FIGURE 2 The scheme reported above has been performed for a total of 5 weeks, of which three of treatment and two of without treatment stop

The Italian Group on Rare Tumors undertook a phase II study of a combination of epirubicin and interleukin-2 in 21 chemotherapy-naive patients with malignant mesothelioma. All patients had bidimensionally measurable disease at CT scan. Treatment included Intravenous administration of epirubicin at a dose of 110 mg/m2 i.v. on day 1, and interleukin-2 at a dose of 9 MU subcutaneously from day 8 to day 12 and from day 15 to day 19. Cycles were repeated every three weeks, up to six times in the absence of progressive disease. Treatment response was evaluated after two cycles of therapy. Only one patient achieved a partial response, resulting in an overall response rate of 5% (1/21) with a median progression-free and overall survival of 5 and 10 months, respectively. Toxicity was relevant and caused treatment discontinuation in many patients. These results do not support the use of such a combination in the management of malignant mesothelioma.

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10652 Introduction: Weekly administration of chemotherapy represents an emerging option for the treatment optimization of metastatic breast cancer (MBC). Moreover, evidences suggest a intriguing mechanism of action for weekly paclitaxel, which involves pro-apoptotic and anti-angiogenetic pathways. In order to identify clinical and biological prognostic factors for weekly chemotherapy outcome, we performed a multivariate analysis in a 10-years experience of weekly 1st line chemotherapy for MBC patients. Methods: The original databases of phase II trials of MBC patients undergone 1st line weekly chemotherapy were collected. Clinical and biological co-variables were screened for the eventual relationship with time to progression (TTP) and overall survival (OS) into a Cox model. Results: From 1990 to 2003, 184 patients were enrolled in 3 consecutive phase II studies, to evaluate activity and tolerability of weekly epirubicin with lonidamine, or vinorelbine or paclitaxel, for 24 weeks. All patients were evaluable for clinical variables, while histological samples were available in only 40 patients. At a median follow-up of 24 months, median TTP was 9 months (95% CI 8–10) and median OS 34 (95% CI 24–42). Independent variables were: response (HR 2.34, p < 0.0001), receptor status (HR 1.62, p = 0.01) Performance Status (PS) (HR 2.31, p < 0.0001) for TTP, and response (HR 1.86, p = 0.005), PS (HR 2.81, p < 0.0001), dominant metastatic site (HR 2.27, p < 0.0001), enrollment period (HR 2.51, p = 0.001) for OS. Although no biological factors entered the Cox model due to the small sample size, some sub-populations showed negative trend in survival. Conclusions: In our series of patients undergone weekly chemotherapy for MBC, independent prognostic factors for survival improvement were responders, PS 0–1, non-visceral dominant metastatic site, and enrollment period. Further greater populations are needed to extensively screen for biological prognostic factors. No significant financial relationships to disclose.