RESUMO
BACKGROUND: Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related death worldwide. The landscape of the systemic treatment for advanced HCC is changing quickly, and recently, the standard of care became either atezolizumab plus bevacizumab or tremelimumab plus durvalumab in the single tremelimumab regular interval durvalumab regimen. Nivolumab monotherapy has proven to be effective sometimes for advanced HCC and could be a valuable treatment option for patients outside current treatment indications and reimbursement criteria for the standard of care. This is a particular population of interest. AIM: To evaluate the real-world effectiveness of nivolumab monotherapy in patients with advanced HCC who are not eligible for other treatment. METHODS: We conducted a retrospective, multicentric study including 29 patients with advanced HCC from 3 Belgian tertiary hospitals. All patients had had prior chemotherapy or were intolerant or ineligible for treatments. All study subjects received nivolumab 3 mg/kg in monotherapy, administered once every two weeks intravenously. Treatment continued until disease progression, severe adverse events or death. Data were retrieved from patients' medical records. The outcome parameters such as radiological response according to response evaluation criteria in solid tumors (RECIST) criteria, the biological response through the evolution of the alpha-fetoprotein (AFP) level, and clinical response considering both the Child-Pugh (CP) score and the World Health Organization (WHO) performance status (PS) were reported. A safety profile was also reported. Statistical analysis was performed using the SPSS Statistics 27 statistical software package. RESULTS: The radiological overall response rate (defined as complete or partial response according to the immune RECIST and modified RECIST criteria) to nivolumab monotherapy was 24.1%. The biological overall response rate (defined as a decrease of ≥ 25% in AFP blood level) was 20.7%. Radiological and biological responses were significantly associated both with each other (P < 0.001) and with overall survival (P < 0.005 for radiological response and P < 0.001 for biological response). Overall survival was 14.5 mo (+/- 2.1), and progression-free survival was 10.9 mo (+/- 2.3). After 4 mo of treatment, 78.3% of patients remained clinically stable or even showed improvement in WHO PS. Grade 3 adverse events occurred in 17.2% of patients, none had grade 4 adverse events, and no patients ceased nivolumab due to adverse events. CONCLUSION: Nivolumab monotherapy is a good treatment choice in frail patients with HCC who are ineligible for the standard of care or other validated systemic treatments.
RESUMO
The application of robotics in the operating theatre for knee arthroplasty remains controversial. As with all new technology, the introduction of new systems might be associated with a learning curve. However, guidelines on how to assess the introduction of robotics in the operating theatre are lacking. This systematic review aims to evaluate the current evidence on the learning curve of robot-assisted knee arthroplasty. An extensive literature search of PubMed, Medline, Embase, Web of Science, and Cochrane Library was conducted. Randomized controlled trials, comparative studies, and cohort studies were included. Outcomes assessed included: time required for surgery, stress levels of the surgical team, complications in regard to surgical experience level or time needed for surgery, size prediction of preoperative templating, and alignment according to the number of knee arthroplasties performed. A total of 11 studies met the inclusion criteria. Most were of medium to low quality. The operating time of robot-assisted total knee arthroplasty (TKA) and unicompartmental knee arthroplasty (UKA) is associated with a learning curve of between six to 20 cases and six to 36 cases respectively. Surgical team stress levels show a learning curve of seven cases in TKA and six cases for UKA. Experience with the robotic systems did not influence implant positioning, preoperative planning, and postoperative complications. Robot-assisted TKA and UKA is associated with a learning curve regarding operating time and surgical team stress levels. Future evaluation of robotics in the operating theatre should include detailed measurement of the various aspects of the total operating time, including total robotic time and time needed for preoperative planning. The prior experience of the surgical team should also be evaluated and reported. Cite this article: Bone Joint J 2020;102-B(4):407-413.
