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Purpose:Rocapuldencel-T is an autologous immunotherapy prepared from mature monocyte-derived dendritic cells (DC), coelectroporated with amplified tumor RNA plus CD40L RNA. This pivotal phase III trial was initiated to investigate the safety and efficacy of a combination therapy dosing regimen of Rocapuldencel-T plus sunitinib in patients with metastatic renal cell carcinoma (mRCC).Patients and Methods:Patients received either Rocapuldencel-T plus standard of care (SOC) or SOC treatment alone. The primary objective compared overall survival (OS) between groups. Secondary objectives included safety assessments, progression-free survival (PFS), and tumor responses based on RECIST 1.1 criteria. Exploratory analyses included immunologic assessments and correlates with OS.Results:Between 2013 and 2016, 462 patients were randomized 2:1, 307 to the combination group and 155 to the SOC group. Median OS in the combination group was 27.7 months [95% confidence interval (CI) 23.0–35.9] and 32.4 months (95% CI, 22.5–) in the SOC group HR of 1.10 (95% CI, 0.83–1.40). PFS was 6.0 months and 7.83 months for the combination and SOC groups, respectively [HR = 1.15 (95% CI, 0.92–1.44)]. The ORR was 42.7% (95% CI, 37.1–48.4) for the combination group and 39.4% (95% CI, 31.6–47.5) for the SOC group. Median follow up was 29 months (0.4–47.7 months). On the basis of the lack of clinical efficacy, the ADAPT trial was terminated on February 17, 2017. Immune responses were detected in 70% of patients treated with Rocapuldencel-T, and the magnitude of the immune response positively correlated with OS. In addition, we report the survival-predictive value of measuring IL-12 produced by the DC vaccine and the observation that high baseline numbers of T regulatory cells are associated with improved outcomes in DC-treated patients, but are associated with poor outcomes in patients receiving SOC treatment. No serious adverse events attributed to the study medication have been reported to date.Conclusions:Rocapuldencel-T did not improve OS in patients treated with combination therapy, although the induced immune response correlated with OS. Moreover, we identified two potential survival-predictive biomarkers for patients receiving DC based immunotherapy, IL-12 produced by the DC vaccine and higher numbers of T regulatory cells present in the peripheral blood of patients with advanced RCC.

subsequent standard of care treaments

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ADAPT study group and participating centers

BACKGROUND Patients with prostate cancer and their providers face uncertainty as they consider adjuvant radiotherapy (ART) or salvage radiotherapy (SRT) after undergoing radical prostatectomy. The authors prospectively evaluated the impact of the Decipher test, which predicts metastasis risk after radical prostatectomy, on decision making for ART and SRT. METHODS A total of 150 patients who were considering ART and 115 who were considering SRT were enrolled. Providers submitted a management recommendation before processing the Decipher test and again at the time of receipt of the test results. Patients completed validated surveys on prostate cancer (PCa)‐specific decisional effectiveness and PCa‐related anxiety. RESULTS Before the Decipher test, observation was recommended for 89% of patients considering ART and 58% of patients considering SRT. After Decipher testing, 18% (95% confidence interval [95% CI], 12%‐25%) of treatment recommendations changed in the ART arm, including 31% among high‐risk patients; and 32% (95% CI, 24%‐42%) of management recommendations changed in the salvage arm, including 56% among high‐risk patients. Decisional Conflict Scale (DCS) scores were better after viewing Decipher test results (ART arm: median DCS before Decipher, 25 and after Decipher, 19 [P, Use of the Decipher test appears to result in a change in treatment decision making in a substantial percentage of men with prostate cancer who are considering adjuvant or salvage radiotherapy after radical prostatectomy. Decisional effectiveness improves for both patients and providers with use of the Decipher test.

Prostate cancer represents a spectrum of disease that ranges from nonaggressive, slow-growing disease that may not require treatment to aggressive, fast-growing disease that does. The NCCN Guidelines for Prostate Cancer Early Detection provide a set of sequential recommendations detailing a screening and evaluation strategy for maximizing the detection of prostate cancer that is potentially curable and that, if left undetected, represents a risk to the patient. The guidelines were developed for healthy men who have elected to participate in the early detection of prostate cancer, and they focus on minimizing unnecessary procedures and limiting the detection of indolent disease.

The wide-ranging effects of prostate cancer can be an emotional burden to the patient and his family. Recognizing important periods during the diagnosis and treatment that can be particularly stressful, the symptoms indicating patients are at high risk for emotional distress, and the signs and symptoms of emotional distress can encourage improved communication, education, treatment, and referral to minimize the effects of the emotional distress.

Limitations of current diagnotic techniques may allow some patients with presumed renal cell carcinoma (RCC) to undergo nephrectomy without definitive confirmation of malignancy.To confirm previous estimates of postnephrectomy renal mass diagnosis and to assess the economic impact of nephrectomy.This retrospective cohort analysis identified commercial enrollees who underwent nephrectomy with a diagnosis of RCC between July 1, 2000, and March 30, 2008. Study subjects were stratified based on medical claims for benign or malignant disease after the nephrectomy date. Cohorts were compared on resource utilization before and after nephrectomy, occurrence of postsurgical complications, and associated 1-year costs of care.Of 10,404 patients undergoing nephrectomy for presumed RCC, 1613 (15.5%) were subsequently identified as having benign disease, despite median presurgical diagnostic expenditures of $1311 per patient (interquartile range [IQR], $467-$2606). Median expenditures for the 12 months postnephrectomy were $26,920 per patient (IQR, $16,851-$46,982) for those with malignant disease and $23,951 per patient (IQR, $14,873-$38,190) for those with benign disease (P.0001). For patients with benign disease, 17.5% experienced a postsurgical adverse event, resulting in a 1.5-fold increase in expenditures (median $31,838 per patient for those with event vs $22,770 per patient for those without event; P.0001).In this study, approximately 1 in 6 patients were found to have a benign renal mass postnephrectomy. Given the risk of surgical complications and related economic consequences, methods for better identifying malignant versus benign disease prior to surgery could provide significant benefits to patients and payers.

Health services research must continually address the question: Under what conditions may data not collected specifically for research, such as primary medical data, be re-used for research without compromising the privacy of the data-subjects? For secondary use of data in research there are basically three options. Option A: Use personal data with consent or other assent from the data-subjects. To make this both fairer and more practical, in many circumstances broader construals of consent, or permission or approval, need to be explored and instituted. Option B: Anonymise the data, then use them. For many studies, this is the most practical and desirable option. The craft of anonymisation, including reversible anonymisation, or key-coding, needs to be developed and more fully supported under law. Option C: Use personal data without explicit consent, under a public interest mandate. Whether and how the data should be anonymised will depend on the situation. Public health mandates and protections deserve to be clarified, strengthened and extended for a variety of surveillance, registration, clinical audit, health services research and other types of investigation. Safeguards are an integral part of the research promise to the public, offer crucial reassurance and should be emphasised. For health services research, databases are core resources, and their stewardship must be cultivated.