1. In which cases is sorafenib recommended? Which conditions should not be used?
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Sorafenib (doxorubicin) was the first multi-target receptor tyrosinase inhibitor marketed for use in metastatic kidney cancer, with a dual anti-tumor effect of direct tumor growth inhibition and anti-tumor angiogenesis, and is now approved for the treatment of advanced kidney cancer (locally progressive, locally invasive, metastatic kidney cancer).
But sorafenib needs to be used with caution or discontinued if the following conditions exist:
- Sorafenib should be observed when combined with other CYP2C9 substrates with a narrow therapeutic range (e.g., celecoxib, diclofenac, dronabinol, tetrahydrocannabinol, phenytoin or fosphenytoin, piroxicam, sertraline, toluenosulfonylurea, topiramate, and warfarin) to prevent serious adverse effects;
- Sorafenib has been shown to be teratogenic in animal studies and is therefore not recommended for patients who are pregnant or breastfeeding;
- Female patients must use contraception while taking the drug and should not attempt pregnancy until at least 2 weeks after discontinuation;
- Patients who have experienced myocardial ischemia and/or myocardial infarction should consider temporary or long-term discontinuation of sorafenib;
- Sorafenib is not indicated for patients with chronic gastrointestinal disease or who cannot tolerate other toxicities due to the high incidence of skin reactions in the hands and feet and gastrointestinal side effects.
Patients with kidney cancer should read the product insert and patient information carefully before taking the drug to understand the potential side effects.
2. How do I take sorafenib? How long do I have to take it?
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Sorafenib use and dosage: 400 mg (2 x 200 mg, tablets) twice daily on an empty stomach or with a low-fat or medium-fat diet. Take orally, swallowed with a glass of warm, boiled water.
Sorafenib is a maintenance drug and should be continued until no longer benefiting from treatment or until unacceptable adverse reactions occur. However, if special circumstances arise that require prompt contact with your doctor for dose adjustment, such as when an adverse reaction is suspected, sorafenib dosage should be suspended or reduced to 400 mg once daily or every other day.
3. Does sorafenib work in non-metastatic kidney cancer?
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Non-metastatic kidney cancer is defined as limited kidney cancer with tumors confined to the kidney tegument, including TNM stage T1 to 2 N0M0.
In May 2016, a double-blind, placebo-controlled, randomized, phase III clinical trial published in the Lancet, a leading international medical journal, showed that there was no survival benefit for patients with metastasis-free kidney cancer taking sorafenib after surgery compared with those taking placebo, meaning there was no use for patients with metastasis-free kidney cancer taking sorafenib.
4. How long can a patient with advanced kidney cancer live on sorafenib?
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A clinical trial of sorafenib in the first-line treatment of metastatic kidney cancer showed that sorafenib had an objective efficiency of 24%, a median progression-free survival (PFS, time to disease progression such as tumor metastasis, growth, discovery of new lesions, or death) of 9.1 months, and a median overall survival (OS, time to death) of 29.3 months.
But because of the lack of validated large study results for first-line treatment with sorafenib and the increasing availability of alternatives, the National Comprehensive Cancer Network (NCCN) guidelines do not currently recommend sorafenib for first-line treatment of renal clear cell carcinoma.
5. What are the dietary concerns while taking sorafenib?
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There are no specific dietary contraindications while taking sorafenib for kidney cancer. However, patients with lung metastases from kidney cancer still need to pay attention to the correct diet. It is advisable to eat more foods with immune enhancing and anti-lung cancer effects, such as barley, sweet almond, diamond, oyster, jellyfish, yellow fish, sea turtle, crab, horseshoe crab, ark, sea cucumber, poria, yam, jujube, wuzhang snake, four seasons bean, shiitake mushroom, walnut, snapper.
In addition, it is essential to stop smoking and drinking while taking medications, because the medications themselves are harmful to the liver and kidneys, and the metabolites of alcohol and tobacco can seriously affect the effects of taking medications.
6. What should I do after sorafenib treatment is not effective/resistant? What other drug options are available?
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The fact that 10% to 20% of kidney cancer patients are innately resistant to sorafenib at initial treatment, and the rest often develop resistance and disease progression (ineffectiveness) after 6 to 15 months of sorafenib treatment, makes sorafenib not effective in extending survival in patients with renal cell carcinoma.
Other drugs currently approved for the treatment of advanced kidney cancer in China include pegaptanib, sunitinib, axitinib, everolimus, interleukin-2, IFN-α, etc. It is recommended that “genetic testing” be performed during treatment to determine if the patient has a specific target to determine which drug is appropriate.
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7. What is the approximate cost of sorafenib treatment? Is it covered by health insurance? Are there free complimentary drugs?
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Sorafenib (200mg*60 tablets/bottle), which originally cost about $17,000 to $25,000, is currently covered by Medicare and is proportionally reimbursed by type of coverage.