Background: We reported the updated results of the MIG-1 study comparing outcomes of early breast cancer patients treated with fluorouracil, epirubicin and cyclophosphamide regimen administered every 3 weeks (FEC21) or every 2 weeks (FEC14). Materials and methods: In this Italian, open-label, multicentre phase III randomized trial, patients were randomised to receive 6 cycles of FEC21 or of FEC14 (including support with a granulocyte colony-stimulating factor). The study end-points were overall survival and event-free survival. Results: From November 1992 to June 1997 a total of 1214 patients were randomly assigned to receive FEC14 (604 patients) or FEC21 (610 patients). At a median follow-up of 15.8 years, overall survival was 71% (95%CI 67-75) in the FEC14 group and 68% (95%CI 64-72) in in the FEC21 group (p = 0.25). Event-free survival rate at 15 years was 47% (95%CI 41-52) in the FEC14 group and 43% (95%CI 37-48) in in the FEC21 group (p = 0.18). In a pre-planned subgroup analyses, among the patients with hormonal receptor negative tumors, the event-free survival was 58% (95%CI 48-67) in the FEC14 regime and 43% (95%CI 33-52) in the FEC21 regime (P = 0.015); overall survival was 70% (95%CI 63-77) in the FEC14 regime and 65% (95%CI 58-72) in the FEC21 regime (P = 0.11). No between the two regimes was observed in patients with hormonal receptor positive tumors. The incidence of second primary cancers was similar between the two arms, 7.3% in the FEC14 arm and 8.2% in in the FEC21 arm. Most of this this (4.4%) were ipsilateral or contralateral breast cancer; other second primary cancers were: gasto-intestinal cancers (1.0%), gynecological cancers (1.0%), urological cancers (0.4%), thyroid cancers (0.4%), skin cancers (0.2%), lung cancers (0.2%), head and neck cancers (0.2%), myeloma (0.1%). Conclusions: The updated results of MIG-1 study confirm the efficacy, in terms of event-free survival, of dose-dence adjuvant chemotherapy in patients with hormonal receptor negative breast cancer.

e11037 Background: The optimal adjuvant treatment approach for TN EBC is not clear. NEMESI assessed the clinical practices adopted by Italian Oncologists with regard to EBC. Methods: The retrospective study included at least 1,500 cases, derived from 30 consecutive patients undergoing adjuvant treatment for EBC between January 1st and June 30th, 2008, in each of 50 Italian Oncology Centers licensed by the Italian Association of Medical Oncology and distributed in northern, central, and southern Italy with institution types, IRCCS, private, universities, and hospitals. Inclusion criteria: age ≥18 years, surgery for EBC, histological diagnosis (stage I-II TNM AJCC version VI), at least one cycle of adjuvant chemotherapy, and/or hormone therapy. TN definition: ER and PgR <10% by IHC and HER2<3+ by IHC and/or FISH not amplified. Results: A total of 1,895 patients from 63 centers have been included; data are presented for 1,542 patients. The TN status was available for 11.9% of patients (183/1542), with primitive tumor median dimension of 2.1 cm, and the following pT status: pT1mic+pT1a+pT1b+pT1c: 60.1% (14.2% <1 cm); pT2/pT3/pT4b: 39.9%. 22.4% of TN had ER1-9%. All 183 TN patients received treatment, of whom 162 (88.5%) received chemotherapy. Anthracycline and taxane regimens were used in 46 (25.1%) patients, of whom 78.2% received docetaxel. The most frequently used regimens were AC/EC or FEC followed by docetaxel (30/46; 65.2%). Conclusions: Treatment of TN EBC is influenced by recurrence risk pN 2-3 stages. In the pN0 category anthracycline regimens were the most prevalent EC/AC or FEC followed by docetaxel was the most used anthracycline-taxane chemotherapy. The use of anthracycline-taxane combinations increases with risk. Study sponsored by sanofi-aventis Italy. pN CMF-like Anthracyclines Anthracyclines + taxanes Taxanes N N % N % N % N % pN0 21 19.6 60 56.6 21 19.8 5 4.0 107 pN1 8 4.6 17 38.6 17 38.6 2 4.5 44 pN2 1 14.3 1 14.3 5 71.4 0 0.0 7 pN3 0 0.0 0 0.0 3 75.0 1 25.0 4 Total 30 18.4 78 48.1 46 28.2 8 5.3 162 Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration sanofi-aventis

The analysis of the airflow from sub-nozzles that have different emitting cross-sections is described. At first, tests were carried out outside the profiled reed and comparison between nozzles was made in terms of air velocity distribution, jet spreading, consumption and exerted drag force. Subsequently, in order to analyze the interaction between the jet emitted by a sub-nozzle and the loom profiled reed, some velocity measurements were repeated inside the weft passage, at various distances from the nozzle exit. Finally, a high-speed camera was used to visualize the weft yarn crossing the weft passage.

Spiral yarn composed with an elastomeric filament DOW XLA, from Dow Chemical, and wool fibres outwardly wound around the elastic core presents a complex behaviour when wound on bobbins to be dyed. This article presents a basic mathematical model with the aim of evaluating radial pressure and transversal stress on bobbins at different angles of winding, different yarn tensions and yarn cross-section areas. Considering the additional complexities of the real problem, an experimental comparison of bobbin alterations under different conditions was carried out with the realisation of two experimental sets. The first experimental test bench allows the variation of winding tension, angle of winding and stroke, then experimental tests were carried out on a winding machine SAVIO varying the yarn tension value and adding a mechanical constrain to the device with the aim of reducing yarn-sliding phenomena, in particular during the thermal cycle. The fundamental parameters have been determined as the angle of wind and the yarn tension during the winding operation. Higher values of wind angle help keeping the bobbin shape. Higher values of yarn tension during winding operation allow the preservation of bobbin shape after the dyeing cycle. On the other hand, the upper limit is represented by yarn tensile strength. Moreover, it is not useful to apply a varying wind tension during the winding process.

This article describes the development of an innovative method for raising the surface of high-quality fabrics. The method consists of replacing the natural teasels, currently used, with experimental metal teeth, which do not damage the fabric and reproduce the same effect as natural cards. Literature on the subject contains several examples of artificial metal teeth, which have the advantage of a longer life than the natural ones, however, some can mark the fabric along the warp, if not properly sized. The study in question was based on both experiment and theory, by simulating a flexural load on the barb wire and evaluating its rigidity. Excellent results have been obtained from various tests, and have led to the construction of a new industrial fabric-raising machine.

18610 Background: Pain is probably under-recognized and under-treated in the Elderly with advanced cancer disease but the effect of a therapy with high potency opioids is not studied so much in geriatric age people. To evaluate efficacy and tollerability of escalating doses of Transdermal Fentanyl (TTS-F) or equipollent doses of oral morphine long acting with Immediate Release Oral Morphine (IROM) as rescue medication for treatment of moderate-severe cancer pain, we have started a Multicentric Observational Analysis in four cancer centres of north-western Italy. Studies of oncological palliation using valid measures of quality of life show that patients may be willing to accept some side effects of treatment as long as they gain relief from tumor-related symptoms Methods: -TIQ (Therapy Impact Questionnaire) -VAS (Visual Analogic Scale): 0 to 10 -Toxicity (WHO criteria) -Geriatric Assessment for pts aged >70 yrs (only at time 0): CIRS (Comorbility Index) IADL/ADL (Instrumental Activities Daily Living/Activities Daily Living). Patients characteristics -159 pts -Total Median Age: 66 yrs (range 38–86) -Median ECOG PS: 1 (range 0–2) -Elderly (>70 yrs): 75. Pain Starting situation -Median starting VAS: 5.5 (range 3–9) -TIQ: depression 70 pts, cachexia 55 pts, dispnoea 40 pts -CIRS (Comorbidity index): comorbidity were present among 66 pts. TTS-Fentanyl starting dose: 25 mcg/h every 72 h (range 25–50 mcg) or oral morphine long acting 60–90 mg plus IROM 10 mg every 4–6 hours for breakthrough pain present in 38 pts Results: -Quickly pain VAS downloading during first two weeks of treatment (median VAS 1) -Analgesic doses were not significantly increased after two months and not exceeded WHO grade 2 -IROM rescue was similar to that observed for the overall population -TIQ, ADL and IADL were not influenced by therapy. Conclusions: High potency opioids (TTS-F or long acting morphine equipollent doses, plus Rescue-IROM) offers durable long term maintenance pain relief wild acceptable toxicity also in elderly people, is particularly useful for cancer pts with compliance problems and may be considered as first-line treatment for moderate/severe cancer pain. No significant financial relationships to disclose.

BACKGROUNDTo determine whether a dose-dense regimen improves outcome in early breast cancer patients, we compared outcomes with the same fluorouracil, epirubicin, and cyclophosphamide (FEC) chemotherapeutic regimen administered every 3 weeks (FEC21) or administered every 2 weeks (FEC14 including support with filgrastim, a granulocyte colony-stimulating factor) in a multicenter phase III randomized trial.METHODSA total of 1214 patients with early-stage breast cancer were randomly assigned to receive six cycles of FEC14 (604 patients) or of FEC21 (610 patients). Study endpoints were overall survival and event-free survival. Associations were assessed by multivariable analysis with adjustment for age; tumor size; grade; proliferative rate; and menopausal, lymph node, estrogen receptor, and progesterone receptor status. All statistical tests were two-sided.RESULTSPatients in the FEC14 arm had fewer dose reductions or treatment delays or discontinuation (26%) than those in the FEC21 arm (33%) (difference = 7%, 95% confidence interval [CI] = 2% to 12%; P = .008). FEC14 therapy, compared with FEC21 therapy, was associated with more asthenia (36% versus 29%, difference = 7%, 95% CI = 2% to 12%; P = .01), bone pain (33% versus 4%, difference = 29%, 95% CI = 25% to 33%; P < .001), anemia (38% versus 19%, difference = 19%, 95% CI = 14% to 24%; P < .001), and thrombocytopenia (8% versus 2%, difference = 6%, 95% CI = 4% to 9%; P < .001), but with less leukopenia (12% versus 45%, difference = 33%, 95% CI = 28% to 37%; P < .001). No acute myelogenous leukemia or myelodysplastic syndrome was observed. At a median follow-up of 10.4 years, no statistically significant difference in the hazard of death (hazard ratio [HR] = 0.87, 95% CI = 0.67 to 1.13) or recurrence (HR = 0.88, 95% CI = 0.71 to 1.08) was found between FEC14 and FEC21 groups after adjustment by multivariable analysis. Although the study was underpowered for subset analysis, we found no evidence that the effect of the treatment type was associated with any of the potential prognostic factors.CONCLUSIONOur results support the long-term safety of FEC14 chemotherapy as an adjuvant treatment of breast cancer. However, this therapy was not associated with improved outcome, but because of the limited statistical power of our study, we cannot rule out a modest improvement in outcome associated with FEC14 therapy.

Aims and background: Rarely are conclusions from clinical trials summarized in international consensus conferences and promptly transferred to patient care. The adjuvant therapy for colorectal cancer used in daily clinical practice in Italy is described and compared with the recommendations of the 1990 NIH Consensus Conference.Patients and methods: We audited prescriptions of adjuvant systemic therapies for Italian colorectal cancer patients in 82 centers during a fixed one-week period.Results: Among 434 patients receiving adjuvant chemotherapy there were 139 (42.5%) colon cancer patients with N- and 169 (51.7%) with N+ regional nodal involvement. Treatment at academic centers, a young age, T4 and a low total number of lymph nodes removed at surgery were the factors potentially justifying the decision for adjuvant chemotherapy in stage II colon cancer patients. The most common chemotherapy used was a bolus of 5-fluorouraci/fiolinic acid for 6 months (75.8%). Adjuvant radiotherapy was not administered to 37 (38.5%) of 96 patients with stage II and III rectal cancer.Conclusions: The study shows that a substantial proportion of patients on adjuvant treatment at a certain time point in a large enough sample of Italian centers are stage II (potential over-treatment) and that an under-treatment of stage II and III rectal cancer patients (lack of radiotherapy) occurs too often in daily clinical practice in this country.

No data are available on the role of HER2 overexpression in predicting the efficacy of dose-dense anthracycline-containing adjuvant chemotherapy in breast cancer patients. We retrospectively evaluated this role in patients enrolled in a phase III study comparing standard FEC21 (5-fluorouracil, epirubicin, and cyclophosphamide, administered every 3 weeks) vs dose-dense FEC14 (the same regimen repeated every 2 weeks). HER2 status was determined for 731 of 1214 patients. Statistical analyses were performed to test for interaction between treatment and HER2 status with respect to event-free survival (EFS) and overall survival (OS); EFS and OS were compared within each HER2 subgroup and within each treatment arm. Median follow-up was 6.7 years. Among FEC21-treated patients, both EFS (HR = 2.07; 95% CI 1.27-3.38) and OS (HR = 2.47; 95% CI 1.34-4.57) were significantly worse in HER2+ patients than in HER2- patients. Among FEC14-treated patients, differences in either EFS (HR = 1.21; 95% CI 0.65-2.24) or OS (HR = 1.85; 95% CI 0.88-3.89) between HER2+ and HER2- patients were not statistically significant. Interaction analysis suggested that the use of dose-dense FEC14 might remove the negative prognostic effect of HER2 overexpression on EFS and OS. Our data suggest a potential role of HER-2 overexpression in predicting the efficacy of dose-dense epirubicin-containing chemotherapy and the need to confirm this hypothesis in future prospective studies.

6117 Background: Lung Cancer incidence in Italy in 1997 was 60.57 cases/100.000 with great variations in terms of survival and treatment modalities in different geographic areas. Outcome research can therefore help investigating medical effectiveness,meaning how effective prevailing treatments are in routine clinical practice and in unselected populations. Methods: Information was collected from 22 Oncology Units in Piemonte and Valle d’Aosta,on 404 newly diagnosed lung cancer patients between October 1999 and March 2000. This number represents 40% of the expected incidence in this geographic area. A minimal set of information about the process and outcome measures was collected from medical records,at first visit and 6 months after,even when no therapy was planned. After 3 years,an audit process was performed on a sample of all registered patients,collecting additional information and updating the follow-up. The audit involved 236 patients from 8 major hospitals. Results: Patients were males in 85% of cases,with a median age 65 years (range 30–94). PS was 0–2 in 73% of cases (missing data 9%). Tumour stage was recorded in 68% of cases;this percentage increased to 95% after the audit. The following data refer to the 236 validated records. Most patients had stage IIIB (16.5%) or IV (55%) disease;information on stage was not available in 4% of patients. 73% were NSCLC and 11% SCLC. Chemotherapy was performed on 75% of patients and those older than 65 years were less likely to be treated (p<0.0009). Patients with a PS 0–2 were more likely to be treated with chemotherapy (p<0.0001). Radiotherapy (adjuvant, prophylactic, for metastases) was performed on 45% of patients with NSCLC, regardless of age and PS. During the audit,specific information on diagnostic procedures were collected: 53% of patients had chest X rays,47% chest tomography,50% whole body CT,40% bronchoscopy,37% biopsy,25% needle aspiration,19% liver US,27% bone scan. This was irrespective of age and PS. Conclusion: This project represents a valid tool for a permanent surveillance of quality of care in lung cancer patients in a defined geographic area, allowing a precise definition of needs for assistance and helping in the decision on how to allocate financial resources. No significant financial relationships to disclose.