Systemic treatment options with proven efficacy for the treatment of metastatic uveal melanoma are limited. In this study, we aimed to evaluate the efficacy of nivolumab in metastatic uveal melanoma patients. In our multi-center study, the files of patients who received nivolumab treatment with a diagnosis of metastatic uveal melanoma were retrospectively reviewed and their information was recorded. Seventeen patients were enrolledand 16 patients were evaluable for efficacy. The objective response rate (ORR) was 18% including one confirmed complete response and two confirmed partial responses. The median progression-free survival (PFS) was 5.8 months (95% CI, 0.03-11.57 months), and the median overall survival (OS) was 10.5 months (95% CI, 3.87-14.14 months). Significant longer OS and PFS were observed in patients with the performance status of the Eastern Cooperative Oncology Group (ECOG-PS) 0. Although significant longer OS was detected in patients with low median lactate dehydrogenase (LDH) levels, no significant difference was found in PFS. Grade 1 and 2 fatigue and decreased appetite were the most common side effects associated with treatment (17%); grade 3 and 4 side effects were not observed. Immunotherapy is also emerging as a treatment option among the limited number of treatment options in metastatic uveal melanoma (mUM), but its efficacy needs to be demonstrated with prospective studies involving a larger number of patients.
BackgroundFamilial Mediterranean fever (FMF), the most common form of hereditary autoinflammatory diseases, is associated with increased risk for secondary (AA) amyloidosisObjectivesWe herein aimed to investigate the features of FMF patients with amyloidosis with respect to their responses to current therapiesMethodsWe enrolled FMF patients with amyloidosis who were regularly followed-up for at least 6 months between 1978 and 2015 into the study. Starting times for colchicine, anakinra or canakinumab and treatment responses were noted. Proteinuria (spot urine protein/creatinine ratio) and C-reactive protein (CRP) levels were measured in every three months of follow-up. Partial response was defined as ≥50% decrease in baseline proteinuria accompanied by a normal serum creatinine level, whereas complete response was defined as <0.3 gr/d baseline proteinuria and stable serum creatinine. Correlations between treatment responders and continuously elevated or normalized CRP levels were tested by using a chi-square testResultsWe identified 79 FMF patients with documented secondary amyloidosis, and all were on colchicine treatment. Their demographic features are shown in Table 1. Mean time to diagnosis after the first symptom was 10 years. Patients were evaluated for partial and complete response after mean follow-up period of 66±85 months. Response to colchicine was observed in 30/65 patients [partial response in 19 (29%), complete response in 11 (17%)]; and 54% was non-responder to colchicine. Anakinra was added to treatment in 22 patients with inadequate response to colchicine, which resulted in partial response in 12, and complete response in 2. Eight patients with partial response to colchicine also received anakinra for better control of attacks and/or elevated acute phase response, and a complete response was achieved in 3 patients. In 3 patients, anakinra was switched to canakinumab because of local injection site reaction (1 patient) and persistence of proteinuria (2 patients). Among those, two patients had partial response, and another underwent hemodialysis due to progressive kidney failure. No significant association was observed between normalized CRP levels and response to treatment with respect to proteinuria and creatinine levels (colchicine; p=0.67, anakinra/canakinumab;p=0.82). No serious infection requiring hospitalization was detected in association with IL-1 blockade.Table 1.Demographic features of FMF patients with amyloidosisMale/Female40/39Age of onset (mean ± SD, range)16±12 (2–68)Age of diagnosis (mean ± SD, range)27±13 (7–70)Family history of FMF47%Disease follow-up duration (mo)66±85 (6–480)Time to diagnosis (mo)121±136 (2–576)Family history of amyloidosis (%)18%Arthritis at presentation (%)60%MEFV variations (n=46)M694V, 68%V726A, 10%M680I, 15%Others, 7%IL-1 inhibitors n (%)43 (54%)Patients on hemodialysis7 (9%)Renal Transplantation n (%)17 (21%)High CRP levels in attack-free periods n (%)31 (39%)ConclusionsAmyloidosis still remains as an important complication of FMF, and a satisfactory respo...
Introduction Among females, breast cancer is the most common type of cancer. Hormon receptor positive (HR+) subtype constitutes 75% of the diagnosed breast cancers. Combination of the cyclin D-cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and endocrine therapy significantly improves overall survival and progression-free survival. Ribociclib is an oral CDK 4/6 inhibitor and some adverse effects are identified. According to MONALEESA 2-3-7 studies, no adverse effect (AE) were reported due to grade 3 or 4 acute kidney injury (AKI) that caused treatment discontinuation. Case report We report a ribociclib-induced grade 3 AKI in an elderly woman who was treated for metastatic breast cancer. During first cycle of therapy, she was admitted to the oncology clinic with diagnosis of AKI. Management and outcome: Ribociclib treatment was discontinued and secondary causes of AKI were excluded. During the follow-up, kidney function values returned to the normal range spontaneously. Ribociclib treatment was re-initiated by reducing the dose (400 mg daily). Despite dose reduction; grade 3 AKI recurred when ribociclib was re-initiated and the drug was permanently discontinued. Discussion According to MONALEESA 2-3-7 studies; no AE were reported due to grade 3 or 4 AKI. Despite these studies, the FDA reported that 20% of patients with ribociclib + letrozole combination therapy may have any stage elevation of creatinine. Ribociclib induced creatinine elevations are generally mild (grade 1–2) and can be managed by dose reduction or close monitoring of creatinine levels. We report the first case of grade 3 AKI that caused treatment discontinuation following administration of ribociclib.
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