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To date, the virtual multidisciplinary tumor boards (vMTBs) are increasingly used to achieve high-quality treatment recommendations across health-care regions, which expands and develops the local MTB team to a regional or national expert network. This review describes the process of lung cancer-specific MTBs and the transition process from face-to-face tumor boards to virtual ones. The review also focuses on the project organization's description, advantages, and disadvantages. Semi-structured interviews identified five major themes for MTBs: current practice, attitudes, enablers, barriers, and benefits for the MTB. MTB teams exhibited positive responses to modeled data feedback. Virtualization reduces time spent for travel, allowing easier and timely patient discussions. This process requires a secure web platform to assure the respect of patients’ privacy and presents the same unanswered problems. The implementation of vMTB also permits the implementation of networks especially in areas with geographical barriers facilitating interaction between large referral cancer centers and tertiary or community hospitals as well as easier access to clinical trial opportunities. Studies aimed to improve preparations, structure, and conduct of MTBs, research methods to monitor their performance, teamwork, and outcomes are also outlined in this article. Analysis of literature shows that MTB participants discuss 5–8 cases per meeting and that the use of a vMTB for lung cancer and in particular stage III NSCLC and complex stage IV cases is widely accepted by most health professionals.Despite still-existing gaps, overall vMTB represents a unique opportunity to optimize patient management in apatient-centeredapproach.

Introduction Despite the large number of drugs active in AGC, no combination can be considered as the gold standard treatment. Modest increase have been obtained in overall survival with the most widely employed regimens such as CF or ECF, often obtained at expense of increased toxicity. So there is a strong need to develop new active drugs to improve the clinical outcome. Taxotere showed to be effective in preclinical studies and some phase II trials confirmed its clinical efficacy. Recently, the addition of TXT to CDDP + FU (TCF regimen), obtained, in a large randomised phase III trial, better survival than CF alone. However the toxicity of this combination was relevant and mainly due to the association with CDDP. Considering these data the GOIM started a phase II study aiming to evaluate efficacy and safety of a three drugs combination, employing EPI instead of CDDP. Materials and methods Forty-one histologically proven untreated gastric cancer patients, with advanced measurable disease, age between 18 and 75 years, performance status ⩾ 70 (Kfsky scale) and available to sign written informed consent, were enrolled. They received the following treatment: Epirubicin at 60 mg/m 2 on day 1, Taxotere at 50 mg/m 2 on day 1, Folinic Acid at 100 mg/m 2 on days 1–2, Fluorouracil bolus at 400 mg/m 2 on days 1–2 and Fluorouracil 22 h continuous infusion on days 1–2 every three weeks. Results Amongst the 38 evaluable patients we observed 5 CR (13%), 9 PR (24%), 9 SD (24%) and 15 PD (39%) for an ORR of 37% (95% CI: 22–52) and a tumor growth control rate of 61%. The median time to progression was 4 months and the median survival was 9 months. The treatment was well tolerated. The main grade III–IV haematologic toxicities were leucopenia 7%, neutropenia 5% and anemia 5% while non-haematologics were diarrhoea 2%, alopecia 2% and cardiac 2%. Conclusion The three drugs combination of Taxotere, Epirubicin and Fluorouracil is active and well tolerated first-line treatment in advanced gastric cancer patients.

PURPOSE: This phase II multicenter trial was aimed at investigating the activity of epirubicin-vinorelbine combination as first-line chemotherapy in metastatic breast cancer patients. PATIENTS AND METHODS: Ninety-seven patients with metastatic breast cancer and no prior exposure to anthracyclines received the following regimen: epirubicin 100 mg/m2 by intravenous (IV) bolus infusion on day 1 plus vinorelbine 25 mg/m2 by 30-minute IV infusion on days 1 and 5, every 3 weeks for up to eight cycles. All patients also received granulocyte colony-stimulating factor (G- CSF) on days 7 to 12 of every cycle. RESULTS: Objective responses, confirmed at least 4 weeks after the first documentation, were observed in 65 out of 92 assessable patients (70.6%; 95% CI, 62% to 80%). Disease remained stable in 17 patients (18.5%). Responses were observed in all disease sites, being 94% in soft tissue, 60% in bone, and 66% in visceral disease. Median time to response, median duration of response, median time to progression, and median overall survival were 2, 9, 10, and 26 months, respectively. The dose-limiting toxicity was neutropenia, which was grade 4 in 36% of the patients, and was accompanied by fever in 26% of the cases. Grade 3 to 4 mucositis was encountered in 28% of the patients. Other toxicities were mild to moderate. No cardiotoxicity was observed. CONCLUSION: The epirubicin-vinorelbine combination with G-CSF support has been shown in this study to be highly active as first-line treatment of metastatic breast cancer patients, with significant although transient toxicity. This justifies further evaluation in the neoadjuvant setting and in early-stage breast cancer.

8531 Background: In patients with a first episode of idiopathic or provoked Deep Vein Thrombosis (DVT), the presence of Residual Vein Thrombosis (RVT), detected by UltraSonography (US) at the 3rd month from the index DVT, is an independent risk factor for developing recurrent Venous Thromboembolism (VTE) in the subsequent 2 years. Its absence can safely permit to stop Oral Anticoagulants (OA). At the present, it is unknown whether RVT may also identify patients at increased risk for developing cancer and/or cardiovascular disease (CD). In patients with previous DVT of the lower limbs, we conducted a prospective study for evaluating the correlation between RVT findings and the risk of new cancer and/or CD. Methods: Three hundred-forty-five patients, with a previous episode of idiopathic or provoked DVT, were evaluated; presence/absence of RVT was detected at the 3rd month of OA and patients managed consequently. In the present study, the incidence of VTE recurrence, cancer and new CD was evaluated in the subsequent 3 years after the index DVT. The Kaplan-Meyer curve and the Breslow test has been used for the statistical comparison among groups. Results: The results among the 3 groups are listed in the Table. Patients without RVT had a significant reduction in recurrent VTE and new cancer in comparison to patients with RVT; they also showed a not significant trend in the reduction of CD; these data are applicable in patients with idiopathic or provoked index DVT. In patients with RVT, the advantage of prolonging anticoagulation over 12 months (Group A1) is lost at the end of the treatment. Conclusions: US-detected RVT, at 3rd month from the index DVT, is an independent risk factor for recurrent VTE and cancer; this risk remains over a period of 3 years, independently whether index DVT was idiopathic or provoked. In these patients, the advantage of indefinite anticoagulation should be assessed in properly designed study. [Table: see text] No significant financial relationships to disclose.

10546 Background: Adjuvant chemotherapy is used in the treatment of breast carcinoma independently of axillar node involvement. Different drug combinations such as CMF, FAC, FEC are still used; recently new drugs such as TXT (NEJM 332:1004,1997) show activity and are used also in adjuvant chemotherapy. 5 Fluorouracil (5Fu), a drug involved in main therapeutic regimens, blocks Thymidylate Synthase (TS), an enzyme involved in the DNA synthesis. TS not only links its own mRNA, but also p53 mRNA, inhibiting post transcriptional p53 protein synthesis. TS protein overexpression (Cancer Res 55:1407,1995), and/or its absence (Cancer Res 61:1421,2001) are some of the main mechanisms of 5-Fu drug resistance; moreover TS protein could inhibit p53 protein synthesis. Many clinical studies demonstrate that tumours with mutations of p53 are resistant to anthracyclines chemotherapy, 5Fu and radiotherapy (Carcinogenesis 17:1417,1996). Other studies show that the relationship between p53 and taxanes chemosensitivity seems to be more complex, because p53 mutations are associated with better taxanes drug response (Nature Med 2:255,1996). Aim of the study is to find association between TS and p53 levels, and relation with CMF or TXT treatment. Methods: We detected TS and p53 protein levels with immunohistochemistry assay in 84 paraffin embedded tumour samples from untreated patients (pts) who underwent surgery for primary breast cancer. Stage was T2N2M0 and pts were divided into two groups depending on the drug treatment received. One group (44 pts) was treated by 6 cycles of adjuvant CMF chemotherapy, the other by 4 cycles TXT alone. Results: 30% of pts showed lower TS and higher p53 levels, and had better TXT, while worse CMF treatment response; 30% of pts showed higher TS and lower p53 levels and all had worse response to all treatments; 40% of pts showed intermediate TS and p53 levels and different response to both CMF or TXT. Conclusions: On the basis of these results we identified a sub-group of pts showing lower TS and higher p53 levels that could be treated by a first line therapeutic regimen including Taxanes, not by drug combinations including 5 FU. No significant financial relationships to disclose.

Background: Paclitaxel-Doxorubicin combination chemotherapy is highly active in metastatic breast cancer patients (pts) but may be cardiotoxic in a small percentage of cases. PLD is a new formulation of Doxorubicin with significant reduced cardiac toxicity and for this reason PLD can be given safe in elderly patients with cardiac risk factors or in younger patients with prior exposure to anthracycline-containing regimens. The main side effect of PLD is Hand-Foot syndrome but when given in intervals not below 4 weeks and with a dose intensity not exceeding 10 mg/sqm per week, this side effects is clearly reduced. Methods: : We carried out a phase 2 study to verify the activity of P 70 mg/sm weekly day 1–8-15 and PLD 30 mg/mq every four weeks. Inclusion Criteria were: age 12months) or patients with LVEF beetween 40–50%, informed consent. Results: Out of the 11 patients so far included, 9 were evaluable for toxicity and response. Five patients (55.5%) showed a response including 4 PR and 1 CR, 1 patients (11.1 %) obtained SD and 2 pts (33.3%) progressed. Median time to progression and median survival have to be reached. Haematological side effects were: Neutropenia G1–2 in 4 pts (44.4%), thrombocytopenia G1–2 in 3 pts (33.3%). The non-haematological side effects were mild with the total absence of grade 3–4 toxicities. Only 3 patients (33.3%) experienced grade 2 nausea and stomatitis. G1–2 peripheral sensory neuropathy was seen in 1 pt (11.1%). Hand-Foot syndrome G1–2 occurred in 2 pts (22.2%). Conclusions: The treatment with weekly Paclitaxel and PLD with this schedule appears to be a well tolerated therapy with an interesting activity in this subset of patients.

Background: Biliary tract cancers are uncommon tumors with a poor prognosis and most patients (pts) present with invasive and inoperable disease at diagnosis. Chemotherapy represents a palliative treatment, but single or combination-drug schedules have demonstrated poor response rates with a median survival less than 6 months. Recently O and G have showed an interesting activity as single agents in this group of pts. Methods: We carried out a multicenter phase II study to evaluate the efficacy and safety of combined O and G in locally advanced and metastatic biliary tract carcinoma. The schedule of chemotherapy included O 100 mg/m2 on day 1 and G 1000 mg/m2 on days 1 and 8, every 21 days. Inclusion Criteria were: histological diagnosis of biliary tract carcinoma, age

10646 Background: The objective of this study is to evaluate the efficacy and toxicity of the liposome- encapsulated doxorubicin (TLC D-99) plus cyclophosphamide (CTX) as first-line treatment of metastatic breast cancer in light of the potential cardioprotective effect of TLC D-99 as compared to conventional doxorubicin. Furthermore the study is aimed also to understand the role of troponin I as a sensitive marker of left ventricular dysfunction. Methods: Sixty-three patients as defined in a phase II group sequential design will be enrolled. Since september 2004, fifty-four patients with untreated metastatic breast cancer were enrolled. They received TLC D-99 at the dosage of 60 mg/m2 plus CTX 600 mg/m2, with cycles repeated every three weeks. Cardiac function was assessed by ultrasonography at baseline and every three weeks, as well as troponin I dosage. Results: The principal characteristics of the 54 actually enrolled patients were as follows: median age 60 years (range 33–75), median WHO performance status 1 (range 0–2) and dominant disease site (viscera/bone/soft tissue) 36/10/8. To date 39 pts are evaluable: 8 complete responses and 18 partial responses were observed for an overall response rate of 67%; a further 9 pts had stable disease and the remaining 4 pts progressed. Median number of administered cycles was 6. Median duration of response was 10 months (range 3–15+) and median duration of survival was 12+ months (range 2+-15+). Hematological toxicity consisted in leucopenia (G1-G2) in 11 patients ed anemia (G1-G2) in 10 pts; G1 thrombocytopenia was observed only in 2 pts. Non-hematological toxicity was generally mild with G1-G2 nausea/vomiting in 14 pts e G2 mucositis in one patient. Hair-loss was registered in 12 pts and it was G2 in 6 pts. As to concer cardiac toxicity, one patient developed an asymptomatic 20% decline of left ventricular ejection fraction from the baseline value. Conclusions: The preliminary data show that the combination of TLC D-99 plus CTX is active and well tolerated, with no unexpected toxicity. The relationship between cardiac function and troponin I is underway. No significant financial relationships to disclose.