Randomized Phase II Trial of Sipuleucel-T with or without Radium-223 in Men with Bone-metastatic Castration-resistant Prostate Cancer.

PURPOSE: To investigate whether radium-223 increases peripheral immune responses to sipuleucel-T in men with bone-predominant, minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND METHODS: A total of 32 patients were randomized 1:1 in this open-label, phase II multicenter trial. Patients in the control arm received three sipuleucel-T treatments, 2 weeks apart. Those in the combination arm received six doses of radium-223 monthly, with sipuleucel-T intercalated between the second and fourth doses of radium-223. The primary endpoint was a comparison of peripheral antigen PA2024-specific T-cell responses (measured by proliferation index). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and PSA responses. RESULTS: We enrolled 32 patients, followed for a median of 1.6 years. Six weeks after the first sipuleucel-T dose, participants in the control arm had a 3.2-fold greater change in PA2024-specific T-cell responses compared with those who received combination treatment (P = 0.036). Patients in the combination arm were more likely to have a >50% PSA decline [5 (31%) vs. 0 patients; P = 0.04], and also demonstrated longer PFS [39 vs. 12 weeks; HR, 0.32; 95% confidence interval (CI), 0.14-0.76] and OS (not reached vs. 2.6 years; HR, 0.32; 95% CI, 0.08-1.23). CONCLUSIONS: Our data raise the possibility of greater clinical activity with the combination of sipuleucel-T and radium-223 in men with asymptomatic bone mCRPC, despite the paradoxically lower immune responses observed. Additional study to confirm these findings in a larger trial is warranted.

The Critical Role of the Oncology Nurse as a Partner in the Management of Patients With Advanced Kidney Cancer: Toxicity Management, Symptom Control, and Palliative Care.

The treatment of advanced renal cell carcinoma has changed dramatically since 2005 with the approval of 12 regimens including oral, intravenous, and combination strategies. These approvals have changed the treatment paradigm for these patients and developed new challenges and a critical role for oncology nurses to ensure that the treatment plan and adverse events are managed effectively. The majority of these regimens include an oral anticancer drug, which requires patients and their caregivers to understand the medication, the potential adverse events, the importance of medicine adherence, and the importance of early and ongoing education with the oncology team to maximize clinical outcomes. The evolution of the role of the nurse in meeting this need and its critical contribution to the comprehensive care of the kidney cancer patient will be reviewed.

Immune Checkpoint Inhibitor Therapy: Key Principles When Educating Patients.

BACKGROUND: Immune checkpoint inhibitor (ICI) therapy is a fast-developing field within the spectrum of cancer care. ICIs are associated with distinctive immune-related adverse events (irAEs), reflecting their unique mechanisms of action. OBJECTIVES: Effective management of irAEs requires early recognition and prompt reporting of their signs and symptoms; appropriate patient education is critical to maximizing this opportunity. METHODS: A comprehensive literature search was conducted in the public domain concerning awareness, assessment, and management of irAEs associated with ICIs. FINDINGS: Educational resources should provide timely, consistent, and personalized information, using a variety of teaching strategies that consider individual patient needs. Patient education should be developed with interprofessional team input and regularly reviewed in response to emerging guidance. Key messages include timing of therapeutic response and corresponding irAEs, early identification of irAEs, and the unique ability of ICIs to influence immune responses after treatment discontinuation.

Renal cell carcinoma: the translation of molecular biology into new treatments, new patient outcomes, and nursing implications.

PURPOSE/OBJECTIVES: To provide an overview of the current knowledge and treatment options for renal cell carcinoma (RCC). DATA SOURCES: Published articles, published abstracts, online databases, and package inserts. DATA SYNTHESIS: Researchers have an increased understanding of the genetic and prognostic risk factors associated with RCC. Most patients with this rare type of cancer have or will develop metastasis. Nephrectomy treats localized disease and cytokine therapy was the previous standard for metastatic disease, but newly approved targeted agents, such as sorafenib, temsirolimus, and sunitinib, as well as investigational agents such as bevacizumab, are improving patient outcomes. CONCLUSIONS: Understanding the biologic basis of RCC has led to therapies that are transforming the goals for treatment outcomes in patients with metastatic disease and increasing time to progression with manageable side effects. IMPLICATIONS FOR NURSING: Counseling patients and managing treatment-related side effects of therapy are critical interventions for healthcare professionals caring for patients with RCC. Evolving treatments for metastatic disease are providing better options for patients and changing disease management.