Purpose: After radiation therapy for painful bone metastases, up to 44% of patients report a pain flare (PF). Our study compared 2 dose schedules of dexamethasone versus placebo to prevent PF... Show morePurpose: After radiation therapy for painful bone metastases, up to 44% of patients report a pain flare (PF). Our study compared 2 dose schedules of dexamethasone versus placebo to prevent PF.Methods and Materials: This double-blind, randomized, placebo-controlled trial allocated patients with painful bone metastases from solid tumors randomly to receive 8 mg dexamethasone before radiation therapy followed by 3 daily doses (group A), 8 mg dexamethasone followed by 3 doses of placebo (group B), or 4 doses of placebo (group C). Patients reported worst pain scores, study medication side effects, and opioid intake before treatment and thereafter daily for 14 days and on day 28. PF was defined as at least a 2-point increase on a 0 to 10 pain scale with no decrease in opioid intake or a 25% or greater increase in opioid intake with no decrease in pain score, followed by a return to baseline or lower. The primary analysis was by intention to treat with patients who had missing data classified as having a PF.Results: From January 2012 to April 2016, 295 patients were randomized. PF incidence was 38% for group A, 27% for group B, and 39% for group C (P = .07). Although patients in group B had the lowest PF incidence, a relatively high percentage did not return to baseline pain levels, indicating pain progression. The mean duration of PF was 2.1 days for group A, 4.5 days for group B, and 3.3 days for group C (P = .0567). Dexamethasone postponed PF occurrence; in group A 52% occurred on days 2 to 5 versus 73% in group B and 99% in group C (P = .02). Patients in group A reported lower mean pain scores on days 2 to 5 than those in group B or C (P < .001). Side effects were similar.Conclusions: There was insufficient evidence that dexamethasone reduced the incidence of radiation-induced PF. However, dexamethasone postponed the occurrence of PF and led to lower mean pain scores on days 2 to 5. (C) 2020 Elsevier Inc. All rights reserved. Show less
Purpose: The aim is to look at the impact of margin status and outcome of invasive lobular carcinoma (ILC) treated with breast-conserving therapy (BCT). Methods: This manuscript describes an... Show morePurpose: The aim is to look at the impact of margin status and outcome of invasive lobular carcinoma (ILC) treated with breast-conserving therapy (BCT). Methods: This manuscript describes an analysis on 330 BCT in 318 patients with ILC. Results: The 12-year local relapse free survival (LRFS) is 89%. In multivariate analysis, positive mar,gin status, age > 50 years. contra lateral breast cancer, and adjuvant systemic therapy were significant predictors of local relapse free survival. In a separate analysis limited to a positive margin for invasive carcinoma or carcinoma in situ, only a positive margin for invasive carcinoma was a significant predictor of local relapse free survival. This was limited to women < 50 years. The 12-year disease-specific survival (DSS) was 85%. In multivariate Cox regression analysis grade 3 compared to grade 2 (HR 7.2) and a tumour size of pT2 (HR 2.5) were significant independent predictors of disease-specific survival (DFS). These factors were also relevant for distant metastasis-free survival (DMFS) and disease-free survival (DFS). Conclusions: Positive margins for invasive carcinoma seem to be a strong predictor for local recurrence in particular for women <= 50-years. Our study showed grade 3 and tumour size to be strong predictors of DMFS, DFS. and DSS. Margin status was not. (C) 2009 Elsevier Ltd. All riahts reserved. Show less
