Baseline data in clinical trials.
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Biomedical subjects
Publications and source records attributed to Val J Gebski.
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BACKGROUND: The treatment of squamous cell carcinoma of the lip with surgery is usually curative but incomplete/inadequate excision may be associated with recurrence and poor outcome. There is no consensus in the literature on the definition of an adequate excision margin. METHODS: Patients treated for squamous cell carcinoma of the lip at Westmead Hospital, Sydney, between 1980 and 2000 were eligible for inclusion. Polytomous logistic regression analysis was undertaken to assess for predictors of recurrence. Recurrence-free and overall survival were calculated using Kaplan-Meier survival curves. RESULTS: A total of 130 patients was identified. Median age at diagnosis was 64 years (23-97 years). Most lesions (90%) were located on the lower lip in 96 (74%) male patients. Median follow-up duration was 54 months (0-189 months). Most patients -presented with T1 lesions (75%). Initial treatment was surgery (39%), radiotherapy (48%) or both (13%). Twenty-seven per cent of excised lesions had a close (< or =2 mm) or positive margin. A total of 40 patients (31%) had recurrence (18% lymph nodes, 11% lip and 2% both). In the surgery group recurrence was significantly more likely with close or positive margins (P = 0.05). The 2 year -recurrence-free survival was 82% and 54% for radiotherapy and surgery, respectively (P < 0.001). The 2 year overall survival was similar (90% radiotherapy vs 100% surgery; P = 0.58). CONCLUSION: Incomplete or inadequate excision of some lip cancers results in local recurrence. If re-excision is not feasible -surgeons should consider the role of adjuvant radiotherapy in improving local control.
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BACKGROUND: Predictors of fertility or spermatogenesis during gonadotrophin therapy of gonadotrophin-deficient men remain poorly defined. METHODS AND RESULTS: In order to evaluate potential predictors, this study evaluated 29 consecutive gonadotrophin-deficient men all desiring paternity who received 43 courses of therapy in one centre between 1982 and 1998. The Kaplan-Meier survival analysis estimates of median (SE) time to a sperm concentration of >0, >5 and >20 x 10(6)/ml were 5.5 (1.1), 12.4 (2.3) and 29.1 (1.9) months respectively. Conception occurred in 22/43 cycles (with eight men achieving two pregnancies) with a median (SE) Kaplan-Meier estimate of 20.5 (4.7) months. The median sperm concentration at conception was 5.0 (SE 2.0; range 0.0-59.5) x 10(6)/ml. Multivariate correlated Cox proportional hazards models predicting these same sperm thresholds and conception were developed by forward stepwise variable selection with verification of the model by backward stepping. Larger testicular volume, prior gonadotrophin therapy, completion of puberty, older age, the absence of adverse fertility factors and the absence of multiple pituitary hormone deficiency predicted a favourable response. Multivariate modelling suggests that the two most important predictors of sperm output are testicular volume and pubertal status. The most important potentially modifiable predictor was prior gonadotrophin therapy. The efficacy of recombinant and urinary FSH were similar. Prior androgen therapy and partner's age did not appear to be significant. CONCLUSIONS: Since prolonged treatment may be required to induce spermatogenesis, attention to these predictors may allow appropriate early use of advanced reproductive technologies.