too low or too high, adjustments can be made accordingly.
In a study published in the Journal of Clinical Oncology, a group of metastatic colorectal cancer patients treated with a BSA-based dose of 5-fluorouracil (5-FU) were tested for blood drug levels. The patients received a wide range of dose adjustments in order to reach optimal 5-FU plasma levels during subsequent treatment cycles. The process was repeated over a period of several weeks. Compared with a control group given standard fixed dosing, the dose-adjusted group achieved higher response (33.7 percent versus 18.3 percent) and survival rates (22 months to 16 months).
Blood testing gave oncologists the data they needed to increase dose intensity in the studied patients, thus enhancing efficacy. At the same time, it enabled them to avoid the toxicity that could lead to debilitating side effects. Ninety-four percent of study-group patients received the target dose with dose management. For those patients receiving personalized therapy, the elusive balance between efficacy and safety was achieved.
Posted by Keith Galloway on Fri, Nov 06, 2009 @ 10:04 AM
The goal of every oncologist is to deliver chemotherapy to patients at doses that are the most efficacious without causing severe toxic effects. The optimal dose lies between doses that are too low to produce a positive response and those that are too high to avoid toxicity.
Compared to other fields of medicine, however, oncology tends to have among the lowest efficacy rates. One reason for this may be that oncologists often err on the side of under-dosing to minimize debilitating side effects. But if a patient receives levels of chemotherapy that are too low, the results are little to no therapeutic response, continued growth of tumors, developing resistance to the drugs, and a higher risk of disease recurrence.
Oncologists have been trained to administer and believe they are administering the maximum tolerated dose (MTD) in order to achieve and maintain the optimal level of a given cancer drug in patients' bloodstream. However, to date, doctors have not had the appropriate tools to verify whether the dose they give is actually the MTD for their individual patient. If the drug dose is too high, the patient suffers from excessive toxicity which can lead to severe adverse reactions and compromised immunity in patients, resulting in termination or interruption of treatment.
Dose optimization offers a solution to these ongoing challenges facing oncologists and patients. With personalized dose management, based on the testing of chemotherapy blood levels, oncologists can more reliably attain the optimal dose for each patient and maintain dose optimization throughout the course of treatment.
How is dose optimization achieved? Through blood testing of individual patients, oncologists can more accurately determine the most effective dose for the individual patient considering age, gender, weight, health status, genetics and other key factors. Repeat testing allows the oncologist to not only account for the fact that each patient absorbs, metabolizes, and eliminates drugs differently but also at a rate that varies over time. Adjustments in dosing can be made accordingly.
The benefits of dose optimization are multiple: more effective dosing, greater therapeutic response, and higher survival rates. Reduced toxicity also translates into better quality of life for patients.
With a tool like Personalized Chemotherapy Management Assays, dose optimization can become standard practice, raising the efficacy of treatment and improving outcomes for cancer patients.
Posted by Keith Galloway on Fri, Oct 09, 2009 @ 07:48 AM
A personalized approach to dose management has multiple benefits for chemotherapy patients and the oncologists who treat them. These benefits include:
More accurate dosing. Personalized dose management begins with testing of actual drug blood levels in patients. Blood tests offer oncologists a more precise tool than body surface area (BSA) for determining the most appropriate drug dosage for a given patient. With the test results, oncologists can better determine whether an individual cancer patient is receiving a dose within the optimal range - high enough to incur a response but low enough to prevent severe side effects or toxicity. With this approach, oncologists can assess treatment and make the critical adjustments to dosage should a patient require them.
In a recently published study in the Journal of Clinical Oncology, 85% of colorectal patients treated with 5-fluorouracil (5-FU) were found to be outside the optimal range when dosed by the standard dosing method - Body Surface Area (BSA). Surprisingly, 68% of patients were underdosed, resulting in sub-optimal therapeutic response with a higher chance of developing drug resistance and disease progression. The other 17% were overdosed, leading to debilitating toxic side effects that can result in treatment delay or termination. Only 15% of patients received the optimal dose of 5-FU to combat their disease.
Better clinical response. With more precise dosing and better dose management over time, oncologists and patients can expect a more positive response to chemotherapy treatment. In the study cited above, , patients receiving pharmacokinetic dose management of 5-FU for colon cancer had nearly double the positive response compared to patients treated by BSA dosing. The patients who underwent blood testing and dose adjustments based on those tests had a reduction in tumor size of at least 50 percent.
Fewer toxic side effects. Personalized dose management reduces the likelihood of both unintentional over-dosing and under-dosing of chemotherapy drugs-common challenges to oncologists. Even patients whose oncologists prescribe dose increases based on blood testing may be less likely to experience toxic effects. In the same study of colon cancer patients described above, recipients of personalized treatment had lower incidences of common chemotherapy toxicities such as diarrhea, mucositis, and blood disease.
Greater survival rates. Higher rates of positive response to chemotherapy treatment translate into greater efficacy and better outcomes. These outcomes may include reduced tumor size, longer periods of progression-free disease, and lower rates of recurrence. The evidence suggests that personalized dose management can boost survival rates, adding months, if not years, to patients' lives.
Better quality of life. In addition to improved survival rates, personalized dose management can enhance patient life quality in several ways. The more accurate dose management achieved through pharmacokinetics may reduce the incidence and severity of toxic side-effects, improving well-being during and after treatment, and reduce the need for medical interventions , supportive medications, and frequent or long hospital stays.
Posted by Keith Galloway on Thu, Oct 01, 2009 @ 10:52 AM
Personalized dose management for chemotherapy patients differs from standard dosing in important ways.
Oncologists typically administer doses of chemotherapy drugs based on body surface area (BSA), a standard determined by the height and weight of a patient. They rely on this standard to deliver cancer drugs in doses that are effective without causing severe side effects or toxicity.
Dose management is also influenced by the practice of delivering the maximum dose tolerated by patients. Oncologists engage in this practice in order to achieve and maintain positive response from a given drug. However, oncologists also aim to avoid toxic side effects. These competing goals often lead to either under-dosing or over-dosing of patients, undermining treatment, efficacy and cost effectiveness. That's one reason why oncology has one of the worst efficacy rates in medicine.
The problem with standard chemotherapy dose management based on current standards (BSA) is that it does not take into account key individual differences among cancer patients. These differences include age, health status, genetic makeup, diet, and other medications that might interfere with chemotherapy drugs. Standard dose management also does not reflect the fact that each patient absorbs, metabolizes and eliminates drugs differently. With this standard, blood drug level variations among patients can be greater than ten-fold. See relevant articles.
Personalized dose management, by contrast, is personal because it is customized to the characteristics of individual patients. It is based on simple blood tests that measure the concentration level of a cancer drug in the patient's body. The results of these blood tests allow oncologists to more accurately prescribe doses that are high enough to be therapeutic but low enough to minimize severe side effects and toxicity. Through blood testing, an oncologist can better determine the level of drug in a patient's bloodstream, and adjust drug doses accordingly.
The therapeutic benefits of blood testing are well established. In a published study, patients given doses of the widely used cancer drug 5-fluorouracil based on blood drug level testing (as opposed to standard BSA) received a range of dose adjustments. Compared to patients receiving fixed doses, the patients on adjusted doses achieved nearly double the positive response and greater survival rates. They also enjoyed lower rates of toxic side effects.
Personalized Chemotherapy Management Assays are an example of this more accurate, personalized approach to dose management. Because personalized dose management is based on multiple variables, it is more likely to deliver the appropriate dose to chemotherapy patients. The more effective treatments resulting from this powerful tool increase patient survival rates and quality of life.