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A flow diagram is shown in Physique 1, and patient demographics are shown in Table 1

A flow diagram is shown in Physique 1, and patient demographics are shown in Table 1. Open in a separate window Fig 1. Flow diagram for the study. change of management in 14% of women (95% CI, 8.4% to 21.5%). Fine-needle aspiration and biopsy of bone led to reduced ability to analyze receptors. After a median follow-up of 12 months, there were no trends for an association between receptor discordance and either time to treatment failure or overall survival. Conclusion Biopsy of metastases is usually technically feasible. Clinicians alter immediate management in one of seven patients on the basis of results of the biopsy, and discordance is not then associated with detrimental effects on outcome. Tissue confirmation should be considered in women with breast cancer and suspected metastatic recurrence. INTRODUCTION Discordance in tumor characteristics between primary and metastatic breast cancer has been described for more than 30 years,1,2 but data describing such discordance have been considered unreliable.3 Therefore, practice guidelines recommend that decisions regarding systemic therapy for women with metastatic disease be based on the properties of the primary breast cancer,4 and confirmatory biopsy of suspected metastatic lesions is not recommended consistently. When compared with the primary tumor, expression of the estrogen (ER) and progesterone (PgR) receptors in metastatic breast cancer can be discordant in up to 40% of women.5 Lower rates of discordance are described for human epidermal growth factor receptor 2 (HER2).6 Most studies describing such discordance are retrospective and have limitations, including selection bias and use of different techniques to evaluate receptors in the primary tumor and metastatic tissue. Such studies cannot evaluate success rates of biopsy of metastatic lesions and cannot accurately inform the impact of receptor discordance on clinical management. Our group undertook a pilot prospective study in which 35 women with suspected new metastases underwent biopsy; we found that 40% had discordance of receptors, and this led to a change in management in 20% of patients.7 Other prospective studies include high proportions of women with operable, locoregional recurrences and have not evaluated the effects of discordance on patient survival.8 Retrospective analyses of primary and recurrent breast cancers suggest that receptor discordance is associated with poorer survival,9C11 perhaps as a result of the use of inappropriate targeted therapy or the selection of tumors with a more unstable phenotype and therefore more Rabbit Polyclonal to GSC2 aggressive behavior. The present study builds on our pilot to address prospectively AZD1152-HQPA (Barasertib) the success rates of biopsy of metastatic lesions in women with distant metastatic disease when a change in treatment is contemplated. We evaluated whether such biopsies altered management and examined the impact of receptor discordance on disease progression and survival in a prospective cohort of patients. We hypothesized that in the presence of discordance, if treatment is modified according to results of the metastatic biopsy, no detrimental effect of outcome would be observed. PATIENTS AND METHODS Study Population This prospective cohort study AZD1152-HQPA (Barasertib) took place at a single large cancer hospital. Women with recurrent or progressive metastatic breast cancer were eligible. Availability of archival primary tumor was mandatory. There were no restrictions relating to the number of prior lines of systemic therapy. Exclusion criteria included operable locoregional recurrence with no evidence of metastatic disease, clotting disorder precluding biopsy, rapidly progressive disease, AZD1152-HQPA (Barasertib) or history of nonbreast second malignancies. The study was approved by the local research ethics board. Trial End Points The primary end point of this study was the proportion of patients in whom results of the metastatic biopsy led to a change in management. The secondary goals were to define the discordance rates in ER, PgR, and between primary and metastatic tissue; assess procedural success rate, risks, and patient satisfaction with performing a metastatic biopsy; and evaluate time to treatment failure (TTF) and overall survival (OS). Trial Design Eligibility was assessed and consent obtained. The treating oncologist completed a questionnaire, before obtaining a biopsy from a metastatic lesion, to determine their treatment plan and the proposed start date. Once biopsy results were available, oncologists were again surveyed to determine whether their treatment plan had changed based on the biopsy results and to determine the actual start date of treatment. Procedural success rate was assessed as the number of matched histopathologic examinations of primary and metastasis as a.