bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cisplatin and Weekly Docetaxel as First-Line Therapy in Patients with Advanced Non-Small Cell Lung Cancer a Phase II Study
Authors: Tartarone Alfredo , Romano Gianpiero , lodice Giovanni , Capobianco Alba , Coccaro Mariarosa , Bochicchio Annamaria , Di Leo Pasquale , Ardito Raffaele , Di Renzo Nicola 
Published: July 2019

Background Based on the results of previous phase I studies, in the current phase II trial we evaluated the efficacy and toxicity of cisplatin plus weekly docetaxel in the treatment of advanced non-small cell lung cancer (NSCLC). Patients and methods The eligibility criteria for the study included newly diagnosed stage IIIB/IV NSCLC, age ≤75 years, Eastern Cooperative Oncology Group performance status of 0-2, adequate organ functions, and signed informed consent. The chemotherapy regimen consisted of cisplatin, 80 mg/m2 on day 1, and docetaxel, 25 mg/m2 on days 1, 8 and 15 every 4 weeks. Results Between January 2002 and December 2003, 31 patients with NSCLC were enrolled in the study. An objective response rate of 40% (95% CI, 21-60) was obtained in 27 assessable patients. The median time to progression was 6.4 months (range, 2.5-26.3) and median overall survival was 10.01 months (range, 5-28.3). The regimen was well tolerated with no grade 4 toxicity. Conclusions Cisplatin plus weekly docetaxel is an effective and well-tolerated regimen in chemo-naive patients with advanced NSCLC. A phase III study of weekly versus the conventional regimen of every three weeks should be conducted to compare the survival benefits, toxicity profile and quality of life.
A Pilot Study on the Effect of Acetyl-L-Carnitine in Paclitaxel-And Cisplatin-Induced Peripheral Neuropathy
Authors: Maestri Antonio , De Pasquale Ceratti Adolfo , Cundari Sante , Zanna Claudio , Cortesi Enrico , Crinò Lucio 
Published: July 2019

Aims and background In addition to bone marrow suppression and renal toxicity, neurotoxicity is a commonly occurring side effect of widely used chemotherapeutic agents like taxanes, cisplatin and vinca alkaloids. Neurotoxicity can cause antitumor therapy discontinuation or dose regimen modification. The aim of the present exploratory study was to investigate the activity of acetyl-L-carnitine in reversing peripheral neuropathy in patients with chemotherapy-induced peripheral neuropathy. Methods and study design Twenty-seven patients (16 males and 11 females) with paclitaxel and/or cisplatin-induced neuropathy (according to WHO recommendations for the grading of acute and subacute toxic effects) were enrolled. Patients received at least one cisplatin- (n = 5) or one paclitaxel- (n = 11) based regimen, or a combination of both (n = 11). Patients with chemotherapy-induced peripheral neuropathy were treated with acetyl-L-carnitine 1 g/die iv infusion over 1-2 h for at least 10 days. Results Twenty-six patients were evaluated for response having completed at least 10 days of acetyl-L-carnitine therapy (median, 14 days; range, 10-20). At least one WHO grade improvement in the peripheral neuropathy severity was shown in 73% of the patients. A case of insomnia related to ALC treatment was reported in one patient. Acetyl-L-carnitine seems to be an effective and well-tolerated agent for the treatment of chemotherapy-induced peripheral neuropathy. Conclusions Our preliminary results should be confirmed in double-blind, placebo controlled studies.
Treatment of Uterine Sarcoma at the University of Florence from 1980-2001
Authors: Livi Lorenzo , Paiar Fabiola , Meldolesi Elisa , Simontacchi Gabriele , Amunni Gianni , Barca Raffaella , Villanucci Alessandro , Scoccianti Silvia , Piperno Gaia , Biti Gianpaolo 
Published: July 2019

Purpose To correlate the treatment used in uterine sarcoma with outcome. The prognostic importance of pathology, clinical parameters and treatment are analyzed. Patients and methods Forty patients (median age, 59 years; range, 37-85) with histologically verified uterine sarcoma were identified from a database compiled at the University of Florence from 1980 to 2001. Patients were followed for a median of 54 months (range, 3 months to 10 years). Twenty-four patients had leiomyosarcoma, 12 patients had mixed mullerian tumors, and 3 patients had endometrial stromal sarcoma. Stage I, II, III and IV tumors were identified in 22, 2, 9 and 7 patients, respectively. High, intermediate, low and unspecified grade sarcoma occurred in 9, 4, 5 and 22 patients, respectively. Results At the time of analysis, 58% of patients had died and 42% were alive, with a median survival of 2 years from the initial diagnosis. Cause-specific survival for the entire group was 81%, 41% and 25% at 1, 3 and 5 years, respectively. In our series, univariate analysis for cause-specific survival did not demonstrate statistical significance for histology, grade, stage or age. There appeared to be a significant impact for postoperative radiotherapy in reducing local recurrence with a total dose higher than 50 Gy. Conclusions Our data favor treatment for uterine sarcoma with radical surgery plus irradiation, even in elderly patients.
Intraoperative Gamma Probe Detection of Head and Neck Paragangliomas with 111In-Pentetreotide: A Pilot Study
Authors: Filippi Luca , Valentina Fabrizio Benedetti , Gossetti Bruno , Gossetti Francesco , De Vincentis Giuseppe , Scopinaro Francesco , Massa Rita 
Published: July 2019

Aims and background The aim of this study was to assess whether intraoperative radiolocalization of head and neck paragangliomas with 111In-pentetreotide may increase surgical effectiveness, reducing the risk of recurrence. Methods Our study included eight patients with untreated, recently diagnosed paragangliomas (four unilateral and four bilateral tumors of the carotid body). After iv injection of −150 MBq 111In-pentetreotide, preoperative somatostatin receptor scintigraphy (SRS) was performed. SPECT of the neck was performed at four hours and planar Images of the head and neck were also obtained at four and 24 hours post injection. Scintigraphy was always compared with the results of conventional imaging methods (MRI, angiography and sonography). Intraoperative detection was performed on 11 lesions 24 hours after radiopharmaceutical administration using a handheld gamma probe. Results Preoperative SRS showed high radiotracer uptake in all patients. All the intraoperatively detected lesions were radically resected and histologically confirmed to be involved by tumor. No false positive results were recorded. Gamma probe detection revealed a small intracranial extension not detected by other imaging methods in a patient with a paraganglioma of the right carotid, and partial involvement of the carotid artery in another patient. During follow-up (median 3.5 years; range, 4 months-7 years) all patients remained disease free according to all parameters. Conclusions To our knowledge, this is the first experience of radioguided surgery in paraganglioma. Although our study included a relatively small number of patients, we suggest that intraoperative gamma probe detection may be a powerful tool to improve surgical effectiveness.
Concurrent 5-Fluorouracil, Mitomycin C and Radiation with or without Brachytherapy in Recurrent Cervical Cancer: A Scoring System to Predict Clinical Response and Outcome
Authors: Smaniotto Daniela , D'Agostino Giuseppe , Luzi Stefano , Valentini Vincenzo , Macchia Gabriella , Mantini Giovanna , Margariti Pasquale Alessandro , Ferrandina Gabriella , Scambia Giovanni 
Published: July 2019

Aims and purpose This is a prospective, phase II study aimed to evaluate the effect of concurrent 5-fluorouracil, mitomycin C, and radiation with or without brachytherapy on the clinical outcome of a series of recurrent cervical cancer patients and to determine the prognostic impact of a subset of factors. Methods Thirty-three patients with locally recurrent, non-metastatic cervical cancer received external beam radiation (4-week split course: 23.4 + 23.4 Gy) plus two courses of concomitant chemotherapy (5-fluorouracil, 96-h continuous infusion, days 1–4, 1 g/m2/day; mitomycin C, 10 mg/m2, bolus iv, day 1). Twelve patients with vaginal recurrence (36.4%) underwent endocavitary low-dose rate brachytherapy boost (20–25 Gy); 11 patients with lateral pelvic recurrence (33.3%) received external beam radiation boost (14–20 Gy). Results Fourteen complete responses (42.4%), 7 partial responses (21.2%), 5 disease stabilizations (15.1%) and 7 progressions (21.2%) were obtained. After a median follow-up of 34 months (range, 6–127), overall actuarial 3-year survival, progression-free survival and local progression-free survival were 59.7%, 48.1% and 51.7%, respectively. Patients with vaginal recurrence of less than 4 cm and negative lymph nodes proved to respond best to the treatment. Two patients (6.1%) experienced hematologic grade 3 toxicity. One patient had grade 3 intestinal toxicity (3.0%). No patient had major skin or urological acute toxicity. Severe late toxicity was infrequent Three patients had prolonged leukopenia (9.0%). Four patients showed severe vaginal stenosis (12.1%). A clinical score of 0 to 1 was assigned to each patient on the basis of the absence (score = 0) or presence (score = 1) of any of the following prognostic factors: time between surgery and recurrence shorter than 12 months, pelvic wall site of recurrence, positive lymph nodes, hemoglobin <11 g/dL. Using this system, it was clear that patients with a low total score had a significantly better outcome (clinical remission, 51% of patients with a score ≤2 vs 12% of patients with a score >2, P = 0.06), local control of the disease (65% vs 20% after 3 years, P = 0.001,) and overall survival (75% vs 30% after 3 years, P = 0.032). Conclusions Our data suggest that this combined modality therapy was relatively well tolerated and resulted in reasonable local control and survival. The scoring system proved to be helpful to identify patients with the greatest chance of benefiting from the treatment Further studies are probably needed to salvage the other patients, whose prognosis remains severe.
Irinotecan and Oxaliplatin Combination, As Second-Line Treatment, In Fluoropyrimidine-Pretreated Advanced Colorectal Cancer. A Phase Ii Study by the Hellenic Cooperative Oncology Group (Hecog)
Authors: Timotheadou Eleni , Papakostas Pavlos , Tsavdaridis Dimitrios , Basdanis George , Kalofonos Haralambos , Aravantinos Gerasimos , Bafaloukos Dimitrios , Fountzilas George 
Published: July 2019

Background The management of patients with fluoropyrimidine-resistant advanced colorectal cancer remains investigational. Irinotecan and oxaliplatin have proved effective in first-line treatment in combination with 5-fluorouracil. Study design From February 1998 to September 2002, 34 patients with 5-fluorouracil-pretreated advanced colorectal cancer were enrolled in the study. Median age was 67 years (range, 32–76) and median performance status was 1. Twenty-one patients had multiple liver metastases. Other sites of disease included lungs, abdomen, pelvis, lymph nodes, bones and skin. They received six 28-day cycles of oxaliplatin (85 mg/m2 in a 2-h infusion on days 1 and 15) and irinotecan (80 mg/m2 in a 30-minute infusion on days 1,8 and 15 immediately following oxaliplatin). Results Thirteen patients (39%) completed treatment. The most common grade III-IV toxicities were diarrhea (27%), anemia (6%), neutropenia (18%), alopecia (6%) and peripheral neuropathy (6%). Thirteen patients (39%) received G-CSF support, and there were 2 episodes of febrile neutropenia. There were no treatment-related deaths. Six patients (18%) had a partial remission and another 11 (33%), disease stabilization. There were no complete remissions. Median time to progression was 6.6 months (range, 0.8–20.1) and median survival 10.6 months (range, 0.8–52.9). Conclusions Irinotecan and oxaliplatin combination has modest activity as second line treatment of 5-fluorouracil-resistant advanced colorectal cancer. Further research is warranted for the development of more effective and less toxic regimens in this setting.
Dose-Finding Study of Weekly Docetaxel plus Estramustine in Patients with Hormone-Refractory Metastatic Prostate Cancer
Authors: Coccaro Mariarosa , Tartarone Alfredo , Romano Gianpiero , Ardito Raffaele , Di Renzo Nicola 
Published: July 2019

Objective The aim of this phase I study was to find the maximum tolerated dose of weekly docetaxel in association with estramustine in hormone-refractory prostate cancer. Methods Eleven patients with hormone-refractory prostate cancer were treated with escalating weekly doses of docetaxel (level I, 3 patients, 30 mg/m2; level II, 3 patients, 35 mg/m2, level III, 3 patients, 40 mg/m2; level IV, 2 patients, 45 mg/m2) associated with fixed dosage of estramuscine (840 mg/day). Results In level I, there was only one episode of grade 3 neutropenia; grade 1 nausea and vomiting were registered in 1 patient; in 1 patient mild edema of the lower limbs was noted. In level II, grade 2 stomatitis and grade 1 sensory symptoms occurred in 1 patient, and grade 1 edema in 1 case. In level III, grade 2 edema was noted in 2 patients, damage to nails in 1 patient, asthenia in 1 patient, grade 1 neuropathy in 2 patients, and grade 1 nausea in 1 patient. In level IV, grade 2 edema was present in 1 patient, grade 3 edema in 1 patient, changes with fall of nails and grade 2 erythema of face in 2 patients, asthenia in 2 patients, grade 1 neuropathy in both patients. Nine patients had a more than a 50% decrease in PSA after 2 cycles of therapy. Conclusions The results of the study suggest a good tolerability of weekly 35 mg/m2 docetaxel in hormone-refractory prostate cancer in association with estramustine.
Re-Irradiation of Brain Metastases and Metastatic Spinal Cord Compression: Clinical Practice Suggestions
Authors: Maranzano Ernesto , Trippa Fabio , Pacchiarini Diamante , Chirico Luigia , Basagni Maria Luisa , Rossi Romina , Bellavita Rita , Schiavone Concetta , Italiani Marco , Muti Marco 
Published: July 2019

The recent improvements of therapeutic approaches in oncology have allowed a certain number of patients with advanced disease to survive much longer than in the past. So, the number of cases with brain metastases and metastatic spinal cord compression has increased, as has the possibility of developing a recurrence in areas of the central nervous system already treated with radiotherapy. Clinicians are reluctant to perform re-irradiation of the brain, because of the risk of severe side effects. The tolerance dose for the brain to a single course of radiotherapy is 50–60 Gy in 2 Gy daily fractions. New metastases appear in 22–73% of the cases after whole brain radiotherapy, but the percentage of re-irradiated patients is 3–10%. An accurate selection must be made before giving an indication to re-irradiation. Patients with Karnofsky performance status >70, age <65 years, controlled primary and no extracranial metastases are those with the best prognosis. The absence of extracranial disease was the most significant factor in conditioning survival, and maximum tumor diameter was the only variable associated with an increased risk of unacceptable acute and/or chronic neurotoxicity. Re-treatment of brain metastases can be done with whole brain radiotherapy, stereotactic radiosurgery or fractionated stereotactic radiotherapy. Most patients had no relevant radiation-induced toxicity after a second course of whole brain radiotherapy or stereotactic radiosurgery. There are few data on fractionated stereotactic radiotherapy in the re-irradiation of brain metastases. In general, the incidence of an “in-field” recurrence of spinal metastasis varies from 2.5–11% of cases and can occur 2–40 months after the first radiotherapy cycle. Radiation-induced myelopathy can occur months or years (6 months-7 years) after radiotherapy, and the pathogenesis remains obscure. Higher radiotherapy doses, larger doses per fraction, and previous exposure to radiation could be associated with a higher probability of developing radiation-induced myelopathy. Experimental data indicate that also the total dose of the first and second radiotherapy, interval to re-treatment, length of the irradiated spinal cord, and age of the treated animals influence the risk of radiation-induced myelopathy. An α/β ratio of 1.9–3 Gy could be generally the reference value for fractionated radiotherapy. However, when fraction sizes are up to 5 Gy, the linear-quadratic equation become a less valid model. The early diagnosis of relapse is crucial in conditioning response to re-treatment.
Perioperative Hyperfractionated High-Dose Rate Brachytherapy Combined with External Beam Radiotherapy in the Treatment of Soft Tissue Sarcomas
Authors: Petera Jiri , Neumanová Renata , Odrazka Karel , Ondrak Martin , Prochazka Egon 
Published: July 2019

Aims and background Low-dose rate brachytherapy alone or in combination with external beam radiotherapy represents a well-established adjuvant treatment in soft tissue sarcomas following surgical resection. The experience with high-dose radiotherapy in this indication is limited. The purpose of our study was an evaluation of the viability of perioperative hyperfractionated high-dose rate brachytherapy in combination with external beam radiotherapy for primary and recurrent soft tissue sarcomas. Patients and methods From February 1998 through June 2002, 10 adult patients with soft tissue sarcomas were treated by interstitial perioperative high-dose rate brachytherapy and external beam radiotherapy. TNM classification was pT2bpN0pM0 in 9 patients and pT1bpN0pM0 in 1 patient. Grade of differentiation was G1 (2 patients), G2 (n = 1), G3 (n = 5), G4 (n = 2). Surgical margins were negative in 7 cases, close in 2 cases and positive in 1 case. The tumor was localized in an extremity in all cases. Hyperfractionation 3 Gy twice daily at 10 mm from the plane of sources was used for brachytherapy, with total doses 18–30 Gy. The patients received external beam radiotheapy with doses 40–50 Gy after brachytherhapy. Follow-up periods were between 24–71 months (median, 46). Results Local control of the disease was achieved in all 10 patients. Distant metastases occurred in 2 cases. One patient was disease free after salvage surgery and chemotherapy, and one patient died of lung disease progression 14 months after brachytherapy. In one case, subcutaneous fistula occurred after radiotherapy and was cured by an excision. Six patients experienced grade 1 or 2 fibrosis and 1 case a mild peripheral neuropathy was recorded. Conclusions Our study on a small number of patients suggests that perioperative hyperfractionated high-dose rate brachytherapy with doses 8 × 3 Gy in combination with external beam radiotherapy 40–50 Gy is a promising method to achieve high biological doses in the postoperative radiotherapy of soft tissue sarcomas without severe late morbidity and warrants further research.
Prostate Brachytherapy with Iodine-125 Seeds: Radiation Protection Issues
Authors: Anglesio Silvia , Calamia Elisa , Fiandra Christian , Giglioli Francesca Romana , Ragona Riccardo , Ricardi Umberto , Ropolo Roberto 
Published: July 2019

Aims and background Brachytherapy for prostate cancer by means of permanently implanted 125 I sources is a well established procedure. An increasing number of patients all over the world are treated with this modality. When the technique was introduced at our institution, radiation protection issues relative to this technique were investigated in order to comply with international recommendations and national regulations. Particular attention was paid to the need for patient shielding after discharge from hospital. Methods The effective and equivalent doses to personnel related to implantation, the effective dose to patient relatives as computed by a developed algorithm, the air kerma strength values for the radioactive sources certified by the manufacturer compared with those measured by a well chamber, and the effectiveness of lead gloves in shielding the hands were evaluated. Results The effective dose to the bodies of personnel protected by a lead apron proved to be negligible. The mean equivalent doses to the physician's hands was 420 μSv for one implant; the technician's hands received 65 μSv. The mean air kerma rate measured at the anterior skin surface of the patient who had received an implant was 55 μGy/h (range, 10–115) and was negligible with lead protection. The measured and certified air kerma strength for 125I seeds in RAPID Strand corresponded within a margin of ± 5%. The measured attenuation by lead gloves in operative conditions was about 80%. We also defined the recommendations to be given to the patient at discharge. Conclusions The exposure risks related to brachytherapy with 125I to operators and public are limited. However, alternation of operators should be considered to minimize exposure. Patient-related measurements should verify the dose rate around the patient to evaluate the need for shielding and to define appropriate radiation protection recommendations.
P53 Alteration in Oral Tongue Cancer is Not Significantly Associated with Age at Diagnosis or Tobacco Exposure
Authors: Siegelmann-Danieli Nava , Ben-lzhack Ofer , Hanlon Alexandra , Ridge John A , Stein Moshe E , Khandelwal Vivek , Langer Corey J 
Published: July 2019

Aims and background The tumor suppressor gene P53 is mutated in almost half of head and neck cancers. The current work assessed the prognostic significance of P53 alteration in patients with squamous cell carcinoma of the oral tongue treated with a curative intent, its association with age at diagnosis (using 45 years as a cut point), and risk exposure as defined by tobacco and/or alcohol consumption. Methods P53 alteration was determined immunohistochemically in 45 patients with tongue cancer treated with a curative intent. Results P53 alteration occurred in 20 of 45 tumors (44%) and was more common among younger patients (58% versus 36% for younger versus older patients, respectively) and those lacking tobacco/alcohol exposure (53% versus 40% for “no-risk” and “risk” groups, respectively), but the differences were not statistically significant. With a median follow-up of 56 months, 5-year progression-free survival rates were 48% and 66% in patients with and without P53 detection, respectively (P = 0.22). Conclusions Despite a trend of a younger age at diagnosis in P53-altered tumors, results did not reach statistically significant differences. A trend of a worse clinical outcome with P53 alteration was noted.