Englewood Hospital & Medical Center, Inc.

The present study aimed to assess organ doses and the associated cancer risks related to secondary radiation (photons and neutrons) exposure during 3D Conformational Radiotherapy (3D-CRT) for patients with prostate cancer in Algeria. To this purpose, a detailed geometric Monte Carlo (MC) modeling of the LINAC, combined with a hybrid whole-body phantom was carried out. The secondary radiation doses were calculated in patient's organs, both within and outside the field. The obtained doses were used to estimate the Lifetime Attributable Risks (LARs) for cancer incidence for out of field organs, using the Biological Effects of Ionizing Radiation VII (BEIR VII) risk model, considering the exposure age range according to the age of the treated patients in Algeria. The survival information and baseline cancer risks were based on relevant statistics for the Algerian population. The results revealed that secondary radiation equivalent doses mostly depend on the distance of organs from the treated volume. The highest and lowest equivalent doses of 5.77 mSv/Gy and 0.24 mSv/Gy were recorded in the small intestine and ocular lens, respectively. LARs decreased as the age of exposure increased, with the highest estimated value per 100,000 individuals identified at a 35-year exposure age (88 for the colon and 15 for the intestine). Conversely, the lowest risks were found at 70 years of age, specifically in rib bone and leg bone with value of (0). The current research could contribute to establishing a database concerning the incidence of secondary cancers induced by radiotherapy during 3D-CRT for prostate cancer in Algeria.

Inappropriate therapy (IAT) is an undesirable side effect of implantable cardiac defibrillator (ICD) therapy. Early studies with the subcutaneous ICD (S-ICD) showed relatively high inappropriate shock (IAS) rates. The PRAETORIAN (Prospective Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) trial demonstrated that the S-ICD is noninferior to the transvenous ICD (TV-ICD) with regard to the combined end point of IAS and complications. This secondary analyses evaluates all IAT in the PRAETORIAN trial.

This international, multicenter trial randomized 849 patients with an indication for ICD therapy between S-ICD (n=426) and TV-ICD therapy (n=423). ICD programming was mandated by protocol. All analysis were performed in the modified intention-to-treat population.

In both groups 42 patients experienced IAT (48-month Kaplan-Meier estimated cumulative incidence, 9.9% and 10.1%, respectively; hazard ratio (HR), 0.99 [95% CI, 0.65–1.52]; P =0.97). There was no significant difference in patients experiencing IAS between both groups ( P =0.14). In the S-ICD group, 81 IAT episodes with 124 IAS and 1 inappropriate antitachycardia pacing occurred versus 89 IAT episodes with 130 IAS and 124 inappropriate antitachycardia pacing in the TV-ICD group. IAT episodes were most frequently caused by supraventricular tachycardias in the TV-ICD group (n=83/89) versus cardiac oversensing in the S-ICD group (n=40/81). In the TV-ICD group, a baseline heart rate >80 bpm (HR, 1.99 [95% CI, 1.05–3.76]; P =0.03), a history of atrial fibrillation (HR, 2.66 [95% CI, 1.41–5.02]; P =0.003), and smoking (HR, 2.46 [95% CI, 1.31–4.09]; P =0.005) were independent predictors for IAT. A QRS duration >120 ms was an independent predictor for IAT caused by cardiac oversensing in the S-ICD group (HR, 3.13 [95% CI, 1.34–7.31]; P =0.008). Post-IAS interventions significantly reduced IAS recurrence in both groups ( P =0.046).

There was no significant difference in IAT and IAS rates between the S-ICD and TV-ICD in a conventional ICD population, but causes and predictors for IAT differed between the devices. After the first IAS, an intervention significantly reduced the recurrence rate of IAS.

URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01296022.