Depending on patient and tumor characteristics, reported 5-year actuarial survival rates of patients with cervical nodal metastasis from an unknown primary carcinoma range from 18% to 63%. Prognostic factors for survival include N-stage, number of nodes, grading, extracapsular extension, and performance status. Retrospective studies suggest that neck relapse is more common than are distant metastases or emergence of mucosal primary tumors. The treatment options include neck dissection alone, radiation alone to the neck with or without the putative mucosal origin, and combination unilateral neck dissection plus limited or comprehensive radiotherapy. Combination of nodal dissection with comprehensive bilateral radiotherapy yielded most favorable results in local-regional disease control. However, its impact on the quality of life should be recognized. Also, the confounding effects of patient selection for various treatment modalities on therapeutic outcome cannot be quantified. Retrospective single-institution comparisons between comprehensive and unilateral neck radiotherapy did not show apparent differences in outcome. A randomized trial to compare the therapeutic value of comprehensive versus volume-limited radiotherapy is being planned. No data were found to support the benefit of chemotherapy for the treatment of this disease.

To investigate the feasibility and antitumoral effect of ketoconazole in the treatment of disseminated prostatic cancer, 22 patients with stage D2 disease were treated with 400 mg. ketoconazole orally every 8 hours. Of the 17 patients evaluable for antitumoral effect an initial tumor response of 88 per cent was observed (1 complete and 8 partial responses, and 6 with stable disease) with a mean duration of 15.8 months (range 5 to more than 30 months). Treatment-related side effects were encountered in 21 patients and consisted of asthenia, gastrointestinal complaints, skin reactions and cardiovascular complications. They were judged to be mild in 8 patients, moderate in 5 and severe in 8. Treatment had to be discontinued because of side effects in 7 patients (32 per cent). During treatment with ketoconazole serum testosterone levels decreased rapidly and attained nearly castrate levels at the end of week 3. However, after 1 month a steady increase was noted and the testosterone levels reached low normal ranges after 5 months. No hormonal or biochemical indications of adrenocortical insufficiency were noted. High dose ketoconazole is effective in the treatment of disseminated prostatic cancer. Its use is limited by the side effects and the inability to maintain castrate levels of testosterone.

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6035 Background: The gold standard endpoint in randomized trials of HNSCC is OS. Our objective was to study if event-free survival (EFS) or loco-regional control (LRC) could be good surrogate endpoints to estimate the effect of radiotherapy (RT) and chemotherapy (CT) on OS. This would permit to decrease the duration and cost of the development of new treatments for HNSCC. Methods: EFS is the time from randomization to first event (loco-regional, distant recurrence or death), LRC the time from randomization to first loco-regional event. Individual patient data from two meta-analyses (MARCH; Bourhis, Lancet 2006, MACH-NC; Bourhis, ASCO 2004) were used. At the individual level, the rank correlation coefficient ρ between the surrogate endpoint (EFS or LRC) and OS was estimated from the bivariate distribution of these endpoints. At the trial level, the correlation coefficient R between treatment effects (estimated by log hazard ratios) on the surrogate endpoint and OS was estimated from a linear regression. EFS and LRC would be acceptable surrogates only if the correlation coefficients ρ and R were close to 1. Results: At the individual level, EFS was more strongly correlated with OS than LRC. For RT, treatment effects on both LRC and EFS were strongly correlated with those on OS. For CT, the correlation coefficients between treatment effects on EFS and OS were larger than those between LRC and OS. Conclusions: The preliminary analysis indicates that EFS can be used as a surrogate for OS to evaluate the treatment effect in randomized trials of patients with HNSCC. LRC is a possible alternative in RT alone trials. Unrestricted grants from ARC, LNCC, PHRC, Sanofi-Aventis. [Table: see text] [Table: see text]

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