Oral-Dose Chemotherapy

[gpawelski]

An important advance that was evident at the annual American Society of Clinical Oncology meeting was the emphasis on kinder, gentler approaches to cancer treatment. Researchers are now routinely studying quality of life. A good example in this hunt for less toxic cancer treatments is a study that is likely to change cancer treatment. Even giving the drug Taxol weekly (at a much lower dose) rather than every three weeks was more effective for metastatic cancer. This kind of regimen enables the immune system to regenerate and contribute to recovery.

Office-based oncology practices derive most of their revenues from treating patients with chemotherapy. The practices are compensated both for delivering the drugs and for the drugs themselves. The Journal of the National Cancer Institute (JNCI) states that private-practice oncologists typically derive two-thirds of their income from selling chemotherapy.

Reimbursement of any kind is often lacking with oral-dose drugs because the patient purchases them directly. The oncologist simply writes a prescription and the patient goes to a pharmacy and obtains the product. There are no administration fees for office-based oncology practices unless they also dispense the drugs, because there is no involvement in their purchase.

The practice will realize almost no revenue from those patients who are treated entirely with oral-dose agents. The core activity in medical oncology is the provision of infusional chemotherapy. The entire structure of office-based practices revolves around this activity and is what distinguishes medical oncology from most other specialties.

Oral-dose chemotherapeutic agents are easy to use and offer the promise of less frequent visits to the physician's office and their infusion rooms. This promise is not trivial, especially as we have come to realize that many forms of cancer may be managed with these drugs, especially when they offer the equivalent outcome as intravenous drugs.

The fact that medical oncologists receive no reimbursement for providing oral-dose therapy to patients had been the principal barrier to the availability of oral-dose protocol. The advent of oral agents ultimately means that medical oncology will need to change its identity, prior to the chemotherapy drug concession.

They will be reimbursed for providing evaluation and management services, making referrals for diagnostic testing, radiation therapy, surgery and other procedures as necessary, and offer any other support needed to reduce patient morbidity and extend patient survival.

Because oral-dose drugs ultimately deliver on their promise of combining equally efficacious therapy with better adverse event profiles and easier administration, they will rightfully gain their appropriate share of the marketplace, again.

Without information provided by Chemosensitivity Testing (assay-testing), oncologists have the freedom to choose between a multiple of different drug regimens, all of which have approximately the same probability of working. Some of these regimens are highly profitable to oncologists. Other regimens are much less profitable. Assay-testing takes away a lot of this freedom to choose and narrows the selection to those drugs that have the highest probability to be successful but may have lower profitability for the oncologist. Many of these less profitable regimens are oral-dose. This cuts into the oncologist's bottom line, though it benefits the patient.

The present system exists to serve the clinical investigators and the clinical oncologists, but not to serve the best interests of the cancer patients. I think it is time to set aside empiric one-size-fits-all treatment in favor of recognizing that breast, lung, ovarian and other forms of cancer represent heterogenous diseases, where the tumors of different patients have different responses to chemotherapy. It requires individualized treatment based on testing the individual properties of each patient's cancer.

Under previous law, Medicare covered chemotherapy as well as radiation treatment for cancer patients, but did not pay for oral-dose anti-cancer drugs, unless they were available in both oral and injectable form. Medicare Part B covered a total of seven oral-dose anti-cancer drugs, under this provision. Older Americans were being denied access to the latest generation of cancer drugs simply because these therapies came only in pill form.

Increasingly, oral-dose anti-cancer drugs are found to treat cancer effectively and seen as an intergral and necessary part of a patient's cancer care. A number of these breakthrough cancer drugs came on to the market that are only in oral form and previously not reimbursed under Medicare. Patients were being forced to compromise their cancer care due to Medicare not covering many of these life-saving therapies.

The new legislation started the process of providing access to a full range of the latest cancer-related prescription drugs at manageable costs to enhance the quality and standard of treatment for cancer. Cancer patients under Medicare are now able to rely on treatment decisions that are dictated by good medicine and not just economics. Medicare recipients were being relagated to treating their diseases with older, more toxic infusional chemotherapy agents at a time when new and more promising cancer drugs were reaching the market.

The new targeted, relatively non-toxic oral anti-cancer drugs are based on a variety of biological mechanisms that essentially stop cancer from spreading. Targeted cancer therapies use drugs that block the growth and spread of cancer. They interfere with specific molecules involved in carcinogenesis (the process by which normal cells become cancer cells) and tumor growth. By focusing on molecular and cellular changes that are specific to cancer, targeted cancer therapies may be more effective than current treatment protocols and less harmful to normal cells.

Normally, cells grow and divide to form new cells as the body needs them. When cells grow old, they die (apoptosis) and new cells take their place. Sometimes this orderly process goes wrong, new cells form when the body does not need them and old cells do not die when they should. These extra cells can form a mass of tissue called a growth or tumor (lesion). Cells in cancerous (malignant) tumors are abnormal and divide without control or order.

These anti-proliferative agents have such names as signal-transduction inhibitors (cascade of cellular and biochemical events), farnesyltransferase inhibitors (cell death inducer) and angiogenesis inhibitors (new blood vessel blocker). Targeted cancer therapies interfere with cancer cell growth and division in different ways and at various points during the development, growth and spread of cancer. By blocking the signals that tell cancer cells to grow and divide uncontrollably, targeted cancer therapies can help to stop the growth and division of cancer cells.

These new products are an indispensable new feature of quality cancer care and will replace, enhance or even make more effective therapies that are largely based on intravenous administration (infusion therapy).

Compared to infusional therapy, oral-dose anti-cancer drugs can make receiving cancer treatment more convenient for patients by allowing flexibility in taking medication without disrupting work or other activities. They can often result in less time spent in office-based oncology practices because of the absence of intravenous administration and its related side-effects.

Targeted cancer therapies will give doctors a better way to tailor cancer treatment. Treatments may be individualized based on the unique set of molecular targets produced by the patient's tumor, and these important treatment advances will require individualizing treatment based on testing the individual properties of each patient's cancer. Chemosensitivity Testing (Cell Culture Drug Resistance Testing) can improve patient survival in chemotherapy for cancer.

These new differences in therapy hold the promise of being more selective, harming fewer normal cells, reducing side-effects and work to improve the quality of life for people with cancer and can translate into savings for them and overall for the health care system.

[gpawelski]

There are many cancer drug regimens, all of which have approximately the same probability of working. The tumors of different patients have different responses to chemotherapy. It requires individualized treatment based on testing the individual properties of each patient's cancer. In other words, test the tumor first.

Chemosensitivity testing (assay-testing) has been showing that there are a number of oral medications that may help better than infusional regimens. It is better having odds what may or may not work rather than one-drug-fits-all empirical methods. In some cases, assay-testing "may" show that one-drug-fits-all would be better.

These new differences in therapy hold the promise of being more selective, harming fewer normal cells, reducing side-effects and work to improve the quality of life for people with cancer and can translate into savings for them and overall for the health care system.

Many infusional therapies are typically biotechnology drugs made of complicated proteins that are injected. This makes them several times more expensive than traditional pill-form pharmaceuticals.

Some oral-dose cancer drugs:

Drug (Brand Name) & Specific Cancer Indication

Imatinib mesylate (Gleevec) -- for chronic myelogenous leukemia and gastrointestinal stromal tumor

Bexarotene (Targretin) -- for cutaneous T-cell lymphoma

Altretamine (Hexalen) -- for epithelial ovarian cancer

Thalidomide (Thalomid) -- for multiple myeloma

Gefitinib (Iressa) -- for non-small cell lung cancer

Letrozole (Femara) -- for stages 2-4 breast cancer

Exemestane (Aromasin) -- for stages 2-4 breast cancer

Anastrozole (Arimidex) -- for stages 2-4 breast cancer

Tamoxifen (Nolvadex) -- for stages 2-4 breast cancer

Toremifene (Fareston) -- for stages 2-4 breast cancer

Mesna (Mesnex) -- for people receiving ifosfamide

Temozolomide (Temodar) -- for anaplastic astrocytoma

Xeloda (Capecitabine) -- for mestastatic breast cancer

Cyclophosphamide (Cytoxan) -- for several types of cancer

Methotrexate (Rheumatrex) -- for several types of cancer

Busulfan (Myleran) -- for blood cancers

Etoposide (VePesid) -- for small cell lung cancer

Melphalan (Alkeran) -- for several types of cancer

Chlorambucil (Leukeran) -- for several types of cancer

Erlotinib (Tarceva) -- for non-small cell lung cancer

[Leslie221]

Very good points. I don't think we'll ever be able to call ourselves an evolved or "civilized" people until profit takes a back burner to healing.

Leslie