ABSTRACT
INTRODUCTION: Apart from transplantation, only azacitidine demonstrated a survival benefit in a phase III study in higher-risk myelodysplastic syndromes (MDS). The approved regimen is 75 mg/m2/day for 7 consecutive days, imposing a logistic challenge for outpatient weekend administration. Schedules with 5 days and 7 days with a weekend break (5 + 2) have been used for convenience despite the lack of strong scientific support. Most studies of alternative schedules were performed in lower-risk MDS and with dose reduction in the 5-day schedules. METHODS: We performed a single-center, retrospective cohort study to compare full-dose azacitidine (7 × 75 mg/m2) administration in 5-day and 5 + 2-day schedules in a higher-risk MDS cohort. We evaluated 100 patients for overall survival and a subsample (49 patients) for acute myeloid leukemia-free survival (AMLFS), probability of infections and transfusion burden. Kaplan-Meier analysis and Cox models were used for survival analyses. Linear and logistic regressions were applied for univariate and multivariate assessment. RESULTS: After a median follow-up of 10.8 months, patients treated with a 5-day schedule had a median overall survival of 12.5 months versus 15.0 months in the 5+2 group: HR 0.95 (95% CI, 0.57-1.56); P= .83. AMLFS was also similar between groups: HR 1.70 (95% CI, 0.70-4.14); P = .24. Azacitidine schedules were not predictive of infections nor number of red blood cell or platelet transfusions in multivariate analyses. CONCLUSIONS: In higher-risk MDS, full-dose azacitidine (7 × 75 mg/m2) can be administered both in 5 days and in 7 days with a weekend break with no significant difference in survival, infection or transfusional outcomes.
Subject(s)
Leukemia, Myeloid, Acute , Myelodysplastic Syndromes , Humans , Azacitidine/therapeutic use , Retrospective Studies , Disease-Free Survival , Survival AnalysisSubject(s)
Histiocytic Necrotizing Lymphadenitis , Purpura, Thrombotic Thrombocytopenic , Sjogren's Syndrome , Humans , Male , Purpura, Thrombotic Thrombocytopenic/complications , Purpura, Thrombotic Thrombocytopenic/diagnosis , Sjogren's Syndrome/complications , Sjogren's Syndrome/diagnosis , Histiocytic Necrotizing Lymphadenitis/complications , Histiocytic Necrotizing Lymphadenitis/diagnosisABSTRACT
Margin status of the surgical specimen has been shown to be a prognostic and risk factor for local recurrence in breast cancer surgery. It has been studied as a topic of intervention to diminish reoperation rates and reduce the probability of local recurrence in breast conservative surgery (BCS). This study aims to validate the Dutch BreastConservation! nomogram, created by Pleijhus et al., which predicts preoperative probability of positive margins in BCS. Patients with diagnosis of breast cancer stages cT1-2, who underwent BCS at the Breast Center of São João University Hospital (BC-CHSJ) in 2013-2014, were included. Association and correlation were evaluated for clinical, radiological, pathological and surgical variables. Multivariable logistic regression and ROC curves were used to assess nomogram parameters and discrimination. In our series of 253 patients, no associations were found between margin status and other studied variables (such as age or family history of breast cancer), except for weight (p-value = 0.045) and volume (p-value = 0.012) of the surgical specimen. Regarding the nomogram, a statistically significant association was shown between cN1 status and positive margins (p-value = 0.014). No differences were registered between the scores of patients with positive versus negative margins. Discrimination analysis showed an AUC of 0.474 for the basic and 0.508 for the expanded models. We cannot assume its external validation or its applicability to our cohort. Further studies are needed to determine the validity of this nomogram and achieve a broader view of currently available tools.
