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• W2003000722 abstract "There has been ongoing debate whether or not a contralateral testis biopsy should be performed routinely in testicular cancer patients to detect the presence of carcinoma in situ (CIS), which then should be treated to prevent a second overt tumour. At the 8th Copenhagen Workshop on CIS Testis & Germ Cell Cancer (CIS Workshop), held in Denmark in May 2014, preliminary data from two recent retrospective studies in Germany and Denmark were presented (Ruf et al., 2015, Kier et al., 2015). A plenary discussion followed and the main points of discussion are briefly summarized here. Some of the arguments which had already been voiced at the 3rd CIS Workshop (Grigor & Rørth, 1993) were reiterated, but concern raised by false-negative biopsies and new emphasis on the quality of life after treatment have clearly marked the discussion. The concept of taking contralateral testicular biopsies was born in Denmark, where CIS of the testis was first described (Skakkebæk, 1972). The findings confirming the pre-invasive malignant character of CIS (Skakkebæk, 1978) led to the proposal of taking testicular biopsies in patients at risk of testicular cancer and looking for such changes to prevent invasive tumour development. The risk of cancer in the contralateral testicle of patients orchidectomized for germ cell cancer was considered high enough to recommend biopsies as a screening procedure, primarily to avoid metachronous cancer (Berthelsen et al., 1982). This procedure has been standard care in many Danish, German and Austrian centres. In many other countries contralateral biopsies are not routinely performed, mainly because of the successful treatment of the second germ cell cancer, which in general is no longer considered a survival issue. It is a prerequisite for performing a biopsy that CIS always precedes invasive germ cell malignancy, and the assessment of the cohorts of patients who have been biopsied is of fundamental importance for ongoing studies and as the basis of future strategies. Skakkebæk demonstrated that 50 and 70% of patients with CIS developed testicular cancer within 5 and 7 years respectively (Skakkebæk et al., 1981). Thus, it is assumed that all cases of CIS will progress eventually into overt cancer. But we will never know if the incidence of invasive cancer would ever reach 100%, because cases of CIS are now treated before tumour develops. Dr Klaus-Peter Dieckmann suggested during the CIS Workshop's discussion to look for CIS changes in testicles removed from older men for other reasons, for instance treatment of prostatic cancer, to see if CIS without tumour can be found later in life. Two studies of this kind have been carried out (Giwercman et al., 1991; Linke et al., 2005), but among relatively young men who died suddenly (median age 35 and 33 years, respectively). Both studies found very few cases of unrecognized CIS; 1/399 (0.25%) in the Danish cohort (Giwercman et al., 1991; Olesen et al., 2007) and 6/1388 (0.43%) in the German cohort (Linke et al., 2005). Thus, the number of CIS cases that do not result in tumour development is probably extremely small. However, our case for recommending the screening of all germ cell cancer patients has been weakened by two aspects. First, a relatively large proportion (>1%) of false negative results was found in the retrospective analysis of the Danish screening programme presented at the CIS Workshop (Kier et al., 2015). Secondly, the incidence of metachronous cancer has probably decreased over the last decades owing to the increasing use of systemic, very effective, cisplatin based chemotherapy in the treatment of germ cell malignancies. We have assumed that if a testicular biopsy is proven to be negative for CIS, then the risk of the patient developing testicular cancer is small. However, new and important information indicates that cancer can develop even in testes that have had a previous negative biopsy. This might be caused by a technical or evaluation error, or a too small amount of tissue examined in a single biopsy. Two biopsies from the testis, as initially suggested (Berthelsen & Skakkebæk, 1981), and subsequently implemented at German centres (Dieckmann et al., 2007a), will undoubtedly increase the detection rate of CIS, but it remains to be shown in clinical studies that the rate of metachronous cancers is thereby significantly decreased. The issue is not straightforward; increasing the number of biopsies from a single testis will furthermore increase the complication rate – and it is likely that sporadic CIS-lesions may still be missed. Efforts have been made to identify patients at the greatest risk of bilateral malignancy (Harland et al., 1998; Rud et al., 2013), and the European Association of Urology currently recommends that a testis biopsy ought to be offered only to the high-risk patients, who have a small contralateral testis (volume <12 mL), a history of cryptorchidism, poor spermatogenesis, and are less than 40 years of age (Albers et al., 2011). However, by limiting the biopsies to high risk individuals, too many cases of CIS might be missed. On the other hand, even if we can define a group of testicular cancer patients who are at low risk of developing a contralateral tumour, for example those with good spermatogenesis and above 40 years of age, the risk still remains greater than in the general population. The patients treated for testicular cancer are usually aware that they have an increased risk of a second cancer and will worry about it for the rest of their lives. They request a biopsy because the alternative is to wait until the tumour becomes manifest, otherwise they have to be observed and undergo annual ultrasound tests until they are around 65 years old. If CIS is identified in the contralateral biopsy, the ensuing treatment by low dose irradiation will leave some function of Leydig cells (Bang et al., 2009). On the other hand, if a biopsy is not taken and a tumour develops, the patient will most likely be cured by surgery, sometimes combined with additional chemotherapy or irradiation treatment, if the disease spreads. In consequence, the patient will require lifelong hormone replacement involving daily applications of dermal testosterone formulations or up to 20 per year intra-muscular injections (depending on the drug). Some patients will also suffer from long-term side-effects of the chemotherapy or irradiation. This is a scenario which we cannot ignore, thus we support management protocols stipulating that the contralateral testis has to be investigated in one way or another (Lee & Holzbeierlein, 2009). Infertile patients have a lower risk, about 2%, of developing testicular cancer compared to patients with a history of a previous testicular cancer. We believe that it is worthwhile looking for CIS in these infertile patients, as they will almost always be cured by unilateral orchidectomy. Biopsy is feasible because the complication rate is very low, and there is important additional information concerning spermatogenesis (Dieckmann et al., 2007b). Optimization of procedures, including obligatory immunohistochemistry with marker antibodies and centralized review by experts is preferable, as previously demonstrated (Van Casteren et al., 2009) and will reduce the number of false negative biopsies. Other, non-invasive approaches are being developed, and cytological semen analysis using combined immuno- and cyto-chemistry has already contributed to CIS diagnosis in some patients, but the sensitivity of this test remains too low for routine clinical practice (Almstrup et al., 2011). It is promising that new molecular markers, such as miRNAs, apparently are extremely specific for malignant germ cells (Voorhoeve et al., 2007; Dieckmann et al., 2012), including CIS cells (Novotny et al., 2012). Clinically applicable serum tests for miRNAs secreted by overt tumours are already under development. However, the low numbers of CIS cells remain a serious challenge and developing a blood test for testicular CIS is not yet around the corner. We hope, however, that morphological and protein expression-based detection methods of CIS cells can be combined with molecular biological markers to detect CIS in semen, and this approach in the future may possibly replace a biopsy. In conclusion, we are still convinced that the basic idea of diagnosing and treating CIS to prevent testicular cancer is important and sound. Much important clinical and biological information can be obtained from the examination of testicular biopsies. We therefore recommend to continue with contralateral biopsies in the centres where this procedure is already established and there is necessary expertise and laboratory base allowing to combine morphology and immunohistochemistry. We should consider taking two biopsies, at least in patients with normal testicular volume, but we need prospective studies to clarify whether double biopsies will significantly decrease the number of metachronous cancers. But we shall also strive to include new developments in molecular biology in research protocols to develop more sensitive tools, so that the goal of preventing contralateral cancers by screening with a safe procedure without too many false negative tests can be achieved. The authors thank all participants who voiced their comments in the debate on the value of contralateral biopsy at the 8th Copenhagen CIS Testis & Germ Cell Workshop, especially Klaus-Peter Dieckmann, Gedske Daugaard, J. Wolter Oosterhuis, Friedemann Honecker, Béatrice Fervers, Remi Beranger, Willem Boellaard, Alberto Ferlin, Luiz Franca, James Amatruda and Finn Edler von Eyben." @default.
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• W2003000722 title "Contralateral biopsy in the management of testicular cancer: what we have learned and what we need to improve" @default.
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