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Program Surveillance in Women with Early Breast Cancer – Pro

capecitabine, aromatase inhibitors and trastuzumab, were not yet available. We have seen evidence that with the introduction of new effective drugs, the overall survival rate of patients with recurrent breast cancer has improved significantly over the past years [5–6]. The retrospective analysis conducted at the M.D. Anderson Institute in Texas [5] showed that 5-year overall survival rates in patients with recurrent breast cancer improved continuously, from 1974 (10%) to 2000 (40%). Similar results were reported for Canada [6]. Although these were retrospective investigations from individual clinics (which are, however, also world-wide leading institutes in this area), the results demonstrate significantly improved treatment possibilities, even in the case of metastatic illness. All of these suggest that cancer patients should be given adequate treatment with no fatalistic attitude to their diseases. There is no doubt that many of our patients really do profit from 3rd and 4th line treatments, and this experience is far from solely being ‘casuistic’. The positive development in stage IV breast cancer is expected to continue even in times of restricted financial resources (e.g. bevacizumab, lapatinib, etc.). The limited therapeutic spectrum, as available when the studies cited above [1, 2] had been performed, remains a real problem and current guidelines should definitely not be based on such biased comparative analyses. Treatment options are considerably limited in advanced diseases if symptoms such as dyspnoea or jaundice are already present at the initial diagnosis of metastatic disease: The associated deteriorated general condition of the patient, as well as elevated levels of GOT/GPT and bilirubin etc. are considered reliable indicators of an unfavourable prognosis. Patients with these symptoms are widely excluded from current study protocols. At the Tumour Centre in Essen, there are numerous cases of patients with inoperable liver metastasis who survived for more than 5 years [7, manuscript in preparation]. If their treatment had been started at the time when the first sympTwo prospective randomised trials published in 1994 [1, 2] continue to be the basis of international guidelines, e.g. ASCO [3, 4] rejects regular laboratory tests and radiological / ultrasound screening procedures in the follow-up of early breast cancer patients. According to these guidelines, follow-ups should be focused on the breast. Only patients with possible tumour-related symptoms should be screened for metastatic disease. In this article, we will review the data of available surveillance studies which did not show an advantage for female patients with intensified follow-up, and discuss arguments for a systematic surveillance in breast cancer patients. In the study published by Del Turco et al. in 1994 [1], X-ray of the chest and bone scan was used, in addition to standard procedures. However, neither ultrasound of the liver nor any laboratory tests were performed. In the trial published by the GIVIO investigators, ultrasound of the liver was performed once a year [2]. Both trials did not examine tumour markers (CEA, CA 15–3). Consequently, the experimental procedures of the two studies are not qualified as ‘intensive surveillance’. Furthermore, approximately 10% of the patients in the GIVIO trial developed metastatic disease during a follow-up of 5 years [2]. This is much lower than the known percentage from epidemiologic data (ca. 40%). The expected statistical death rate for the population in this study is 35% at 5 years [2]. However, the study results show 18 and 20% death rates in the control group and in the intensive group, respectively [2]. The lower death rates can be explained by the fact that both studies enrolled mainly patients with ‘good-risk’ profile, as can be seen by the absence of axillary lymph nodes in approximately 50% of the patients, and by the very small number of patients (<10%) with pT3 or pT4 tumours at the time of diagnosis [1, 2]. Therefore, it is not surprising that no differences in the survival rates had been observed in the two studies. At the time the surveillance studies discussed above were published, many substances, such as taxanes, vinorelbin,