Renal cell carcinoma represents 3% of all cancer cases but has a significant death rate associated with it: It’s estimated that there will be 60,000 new cases this year and 16,000 deaths from kidney cancer. The risk factors associated with kidney cancer include smoking, obesity, hypertension, and some occupational exposure.
Unfortunately, disease spread is more likely than not in patients with RCC, but dramatic shifts in treatment options have led to longer progression-free survival. “The challenge for those diagnosed with localized disease is that many of them will have recurrence or metastatic disease following their surgery,” said Laura Wood, RN, MSN, OCN, renal cancer research program coordinator in the Cleveland Clinic Cancer Center’s Experimental Therapeutics Program.
In seminars sponsored by Pfizer Oncology, Ms. Wood, along with other experts, highlighted key concepts in adverse event management during RCC treatment and also discussed the importance of patient-reported outcomes. The other participants were:
• Patricia Creel, RN, clinical research coordinator in the Duke Prostate Center at Duke University Medical Center in Durham, N.C.
• David Cella, PhD, associate director for cancer prevention and control at Robert H. Lurie Comprehensive Cancer Center, Northwestern University in Chicago
• William P. Bro, CEO, Kidney Cancer Association in Chicago
Ms. Wood pointed out the main steps for adverse event management: assessment, early intervention, and patient education. The different RCC therapies have distinct targets so adverse events can be unique to the type of treatment as well as to the patient, she said. In addition, drug combinations and dosing can influence adverse effects.
“We can give two patients the same drugs, at the same dose, and the side effects that they experience will be different,” said Ms. Wood.
Still, there is some overlap in the adverse effects associated with the major RCC treatment options—tyrokinase inhibitors, mTOR inhibitors, and vascular endothelial growth factor inhibitors—and these can be grouped into several broad categories.
“The agents...have a very distinct pattern of adverse events that become obvious in clinical trials and that we have seen over these few years,” Ms. Creel said (see Tables 1 and 2). One of the most common adverse effects is fatigue, and the speakers used this as an example of an adverse event that requires individualized management. “[This] is an adverse event that can be multifaceted depending on the patient’s perspective and how severe it is,” Ms. Wood said. “It may improve as disease-related symptoms resolve. Some of our management strategies include teaching patients how to stay active and how to maintain a normal schedule.” Rather than try to “tough it out” through fatigue, patients should be encouraged to report if they are unable to tolerate the activities of daily living.
Patient assessment and education
The speakers pointed out that early intervention is imperative. “With many of the side effects, we have early interventions that can decrease the severity and allow ongoing treatment,” Ms. Creel said. “Meeting with the patient at the beginning of treatment cycles is important. Also, it’s important to remind patients to notify their healthcare providers when they first notice adverse events.”
Patient education should ensure that the patients comprehend the treatment plan, including dosing, possible side effects, and how to manage them. During patient assessment, it’s important to keep in mind that the goal is to maintain the highest drug exposure and have the patient continue therapy so that it can be effective. Ms. Wood and Ms. Creel advocated frequent monitoring of dosing, particularly for oral therapy; assessing compliance strategy; and making sure that patients are following directions. “Very often, we can intervene with something to help the patients before we need to interrupt their dosing,” Ms. Creel said.
Also, when discussing adverse effects with patients, ask about concomitant prescription and over-the-counter medication use. “We live in a society where people add their own remedies to their therapy,” she said. “We need to know all the OTC medications that they are taking and have them feel comfortable to share that with us.”
Up to 30% of RCC patients present with metastatic disease and another one-third experience recurrence after localized disease, Dr. Cella said. “More than half of [RCC] patients must contend with metastatic and incurable disease. The impact of this metastatic disease on people’s well-being is significant and varied.”
The physical and emotional impact of RCC has historically been underestimated, according to Dr. Cella. Overall survival is considered the gold standard of outcomes in clinical trials, but most trial endpoints don’t address symptom relief or improvement in function. Measuring patient-reported outcomes (PROs) can complement historical and traditional efficacy measures. “PROs have become increasingly important in cancer treatment research,” he explained. “They are an essential component to understanding of how well [patients] are going to respond to treatment and how long they will survive. They tend to correlate with how well people are doing.”
In fact, symptom patterns can be the first sign of disease progression and can be correlated with tumor response. They may serve as a harbinger that the treatment is failing. While there are many generic questionnaires available for evaluating patients, Dr. Cella recommended a more disease-specific approach. His group has developed a test called the Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index (FKSI; see Fact Box). The 15 questions capture the most important concerns of patients with RCC and focus on symptoms specific to their disease.
“The goal is to enhance treatment decision-making; to inform practice guidelines for best management; and to evaluate baseline, follow up, and symptom management,” Dr. Cella said. “You can take these 15 questions and sum them into one score or you can take a subset and target disease-related symptoms” (see Fact box).