Discrimination, Reliability, Sensitivity, and Specificity of Robotic Surgical Proficiency Assessment With Global Evaluative Assessment of Robotic Skills and Binary Scoring Metrics: Results From a Randomized Controlled Trial.

Objective: To compare binary metrics and Global Evaluative Assessment of Robotic Skills (GEARS) evaluations of training outcome assessments for reliability, sensitivity, and specificity. Background: GEARS-Likert-scale skills assessment are a widely accepted tool for robotic surgical training outcome evaluations. Proficiency-based progression (PBP) training is another methodology but uses binary performance metrics for evaluations. Methods: In a prospective, randomized, and blinded study, we compared conventional with PBP training for a robotic suturing, knot-tying anastomosis task. Thirty-six surgical residents from 16 Belgium residency programs were randomized. In the skills laboratory, the PBP group trained until they demonstrated a quantitatively defined proficiency benchmark. The conventional group were yoked to the same training time but without the proficiency requirement. The final trial was video recorded and assessed with binary metrics and GEARS by robotic surgeons blinded to individual, group, and residency program. Sensitivity and specificity of the two assessment methods were evaluated with area under the curve (AUC) and receiver operating characteristics (ROC) curves. Results: The PBP group made 42% fewer objectively assessed performance errors than the conventional group (P < 0.001) and scored 15% better on the GEARS assessment (P = 0.033). The mean interrater reliability for binary metrics and GEARS was 0.87 and 0.38, respectively. Binary total error metrics AUC was 97% and for GEARS 85%. With a sensitivity threshold of 0.8, false positives rates were 3% and 25% for, respectively, the binary and GEARS assessments. Conclusions: Binary metrics for scoring a robotic VUA task demonstrated better psychometric properties than the GEARS assessment.

False-positive fluorodeoxyglucose positron emission tomography results after chemotherapy in patients with metastatic seminoma.

INTRODUCTION: The treatment of residual masses after chemotherapy in seminomas remains a controversial topic. Postchemotherapy retroperitoneal lymph node dissection (PC-RPLND) in all patients would lead to severe overtreatment with a high rate of complications and additional procedures. For this reason, fluorodeoxyglucose positron emission tomography (FDG-PET) was introduced. FDG-PET has an accuracy of 88%. In 15% of cases, FDG-PET findings are false positive (FP) with unclear consequences. Therefore, we retrospectively investigated the rate of unnecessary procedures due to FP results on FDG-PET. MATERIALS AND METHODS: Between July 2003 and September 2013 we performed 305 PC-RPLNDs in 277 patients, 22 because of metastatic seminoma. Of them, 11 patients had a preoperative FDG-PET at least 6 weeks after chemotherapy. Indication for surgery was a marker-negative progression of the lesion in 7 patients who did not undergo FDG-PET, a marker-negative progression with a negative result on FDG-PET in 2 patients, and a positive result on FDG-PET with normal markers in 9 patients. Furthermore, PC-RPLND was indicated in 3 patients because of ureteral compression/infiltration with ureteral stents or nephrostomies. In 1 patient, there was uncertainty whether the initial retroperitoneal tumor contained choriocarcinoma elements. Standardized uptake values (SUVs) were recorded for all patients undergoing FDG-PET. RESULTS: The FDG-PET findings were FP in 7 of 11 (64%) patients. The median age of the patients was 45.4 years (39-49). The median SUV in the patients was 6.6 (3.1-11.6), and the median diameter of the residual mass was 6.8 cm (2.9-11). In 4 of 7 patients, intraoperative or postoperative complications occurred (polar artery ligation with functional loss, bilateral non-nerve-sparing technique with retrograde ejaculation, ureteral replacement with an ileal segment, and pulmonary embolism). CONCLUSION: In patients with metastatic seminoma who received chemotherapy, FDG-PET is a valuable tool to evaluate whether the residual mass contains viable tumor tissue or only necrosis. Nevertheless, because of FP results, a subgroup is overtreated with consecutive mortality or morbidity. We suggest an alternative therapy algorithm. In case of a positive result on FDG-PET studies, at least 8 weeks after the end of the chemotherapy, only a minority require surgery (e.g., patients with ureteral compression, patients with high risk of recurrence, or patients with unclear initial histology). In all other cases, we suggest a repeat FDG-PET study at least 6 weeks after the initial PET scan. Only in cases of increased SUVs or progressive disease histology should be obtained, all others can be on active surveillance.

Renal cell carcinoma with synchronous metastasis to the calcaneus and metachronous metastases to the ovary and gallbladder.

Renal cell carcinomas (RCCs) are known for their unpredictable metastatic pattern. We present the case of a 63-year-old woman who initially presented in 1992 with a metastasis in the left calcaneus that led to the discovery of RCC. In 1998, a new metastasis was found in the ovary. In 2008, the diagnosis of a gallbladder metastasis was made. All metastases were surgically removed; no additional systemic therapies were used. Aggressive surgical treatment can prolong the survival of patients with resectable metastases. Patterns of metastasis are discussed, and a brief review of the literature is given regarding each localization.

Sunitinib for the treatment of metastatic renal cell carcinoma.

Sunitinib is an orally administered multitargeted tyrosine kinase inhibitor approved multinationally for the first- and second-line treatment of metastatic renal cell carcinoma (mRCC). The recommended dose of sunitinib is 50mg per day for 4 weeks followed by 2 weeks off-treatment (Schedule 4/2). In a phase III trial in 750 patients with mRCC who had not received prior treatment, sunitinib demonstrated superior efficacy to interferon-α for the first-line treatment of mRCC. Sunitinib doubled progression-free survival compared with interferon-α; furthermore, median OS with sunitinib was greater than 2 years. As a result, sunitinib is now considered a reference standard of care for first-line mRCC treatment in patients at favourable or intermediate prognostic risk and is recommended in treatment guidelines. Additionally, results from an expanded-access programme, in a broad, heterogeneous patient population, confirmed the efficacy of sunitinib. Sunitinib has a distinct and predictable profile of adverse events, most of which are manageable with standard medical interventions. Therapy management strategies, including optimisation of dose and treatment duration and adverse event management can help patients achieve optimal efficacy with sunitinib in clinical practice. To further improve outcomes in patients with mRCC, current trials are evaluating sequencing or combination of targeted agents. The use of sunitinib as adjuvant therapy after nephrectomy and as neoadjuvant therapy is also being assessed. This paper provides an in-depth critical review of sunitinib, with particular focus on the data supporting the use of sunitinib for mRCC.