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Sipuleucel-T (sip-T) is a Food and Drug Administration (FDA)-approved autologous cellular immunotherapy for metastatic castration-resistant prostate cancer (mCRPC). We hypothesized that combining sip-T with interleukin (IL)-7, a homeostatic cytokine that enhances both B and T cell development and proliferation, would augment and prolong antigen-specific immune responses against both PA2024 (the immunogen for sip-T) and prostatic acid phosphatase (PAP). Fifty-four patients with mCRPC treated with sip-T were subsequently enrolled and randomized 1:1 into observation (n=26) or IL-7 (n=28) arms of a phase II clinical trial (NCT01881867). Recombinant human (rh) IL-7 (CYT107) was given weekly×4. Immune responses were evaluated using flow cytometry, mass cytometry (CyTOF), interferon (IFN)-γ ELISpot, 3H-thymidine incorporation, and ELISA. Treatment with rhIL-7 was well tolerated. For the rhIL-7-treated, but not observation group, statistically significant lymphocyte subset expansion was found, with 2.3-2.6-fold increases in CD4+T, CD8+T, and CD56bright NK cells at week 6 compared with baseline. No significant differences in PA2024 or PAP-specific T cell responses measured by IFN-γ ELISpot assay were found between rhIL-7 and observation groups. However, antigen-specific T cell proliferative responses and humoral IgG and IgG/IgM responses significantly increased over time in the rhIL-7-treated group only. CyTOF analyses revealed pleiotropic effects of rhIL-7 on lymphocyte subsets, including increases in CD137 and intracellular IL-2 and IFN-γ expression. While not powered to detect clinical outcomes, we found that 31% of patients in the rhIL-7 group had prostate specific antigen (PSA) doubling times of >6 months, compared with 14% in the observation group. Treatment with rhIL-7 led to a significant expansion of CD4+ and CD8+ T cells, and CD56bright natural killer (NK) cells compared with observation after treatment with sip-T. The rhIL-7 treatment also led to improved antigen-specific humoral and T cell proliferative responses over time as well as to increased expression of activation markers and beneficial cytokines. This is the first study to evaluate the use of rhIL-7 after sip-T in patients with mCRPC and demonstrates encouraging results for combination approaches to augment beneficial immune responses.

PURPOSE: Initiating antineoplastic therapy can be distressful and affect patient retention of treatment-related side effects and safety protocols. Return visits can range from 8 to 28 days after treatment, during which patients may develop treatment-related questions and toxicities. This study's objective is to evaluate how implementing a follow-up phone call 24-48 hours after initial antineoplastic infusion, compared with standard pretreatment education, affects patient satisfaction and education retention. METHODS: We conducted a single-center pilot study where patients who were literate, English-speaking, with genitourinary malignancies, initiating intravenous chemotherapy or immunotherapy were eligible. The primary end point was patient knowledge retention. Secondary end points included patient satisfaction. The Leuven's Questionnaire Patient Knowledge Tool, a validated, standardized tool, was used to evaluate patient knowledge retention, with a higher score indicating more retention. Telephone follow-up was initiated 24-48 hours after initial infusion, where Leuven's Questionnaire was used to assess patient knowledge. A nurse then reinforced treatment-related education, reviewed notification parameters, and coordinated appropriate follow-up. One week later, participants were sent a follow-up Leuven's Questionnaire and standardized patient satisfaction assessment. RESULTS: Thirty-one patients with renal cell carcinoma, prostate, bladder, germ cell/testicular, or adrenal cancers were included in the study. Mean preintervention Leuven's Questionnaire score was 5.3 and mean postintervention score was 8.1 on a 1-10 scale (P <.0001). Ninety-seven percent of patients reported improved satisfaction postintervention. CONCLUSION: Proactive telephonic follow-up for oncology patients improves education retention, patient satisfaction, and has potential to improve patient safety and quality of care. Telephonic follow-up for oncology patients postinfusion improves satisfaction and quality of care. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this project was to characterize the incidence of men's health disorders, specifically focusing on the incidence of erectile dysfunction (ED) and testosterone deficiency (TD) in a large, nationwide study of testicular cancer (TC) survivors treated in a centralized health care system., Patients and Methods: We conducted a retrospective cohort study of US veterans diagnosed with TC from 1990 to 2021. These veterans were compared with an age-matched and race-matched control group of US veterans without a diagnosis of TC. ED and TD were defined by the presence of diagnosis codes or at least a 6-month prescription for medications treating these conditions or both. Time was measured from the date of TC diagnosis (for patients with TC and matched TC patient date for the corresponding noncancer controls). Impact of chemotherapy among TC survivors on ED and TD was evaluated using multivariable Cox regression models., Results: The cohort included 1754 patients with TC compared with 7117 noncancer controls, with a mean age at diagnosis of 42 years. Patients with TC were significantly more likely than controls to experience ED (HR, 2.97; 95% CI, 2.68-3.28; P < .001) and TD (HR, 6.71; 95% CI, 5.78-7.81; P < .001). However, within the TC group, there was no significant difference in the incidence of ED and TD when stratified by receipt of chemotherapy ( P = .9 and P = .066, respectively)., Conclusions: Men's health disorders arise commonly in the lives of TC survivors. It is important for treating physicians to identify these and conduct sexual health assessments as part of survivorship care.

Introduction: To compare surgical complications and tyrosine kinase inhibitor (TKI)-toxicities in patients who underwent primary cytoreductive nephrectomy (CN) followed by adjuvant TKI therapy versus those who underwent neoadjuvant TKI therapy prior to planned CN for metastatic renal cell carcinoma (mRCC)., Materials and Methods: Two-center retrospective analysis. Sixty-one mRCC patients underwent TKI therapy with sunitinib between July 2007 to January 2014. Patients were divided into three groups: primary CN followed by adjuvant TKI (n = 27, Group 1), neoadjuvant TKI prior to CN (n = 21, Group 2), and primary TKI alone (no surgery, n = 13, Group 3). Primary outcome was frequency and severity of surgical complications (Clavien). Secondary outcome was frequency and severity of TKI-related toxicities (NIH Common Toxicity Criteria). Multivariable analysis was carried out for factors associated with complications., Results: There were no significant differences in demographics, ECOG status, and median number TKI cycles (p = 0.337). Mean tumor size (cm) was larger in Group 3 (12.8) than Group 2 (8.9) and Group 1 (9.3), p = 0.014. TKI-related toxicities occurred in 100%, 90.5%, and 88.9% in Group 3, Group 2, and Group 1 (p = 0.469). There was no difference in incidence of high grade (p = 0.967) and low grade (p = 0.380) TKI-toxicities. Overall surgical complication rate was similar between Group 2 (47.6%) and Group 1 (33.3%), p = 0.380. Group 2 had more high grade surgical complications (28.6%) than Group 1 (0%), p = 0.004. Multivariable analysis demonstrated increasing age was independently associated with development of surgical complications (HR 1.059, p = 0.040)., Conclusion: Patients receiving neoadjuvant TKI therapy prior to CN experienced more high grade surgical complications than patients who underwent primary CN. Potential for increased high grade surgical complications requires further investigation and may impact pretreatment counseling.