High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study

Introduction: In patients with atrial fibrillation (AF) at risk for stroke, dabigatran 150 mg twice a day (DE150) is superior to warfarin for stroke prevention. However, there is paucity of data with respect to bleeding risk at this dose in elderly patients (≥75 years). We aimed to evaluate the safety of DE150 in comparison to warfarin in a real-world population with AF and low bleeding risk (HAS-BLED score ≤2). Methods: In this prospective observational study, 754 consecutive patients with AF and HAS-BLED score ≤2 were included. We compared outcome of elderly patients (age ≥75 tears) to younger patients (age <75 years). The primary end point was the combined incidence of all-cause mortality, stroke, systemic emboli, and major bleeding event during a mean follow-up of 1 year. Results: There were 230 (30%) elderly patients, 151 patients were treated with warfarin, and 79 were treated with DE150. Fifty-two patients experienced the primary endpoint during the 1-year follow-up. Among the elderly, at 1-year of follow-up, the cumulative event rate of the combined endpoint in the DE150 and warfarin was 8.9 and 15.9% respectively (p = 0.14). After adjustment for age and gender, patients who were treated with DE150 had a nonsignificant difference in the risk for the combined end point as patients treated with warfarin both among the elderly and among the younger population (HR 0.58, 95% C.I = 0.25–1.39 and HR = 1.12, 95% C.I 0.62–2.00, respectively [p for age-group-by-treatment interaction = 0.83). Conclusions: Our results suggest that Dabigatran 150 mg twice a day can be safely used among elderly AF patients with low bleeding risk.

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Tumor volume regression during preoperative chemoradiotherapy for rectal cancer: a prospective observational study with weekly MRI

Acta Oncologica ◽

10.1080/0284186x.2017.1400689 ◽

2017 ◽

Vol 57 (6) ◽

pp. 723-727 ◽

Cited By ~ 10

Author(s):

Robbe Van den Begin ◽

Jean-Paul Kleijnen ◽

Benedikt Engels ◽

Marielle Philippens ◽

Bram van Asselen ◽

...

Keyword(s):

Rectal Cancer ◽

Observational Study ◽

Prospective Observational Study ◽

Tumor Volume ◽

Preoperative Chemoradiotherapy

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Preliminary outcomes of a prospective observational study of combinatorial abiraterone acetate/enzalutamide (AA/Enz) and radical radiotherapy (RT) in nonmetastatic node-positive (N+M0) prostate cancer (PCa).

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.6_suppl.227 ◽

2020 ◽

Vol 38 (6_suppl) ◽

pp. 227-227

Author(s):

Mark Ting Le Tan ◽

Wai Yee Woo ◽

Jeffrey Tuan ◽

Terence Wee Kiat Tan ◽

Michael Lian Chek Wang ◽

...

Keyword(s):

Observational Study ◽

Prospective Observational Study ◽

Treatment Protocol ◽

Median Number ◽

Abiraterone Acetate ◽

Whole Body ◽

High Dose ◽

Once Daily ◽

Genetic Profiling ◽

Psma Pet

227 Background: Treatment paradigm for N+M0 PCa has evolved, with the advent of multiple options for upfront AA/Enz or RT in combination with conventional hormonal therapy (HT). However, the optimal treatment protocol remains undefined. We therefore conducted a prospective observational study of combination AA/Enz+RT in N+M0 PCa patients. Methods: Patients with biopsy-proven adenocarcinoma of the prostate and N+M0 by imaging (68Ga-PSMA-PET or whole body MRI) were included. Exclusion criteria were 1) ECOG ≥2; 2) severe comorbidities; 3) cardiac event of <6 mo interval. Treatment protocol involved 18 mo of AA (1000 mg with 5 mg prednisolone once daily)/Enz (160 mg once daily)+HT (LHRH agonist/antagonist) in combination with RT to pelvis (54 Gy with simultaneous boost of 60-66 Gy in 27 fr) and prostate (78 Gy/39 fr); RT commenced 1-3 mo upon initiation of AA/Enz. Primary endpoint of this analysis was PSA of ≤0.1 ng/ml at 12 mo. Results: From Jun 2017-Sep 2019, 13 men were recruited; median follow-up duration was 14.0 mo (range 3.0-28.0 mo). Median age of the cohort was 67.0 y (IQR 61.0 – 69.0 y); 84.0% of men had GS8-10 disease, and median number of cN+ nodes was 2 (range 1-5 nodes). 11 received AA, and 2 received Enz. 53.8% (N = 7) and 69.2% (N = 9) of patients achieved a PSA nadir of ≤0.1 ng/ml at 6.0 and 12.0 mo, respectively; this contrasts against a propensity-matched cohort (N = 27) treated by HT+RT alone (33.3% and 51.9%, respectively). No biochemical recurrence was recorded at the time of analysis. 3 and 2 acute ≥G2 GU and GI toxicities were reported during RT. Late ≥G2 GU toxicities were observed in 2 men (G2 frequency). 2 patients experienced G2 fatigue and one with G2 transaminitis secondary to AA, with dose reduction. Germline genetic profiling with whole exome sequencing revealed two patients (15.4%) with BRCA2 frameshift mutations; interestingly, GU/GI RT toxicities were not observed in these patients. Conclusions: Our preliminary results suggest that combinatorial AA/Enz and high dose RT is tolerated and can induce a pronounced PSA response in low volume N+M0 PCa.

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