Radiation therapy in early stage Hodgkin's disease: long-term results and adverse effects

INTRODUCTION: Radiation therapy (RT) was the first treatment modality demonstrating cure of Hodgkin's disease. Long-term side-effects of this treatment, however, have become evident in the past few years. PATIENTS AND METHODS: By reviewing the results of megavoltage radiotherapy as initial treatment in a consecutive series of 106 patients with early-stage Hodgkin's disease (HD), survival, relapse-free interval, salvage rate of relapsing cases, and incidence of second tumours were evaluated. RESULTS: Subtotal node irradiation was given to all patients with supradiaphragmatic disease, except for 15 patients with limited stage IA-IIA, who received mantle field treatment only. Inverted Y field irradiation was given to all seven patients with subdiaphragmatic disease. The median age was 32 years (range 14-77). The median follow-up was 140 months. The relapse-free interval of the patient population was 78% at 5 years and 72% at 10 years. The overall survival (OS) was 90% and 79%, respectively. Salvage therapy was successful in 26 of 30 relapsing patients. Twelve recurrences were located inside the treatment field. Sixteen patients (15%) developed second malignancies: cancer of the lung (two), ovary (two), cervix (one), colon (two), breast (three), stomach (one), skin (two), hypopharynx (one), and non-Hodgkin lymphoma (two). Eleven of these were located within the radiation field. CONCLUSION: Although RT is intended to be a curative treatment, up to 30% recurrences occur. Mortality was not determined by primary HD, but by second malignancies, which are likely related to treatment. New treatment strategies, aiming at long-term freedom from relapse without carcinogenic side-effects, are urgently needed

Tailored anticoagulant treatment after a first venous thromboembolism: protocol of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study - cohort-based randomised controlled trial

Introduction Patients with a first venous thromboembolism (VTE) are at risk of recurrence. Recurrent VTE (rVTE) can be prevented by extended anticoagulant therapy, but this comes at the cost of an increased risk of bleeding. It is still uncertain whether patients with an intermediate recurrence risk or with a high recurrence and high bleeding risk will benefit from extended anticoagulant treatment, and whether a strategy where anticoagulant duration is tailored on the predicted risks of rVTE and bleeding can improve outcomes. The aim of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study is to evaluate the outcomes of tailored duration of long-term anticoagulant treatment based on individualised assessment of rVTE and major bleeding risks.Methods and analysis The L-TRRiP study is a multicentre, open-label, cohort-based, randomised controlled trial, including patients with a first VTE. We classify the risk of rVTE and major bleeding using the L-TRRiP and VTE-BLEED scores, respectively. After 3 months of anticoagulant therapy, patients with a low rVTE risk will discontinue anticoagulant treatment, patients with a high rVTE and low bleeding risk will continue anticoagulant treatment, whereas all other patients will be randomised to continue or discontinue anticoagulant treatment. All patients will be followed up for at least 2 years. Inclusion will continue until the randomised group consists of 608 patients; we estimate to include 1600 patients in total. The primary outcome is the combined incidence of rVTE and major bleeding in the randomised group after 2 years of follow-up. Secondary outcomes include the incidence of rVTE and major bleeding, functional outcomes, quality of life and cost-effectiveness in all patients.Ethics and dissemination The protocol was approved by the Medical Research Ethics Committee Leiden-Den Haag-Delft. Results are expected in 2028 and will be disseminated through peer-reviewed journals and during (inter)national conferences.Trial registration number NCT06087952