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Background Uncertainty about the benefit/risk ratio of regional lymph node irradiation led to varying clinical protocols. We investigated long-term late side effects after internal mammary and medial supraclavicular (IM-MS) lymph node irradiation to improve shared decision-making. Methods The multicentre EORTC trial (ClinicalTrials.gov, NCT00002851) randomized stage I-III breast cancer patients with involved axillary nodes and/or a medially located primary tumor. We analyzed late side effects, both longitudinally at every follow-up and cross-sectionally at 5-year intervals. All statistical tests were 2-sided. Results Between 1996 and 2004, 46 departments from 13 countries accrued 4004 patients. Median follow-up was 15.7 years. Longitudinal follow-up data showed cumulative incidence rates at 15 years of 2.9% (95% confidence interval [CI] = 2.2%–3.8%) vs. 5.7% (95% CI = 4.7%–6.9%) (P<.001) for lung fibrosis, of 1.1% (95% CI = 0.7%–1.7%) vs. 1.9% (95% CI = 1.3%–2.6%) (P=.07) for cardiac fibrosis, and of 9.4% (95% CI = 8.0%–10.8%) vs. 11.1% (95% CI = 9.6%–12.7%) (P=.04) for any cardiac disease, when treated without or with IM-MS lymph node irradiation. There was no evidence for differences between left- and right-sided breast cancer (Wald chi-square test of treatment by breast side interaction, P=.33 and P=.35, for cardiac fibrosis and for any cardiac disease, respectively). The cumulative incidence probabilities of cross-sectionally reported side effects with a score of 2 or greater at 15 years were 0.1% (95% CI = 0.0%–0.5%) vs. 0.8% (95% CI = 0.4%–1.4%) for pulmonary (P=.02), 1.8% (95% CI = 1.1%–2.8%) vs. 2.6% (95% CI = 1.8%–3.7%) for cardiac (P=.15), and 0.0% (95% CI not evaluated) vs. 0.1% (95% CI = 0.0%–0.4%) for oesophageal (P=.16), respectively. No difference was observed in the incidence of second malignancies, contralateral breast cancer or cardiovascular deaths. Conclusions The incidence of late pulmonary side effects was statistically significantly higher after IM-MS lymph node irradiation, as were some of the cardiac events, without a difference between left- and right-sided treatments. Absolute rates and differences were very low, without increased non-breast cancer related mortality, even before introducing heart-sparing techniques.

Background While the risk of diabetes is increased following radiation exposure to the pancreas among childhood cancer survivors, its association among testicular cancer (TC) survivors has not been investigated. Methods Diabetes risk was studied in 2998 1-year TC survivors treated before 50 years of age with orchidectomy with/without radiotherapy between 1976 and 2007. Diabetes incidence was compared with general population rates. Treatment-specific risk of diabetes was assessed using a case–cohort design. Results With a median follow-up of 13.4 years, 161 TC survivors were diagnosed with diabetes. Diabetes risk was not increased compared to general population rates (standardised incidence ratios (SIR): 0.9; 95% confidence interval (95% CI): 0.7–1.1). Adjusted for age, para-aortic radiotherapy was associated with a 1.66-fold (95% CI: 1.05–2.62) increased diabetes risk compared to no radiotherapy. The excess hazard increased with 0.31 with every 10 Gy increase in the prescribed radiation dose (95% CI: 0.11–0.51, P = 0.003, adjusted for age and BMI); restricted to irradiated patients the excess hazard increased with 0.33 (95% CI: −0.14 to 0.81, P = 0.169) with every 10 Gy increase in radiation dose. Conclusion Compared to surgery only, para-aortic irradiation is associated with increased diabetes risk among TC survivors.

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