California Kidney Cancer Foundation: Treatment

Kidney Cancer Treatment

This year it is estimated that 30,000 people in the U.S. will be diagnosed with kidney cancer and 12,000 will die of the disease. The California Kidney Cancer Center was founded to make new and advanced forms of therapy for kidney cancer readily available in Northern California.

1/26/06
FDA Approves New Treatment for Gastrointestinal and Kidney Cancer
The Food and Drug Administration (FDA) today announced approval of Sutent (sunitinib), a new targeted anti-cancer treatment for patients with gastrointestinal stromal tumors (GIST), a rare stomach cancer, and advanced kidney cancer. Today's action marks the first time the agency has approved a new oncology product for two indications simultaneously.

Sutent, which received a priority review and was approved in less than six months, is a tyrosine kinase inhibitor working through multiple targets to deprive the tumor cells of the blood and nutrients needed to grow.

According to the American Cancer Society, about 32,000 new cases of advanced kidney cancer and 5,000 cases of GIST are diagnosed each year.

Sutent was approved for the treatment of patients with gastrointestinal stromal tumors (GIST) whose disease has progressed or who are unable to tolerate treatment with Gleevec, the current treatment for GIST patients. While studying the treatment in patients, researchers conducted an early (interim) analysis of data that showed Sutent delayed the time it takes for tumors or new lesions to grow in patients with this rare type of stomach cancer. Specifically, the median time-to-tumor progression (TTP) for patients treated with Sutent was 27 weeks compared to 6 weeks for patients who were not treated.

FDA also granted accelerated approval for Sutent in the treatment of patients with advanced renal cell carcinoma (RCC). In contrast to the approval for GIST, which was based on the drug's ability to delay the growth of the tumors, this approval was based on Sutent's ability to reduce the size of the tumors in patients. An overall response rate ranging from 26-37 percent was found in patients with metastatic kidney cancer whose tumors had progressed following cytokine-based therapy.

The FDA has a long-standing commitment of providing patients suffering from serious and life-threatening diseases access to safe and effective treatments, in some cases prior to FDA approval. In the GIST clinical trial, significant clinical benefit was determined through an early interim analysis of data, thereby allowing researchers to convert all patients in the trial to treatment. For the RCC indication, the FDA used its accelerated approval process, a regulatory mechanism that expedites drug approvals for serious and life-threatening diseases.

FDA worked with the product sponsor to offer an expanded access program prior to approval, making the product available to patients not enrolled in a clinical trial. Currently, more than 1700 patients are being treated with Sutent through the expanded access program.

The most commonly reported Sutent-related side effects included diarrhea, skin discoloration, mouth irritation, weakness, and altered taste. Patients treated with Sutent also experienced, fatigue, high blood pressure, bleeding, swelling, and taste disturbance. Hypothyroidism was also observed.

Sutent will be distributed by Pfizer Labs, Division of Pfizer, Inc. in New York, NY.

12/20/05
FDA Approves New Treatment for Advanced Kidney Cancer
The Food and Drug Administration (FDA) today approved Nexavar (sorafenib tosylate), a new anti-cancer medicine used to treat adults with advanced renal cell carcinoma, the most common type of kidney cancer.

In the United States, kidney cancer accounts for approximately 3 percent of all adult cancers. According to the American Cancer Society, about 32,000 new cases are diagnosed and about 12,000 people die from the disease annually. Kidney cancer occurs most often in people between the ages of 50 and 70, affects men almost twice as often as women and, if detected early enough, may be curable surgically. However, tumors that are advanced (i.e., cannot be surgically removed or have spread to other parts of the body) are difficult to treat.

Two studies in patients with advanced kidney cancer have shown that patients treated with Nexavar had more time before tumor progression or death. In the larger study, most patients had previously received treatment with interleukin-2 or interferon. The median time to tumor progression or death in the Nexavar treated arm was 167 days compared to 84 days in people not treated with the drug.

Some common temporary side effects reported with Nexavar are rash, diarrhea, increases in blood pressure, and redness, pain swelling, or blisters on the palms of the hands or soles of the feet.

Nexavar will be distributed and marketed by Bayer Pharmaceuticals Corporation of Westhaven, CT.

Please contact Dana Monroe RN, OCN at 415-885-8600 for more information.

Treatment of Kidney Cancer at the California Kidney Cancer Center
Kidney Cancer treatment is based on the anatomic extent (stage) of the cancer. In most cases the stage can be determined by a CT scan of the patient's abdomen and chest. Kidney Cancer is divided into 4 initial stages and the classification of recurrent if it has recurred or spread after initial treatment. The stages of kidney cancer are:

Stage 1
Cancer is found only in the kidney and is 7 centimeters or less in size.
Stage 2
Cancer is found only in the kidney and is over 7 centimeters in size.
Stage 3
Cancer has spread to the fat around the kidney, or to the vein that carries blood from the kidney (the renal vein), or to the big blood vessel that carries blood from the lower part of the body (the inferior vena cava) , or to lymph nodes near the kidney.
Stage 4
Cancer has spread to nearby organs such as the bowel or pancreas or has spread to other places in the body such as the lungs or the bones.
Recurrent
Recurrent disease means that the cancer has come back (recurred) after it has been treated. It may come back in the original area or in another part of the body.

The treatment for stage 1 and stage 2 kidney cancer is usually surgical removal of the kidney, with or without removal of the adjacent tissues and lymph nodes. Most urologists are quite skilled at this type of operation.

For stage 3 kidney cancer the operation should be a "radical nephrectomy" which means removal of the kidney, the renal vein, adrenal gland, and nearby lymph nodes. For some cases of stage 3 kidney cancer the operation can be technically very difficult with removal of a portion of the inferior vena cava and even sometimes cardiopulmonary bypass being needed. Because of the technical difficulty of these operations patients with stage 3 kidney cancer should have surgery at a center where the necessary surgical skills and equipment are present. The surgical team at the California Kidney Cancer Center has over two decades of experience with these difficult operations and has cardiopulmonary bypass available in the rare cases where this is needed.

The current standard of therapy for stage 4 and recurrent kidney cancer is biologic therapy based on interleukin-2 (IL-2). In part because kidney cancer responds so poorly to conventional chemotherapy, kidney cancer patients were among the first to be treated with this form of immunotherapy over 10 years age. IL-2 is a cytokine (cellular hormone) produced predominately by activated white cells and is central to the functions of the human immune system, including the rejection or destruction of tumor cells. Recombinant human interleukin-2 under the trade name Proleukin was approved by the US Food and Drug Administration for use in patients with kidney cancer in 1992. Because kidney cancer is so refractory to conventional chemotherapy, it remains the only drug approved by the FDA for kidney cancer.

Although IL-2 therapy can have severe side effects, studies begun at the National Cancer Institute 15 years ago show that therapy with high-dose IL-2 alone may produce complete disappearance of kidney cancer in a small percentage of patients with advanced cancer, and some of these patients may be cured.The 1997 update of this study of 255 patients with stage 4 kidney cancer treated with IL-2 showed 10 to 20% of patients alive 5 to 10 years later. A more recent study from Germany compared IL-2 with hormonal therapy for kidney cancer, and found that patients receiving IL-2 lived substantially longer than those not receiving IL-2. Thus IL-2 therapy may produce longer survival not only for those small number of patients with complete disappearance to their cancer but in the average patient as well.

Because of the sometimes severe side effects and the need for hospitalization for high-dose IL-2, many physicians, especially in Europe, have used IL-2 in low-dose outpatient schedules. Although many of these studies show overall rates of improvement similar to high-dose IL-2, the number of patients with durable complete disappearance of their tumors appears smaller than with high-dose interleukin-2. For that reason the physicians at the California Kidney Cancer Center feel that inpatient IL-2 is the preferred therapy for young patients with stage 4 or recurrent kidney cancer. Indeed the most recent protocol at the California Kidney Cancer Center has seen complete disappearance of cancer in 6 of 44 (15%) of patients. If patients are over age 60, have poor renal function or other medical, problems, a clinical trial is prefered.

Alpha-interferon is another biological agent that has been used in the treatment of Kidney Cancer since 1983. Interferon appears to work by altering the surface proteins of the cancer cells as well as by directly slowing their growth. Responses to treatment with interferon alone do occur, but are rarely complete or long lasting. A recent English study, however, showed a modest survival benefit for patients treated with alpha-interferon. For theoretical reasons alpha-interferon and interleukin-2 should be a potent combination, but many early studies with small numbers of patients failed to show that the two drugs together were better than IL-2 by itself. The April 30, 1998 issue of the New England Journal of Medicine reported a French study with 425 patients which showed that inpatient high-dose IL-2 and interferon gave a higher response rate than IL-2 alone. Because of this and other studies the protocol at the California Kidney Cancer Center uses interferon together with IL-2. Because the side effects of high-dose IL-2 immunotherapy can be severe, it is important that the physicians and nurses administering this form of therapy have experience using this therapy and treating the side effects as they appear. The physicians and nurses at the California Kidney Cancer Center have had experience with this form of therapy since 1988. The current protocol utilizes an intensive therapy of nutritional support with multivitamins and the nutritional supplement L-carnitine to prevent some of the side effects of IL-2.

For more information contact the California Kidney Cancer Center directly at 415-885-8600 or see the National Cancer Institutes' web site PDQ.

California Kidney Cancer Foundation
2100 Webster St. Suite. 326
San Francisco, CA 94115
Email CKCC

Referrals may be arranged by calling 415-885-8600 or fax 415-885-8680