Tag: Medications

Success of Abiraterone Trials Prompts ‘Mind Shift’ in Prostate Cancer Treatment

The below has been adapted and excerpted from an article in Healio in which Dr. David Nanus HeadshotNanus comments on The LATITUDE and STAMPEDE trials — results of which were presented at this year’s ASCO Annual Meeting and subsequently published in The New England Journal of Medicine. Read the full story here.

Abiraterone acetate is poised to challenge docetaxel as the standard addition to androgen deprivation therapy for treatment of newly diagnosed, metastatic castration-resistant prostate cancer. The LATITUDE and STAMPEDE trials showed the addition of abiraterone acetate and prednisone to androgen deprivation therapy (ADT) reduced risk for death by nearly 40%.

Docetaxel — an IV chemotherapy — can cause nausea, constipation, diarrhea, neutropenia or fatigue during its 18-week dosing schedule. Abiraterone, an oral adrenal inhibitor traditionally used in later-line therapy, is administered until disease progression and has relatively few side effects.

Docetaxel became the standard of care in patients with metastatic hormone-resistant prostate cancer following results from the CHAARTED study, published in 2015 in The New England Journal of Medicine. The results, based on median follow-up of 28.9 months, showed docetaxel improved median overall survival (OS) from 44 months to 57.6 months.

Abiraterone typically has been reserved as second-line therapy for men resistant to ADT. The LATITUDE and STAMPEDE trials — both supported by Janssen, the manufacturer of abiraterone — evaluated whether abiraterone would be more beneficial if used earlier.

Although abiraterone conferred unprecedented survival benefits and is better tolerated, not all oncologists agree it should replace docetaxel in the absence of a head-to-head comparative trial.

HemOnc Today asked urologic oncologists and researchers about the promise of abiraterone; the potential impact of its long-term use; if its cost in comparison with docetaxel is prohibitive; and whether abiraterone soon will be challenged by other therapies for the treatment of metastatic hormone-resistant prostate cancer.

“Abiraterone is a whole new paradigm because your patient is not coming in for an infusion every few weeks for six cycles,” David M. Nanus, MD, professor of medicine and urology at Weill Cornell Medicine, told HemOnc Today. “With six cycles of docetaxel, patients are often wiped out by the time they’re done, and it might take a few months to recover afterward.”

Based on the findings of the LATITUDE and STAMPEDE trials and the potential of targeted therapy, oncologists with whom HemOnc Today spoke agreed researchers are on the precipice of significantly extending the lives of men with prostate cancer.

In addition to the enthusiasm surrounding abiraterone and its potential to be the new standard of care in the treatment of metastatic, castration-resistant prostate cancer, several ongoing clinical trials are investigating other strategies to reduce androgen exposure. Results of those trials also could be practice changing, and again raise questions about the standard of care.

 

2017 Genitourinary Cancers Symposium Day 3

gu_symposium_2017_img_3054The third day of the 2017 Genitourinary Cancers Symposium started with a Best of Journals session on renal cell carcinoma (the most common form of kidney cancer) and the early poster sessions focused on renal cell, testicular, penile, and urethral cancers.

The first major morning session was focused on “novel targets and controversies in advanced testicular cancer.” Experts in the field first discussed actionable targets in testicular tumors, also referred to as germ cell tumors. This session also addressed a debate regarding treatment intensification in the subset of patients with “poor prognosis” – or germ cell tumors whose blood tumor markers do not decline optimally after initial chemotherapy. This subject remains controversial, but fortunately only affects a small number of patients, as in the current treatment era, after initial chemotherapy treatment, approximately 95% of all patients diagnosed with testicular cancer will be cured.

linehanThe Keynote Lecture on renal cell carcinoma was delivered by Dr. Marston Linehan from the National Cancer Institute. He discussed the current state-of-the-art treatment which is based upon decades of research largely led by him on the genetic basis of renal cell carcinoma (RCC). Several of his discoveries about the genomics and biology of RCC have led to the current wealth of drugs available to treat this disease. One such discovery was the importance of the von Hippel Lindau gene in patients with familial cancer syndromes that also affects tumor genomics in most patients with clear cell RCC. This discovery led to investigation in targeting the VEGF pathway which is the backbone of most currently approved drugs.

The session on the diagnosis and treatment of local renal cancer (confined to the kidney) started with a presentation on the role of active surveillance or watchful observation in small renal tumors, and was followed by discussions on imaging and biopsy of renal masses. A talk about the use of ablation in small renal tumors was followed by an abstract presentation on a registry of active surveillance of patients with small renal masses.  In summary, experts in the field discussed strategies and data behind the options of imaging and/or biopsy followed by either close surveillance or minimally invasive treatment strategies for patients with small renal masses.

The oral abstract scientific presentation session featured a presentation that followed up on the morning theme of small renal masses, also discussing surveillance, imaging, and circulating biomarkers. The Mayo Clinic group highlighted the success of treating carefully selected healthy patients with cryoablation in an expert center. A novel computer-assisted technique appears to be useful in assessing response to therapy compared to standard radiology assessment. A collaborative group led by Drs. Pal and Choueiri presented results of a large group of patients who had assessment of circulating tumor DNA (cfDNA) with a commercial platform prior to first-line or subsequent lines of treatment for metastatic disease.  Additionally, an Italian group presented an abstract on changes in tumor burden and prognostic classification when patients with metastatic RCC utilize an active surveillance strategy rather than take medications or undergo a local procedure. This is important to realize that for carefully selected patients, just because there are metastatic (spread) tumors on scans, immediate treatment is not always necessary. Sometimes these remain stable over long periods of time without treatment and this can be discussed with experienced clinicians.

Kidneys_GU Blog_FBThe final session of the conference reviewed the opportunities and challenges in systemic therapy for advanced kidney (renal) cancer. Imaging techniques to optimally evaluate one’s response to targeted therapies was discussed, highlighting examples of successful treatment with very little change in tumor measurements by traditional techniques. For example, it’s possible for a tumor to appear the same size after treatment by standard measurement, but it can be 95% necrotic (dead) tissue and in this scenario, the patient feels better and may live longer. This would be classified as non-response (or stable disease). Unfortunately, for patients with larger or more invasive tumors, many patients are not cured with surgery alone despite normal scans elsewhere in the body. Dr. Karam reviewed the results of recently presented trials utilizing targeted therapy following surgery. While these are not quite ready for primetime, the medical community is currently awaiting the results of other studies well as current studies utilizing immune checkpoint inhibitors in combination with surgery. Drs. Vaishampayan and Jonasch discussed the multiple different treatment options available to physicians and patients with advanced RCC. Physicians were reminded to consider referral to a highly experienced center for high-dose interleukin (IL)-2, a treatment which offers long-term disease-free survival off therapy in a selected subset of patients with advanced kidney cancer. Current studies are ongoing to assess different drug combinations, as well as novel agents. The last presentation of the conference was led by Dr. Powles who presented a late-breaking abstract on the randomized phase II study of atezolizumab with or without bevacizumab versus sunitinib in patients with advanced previously untreated metastatic RCC. While not definitive, the results were intriguing and support the continuing phase III study assessing the use of the combination of atezolizumanb and bevacizumab. There are multiple new studies looking at combinations of drugs and we encourage patients interested in this type of treatment to look for sites that are enrolling.

Overall, the conference was a great opportunity for both academic and community physicians from all different specialties (including medical oncology, urology, radiation oncology, radiology, and pathology) to mix with and learn from each other.  We look forward to participating next February in San Francisco for the 2018 Genitourinary Cancers Symposium.

Living with One Kidney? 5 Things to Know

Dr. Molina and Dan R.
With many types of kidney cancer, surgical removal of the cancerous part of the kidney is part of treatment. This is also known as a “nephrectomy.” Depending on the size and location of your tumor, you may have had all or part of the kidney removed. People only need one kidney, but it’s very important to protect your remaining kidney function since the kidneys are responsible for filtering your blood and removing wastes from your body.

March is Kidney Cancer Awareness Month and the second Thursday in March is World Kidney Day. After you’ve had all or part of your kidney resected in order to remove a tumor, there are certain things to keep in mind in order to preserve your remaining kidney function. Here are five things you should know:

  1. Certain medications may need to be adjusted or avoided. Medications should be dosed according to your level of remaining kidney function. This is called “renal dosing” and pertains to all medications filtered by the kidneys (which covers a diverse group ranging from certain medications for cholesterol, heart disease, blood pressure, diabetes, infections and pain). A medical oncologist who specializes in kidney cancer should take this into account when prescribing medications, including dosing for cancer treatments. Some over-the-counter drugs are also “nephro-toxic” or harmful to the kidneys. These include non-steroidal anti-inflammatory drugs (NSAIDs), a type of pain medication that includes ibuprofen (Advil®), aspirin and naproxen (Aleve®).
  2. Speak up before imaging tests. Certain imaging tests that might be necessary to see what’s going on in your body and determine whether your cancer has spread, require the injection of contrast dyes. It’s critical to tell the imaging technician that you only have one kidney before undergoing these tests or any procedures. You should also hydrate before and after the test, and you may need to stop taking certain medications beforehand, such as metformin for diabetes. It’s important to discuss your specific situation with your healthcare team before you undergo any procedures.
  3. Drink up! Drinking plenty of water and staying hydrated is important on an ongoing basis, not just when undergoing imaging tests. Being hydrated helps your kidneys filter the wastes and toxins out of your blood so that they can leave your body as urine. Aim for your urine to be clear or pale yellow. Staying hydrated also helps prevent kidney stones.
  4. Watch the sugar and hold the salt. Diabetes and high blood pressure can damage the kidneys, so it’s important to monitor your sugar and salt/sodium intake. People with only one kidney should consume less than 2300mg sodium each day. This is approximately one teaspoon of salt. Those with diabetes should regularly check blood sugar levels. Additionally, maintaining a healthy weight and incorporating physical activity can help prevent developing type II diabetes.
  5. Know your numbers. There are certain blood and urine tests that you’ll want to monitor for changes in your level of kidney function over time. These include your estimated glomerular filtration rate (eGFR) which indicates how well your kidneys are filtering the wastes from your blood, the albumin to creatinine (A:C) ratio which indicates the level of protein in your urine, as well as tests for blood and infection. Work with your primary care physician to make sure you’re receiving these tests on an annual basis and you should see a nephrologist (kidney function specialist) if your eGFR is less than 30 milliliters per minute (ml/min) or if you have large amounts of blood or protein in the urine.