RN, BSN, OCN, CCRP
Nurses play vital roles in assuring that patients with metastatic castration-resistant prostate cancer (mCRPC) are optimally treated with sipuleucel-T (Provenge), the novel immunotherapy that is first-line treatment for symptomatic or minimally symptomatic mCRPC.
Sipuleucel-T activates T-cells to stimulate a response to prostate cancer. In the pivotal IMPACT trial, men treated with the drug survived a median of 4 months longer than the control arm. Median overall survival was 25.8 months, versus 21.7 months, for a 22.5% reduction in risk (P
“Nurses wear many hats. As patient care providers, they can help successfully integrate the drug into clinical practice and promote patient success. As educators, they ensure patients have confidence in the drug. And as patient advocates they can assist patients with treatment access and connect them with resources and support,” said Allison Tyler, RN, BSN, OCN, CCRP, clinical research nurse at the Cleveland Clinic, speaking at the Oncology Nursing Society’s 37th Annual Congress.
She noted that 80% of men with CRPC will develop metastases, and this occurs within 2 years for half of this population. These men often remain undiagnosed. “Regular monitoring can help identify disease progression in CRPC while patients are still asymptomatic or minimally symptomatic,” Tyler said, emphasizing that the presence of advanced symptoms eliminates sipuleucel-T as a treatment option.
What patients need to know:
Proper patient education is critical for effective treatment with this drug, which acts in a manner much different from chemotherapy, Tyler emphasized. “The main goal of the clinical study was not to lower prostate-specific antigen (PSA) levels, but to prolong survival,” she said. “Patients need to know that even if their PSA level does not decline, sipuleucel-T may help them live longer.”
Patients also need to appreciate the logistics entailed in the treatment, and nurses must appreciate the particular requirements on their end, Tyler said.
Prior to treatment, patients will be scheduled by Dendreon’s “On Call” service for leukapheresis (collection of immune cells that become part of the product) and then infusion of the drug. Within 30 days of the first leukapheresis procedure, nurses should assess the patient’s status and obtain a complete blood count, and at least one week prior they should assess the patient’s veins for compatibility with a large-bore needle; if the veins cannot accommodate this, a double-lumen central venous catheter should be placed.
Patients should be advised, prior to leukapheresis, to drink plenty of water and to consume a calcium-rich diet and avoid caffeine and. They should wear loose-fitting pants and a shirt with sleeves that can be raised above the elbow.
The drug, which is manufactured using the patient’s own cells, is shipped to the infusion site within two to three days of leukapheresis. Prior to infusion, premedication with acetaminophen and diphenhydramine is recommended but steroids are not required. Importantly, patients must arrive on time for their appointment, which is scheduled to coincide with the drug shipment, Tyler said.
The drug is administered in three infusions at approximately two-week intervals. After three successful treatment cycles, no further treatment is necessary.
Tyler told nurses they can “have confidence starting patients” on sipuleucel-T. She acknowledged that the drug is expensive, but said Medicare and most healthcare plans cover it and out-of-pocket costs are minimal. For patients who need help, financial assistance is available through copay assistance programs and uninsured patient programs.
“For the majority of patients, this drug is a reasonably priced treatment option,” Tyler noted.
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