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Background Five to 10% of women with newly diagnosed breast cancer have synchronous metastases ( de novo stage IV). A further 20% will develop metastases during follow-up (recurring stage IV). We compared the clinical outcomes of women with HER2-positive metastatic breast cancer (MBC) receiving first-line trastuzumab-based therapy according to type of metastatic presentation. Patients and methods Retrospective analysis of 331 MBC patients receiving first-line trastuzumab-based treatment. Response rates (RR) were compared by the chi-square test. Time-to progression (TTP) and overall survival (OS) curves were compared by the log-rank test. Cox-proportional hazards models were used to study predictors of PFS and OS, including the type of metastatic presentation. Results Seventy-seven patients (23%) had de novo stage IV disease. Forty-six of these patients underwent surgery of the primary (“ de novo /surgery”). Response rates to first-line trastuzumab-based therapy and median progression-free survival did not differ in patients with “recurring”, “ de novo /surgery” and “ de novo ” without surgery (“ de novo /no surgery) stage IV breast cancer. However, women with “ de novo /surgery” stage IV breast cancer had the longest median OS (60 months), and those with “ de novo /no surgery” stage IV breast cancer the shortest (26 months). For women with recurring metastatic breast cancer median OS was 40 months (overall log-rank test, p Conclusion Our analysis shows that response rates and PFS to first-line trastuzumab-based therapy do not differ significantly between de novo and recurring stage IV, HER2 positive breast cancer. The observed difference in OS favoring women with de novo stage IV disease submitted to surgery of the primary tumor could be the result of a selection bias.

Summary The reproducibility of diagnosing isolated tumor cells (ITC) and micrometastases has been recently tested by expert breast pathologists, but might be different in a community setting. Digital images of 50 cases of low volume nodal involvement were circulated among pathologists from the Piedmont region (Italy) and from the Helios Medical Center in Berlin. Participants were asked to categorize the lesions into micrometastasis, ITC or others. The test was performed on the basis of a previous consensus statement. Kappa statistics were used for the assessment of interobserver variability. The kappa values for the consistency of categorizing cases were 0.47 and 0.57 for the regional and the institutional tests, respectively. Our study suggests that the reproducibility of diagnosing micrometastases and ITC in a community setting may reach that of experts, but is in the moderate range, and this may interfere with studies trying to solve the prognostic significance of these diagnostic categories.