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Chronic pain was more prevalent in BCS compared to the general population. Significant predictors for sequelae related to breast cancer were radiotherapy and younger age. Future research should therefore prioritize sequelae prevention.

The study failed to demonstrate superiority of any drug in terms of efficacy, but the vinorelbine combination had significantly fewer adverse effects and should be considered as an alternative first-line option.

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Background:The literature shows considerable between-study variation in the prevalence of post-traumatic stress symptoms (PTSS) among women with breast cancer. Our aim was, therefore, to explore the prevalence of and risk factors for cancer-related PTSS in a nationwide inception cohort of women treated for primary breast cancer.Methods:In all, 68% of all Danish women receiving surgery for primary breast cancer between October 2001 and March 2004 completed a questionnaire at 3 months post surgery (n=3343), which included the impact of event scale (IES). In all, 94% of the disease-free women also completed a follow-up questionnaire at 15 months post surgery. Data on pre-cancer demographic, socioeconomic, and psychiatric status were obtained from national registries. The Danish Breast Cancer Cooperative Group and surgical departments provided information on disease variables, treatment, and comorbidity.Results:At 3 months post surgery, 20.1% had IES total scores suggesting severe PTSS (⩾35), compared with 14.3% at 15 months. In all, 48% with severe PTSS at 3 months also had scores above the cutoff at 15 months. Main predictors of severe PTSS at 15 months were low social status, previous physical and mental illness, axillary lymph node involvement (>3), and reduced physical functioning (PF) at 3 months.Conclusion:The results confirm that receiving a breast cancer diagnosis can be a significant traumatic experience, and that many women experience persistent cancer-related PTSS. Low social status, poor health status, low levels of PF, and disease severity were found to be risk factors for severe PTSS.

In a phase I clinical trial in cancer patients, the drug involved had one known main adverse effect, which also occurs spontaneously in cancer patients with a fairly high frequency. Experiments in rats have shown marked effects of the drug on tumour growth in high doses, but also dose-dependent toxicity. Consequently, the aim of the study was to determine a dose with a prespecified, acceptable rate of toxicity. As a traditional design could result in inaccurate conclusions, use of the continual reassessment method (CRM) was considered. Twelve dose levels were chosen, allocating to the first patient the lowest, but safe, dose. It is likely that the target dose is far above that, and that CRM then would escalate too fast, skipping certain levels. To ensure that all dose levels inferior to the target dose were tried, some combined methods were proposed: (1) an extension of the design, combining the CRM with a preliminary up-and-down design in order to reach the neighbourhood of the target dose during a successive escalation, and (2) a restriction on the CRM of never escalate more than a single dose level. Simulations showed the extended CRM to be superior by making it possible to investigate a greater range of doses using fewer patients, and to provide more accurate estimates.