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Objective Klinefelter syndrome (KS) (47,XXY and variants, KS) is the most common sex chromosome disorder in humans. However, little is known about the onset and progression of puberty in patients with KS. In this study, we describe the onset and progression of puberty in a large series of boys with KS in a single tertiary centre. Design and Patients Retrospective data (Tanner stages, testicular length, testosterone supplementation, levels of luteinizing hormone [LH] and testosterone) before possible testosterone treatment on 72 KS patients with 47,XXY karyotype were reviewed, and G (n = 59 patients) and P (n = 56 patients) stages were plotted on puberty nomograms. Measurements and Results One boy had a delayed onset of puberty, as he was at the G1 stage at the age of 13.8 years (−2.2 SDs). No observations of delay were made of boys at Stage G2. The progression of G stages was within normal limits in the majority of patients; only few boys were late at G3 (4.1%; 1 out of 24) and G4 (7.4%; 2 out of 27). Testosterone supplementation was started at the average age of 15.5 years to 35 boys (47%), 2 of whom were over 18 years old. LH level was on average 18.2 IU/L (SD: 6.3 IU/L) and testosterone 9.1 nmol/L (SD: 3.1 nmol/L) when testosterone supplementation was started. Conclusions Our results suggest that puberty starts within the normal age limits in boys with KS, and testosterone supplementation is not needed for the initial pubertal progression in the majority of patients.
#82 Background: Adding X to T extends survival in patients (pts) with metastatic BC. The primary objective of the FinXX-trial is to compare RFS with XT→CEX vs. T→CEF as adjuvant therapy in pts with early BC. Secondary objectives are comparison of overall survival, distant RFS and safety. Methods: Between Jan 2004 and May 2007, 1500 pts were randomized to receive T x 3 → CEF x 3 (T 80mg/m² d1 → C 600mg/m² d1, E 75mg/m² d1, F 600mg/m² d1, q3 wks) or XT x 3 → CEX x 3 (T 60mg/m² d1 + X 900mg/m² bid d1–15 → C 600mg/m² d1, E 75mg/m² d1, X 900mg/m² bid d115, q3 wks). Results: 1496 pts were included in the ITT analysis (two pts withdrew consent, two had metastatic disease). The study population represented a high-risk group (90% node positive, 19% HER2 positive, 88% poorly or moderately differentiated tumors). The baseline characteristics were well balanced in the two treatment arms. After median follow-up of 3 years, there have been 134 events (deaths, distant or local relapses; Table). The significantly improved RFS rate was achieved despite a higher number of study treatment discontinuations in the X-containing arm (178 vs. 23 pts in the control arm; when XT was discontinued, the remaining XT cycles were replaced with an equal number of T cycles, and CEX cycles with CEF cycles). 75% of pts in the X-containing arm received all six planned cycles of therapy compared with 96% in the control arm. The adverse effect profiles of XT→CEX and T→CEF were in part different (Gr. 3/4 neutropenic fever/infection 10.0% vs. 20.2%, hand-foot syndrome 11.1% vs. 0.3%, diarrhea 6.2% vs. 3.4%, stomatitis 4.2% vs. 1.6%, myalgia 1.9% vs. 8.0%, respectively).
 
 Conclusions: The primary endpoint of this trial, to demonstrate a significant improvement in RFS, was achieved after median follow-up of 3 years. The hazard ratio of 0.66 (95% CI 0.47–0.94; p=0.020) for RFS translates into a 34% reduction in the rate of recurrences or deaths in pts receiving XT→CEX. This significant benefit was seen using an X dose of 900 mg/m² bid, and with a lower T dose in the XT arm than with T monotherapy. Overall survival data are not yet mature but a trend towards improvement (hazard ratio 0.66 [95% CI 0.401.07]; p=0.089) can be seen in the XT→CEX arm. The results suggest that the risk of breast cancer recurrence can be reduced substantially with integration of capecitabine into a taxane-/anthracycline-based regimen. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 82.
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