Impact of temozolomide on gonadal function in patients with primary malignant brain tumors.

BACKGROUND: Cumulative exposure to alkylating agents may produce impaired reproductive function. Temozolomide is an alkylating agent approved for treating malignant gliomas. OBJECTIVE: A pilot study was undertaken to investigate the effects of temozolomide on semen integrity in men with newly diagnosed or recurrent malignant gliomas. METHODS: Eligible patients had no known fertility problems or impotence. Comprehensive semen analysis and serum sex hormones were obtained at baseline and following 3 and at least 6 months of temozolomide. RESULTS: Thirteen men were recruited. Mean age was 42 years (28-58). Three had recurrent and 10 newly diagnosed malignant glioma. Four were unable to ejaculate or were azoospermic at baseline. Four provided samples at baseline and after at least 6 months of temozolomide. Five were unable to complete the study. Two of four patients with paired baseline and 6-month samples received 6 months of standard monthly temozolomide. Two patients received standard radiation and concurrent temozolomide followed by adjuvant temozolomide. At 6 months, three of these four patients demonstrated low sperm motility (two low at baseline); three had abnormally low percent normal forms (one abnormal at baseline); two developed abnormally low sperm density. Sex hormone values were normal in all four patients at all time points. CONCLUSION: Changes in semen analysis parameters following 6 months of temozolomide were observed. The small sample size precludes any firm conclusions regarding the importance and duration of these findings and their relation to temozolomide exposure. With validation in a larger study, these results may have important implications for counseling prior to initiation of temozolomide therapy in these patients.

Providing psychosocial group support for young women with breast cancer: findings from a wellness-based community collaboration.

This article describes our experience offering a collaborative, wellness-based group support program for young women with breast cancer. Goals were (1) to identify needs and priorities of young women with breast cancer; (2) to test the feasibility of a collaboration between an academic medical center, a regional cancer center, and a community-based agency; and (3) to positively influence participants' overall quality of life (QOL), emotional distress, and psychological well-being. The group intervention consisted of presentation of various topics, group discussion, and relaxation exercises. No significant changes on QOL or emotional measures were seen. Participants rated the session on symptom management as most useful and identified two areas for potential improvement (more homogeneity of participants, suggestions for additional topics).

Asymptotic power calculations: description, examples, computer code.

This paper describes two asymptotic methods for sample size and power calculation for hypothesis testing. Both methods assume that the distribution of the likelihood ratio is approximately distributed as a central chi(2) distribution under the null hypothesis and as a non-central chi(2) under the alternative hypothesis. The approximation to the non-centrality parameter differs between the methods. It is shown how these methods can be automatically extended from constraints setting parameters to constant values to constraints positing equality of parameters. Two very simple examples are presented; one demonstrates that the information method can produce arbitrarily incorrect results. Four more comprehensive examples are then discussed. In addition to demonstrating the wide range of applicability of these methods, the examples illustrate techniques that may be used in cases in which there is insufficient initial information available to perform a realistic calculation. The availability of a computer implementation of these methods in S-plus is announced, as are routines for computing the cumulative distribution function of the non-central chi(2) and its inverse.