Effectiveness of Palliative Hemostatic Radiotherapy for Hemoptysis; A Prospective Single Arm Observational Study

Abstract

Palliative external beam radiotherapy is commonly used for malignancy associated hemoptysis. Few studies have focused on the effectiveness of radiotherapy in a cohort of patients with uncontrolled bleeding. The purpose of this study is to determine radiotherapy control probability, durability and influencing factors. This is a single institution prospective observational study that included patients ≥18 years with any lung malignancy and active hemoptysis at time of presentation. Hemoptysis severity was captured and monitored via an in-house developed patient reported outcome tool. The tool captures bleeding description, amount and frequency within 1 week prior to presentation and assigns a cumulative score ranging from 0-12. Patients were interviewed at enrollment, 2 weeks, 3 months and 6 months post treatment. Definition of a complete response was a total score of 0, partial response was a decrease from baseline score but >0, and progression was an increase from baseline score. Descriptive statistics, Kaplan-Meier method, Wilcoxon signed-rank test and Cox regression models were used. From April 2016 to November 2018, 41 patients were enrolled. One patient withdrew consent and was excluded. Median age was 68 years. The majority of patients were male (67%) with stage 4 (87%), lung primary (85%) disease and ECOG performance status 2 (55%). Prior to enrollment, 15% of patients received a blood transfusion and 5% had a bleeding associated intervention. Median baseline bleeding score was 7 (IQR; 5-8). Most common fractionation scheme (72.5%) was 2000 cGy in 5 fractions. Median Planning Target Volume (PTV) was 364 cc. Median follow up was 6.1 months (range 0.9-6.2). Forty patients had scores available at baseline versus 32, 19 and 10 scores at 2 weeks, 3 and 6 months. Complete response was achieved in 17 (53%) of surviving patients at 2 weeks (z= -4.2, p<0.001), 15 (79%) at 3 months (z= -3.5, p<0.001) and 8 (80%) at 6 months (z= -2.6, p=0.004). Of the patients with complete hemoptysis response, 2 (20%) recurred at 3 months and 1 (16%) at 6 months. The 6-month OS was 26% (95% CI 0.13, 0.41). No patient received re-radiation for their hemoptysis. On univariate analysis, ECOG status (p=0.012) and prior radiation (p=0.006) were strongly associated with freedom from hemoptysis survival, while baseline hemoptysis score was borderline (p=0.072). Multivariate analysis was not performed due to small sample size. Hemostatic radiotherapy is an effective modality for controlling hemoptysis in a poor prognosis population with acceptable durability and no re-treatments required. However, a larger sample size is required to assess the impact of influencing factors.