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Introduction/Background Patients with advanced NSCLC who experience disease progression after second-line therapy might receive further active treatment. LIFE was an Italian cohort multicenter observational study composed of a cross-sectional and a longitudinal phase. Patients and Methods In the longitudinal phase, described here, the primary aim was to determine the proportion of patients receiving third-line therapy among those who received second-line active treatment according to clinical practice. The proportion of patients receiving further treatment lines was also estimated. Results The longitudinal phase was conducted between January and August 2012. Of 464 patients who began second-line therapy outside of clinical trials within the baseline evaluation, 56 (12.1%) were still receiving second-line therapy at the end of the observation period and 17 (3.7%) withdrew during or after second-line therapy. Of the remaining 391 patients, 158 (40.4%) received third-line treatment outside of clinical trials: 93 received a third-line chemotherapy and 65 a targeted agent. The main reason for interrupting third-line treatment was disease progression or death. During the same observation period, 25 of 113 patients who completed a third-line therapy received a fourth line of treatment. From diagnosis of NSCLC to the end of observation, biomarkers were tested in 323 patients (59.7%): epidermal growth factor receptor mutations in 315 (58.2%), Kirsten rat sarcoma 2 viral oncogene homolog (KRAS) mutations in 83 (15.3%) and Anaplastic lymphoma kinase (ALK) translocation in 84 (15.5%). Conclusion In Italian clinical practice, the proportion of patients with advanced NSCLC receiving more than 2 treatment lines of therapy is not negligible.

Poster Abstract

It is not known whether frontal cerebral rhythms of the two hemispheres are implicated in fine motor control and balance. To address this issue, electroencephalographic (EEG) and stabilometric recordings were simultaneously performed in 12 right-handed expert golfers. The subjects were asked to stand upright on a stabilometric force platform placed at a golf green simulator while playing about 100 golf putts. Balance during the putts was indexed by body sway area. Cortical activity was indexed by the power reduction in spatially enhanced alpha (8-12 Hz) and beta (13-30 Hz) rhythms during movement, referred to as the pre-movement period. It was found that the body sway area displayed similar values in the successful and unsuccessful putts. In contrast, the high-frequency alpha power (about 10-12 Hz) was smaller in amplitude in the successful than in the unsuccessful putts over the frontal midline and the arm and hand region of the right primary sensorimotor area; the stronger the reduction of the alpha power, the smaller the error of the unsuccessful putts (i.e. distance from the hole). These results indicate that high-frequency alpha rhythms over associative, premotor and non-dominant primary sensorimotor areas subserve motor control and are predictive of the golfer's performance.

"Attentional" adaptations are fundamental effects for sport performance. We tested the hypothesis that tiredness and muscular fatigue poorly affect visuo-spatial attentional processes in elite karate athletes. To this aim, 14 elite karate athletes and 11 non-athletes were involved in an isometric contraction exercise protocol up to muscular fatigue. Blood lactate and attention measurements were taken. Posner's test probed "endogenous" (i.e., internally planned allocation of spatial attention) and "reflexive" (i.e., brisk variation of endogenous spatial attention due to unexpected external stimuli) attention. Lactate and attentional measurements were performed before (Block 1, B1) and after the fatiguing exercise (B2) and at the end of a recovery period (B3). Compared to the non-athletes, the athletes showed a better performance in the fatigue protocol, confirmed by the higher absolute lactate values in B2. The correct responses in the "valid trials" probing "endogenous" attention were 92.4% (B1), 93.9% (B2), and 95.8% (B3) in the non-athletes, and 98.5%, 96.4%, 95.5% in the elite karate athletes. The correct responses in the "invalid trials" probing "reflexive" attention were 95.4%, 89.7%, 93.2% in the non-athletes, and 96.4%, 97.3%, 98.5% in the elite karate athletes. The percentage of correct responses in the "invalid" trials significantly decreased from B1 to B2 in the non-athletes but not in the elite karate athletes. In conclusion, tiredness and muscular fatigue do not affect "reflexive" attentional processes of elite karate athletes, which is crucial to contrast attacks coming from an unexpected spatial region.

Cortical sources of resting state electroencephalographic (EEG) rhythms are abnormal in subjects with mild cognitive impairment (MCI). Here, we tested the hypothesis that these sources in amnesic MCI subjects further deteriorate over 1 year. To this aim, the resting state eyes-closed EEG data were recorded in 54 MCI subjects at baseline (Mini Mental State Examination I = 26.9; standard error [SE], 0.2) and at approximately 1-year follow-up (13.8 months; SE, 0.5; Mini Mental State Examination II = 25.8; SE, 0.2). As a control, EEG recordings were also performed in 45 normal elderly and in 50 mild Alzheimer's disease subjects. EEG rhythms of interest were delta (2-4 Hz), theta (4-8 Hz), alpha1 (8-10.5 Hz), alpha2 (10.5-13 Hz), beta1 (13-20 Hz), and beta2 (20-30 Hz). Cortical EEG sources were estimated using low-resolution brain electromagnetic tomography. Compared with the normal elderly and mild Alzheimer's disease subjects, the MCI subjects were characterized by an intermediate power of posterior alpha1 sources. In the MCI subjects, the follow-up EEG recordings showed a decreased power of posterior alpha1 and alpha2 sources. These results suggest that the resting state EEG alpha sources were sensitive-at least at the group level-to the cognitive decline occurring in the amnesic MCI group over 1 year, and might represent cost-effective, noninvasive and widely available markers to follow amnesic MCI populations in large clinical trials.

article i nfo Playing music in ensemble represents a unique human condition/performance where musicians should rely on empathic relationships. Recent theories attribute to frontal Brodmann areas (BAs) 44/45 and 10/11 a neu- ral basis for "emotional" and "cognitive" empathy. We hypothesized that activity of these structures reflects empathy trait in professional musicians playing in ensemble. Simultaneous electroencephalographic (EEG) alpha rhythms (8-12 Hz) were recorded in three saxophone quartets during music performance in ensemble (EXECUTION), video observation of their own performance (OBSERVATION), a control task (CONTROL), and resting state (RESTING). EEG source estimation was performed. Results showed that the higher the empathy quotient test score, the higher the alpha desynchronization in right BA 44/45 during the OBSERVATION refer- enced to RESTING condition. Empathy trait score and alpha desynchronization were not correlated in other control areas or in EXECUTION/CONTROL conditions. These results suggest that alpha rhythms in BA 44/45 reflect "emotional" empathy in musicians observing own performance.

Here we describe a methodological approach for the simultaneous electroencephalographic (EEG) recording in musicians playing in ensemble. Four professional saxophonists wore pre-wired EEG caps (30 electrodes placed according to an augmented 10-20 system; cephalic reference and ground). Each cap was connected to a single multi-channel amplifier box [Brain Explorer (BE), EB-Neuro(©)]. The four boxes converged to a single workstation equipped with a software (GALILEO NT, EB-Neuro(©)) allowing the simultaneous recording of sounds, digital trigger, and EEG-electrooculographic (EOG)-electromyographic (EMG) data, and providing a separate output file for each individual. Noteworthy, the subjects were electrically decoupled to satisfy international safety guidelines. The quality of the EEG data was confirmed by the rate of artifact-free EEG epochs (about 80%) and by EEG spectral features. During the resting state, dominant EEG power density values were observed at alpha band (8-12Hz) in posterior cortex. The quality of EMG can be used to identify "on" and "off" states of the musicians' motor performance, thus potentially allowing the investigation of the relationships between EEG dynamics and different characteristics of the specific performance. During the music performance, alpha power density values decreased in amplitude in several cortical regions, whereas power density values enhanced within narrow high-frequency bands. In conclusion, the present methodological approach appeared to be suitable for simultaneous EEG recordings in musicians playing in ensemble.

To determine the activity of sequential administration of thymopentin (TP-5), interferon alpha-2a (IFN) and interleukin-2 (IL-2) in metastatic renal cell cancer (RCC), 17 patients with RCC were treated with TP-5 50 mg/d on days 1 to 14, IFN 3 MIU/d on days 14, 15, 21, 22 and IL-2 18 MIU/d on days 16 to 20, and 23 to 27. Treatment was given subcutaneously and cycles were repeated every 6 weeks. All patients were assessed for toxicity and response. No objective responses were observed. Two patients had a short-lived disease stabilization. Median survival was 9 months. Toxicity was generally moderate. The most important side-effects were related to IL-2 administration. In view of the lack of antitumor activity, the combination of TP-5 + IFN + IL-2 in the doses and schedule used in this trial cannot be recommended. The investigation of chemotherapeutic and immunological agents that can effectively synergize with IFN or IL-2 is essential.

23 citazioni: 22 su Scopus e una citazione presente in GoogleScholar ("Das Taxol-Buch" di Volker Bartsch THIEME Ed. 2004 ISBN 3-13-105462-X) ----- Paclitaxel and vinorelbine are among the most active new agents in metastatic breast cancer. Both in vitro and in vivo studies have shown that the combined administration of these two microtubule-targeting agents is feasible and worthwhile. Based on the promising preclinical data, patients with metastatic breast cancer no longer amenable to conventional treatment were entered into a phase I/II study in which the vinorelbine dose was fixed at 30 mg/sqm and paclitaxel was started at 90 mg/sqm and then subsequently escalated by 30 mg/sqm per step. Cycles were repeated every 21 days. Hematopoietic growth factor support was provided from the 4th dose level onwards. Grade III neutropenia was observed only in 2 patients treated at the 5th dose level. Thrombocytopenia never reached grade 3. Neurotoxicity was considered dose-limiting, since grade 3 peripheral neuropathy occured in all three patients treated at the 6th dose level. Other toxicities were mild. Paclitaxel 210 mg/sqm and vinorelbine 30 mg/sqm was the selected combination for phase II. Overall response rate in 34 evaluable patients was 38% (95% confidence interval (C.I.), 22% to 54%). In particular, 3 complete responses (9%) and 10 partial responses (29%) were observed. The observed level of antitumor activity, with an overall response rate of 38% and a median duration of response of 12 months, is of interest, since the study was targeted only to anthracycline-pretreated patients, most of whom had adverse prognostic features. The evaluation of a combination of vinorelbine and paclitaxel as first-line therapy in metastatic breast cancer seems worthwhile and is currently undergoing.

To determinate MTD, DLT and safe doses for phase II study, a dose finding study with Mitomycin and Adriamycin Stop-Flow administration was carried out. A phase II study focused on resectability of pelvic colorectal relapses is in progress. From November 1995, 84 pts, 52 male and 32 female (94 treatments), with advanced not resectable abdominal (14 pts) or pelvic (70 pts) relapses, and resistant to previous systemic chemotherapy, were enrolled in the study. 46 pts entered the phase I-early phase II study, while subsequently 38 pts were recruited in ongoing phase II study. Safe dose were: MMC 20 mg/mq and ADM 75 mg/mq. The phase II study focused on colorectal relapses registered very promising responses: 90% pain control, 1 pCR and 26 PR / 63 (OR 43%), 8 NC (13%) 9/27 responder patients (33%) obtained a complete resectability of colorectal relapses. Stop-Flow is a safe and feasible technique very useful as a palliation treatment.