Avastin Used in Combination with Taxol and Paraplatin Will Become the Clinical Gold Standard Treatment by 2011

“Avastin Used in Combination with Taxol and Paraplatin Will Become the Clinical Gold Standard Treatment by 2011, According to a New Report from Decision Resources

WALTHAM, Mass., April 23 /PRNewswire/ — Decision Resources, one of the world’s leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that surveyed oncologists say that a therapy’s effect on overall survival is the attribute that most influences their prescribing decisions in advanced ovarian cancer. Clinical data and expert opinion show that Roche/Genentech/Chugai‘s Avastin (bevacizumab) plus the regimen of paclitaxel (Bristol-Myers Squibb’s Taxol, generics) and carboplatin (Bristol- Myers Squibb’s Paraplatin, generics) has advantages in this attribute over the combination of paclitaxel/carboplatin, the current sales leader in ovarian cancer treatment.

The new report entitled Ovarian Cancer (Advanced): Therapies Must Increase Survival over Paclitaxel/Carboplatin to Successfully Enter this Generic Market finds that, according to surveyed oncologists, a drug that offers improved median overall survival compared with paclitaxel/carboplatin would earn a 50 percent patient share in the ovarian cancer market. Surveyed oncologists indicated that they would prescribe Avastin plus paclitaxel/carboplatin to 29 percent of their patients with advanced ovarian cancer. As a result, Avastin plus paclitaxel/carboplatin will earn a 22 percent patient share in the U.S. advanced ovarian cancer market in 2016.

The report also finds that Avastin plus paclitaxel/carboplatin will earn the clinical gold-standard status for treatment of advanced ovarian cancer in 2011, following its approval for the indication in 2010. Surveyed oncologists indicated that Avastin plus paclitaxel/carboplatin has competitive advantages in efficacy over paclitaxel/carboplatin, the current gold standard.

‘Avastin plus paclitaxel/carboplatin has the same delivery attributes and only marginally different safety attributes when compared with paclitaxel/carboplatin,’ said Jenna Avent, analyst at Decision Resources. ‘However, the regimen of Avastin plus paclitaxel/carboplatin has better efficacy when compared to the current gold standard, paclitaxel/carboplatin, and oncologists rate efficacy as the most important parameter in the treatment of advanced ovarian cancer.’”

[Quoted Source:  “Avastin Used in Combination with Drugs from Bristol-Myers Squibb Has Advantages in Survival Rates Over the Current Sales-Leading Therapy for Advanced Ovarian Cancer,” News, EarthTimes.org, April 23, 2008][Emphasis added].

One thought on “Avastin Used in Combination with Taxol and Paraplatin Will Become the Clinical Gold Standard Treatment by 2011

  1. A good benchmark assessment of the efficacy of drugs that come out of clinical trials, could be Cell Function Analysis.

    At present, clinical trials are highly empirical, they test drugs on general populations and then look for a clincial response and a treatment effect that is not likely to be a chance result. However, the side effect of this is inflexibility, some patients may unnecessarily be exposed to inferior experimental therapies.

    A problem with the empirical approach is it yields information about how large populations are likely to respond to a treatment. Doctors don’t treat populations, they treat individual patients. Because of this, doctors give treatments knowing full well that only a certain percentage of patients will receive a benefit from any given medicine. The empirical approach doesn’t tell doctors how to personalize their care to individual patients.

    The number of possible treatment options supported by completed randomized clinical trials becomes increasingly vague for guiding physicians. Even the National Cancer Institute’s official cancer information website states that no data support the superiority of more than 20 different regimens in the case of metastatic breast cancer, a disease in which probably more clinical trials have been done than any other type of cancer.

    More clinical trials have not produced more clear-cut guidance, but more confusion in this situation. It is more difficult to carry out clinical trials in early stage breast cancer, because larger numbers of patients are needed, as well as longer follow-up periods. But it is likely that more trials would lead to the identification of more equivalent chemotherapy choices for the average patient in early stage breast cancer and in virtually all forms of cancer as well.

    So, it would appear that published reports of clinical trials provide precious little in the way of “gold standard” guidance. Almost any combination therapy is acceptable in the treatment of cancer these days. Physicians are confronted on nearly a daily basis by decisions that have not been addressed by randomized clinical trial evaluation.

    The needed change in the “war on cancer” will not be on the types of drugs being developed, but on the understanding of the drugs we have. The system is overloaded with drugs and underloaded with the wisdom and expertise for using them.

    Patient tumors with the same histology do not necessarily respond identically to the same agent or dose schedule of multiple agents. Laboratory screening of “live” samples from a patient’s tumor can help select the appropriate treatment to administer, avoiding ineffective drugs and sparing patients the side effects normally associated with these agents.

    It can provide predictive information to help physicians choose between chemotherapy drugs, eliminate potentially ineffective drugs from treatment regimens and assist in the formulation of an optimal therapy choice for each patient. This can spare the patient from unnecessary toxicity associated with ineffective treatment and offers a better chance of tumor response resulting in progression-free survival.

    Identifying patients with resistant neoplasms may not only spare them toxicity but may prolong their lives, by sparing them from the life shortening effects of ineffective chemotherapy.

    Patients would certainly have a better chance of success had their cancer been chemo-sensitive rather than chemo-resistant, where it is more apparent that chemotherapy improves the survival of patients, and where identifying the most effective chemotherapy would be more likely to improve survival above that achieved with empiric chemotherapy.

    With the absence of effective laboratory tests to guide physicians, many patients do not even get a second chance at treatment when their disease progresses. Spending six to eight weeks to diagnose treatment failure often consumes a substantial portion of a patient’s remaining survival, not to mention toxicities and mutagenic effects. In cases where there are several equivalent treatments available, patients can benefit from these assay-testing results as a supplement to other clinical data when deciding on a treatment option.

    Good review papers exist and are increasingly appreciated, understood, and applied by private sector and European clinicians and scientists. This literature is not understood by many NCI investigators and by NCI-funded university investigators. NCI studies never determine if fresh tumor assays worked. All of the considerable literature which supports the use of these assays in patient management has been based on true fresh tumor (non-passaged) cell assays.

    The NCI used “cell lines” because the major expertise of the investigators who carried out any study was in the creation of cancer cell lines, and they wanted to see if they could perform assays on these cell lines to use in patient therapy. The results were that they were able to test successfully only 22% of specimens received, including only 7% of primary lesions.

    This contrasts with a 75% overall success rate reported by earlier investigators who used the same assay system in fresh tumors and a routinely obtained > 95% success rate using improved methods available today.

    Cell culture analysis using functional profiling differs from other tests in that it assesses the activity of a drug upon combined effect of all cellular processes, using several metabolic (cell metabolism) and morphologic (structure) endpoints, at the cell “population” level (rather than at the “single cell” level), measuring the interaction of the entire genome.

    I believe that improving cancer patient diagnosis and treatment through a combination of cellular and gene-based testing will offer predictive insight into the nature of an individual’s particular cancer and enable oncologists to prescribe treatment more in keeping with the heterogeneity of the disease.

    The biologies are very different and the response to given drugs is very different. Having a good tumor-drug match not only would improve survival rates, it would be cost-effective, and the high cost of the newer cancer therapies reinforces the necessity of choosing the right therapy the first time around.

    Like

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