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.

The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to overcome the risk of lead-related complications associated with the transvenous implantable cardioverter-defibrillator (TV-ICD). In contrast to the TV-ICD, the S-ICD is a completely extrathoracic device. Subsequently, complications differ between these 2 implantable cardioverter-defibrillators, which might impact patient perceptions of the therapies. This prespecified secondary analysis of the PRAETORIAN trial evaluates differences in quality of life.

The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) randomized patients with an implantable cardioverter-defibrillator indication, without the need for pacing to S-ICD or TV-ICD therapy. Two questionnaires were collected at baseline, discharge, 12 months, and 30 months. The Duke Activity Status Index measures cardiac-specific physical functioning, and the 36-Item Short Form Health Survey measures physical and mental well-being, with the subscales bodily pain and mental health being of interest in this analysis. Mann-Whitney U tests were used to compare study arms, and a mixed model was used to describe the questionnaire outcomes over time.

Patients were randomized to S-ICD (n=426) and TV-ICD (n=423). In the S-ICD group, 20% were women versus 19% in the TV-ICD group. The median age was 63 (interquartile range, 54–69) years in the S-ICD group versus 64 (interquartile range, 56–69) years in the TV-ICD group. There were no significant differences in the Duke Activity Status Index and 36-Item Short Form Health Survey subscales for bodily pain and mental health between the groups at any time point. Patients with a shock in the last 90 days had significantly lower scores for social functioning ( P =0.008) and role limitations due to emotional problems ( P =0.001) than patients without a shock, but this effect did not differ between treatment arms.

In a large randomized cohort of patients with an S-ICD or TV-ICD, no difference in overall quality of life was observed. However, implantable cardioverter-defibrillator shocks resulted in a reduction in quality of life, regardless of the device type or appropriateness.

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