On the use of field programmable gate arrays in light detection and ranging systems.

This work aims to provide details on the latest technological developments regarding LiDAR (Light Imaging Detection And Ranging) systems, with particular reference to the techniques, architectures, and methodologies partially or entirely implemented by means of the FPGA (Field Programmable Gate Array) environment. Currently, LiDAR technology is considered of great interest as it is widely employed in a variety of application fields, such as automotive, seismology, archaeology, metrology, and military. For this reason, the required performances are gradually increasing, which leads to complex and stringent solutions. The growth in LiDAR systems' complexity suggests the use of high-end general-purpose computing units such as central processing units to perform very complex tasks and FPGAs to perform multiple tasks in real-time through the implementation of dedicated computational blocks. The latter, in recent architectures, are therefore used for the execution of specific tasks that require high computational speed and system flexibility. This paper reports some case studies recently applied in the LiDAR field, with the aim of illustrating the role of FPGA technology and its benefits.

Choosing the individual rehabilitation program for patients with intermittent claudication.

This study is aimed at identifying the collateral circulation in case of femoral-aorta-iliac axis obstruction, with the purpose of a more correct therapeutic indication being either medical or surgical or physiotherapeutic or combined.

Body-worn triaxial accelerometer coherence and reliability related to static posturography in unilateral vestibular failure.

Since changes in vestibular function may be one cause of disequilibrium, major advances in measuring postural control and sensory integration in vestibular impairments have been achieved by using posturography. However, in order to overcome problems related to this type of technology, body-worn accelerometers (ACC) have been proposed as a portable, low-cost alternative to posturography for measurements of postural sway in a friendly and ecologic environment. Due to the fact that no study to date has shown the experimental validity of ACC-based measures of body sway with respect to posturography for subjects with vestibular deficits, the aim of the present study was: i) to develop and validate a practical tool that can allow clinicians to measure postural sway derangements in an otoneurological setting by ACC, and ii) to provide reliable, sensitive and accurate automatic analysis of sway that could help in discriminating unilateral vestibular failure (UVF) patients. Thus, a group of 13 patients (seven females, 6 males; mean age 48.6 ± 6.4 years) affected for at least 6 months by UVF and 13 matched healthy subjects were instructed to maintain an upright position during a static forceplate-based posturography (FBP) acquisition while wearing a Movit® sensor (by Captiks) with 3-D accelerometers mounted on the posterior trunk near the body centre of mass. Pearson product moment correlation demonstrated a high level of correspondence of four time-domain and three frequency-domain measures extracted by ACC and FBP testing; in addition, t-test demonstrated that two ACC-based time- and frequency-domain parameters were reliable measures in discriminating UVF subjects. These aspects, overall, should further highlight the attention of clinicians and researchers to this kind of sway recording technique in the field of otoneurological disorders by considering the possibility to enrich the amount of quantitative and qualitative information useful for discrimination, diagnosis and treatment of UVF. In conclusion, we believe the present ACC-based measurement of sway offers a patient-friendly, reliable, inexpensive and efficient alternative recording technique that is useful - together with clinical balance and mobility tests - in various circumstances, as well as in outcome studies involving diagnosis, follow-up and rehabilitation of UVF patients.

Support vector machines to detect physiological patterns for EEG and EMG-based human-computer interaction: a review.

Support vector machines (SVMs) are widely used classifiers for detecting physiological patterns in human-computer interaction (HCI). Their success is due to their versatility, robustness and large availability of free dedicated toolboxes. Frequently in the literature, insufficient details about the SVM implementation and/or parameters selection are reported, making it impossible to reproduce study analysis and results. In order to perform an optimized classification and report a proper description of the results, it is necessary to have a comprehensive critical overview of the applications of SVM. The aim of this paper is to provide a review of the usage of SVM in the determination of brain and muscle patterns for HCI, by focusing on electroencephalography (EEG) and electromyography (EMG) techniques. In particular, an overview of the basic principles of SVM theory is outlined, together with a description of several relevant literature implementations. Furthermore, details concerning reviewed papers are listed in tables and statistics of SVM use in the literature are presented. Suitability of SVM for HCI is discussed and critical comparisons with other classifiers are reported.

A Simple fMRI Compatible Robotic Stimulator to Study the Neural Mechanisms of Touch and Pain.

This paper presents a simple device for the investigation of the human somatosensory system with functional magnetic imaging (fMRI). PC-controlled pneumatic actuation is employed to produce innocuous or noxious mechanical stimulation of the skin. Stimulation patterns are synchronized with fMRI and other relevant physiological measurements like electroencephalographic activity and vital physiological parameters. The system allows adjustable regulation of stimulation parameters and provides consistent patterns of stimulation. A validation experiment demonstrates that the system safely and reliably identifies clusters of functional activity in brain regions involved in the processing of pain. This new device is inexpensive, portable, easy-to-assemble and customizable to suit different experimental requirements. It provides robust and consistent somatosensory stimulation, which is of crucial importance to investigating the mechanisms of pain and its strong connection with the sense of touch.

[Injuries: preventive approach and progress of injuries in the construction of the line B1 of the underground of Rome]. / Infortuni: approccio preventive e andamento infortunistico nella costruzione della linea B1 della Metropolitana di Roma 2005/2010.

The line B1 is a branch of the existing Metro line B in Rome. The route is long about 5 km, is completely underground and involves the construction of four new stations: Annibaliano, Libia /Gondar, Conca d'Oro and Jonio. The line will have a capacity of transport of 24,000 people/hour in each direction. The works started in 2006 involve about 500 workers. The report provides a statistical analysis of the events that occurred in the period 2005/2010 and aims to introduce the starting and management of this study, also on the basis of the "Operating procedures" issued by the acquisition of OSHAS 18001 certification from the agent of Metro B) / R.I.M.A.T.I. This analysis aims to provide to supervisors, to social security institutions and to workers, a usefull analysis tool in the prevention of the monitored events.

Multicentre phase II study of bifractionated CPT-11 with bimonthly leucovorin and 5-fluorouracil in patients with metastatic colorectal cancer pretreated with FOLFOX.

This multicentre phase II study was designed to evaluate the antitumour activity and toxicity of bifractionated camptothecin (CPT-11) and 5-fluorouracil/ leucovorin (5-FU/LV) in the treatment of patients with metastatic colorectal cancer (MCC) who had been pretreated with 5-FU/LV-oxaliplatin (FOLFOX regimen). In all, 35 patients were enrolled in a two-stage trial. Treatment consisted of two daily doses of CPT-11, 90 mg m2 administered over 90 min, followed by LV, 200 mg m2 administered over 2 h plus 5-FU 400 mg m2 as a bolus and 600 mg m2 as a 22-h continuous infusion administered with disposable pumps as outpatient therapy. Toxicity was closely monitored. Response was evaluated by computed tomography scans every 8 weeks. All 35 patients were assessable for toxicity and response to treatment. Seven patients had a partial response, giving an overall response rate of 20%; 11 patients had stable disease (31.4%) and 17 progressed (48.5%). The median progression-free survival was 7.1 months and median survival was 14 months. A total of 10 patients (30%) experienced grade 3-4 toxicity, including nausea (15%), diarrhoea (12%) and neutropenia (15%), while seven patients (21%) had grade 2 alopecia. The bifractionated bimonthly schedule of CPT-11 plus 5-FU/LV showed substantial antitumour activity and was well tolerated in this group of patients with a poor prognosis, pretreated with the FOLFOX regimen.

Multicenter phase II study of CPT-11 fractionated over two days with bimonthly leucovorin and 5-fluorouracil in patients with metastatic colorectal cancer.

PURPOSE: This multicenter phase II study evaluated the activity and toxicity of the combination of fractionated camptothecin (CPT-11) and 5-fluorouracil/leucovorin (5-FU/LV) (de Gramont regimen) for the treatment of metastatic colorectal cancer (MCC) patients who had received no prior chemotherapy for metastatic disease. PATIENTS AND METHODS: Fifty-four patients with a median age of 63.5 years (range: 43-75), received, every two weeks, a regimen consisting of 2 daily doses of CPT-11, 90 mg/m2 administered over a period of 90 minutes, followed by LV, 200 mg/m2 administered over 2 hours and 5-FU 400 mg/m2 as a bolus and 600 mg/m2 as a 22-hour continuous infusion. Sixty-five percent of patients had synchronous metastatic disease at diagnosis, while 35% of the patients had received adjuvant chemotherapy after radical surgery. RESULTS: All 54 patients, receiving a total of 561 cycles of chemotherapy (median 12 per patient, range 1-26), were assessable for toxicity and response to treatment. The most common toxicities (grade 3-4) among treated patients were as follows: diarrhea in 3 patients, (6%), neutropenia in 9 patients (17%) and asthenia in 3 patients (6%), with no treatment-related death. We observed 4 complete (7.4%) and 18 partial responses (33.3%), giving an overall response rate of 40.7% (95% CI: 28% to 55%); 22 patients had stable disease (40.7%) and 10 patients progressed (18.5%). After a median follow-up of 22 months, the median time to progression was 8.7 months (range 2.3-43.9+), while overall median survival was 18.8 months (range 0.7-43.9+). CONCLUSION: The fractionated bimonthly schedule of CPT-11 plus 5-FU/LV showed a lower gastrointestinal toxicity profile than expected, with substantial activity in patients with MCC.

Multicenter phase II study of fractionated bimonthly oxaliplatin with leucovorin and 5-fluorouracil in patients with metastatic colorectal cancer, pre-treated with chemotherapy.

In vitro and in vivo studies have shown that oxaliplatin (L-OHP), 5-fluorouracil (5-FU) and leucovorin (L) have a synergistic activity on metastatic colorectal cancer (MCC). In order to better exploit the synergism of action between the three drugs, L-OHP was administered over 2 days, together with 5-FU-L, in a cohort of patients with MCC that had been pre-treated with chemotherapy. Forty-six patients were entered into the trial. All had been pre-treated with chemotherapy for metastatic disease: 14 with the 'de Gramont' regimen alone, and 32 with the same regimen combined with irinotecan (CPT-11). The outpatient treatment consisted of L-OHP 50 mg/m(2), followed immediately by the 'de Gramont' regimen. All drugs were administered on days 1 and 2, every 14 days. Median patient age was 65 years (range: 46-78), male/female ratio was 29/17. All 46 patients were evaluated for response and toxicity. We observed 1 complete response (2.2%) and 14 partial responses (30.4%), giving an overall response rate of 32.6% (95% CI: 19.5-48.06%); 22 patients had stable disease (47.8%) and 9 patients progressed (19.6%). After a median follow-up of 13 months, median time to progression was 6.4 months (range: 3.1-31.2+), while overall median survival was 12.2 months (range: 3.7-31.2+). Toxicity was manageable: grade 3 or 4 neutropenia was observed in 33% of patients, while only 6% of patients had grade 1-2 neurotoxicity. The fractionated bimonthly schedule of L-OHP plus 5-FU-L, showed activity, with an acceptable toxicity profile, both in patients with MCC pre-treated with the 'de Gramont' regimen alone, or with this regimen associated with CPT-11.

Primary chemotherapy in stage IV ovarian cancer. A prospective phase II study.

BACKGROUND AND RATIONALE: Non-curative surgical cytoreduction of advanced tumors is associated with increased proliferation of the remaining tumor cells. Thus, appropriate preoperative chemotherapy should prevent both cell proliferation and the increase of resistant cells. The aim of the present study was to evaluate the efficacy and toxicity of primary chemotherapy (P-CT) in previously untreated patients with stage IV ovarian cancer (OC). PATIENTS AND METHODS: Thirty-four patients with stage IV OC were treated from January 1993 to April 2000 with P-CT. Eligibility criteria included: histologically or cytologically confirmed, unresectable stage IV OC and performance status < or = 3. P-CT consisted of four courses of carboplatin, cyclophosphamide and epirubicin until October 1996, and paclitaxel, carboplatin thereafter. Surgery followed P-CT. After the operation patients received two further courses of chemotherapy that were tailored according to their individual response. Median (M) age was 61 years, range 32-73; median performance status was 2. A total number of 197 courses of CT were administered, median 5.7 per patient. RESULTS: Complete or partial response (CR, PR) was observed in 28 patients (response rate 82%, 95% CI: 65.4% to 93.2%), disease stability and progression (SD, PD) was observed in three and three patients, respectively. Median time to progression was 16.45 months (range 4.8-90.4+), median survival time was 28 months (range 4.5 - 90.4+): 1-year survival rate was 94%. Toxicity according to WHO: nausea and vomiting grade (G) 2, 30% of patients; gastrointestinal G 2-3, 20% of patients; alopecia G 3, 88% of patients; hematological G 3-4, 73% of patients; neurologic G 2, 12% of patients. Nine pathological CRs were observed. CONCLUSION: Neoadjuvant treatment with CBDCA with either CTX and EPI or Taxol is feasible and shows activity in OC.

Ifosfamide, cisplatin, and 13-Cis retinoic acid for patients with advanced or recurrent squamous cell carcinoma of the head and neck: a phase I-II study.

BACKGROUND: Ifosfamide (IFO) and cisplatin (CDDP) are active drugs in the treatment of patients with squamous cell carcinoma (SCC) of the head and neck. 13-Cis retinoic acid (RA), along with its antiproliferative and differentiating activity on SCC cell lines, has immunomodulatory and chemopreventive effects. The objective of the current Phase I-II study was to evaluate the combination of CDDP, IFO, and RA in patients with advanced or recurrent SCC of the head and neck. METHODS: Patients with measurable recurrent, metastatic, or locally advanced SCC of the head and neck were eligible. Patients received a fixed dose of 20 mg/m(2) CDDP, and IFO was administered with sodium mercaptoethanesolfonate in three-dose increments (1000 mg/m(2), 1200 mg/m(2), and 1500 mg/m(2)) up to dose limiting toxicity. Both drugs were given for 5 consecutive days every 3 weeks. RA (0.5 mg/kg) was given orally for 5 days per week. RESULTS: Fifty-two patients either with locoregional recurrence or distant metastases (50%) or with locally advanced SCC of the head and neck beyond surgery or radiation therapy (50%) were entered into the trial. Fifteen patients were enrolled in the Phase I study, during which the maximum tolerated dose of IFO was 1500 mg/m(2). In the Phase II study (CDDP 20 mg/m(2) and IFO 1200 mg/m(2)), the response rate was 72% (95% confidence interval, 57-83%). After a median follow-up of 23 months, the median time to disease progression was 10.4 months (range, 2.9-47.2+ months), and the median overall survival was 12.95 months (range, 1.7-47.2+ months). Two patients were converted from a partial response to a complete response with RA. Toxicity was relatively well tolerated and caused no deaths. Grade 3-4 neutropenia was observed in 16 patients, and Grade 2-3 diarrhea toxicity occurred in 9 patients. CONCLUSIONS: The dose and schedule for the combination of CDDP, IFO, and RA that were used in this study are feasible and active in the treatment of patients with SCC of the head and neck, with durable responses and a relatively well tolerated toxicity.

Combined 5-fluorouracil infusion with fractionated epirubicin and cyclophosphamide in advanced breast cancer.

5-Fluorouracil (5-FU) given by continuous infusion (c.i.) allows higher dose delivery, causes less myelosuppression, and may interfere with repair of DNA damage caused by epirubicin and cyclophosphamide. With this rationale, we conducted a phase II study to test the activity and toxicity of 5-FU c.i., epirubicin, and cyclophosphamide in patients with metastatic breast cancer (MBC). Twenty-eight patients with MBC were entered in the trial. 5-FU (200 mg/m(2)) was administered by c.i. from day 1 to day 20. Epirubicin (35 mg/m(2)) and cyclophosphamide (400 mg/m(2)) were administered from day 2 to day 4, every 4 weeks. All patients were evaluable for response and toxicity. A total of 125 courses of chemotherapy were administered, with a median of 4 per patient (range: 2--6). Toxicity, assessed using World Health Organization criteria, was as follows: nausea and vomiting grade III--IV occurred in 36%, alopecia (grade III) in 86%, neutropenia (grade III--IV) in 50%, and cardiac toxicity grade I--II in 11% of patients. Five patients (17.9%) had a complete response to therapy, and 16 (57.1%) had a partial response (response rate 75%, 95% CI 55--89%). Disease stability and progression occurred in 4 (14.3%) and 3 (10.7%) patients, respectively. Median time to progression was 13.1 months (range: 3.4--66.9+), and median survival time was 27.7 months (range: 5.4--67.1+). Outpatient treatment with combined 5-FU c.i., epirubicin, and cyclophosphamide shows high activity in advanced breast cancer and gives prolonged remission with acceptable toxicity.

Phase 1B study of subcutaneously administered interleukin 2 in combination with 13-cis retinoic acid as maintenance therapy in advanced cancer.

At present, no therapeutic strategy is available to maintain responses achieved in patients treated with chemotherapy. This Phase IB study was aimed at identifying the optimal biological dose of chronic maintenance therapy using s.c. interleukin (IL) 2 and oral 13-cis retinoic acid (RA) in patients with either tumor stabilization or response to chemotherapy. IL-2 has no cross-resistance with chemotherapy and improves cancer-related lymphocytopenia, a factor that determines poor prognosis, whereas RA has immunomodulatory properties, potentially synergistic with IL-2. Eighteen patients with advanced solid tumor who achieved a response or stable disease as a result of standard chemotherapy, received RA (0.5 mg/kg) and IL-2 5 days/week for two cycles of 3 weeks/month for up to 1 year. Three doses of IL-2 were used: 9.0, 4.5, and 1.8 x 10(6) IU/day. Monitoring consisted in a weekly blood differential count and a bimonthly assessment of tumor markers, CD4+, CD8+, and natural killer cells. Patients were evaluated for toxicity, response maintenance, time to progression, and survival. Patients chronically treated with 9 and 4.5 x 10(6) IU of IL-2 developed dose-limiting toxicity grade III or IV, consisting of fever, fatigue, thrombocytopenia, mucositis, and local cutaneous reaction. No grade III or IV toxicity was observed with the 1.8 x 10(6) IU dose, considered as the optimal biological dose. Fifty courses of IL-2 were administered (median, 3 per patient). An increase in total lymphocyte number, CD4:CD8 ratio and natural killer cell count was observed at all of the three dose levels with respect to baseline values. Two patients with a partial response to chemotherapy achieved a complete response after 6 and 7 months, respectively, of IL-2 + RA maintenance therapy. Median time to progression and overall survival were, respectively, 8.1 and 13.7 months (range, 2-48.8+ months). Low-dose IL-2 + RA as maintenance therapy after chemotherapy is, therefore, feasible and well tolerated and improves immunological parameters known to have a prognostic value in cancer.

5-fluorouracil-carboplatin continuous infusion as salvage chemotherapy in advanced cancer.

AIMS AND BACKGROUND: 5-fluorouracil given by continuous infusion allows higher dose delivery, causes less myelosuppression and may interfere with repair of DNA damage caused by carboplatin. With this rationale, we conducted a phase II study to test the activity and toxicity of 5-fluorouracil and carboplatin given in continuous infusion to patients with advanced cancer and pretreated with at least two chemotherapy regimens. METHODS: Forty patients with advanced tumors (21 colon, 4 stomach, 3 breast, 3 bladder, 3 ovary, and 6 at other sites) were entered in the trial. 5-fluorouracil (200 mg/m2) and carboplatin (20 mg/m2) were administered by continuous infusion from days 1 to 20, every 4 weeks. RESULTS: All patients were assessable for response and toxicity. A total of 138 courses of chemotherapy were administered, with a mean of 3.5 per patient (range, 2-9). Toxicity, assessed using WHO criteria, was as follows: nausea and vomiting grade 2-3 in 34% of patients, alopecia grade 2-3 in 96%, and neutropenia grade 3-4 in 26%. One patient (2.5%) had a complete response to therapy and 7 (17.5%) had a partial response (response rate 20%; 95% Cl, 9.06-35.68%). Disease stability and progression occurred in 12 (30%) and 20 (50%) patients, respectively. Median time to progression was 5.6 months (range, 2.8-45.9+), with a median survival time of 7.7 months (range, 1.5-45.9+). CONCLUSIONS: Outpatient treatment with a combination of 5-fluorouracil and carboplatin in continuous infusion was active as salvage treatment for advanced tumors and may give prolonged palliation of symptoms with manageable toxicity.

Cisplatin, vindesine, mitomycin-C and 13-cis retinoic acid in the treatment of advanced non small cell lung cancer. A phase II pilot study.

BACKGROUND: Thirteen-cis retinoic acid (RA) has been shown to have growth-inhibitory and differentiative activity on non-small cell lung cancer (NSCLC) cells in vitro. This promoted the rationale for combining RA with three active drugs, cisplatin (CDDP) vindesine (VDS) and mitomycin-c (MMC) in the treatment of advanced NSCLC. PATIENTS AND METHODS: Patients with a histologically confirmed non-resectable NSCLC, measurable lesion, performance status < or = 3, and informed consent were enrolled. The chemotherapy schedule included cisplatin 60 mg/m2 and mitomycin-c 10 mg/m2 day 1 and vindesine 3 mg/m2 on days 1 and 5, every 4 weeks. RA was administered orally, at a dose of 0.5 mg/kg, 5 days per week, during chemotherapeutic intervals and to responding patients until disease progression was observed. RESULTS: Thirty patients, receiving a total of 163 chemotherapy courses, were evaluated for response and toxicity. Objective responses included complete response in 2 patients (7%), partial response in 10 patients (33%), stable disease in 9 patients (30%) and progressive disease in 9 patients (30%), (response rate 40%: Confidence interval 95% 22.7% to 59.4%). Median time to progression was 8.6 months (range 3.9-45+). Median overall survival was 11.3 months (range 1-45+). The 1-year survival rate was 47%. Toxicity (WHO) included nausea and vomiting grade 2 in 6 patients, transient ileus in 3 patients and grade 3-4 leukopenia in 5 patients. Two patients underwent surgical resection of residual disease and remain in CR. CONCLUSIONS: The addition of RA to cisplatin, vindesine and mitomycin-c is feasible and shows some activity in the treatment of NSCLC, with manageable toxicity.

Carboplatin, vindesine, 5-fluorouracil-leucovorin and 13-cis retinoic acid in the treatment of advanced non-small cell lung cancer. A phase II study.

PURPOSE: Carboplatin, vindesine and 5-fluorouracil/leucovorin are drugs active in the treatment of non-small cell lung cancer (NSCLC) and they can be administered in an outpatient setting. Retinoids, which are widely used agents in chemoprevention, have been reported to exert (in vitro models) growth inhibitory effects of synergistic type with chemotherapy, and differentiating effects on NSCLC cells. PATIENTS AND METHODS: 28 patients with advanced NSCLC with measurable disease were entered into the trial. Eligibility criteria included performance status < or = 3 and adequate renal and liver function. Patients with brain metastases were not excluded. Treatment was as follows: Carboplatin (CBCDA) 300 mg/m2 day 1, Vindesine (VDS) 3 mg/m2 days 1 and 5, leucovorin (L) 100 mg/m2, 5-fluorouracil (5-FU) 370 mg/m2 for 5 days and 13-cis retinoic acid (R) 1 mg/kg, administered between chemotherapy courses. After 6 courses of chemotherapy responders were maintained with R, until progression. RESULTS: 120 courses of chemotherapy have been delivered (median 4 courses per patient, range 1 to 6). All patients were evaluable for response and toxicity. Objective responses: 2 complete responses (CR) (7%), 9 partial responses (PR) (32%), 9 stable disease (SD) (32%), 8 progressive disease (PD) (29%). (Response rate 39%, 95% CI: 22% to 60%). Median time to progression was 7.7 months (range 3.4-22) and median survival was 9.7 months (range 0.5-27) with 40% of patients alive after one year. Toxicity WHO: hematological grade 3-4 in 46% of patients, grade 2 diarrhea in 21% of patients, ileus in 14% of patients, Neurologic grade 2 in 11% of patients. CONCLUSIONS: The addition of RA to CBDCA, VDS, FU, L, R represents an effective treatment in NSCLC, with manageable toxicity.

Chemo-immunotherapy in advanced head and neck cancer.

BACKGROUND: Patients with advanced squamous cell carcinoma of the head and neck (SCC) have a depressed immune system whose function is worsened by chemotherapy. In a pilot phase II study, in order to improve the immune function during chemotherapy, we combined to cisplatin (CDDP) and 5-fluorouracil (5-FU) two biological response modifiers, retinyl palmitate (R) and Thymopentin (TP-5) for the treatment of SCC. PATIENTS AND METHODS: Fifty patients with recurrent or metastatic SCC of the head and neck were treated with Cisplatin 24 mg/m2 from day 1 to 5 and 5-FU 1,000 mg/m2 by a 120 hour continuous infusion. Retinyl palmitate was administered orally 50,000 i.u. b.i.d and Thymopentin 50 mg subcutaneously 3 times a week. RESULTS: Chemotherapy treatment was well tolerated with G3 hematological toxicity in 30% of patients and G2 gastrointestinal toxicity in 20% of patients. 16 patients (32%) had a complete response (CR), 13 patients had partial response (PR) (26%), (response rate 58%, 95% c.i. 43%-72%); stable disease (SD) was observed in 7 patients (14%), while 14 patients progressed (PD) (28%). Median time to progression was 12 months (range 2.8-94.5). Median overall survival was 13.5 months (range 2-104). CONCLUSIONS: The association of CDDP and 5-FU with Retinyl Palmitate and TP5 has a major activity in the treatment of advanced head and neck cancer and a relatively well tolerated toxicity.