Keytruda & Renal Cell Carcinoma
- Keytruda is approved to treat various cancers, and experts agree that its newest approval to treat kidney cancer could be practice-changing.
- One example of Keytruda's success in treating renal cell carcinoma is Nick Pannoni. He was part of the successful drug trial that led to Keytruda's approval for treating renal cell carcinoma.
- Last week, the FDA approved pembrolizumab (brand name: Keytruda) for the adjuvant treatment of patients with renal cell carcinoma at an intermediate-high or high risk of recurrence following surgery.
Pannoni is a 62-year-old from Massachusetts with a thick Boston accent. He has four children one daughter and three sons. Pannoni also had kidney cancer; he was part of the successful Keytruda drug trial KEYNOTE-564 that led to its approval for treating renal cell carcinoma. The U.S. Food and Drug Administration approved the drug's newest use last week.
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"We launched this study, and after two years of average follow-up, which is a very short follow-up by the way, the results were clear pembrolizumab (Keytruda) decreases the chance of a cancer of the kidney coming back or killing you by 32 percent," Dr. Choueiri says, adding that Keytruda has the potential to become the new standard of care for this type of kidney cancer.
Pannoni says that he doesn't talk about his cancer too much, but stresses that he's "grateful" for being given the chance to participate in this clinical trial. His doctors were able to utter those magic words every cancer patient dreams of "No evidence of disease."
Keytruda's Approval
Merck announced last week that the FDA approved its anti-PD-1 therapy drug Keytruda for the adjuvant treatment (additional cancer treatment given after the primary treatment) of patients with renal cell carcinoma at an intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection (removal) of metastatic lesions. (Nephrectomy is the surgical removal of a kidney. The procedure is done to treat kidney cancer, as well as other kidney diseases and injuries, according to the National Kidney Foundation.)
For inclusion in the trial, patients were required to have a clear-cell component of their tumor, which means that when seen in the lab, the cells that make up clear cell RCC look very pale or clear, according to the American Cancer Society.
Patients also had to be at intermediate-high or high risk of recurrence. But how is a patient’s risk of recurrence determined? Dr. Choueiri says that a patient’s recurrence risk level was considered intermediate-high or high risk if their tumor was stage 2 with nuclear grade 4 or sarcomatoid differentiation (cells resembling a sarcoma cancer); if their tumor was stage 3 or higher; if the patient had regional lymph node metastasis; or if the patient was stage M1 (metastases that had been surgically removed) with no evidence of disease. Pannoni falls into the last category having metastases that were surgically removed with no evidence of disease.
What’s a tumor that’s considered nuclear grade 4 or sarcomatoid differentiation? Well, according to the National Cancer Institute, tumor grade is the description of a tumor based on how abnormal the tumor cells and the tumor tissue look under a microscope. And tumor sarcomatoid differentiation is currently thought to represent transformation to a malignancy of a higher grade.
Renal cell carcinoma is the most common type of kidney cancer. According to the American Cancer Society, about nine out of 10 kidney cancers are renal cell carcinomas. (There are also various subtypes of renal cell carcinoma.) ACS reports that about 76,000 new cases of kidney cancer will be diagnosed in the United States this year.
Dr. Choueiri says that Keytruda has the potential to become the new standard of care when it comes to treating this type of kidney cancer, as the current standard of care is surgery, “and no other adjuvant therapy have been used widely and certainly no adjuvant immunotherapy approved.” Following surgery, nearly half of patients can eventually experience disease recurrence, Dr. Choueiri adds, highlighting the importance of this drug trial.
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"We are quite encouraged and we are very glad that the FDA has approved the drug that hopefully will help a lot of patients," Dr. Choueiri says. "There (are) a lot of patients that this drug may be able to help, but in the right patient setting and in the right patient population."
That specific patient population is certain renal cell carcinoma patients who have already had surgery to remove one or both of their kidneys. There are two types of nephrectomy procedures for a diseased kidney partial and radical, according to NKF. “In partial nephrectomy, only the diseased or injured portion of the kidney is removed. Radical nephrectomy involves removing the entire kidney, along with a section of the tube leading to the bladder (ureter), the gland that sits atop the kidney (adrenal gland) and the fatty tissue surrounding the kidney.”
If both kidneys are removed at the same time, the procedure is called bilateral nephrectomy, and the procedure used to remove a healthy kidney from a donor for the purpose of transplantation is called donor nephrectomy. It’s not possible for a person to live without their kidneys, so if both kidneys are removed, dialysis or a transplant is necessary to maintain life.
Pannoni had a radical nephrectomy before entering the Keytruda drug trial.
Nick Pannoni's Cancer Battles
It was about six years ago that Pannoni was diagnosed with prostate cancer. The cancer was luckily caught early and doctors promptly removed Pannoni's prostate; he didn't have to go through anymore treatment. He was "cancer-free."
However, about three years later, he was diagnosed with a second cancer kidney cancer, specifically renal cell carcinoma. Pannoni tells SurvivorNet that his kidney cancer was completely unrelated to his prostate cancer; this was a "completely new cancer," he says.
Upon learning of his diagnosis, Pannoni says he went with his doctor's recommendation surgery. The cancer was encased in his left kidney, so he had the entire organ removed. "I didn't have to go through chemo or anything else luckily," he says.
Once he had recovered from surgery, his doctor Dr. Steven Chang at Dana-Farber recommended Pannoni see Dr. Choueiri and become a participant in the Keytruda clinical trial.
While Pannoni knows there's no way to tell whether he got the drug, he thinks he received Keytruda. "The nice thing about the drug trial, even though it was a blind study, I do believe I received Keytruda" because many of the symptoms commonly associated with Keytruda are symptoms Pannoni says he exhibited during the trial. Common side effects of Keytruda when used alone include: feeling tired, pain, including pain in muscles, bones or joints, and stomach-area (abdominal) pain, decreased appetite, itching, diarrhea, nausea, rash, fever, cough, shortness of breath and constipation.
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Since the clinical trial and being told he has "no evidence of disease," Pannoni is moving on with his life and putting cancer in the rear-view mirror. He still goes in for scans and blood work every four months, only to make sure his cancer hasn't returned.
"To be honest, I don't really talk about (my cancer) with our children," Pannoni says. "They know about it, but they don't delve into it. I don't think about it that much; I live my life."
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