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Biomedical subjects

S Giudici

Publications and source records attributed to S Giudici.

At least 19 recordsLinked to original sources

Clinical, ethical, and medical legal considerations on emergency contraception.

PURPOSE OF INVESTIGATION: To evaluate how many women required the so-called "emergency contraception" at our outpatient service and what the actual role is of this kind of pharmacological administration in interfering with ovulation and pregnancy, paying particular attention to the ethical and medico-legal aspects of this subject. METHODS: During the period from 1 December 1998 to 30 November 2003, emergency contraception was prescribed to a total of 1,160 women. With regard to the contraceptives used, in most cases (1,132, 97.6%) a combined oral estrogen-progestogen pill (ethinyloestradiol 0.05 mg plus levonorgestrel 0.25 mg) was prescribed; in some cases (20 patients, 1.8%) danazol (400 mg), in four women (0.3%) a progestin-only pill (levonorgestrel 0.75 mg), and in four other women (0.3%) an intrauterine device. RESULTS: It does not come out that there were any pregnancies in our study patients since none of them, who were told to come back for follow-up, were seen at our termination of pregnancy service or delivery room. CONCLUSION: The "Yuzpe regimen" of a combined oral estrogen-progestogen pill has been the most commonly used method for emergency contraception. A new method recently proposed, a progestin-only pill with levonorgestrel 0.75 mg, is having better results than the previous one, with a lower incidence of side-effects and higher efficacy. Moreover, the treatment with this method does not interfere in case of a pregnancy already being carried and cannot interrupt it.

Adolescent↗

Fetal and neonatal ovarian cysts: what's their real meaning?

PURPOSE OF INVESTIGATION: The management of fetal ovarian cysts is still controversial despite the improvement in prenatal diagnosis with ultrasonography. Some studies suggest an aggressive management, while others opt for a conservative one. The prognosis of the majority of congenital ovarian cysts is good since they have a benign origin. Sometimes, however, complications such as torsion or rupture can occur which often require surgical intervention after delivery. In this paper we report our experience and a brief review of the literature. METHODS: The authors report on 32 pregnant women in whom ultrasonography revealed the presence of an echo-rare or echo-free area in the fetal abdomen suggestive of an ovarian cyst. All women were followed-up during pregnancy with serial ultrasound examinations. Postnatal ultrasound controls confirmed the prenatal diagnosis in all cases. The diameters of the cysts ranged from 2.7 to 7.5 cm. RESULTS: In the 16 cases (50%) in which the cyst diameter was below 4 cm, periodic ultrasound examinations revealed a tendency towards spontaneous regression of the cysts. In the other 16 cases (50%) in which the cyst diameter exceeded 4 cm, cystectomy was necessary due to subsequent complications (torsion in 6 cases, 37.5%, and intracystic hemorrhage in the other 10, 62.5%). CONCLUSION: The most appropriate clinical approach in the management of benign feto-neonatal ovarian cysts is to adopt a wait-and-see policy, assessing the course of the condition by means of periodic ultrasound monitoring. Only when tumefactions measure more than 4 cm in diameter with attendant complications is surgical therapy indicated. Without complications, however, aspiration of the cystic contents is possible even in ovarian cysts exceeding 4 cm in diameter.

Adult↗

Lack of predictive value of the Epworth Sleepiness Scale in patients after uvulopalatopharyngoplasty.

The Epworth Sleepiness Scale (ESS) has been recognized as a valid measure of sleep propensity. Statistically significant correlations between ESS scores, the respiratory disturbance index (RDI), and the lowest arterial oxygen saturation (LSAT) have been described in patients with surgically untreated obstructive sleep apnea (OSA). We investigated whether the same relationships hold true after uvulopalatopharyngoplasty (UPPP). Forty-two adults with documented OSA treated by UPPP were reevaluated with the ESS questionnaire and 8-hour diagnostic nocturnal polysomnography (nPSG). We found no significant correlation between the ESS scores and the RDI or LSAT in patients after UPPP. Because postoperative ESS scores do not correlate with the RDI or LSAT, we conclude that the ESS is not a reliable surrogate for nPSG testing.

Adult↗

Induction chemotherapy followed by concurrent standard radiotherapy and daily low-dose cisplatin in locally advanced non-small-cell lung cancer.

Both induction chemotherapy and concurrent low-dose cisplatin have been shown to improve results of thoracic irradiation in the treatment of locally advanced non-small-cell lung cancer (NSCLC). This phase II study was designed to investigate activity and feasibility of a novel chemoradiation regimen consisting of induction chemotherapy followed by standard radiotherapy and concurrent daily low-dose cisplatin. Previously untreated patients with histologically/cytologically proven unresectable stage IIIA/B NSCLC were eligible. Induction chemotherapy consisted of vinblastine 5 mg m(-2) intravenously (i.v.) on days 1, 8, 15, 22 and 29, and cisplatin 100 mg m(-2) i.v. on days 1 and 22 followed by continuous radiotherapy (60 Gy in 30 fractions) given concurrently with daily cisplatin at a dose of 5 mg m(-2) i.v. Thirty-two patients were enrolled. Major toxicity during induction chemotherapy was haematological: grade III-IV leukopenia was observed in 31% and grade II anaemia in 16% of the patients. The most common severe toxicity during concurrent chemoradiation consisted of grade III leukopenia (21% of the patients); grade III oesophagitis occurred in only two patients and pulmonary toxicity in one patient who died of this complication. Eighteen of 32 patients (56%, 95% CI 38-73%) had a major response (11 partial response, seven complete response). With a median follow-up of 38.4 months, the median survival was 12.5 months and the actuarial survival rates at 1, 2 and 3 years were 52%, 26% and 19% respectively. The median event-free survival was 8.3 months with a probability of 40%, 23% and 20% at 1, 2 and 3 years respectively. Induction chemotherapy followed by concurrent daily low-dose cisplatin and thoracic irradiation, in patients with locally advanced NSCLC, is active and feasible with minimal non-haematological toxicity. Long-term survival results are promising and appear to be similar to those of more toxic chemoradiation regimens, warranting further testing of this novel chemoradiation strategy.

Aged↗

Alternating chemo-radiotherapy in bladder cancer: a conservative approach.

PURPOSE: The aim of this Phase II study was to determine a bladder-sparing treatment in patients with invasive bladder cancer, allowing a better quality of life. Objectives were to test toxicity and disease-free and overall survival of patients given an alternated chemo-radiotherapy definitive treatment. METHODS AND MATERIALS: Seventy-six patients with bladder cancer Stage T1G3 through T4 N0 M0 were entered in the same chemotherapy regimen (Cisplatin 20 mg/mq and 5-Fluorouracil 200 mg/mq daily for 5 days) alternated with different radiotherapy scheduling, the first 18 patients received two cycles of 20 Gy/10 fractions/12 days each; the second group of 58 patients received two cycles of 25 Gy/10 fractions/12 days each (the last 21 patients received Methotrexate 40 mg/mq instead of 5-Fluorouracil). RESULTS: A clinical complete response was observed in 57 patients (81%), partial response in 7 patients (10%), and a nonresponse in 6 patients (9%). At a median follow-up of 45 months, 33 patients (47%) were alive and free of tumor. The 6-year overall survival and progression-free survival was 42% and 40%, respectively. Systemic side effects were mild, while a moderate or severe local toxicity was observed in 14 patients and 13 patients (about 20%), respectively. CONCLUSION: Our conservative combination treatment allowed bladder-sparing in a high rate of patients and resulted in a survival comparable to that reported after radical cystectomy.

Adult↗

[Single-dose palliative radiotherapy in inoperable non-small-cell lung carcinoma].

The treatment of choice for advanced inoperable non-small cell lung cancer (NSCLC) is radiation therapy. Palliative radiotherapy schedules vary considerably in different centers, but a 30-Gy dose given in ten fractions over two weeks is a typical standard schedule. Our study was aimed at investigating whether a shorter course of only one 10-Gy fraction allows good palliation in the treatment of inoperable NSCLC patients whose main symptoms are related to an intrathoracic lesion. Patients of both sexes and any age, untreated with radiotherapy, with inoperable and histologically or cytologically proved NSCLC were examined. Seventeen patients, too advanced for radical "curative" radiotherapy and whose main symptoms were related to primary intrathoracic lesions, entered the study even though they had metastases. On admission, 76% (13/17) of patients had cough 76% (13/17) dyspnea, 70.7% (12/17) chest pain and 23.6% (4/17) hemoptysis. They received a single dose of 10 Gy, delivered with an 18-Mv linear accelerator via anteroposteriorly opposing portals without spinal cord shielding. Treatment volume usually included the macroscopically detected lesion identified with a CT simulator. Palliation of symptoms was achieved in high rates of patients: 46% for cough, 69% for dyspnea, 83% for pain and 75% for hemoptysis. These results were obtained within one month of treatment. Unfortunately, palliation of symptoms did not last long, decreasing to 42% within two months of the end of treatment and to 32% at three months. Four patients were retreated, one patient three months and three patients two months after the end of radiotherapy. Ten Gy to the target volume were administered as retreatment with spinal cord shielding. Side-effects were mild: nausea in 3 patients (17%), vomiting in one patient (5%) and grade-II dysphagia in two patients were observed and classified according to WHO criteria. Pain increased 24 hours after radiotherapy in five patients. We can conclude that single dose radiotherapy yields good, but short, palliation of symptoms with acceptable side-effects.

Adult↗

Phase II study of weekly mitoxantrone, 5-fluorouracil, and leucovorin in metastatic breast cancer.

A phase II study to test the toxicity and the efficacy of a weekly combination of Mitoxantrone, 5-Fluorouracil and L-Leucovorin (MFL) was carried out in 43 patients with metastatic breast cancer. Chemotherapy consisted of mitoxantrone 4 mg/m2, 5-fluorouracil 375 mg/m2, and L-leucovorin 100 mg/m2 on day 1, weekly. Patient characteristics were: median age 53 years (range 36-65); estrogen receptor (ER) status was known in 26 patients and of these 15 (57.7%) patients were ER-positive and 11 (42.3%) ER-negative. Of the 43 patients, 25 (58.1%) and 18 (41.9%) patients had received prior adjuvant chemotherapy and prior adjuvant endocrine treatment, respectively. MFL was administered to 22 (51.1%) patients as first line chemotherapy for advanced disease, while 21 (48.9%) patients had received 1 to 2 cytotoxic regimens for metastatic disease. The dominant sites of metastases were: soft tissue in 11 (25.5%) patients, bone in 8 (18.6%) patients and viscera in 24 (55.9%). All patients were assessable for toxicity: only 8 patients experienced WHO grade 3 leukopenia. Thrombocytopenia, diarrhea, stomatitis, and nausea/vomiting were negligible. Anemia and alopecia were not observed. Thirty-nine patients were assessable for response: overall response rate was 28.2% (complete response 7.7% and partial response 20.5%). Median duration of response was 12 months (range 6-34). Patients with no prior anthracyclines had a 42.1% response rate compared to 15% in patients who had received anthracyclines. Median overall survival of the 43 patients was 6 months (range 1-34). Weekly MFL is a well-tolerated and a moderately effective regimen for the treatment of metastatic breast cancer.

Adult↗

Ondansetron and dexamethasone versus standard combination antiemetic therapy. A randomized trial for the prevention of acute and delayed emesis induced by cyclophosphamide-doxorubicin chemotherapy and maintenance of antiemetic effect at subsequent courses.

The antiemetic efficacy of ondansetron and dexamethasone (Ondex) was randomly compared to that of high-dose metoclopramide, dexamethasone, and orphenadrine (Control) in the prevention of emesis induced by cyclophosphamide-doxorubicin chemotherapy in 64 chemotherapy-naive breast cancer patients. For the control of acute emesis (day 1), patients were randomized to receive either ondasetron 8 mg p.o. 1 hour prior to chemotherapy (CT) and repeated after 6 and 12 hours plus dexamethasone 20 mg i.v. 40 minutes prior to CT (Ondex) or dexamethasone 20 mg i.v. 40 minutes prior to CT, orphenadrine 40 mg i.m. 35 minutes prior to CT and metoclopramide 3 mg/kg i.v. 30 minutes prior to CT and repeated after 90 minutes followed by 40 mg p.o. every 3 hours for 4 times (Control). To control delayed emesis, patients on Ondex received ondansetron 8 mg PO t.i.d. days 2 and 3 and patients in the Control arm received metoclopramide 0.5 mg/kg p.o. q.i.d. and dexamethasone 8 mg i.m. b.i.d. days 2 and 3. Complete and major control of acute emesis was observed in 74%/94% and 44%/67% of patients treated with Ondex and Control, respectively (p < .01/p < .005). Acute nausea was absent in 38% and 34% of patients treated with Ondex and Control, respectively (p = NS). Complete and major control of delayed emesis (days 2-5) was observed in 65%/91% versus 44%/66% of patients in the Ondex and Control arms, respectively (p = NS/p < .01). In patients receiving 6 courses of FEC/FAC, control of acute emesis was significantly superior with Ondex at all treatment courses.

Acute Disease↗

Radio-hyperthermia in post-surgical recurrence of melanoma.

AIMS AND BACKGROUND: Malignant melanoma is one of the most radioresistant tumors. It can be treated with combinated hyperthermia and radiation therapy. METHODS: From January 1991 through June 1992, 7 patients, 1 male and 6 female, aged 40-88 years (mean 75), with skin and nodal post-surgical recurrences of melanoma, were treated with a combination of radiation therapy and hyperthermia. Two patients presented systemic disease when they reached our observation, but all of them were without symptoms. None of them underwent surgical excision of the recurrence before or during thermoradiotherapy. None received chemotherapy for these recurrences or had received radiotherapy in the past. They were irradiated with electron beams, with electron energies selected according to the depth of the lesions. The total dose was 40 Gy in 10 fractions in 5 weeks. Hyperthermia was administered for 10 minutes to 1 hour after irradiation. An inductive method of radiofrequency heating at 434 of 915 MHz was used depending on the depth of the lesions. In all of these treatments a ionized water bolus was used. The prescribed hyperthermic dose was 42 degrees C for half a hour. The treatments were carried out twice a week for 5 weeks. A fiberoptic multichannel thermometer was used for thermometry. RESULTS: Four patients (57%) achieved a complete response, 2 patients (29%) a partial response, and 1 patient (14%) stabilization. We found no correlation between tumor volume and response rate. Site effects and complications of the treatment were minimal (moderate erythema). CONCLUSIONS: Our results are in the wide range of values reported in the literature.

Adult↗

Cerebral metastases secondary to ovarian cancer: still an unusual event.

An incidence of cerebral metastases secondary to epithelial ovarian cancer as high as 11.6% has been reported in small series and related to the prolonged survival of ovarian cancer patients treated with platinum compounds (Hardy, J. R., and Harvey, V. J. Gynecol. Oncol. 33, 296-300, 1989). A review of the histories of 413 ovarian cancer patients, treated from 1981 to 1989 with platinum-based combination chemotherapy according to the protocols of the Gruppo Oncologico Nord Ovest (GONO) (North West Oncology Group), showed that only 9 patients (2.2%) developed clinical evidence of cerebral metastases. Six of 9 patients had FIGO Stage IIIc disease and 1 each with FIGO Stages Ic, IIc, and IV. All these patients had received cisplatin or carboplatin-based combination chemotherapy. Clinical response to initial cytotoxic therapy was as follows: complete response, 3 patients; partial response, 4 patients; stable disease, 1 patient; progressive disease, 1 patient. Cerebral metastases occurred at a median of 19 months (range 3-36) from diagnosis and median survival of patients with central nervous system (CNS) metastasis was 26 months (range 10-81) from diagnosis of primary disease and 8 months (range 1-45) from diagnosis of CNS involvement. The incidence of CNS metastases in our series is similar to that reported in the past and significantly lower than figures reported by the above mentioned paper. On the basis of our data we do not agree with Hardy and Harvey about the relationship possibly existing between prolonged survival and incidence of CNS metastases and, particularly, about the need for prophylactic cranial irradiation.

Aged↗

Cisplatin-based chemotherapy in recurrent or high risk ovarian granulosa-cell tumor patients.

Nine chemotherapy-naive women with recurrent (2 patients) or high risk factors (bilateral or extraovarian spread, poorly-differentiated tumor, age > or = 40 years at diagnosis, residual disease after surgery) granulosa-cell tumors were treated with cisplatin, cyclophosphamide with or without doxorubicin (PAC, PC) or cisplatin, etoposide and bleamycin (PVP-16B). Toxicity was acceptable and the most frequently encountered adverse reactions were WHO grade 3 gastrointestinal toxicity in 77% of patients, and grade 3 myelosuppression in 22% of cases. Clinical complete response was achieved in the 2 patients with recurrent disease. Five patients underwent second look surgery which documented: complete response in 3 patients, partial response in 1 patient and progressive disease in 1 case. Median survival was 85 months (range 14-103). Cisplatin-based cytotoxic regimens may be of benefit in the treatment of recurrent or high risk granulosa-cell tumors.

Adult↗

Serum CEA, CA 15-3, and MCA in breast cancer patients: a clinical evaluation.

With the aim of investigating the clinical usefulness of CEA, CA 15-3, and MCA serum levels, we studied 143 women whose breast cancer was submitted to serial tumor marker determinations: 79 women had stage I-II tumors and were undergoing follow-up after local and adjuvant treatment; 64 women presented metastatic lesions. Among the stage I-II patients, 63 women remained disease-free during the observation period and 16 developed metastases. In 13 out of 16 patients, tumor markers were elevated and in 11 out of 16 patients the increased tumor markers were the first sign of disease progression. Among metastatic patients, 49 presented increased tumor markers and 15 normal value. Moreover, we observed a decrease or normalization of tumor markers in patients responding to treatment and increased values in progressive disease. No correlation was noted between site of disease and tumor markers. We concluded that tumor markers are of clinical value in the detection of metastasis and may be useful in monitoring response to treatment in metastatic patients.

Adult↗

The impact of chemotherapy on the quality of life of breast cancer patients.

One hundred and thirty-seven breast cancer patients, 102 receiving adjuvant chemotherapy and 35 receiving palliative chemotherapy for metastatic disease underwent a 37-item quality-of-life questionnaire to evaluate the impact of disease and treatment on physical, psychological and social well being. Patient groups were designated as follows--Adj CT: patients undergoing the questionnaire during their adjuvant chemotherapy program; Post Adj CT: patients evaluated 3 to 8 months after termination of adjuvant chemotherapy; Mts CT: patients assessed during palliative chemotherapy for metastatic disease, and Post Mts CT: patients 3 to 8 months after termination of palliative chemotherapy. Physical and social activities were reported as unaltered or normal by 64 to 70% and 52 to 67% of patients, respectively. Psychological status was judged normal by 39 to 45% of patients. No significant differences were observed between the patients groups. In 83 to 90% of cases the patient normally took care of herself. In 62 to 87% of cases time dedicated to recreational activities was reported as unaltered. The majority of patients (84%) judged that their relationship with partner and/or family were good. Severe anxiety was reported in 19 to 28% of patients and severe depression was infrequent (3.9%). Information regarding disease and treatment given by health professionals was considered satisfactory by 80 to 100% of patients.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Mitoxantrone and mitomycin C as second-line treatment for advanced breast cancer.

Forty-three evaluable patients with advanced breast cancer were treated with a combination of mitoxantrone 10 mg/sqm and mitomycin C 10 mg/sqm every 3 weeks. Two patients (4%) achieved objective responses lasting 3 and 16 months. The median duration of survival after protocol entry was 6 months (range 1-22) and the median progression-free survival was 3.5 (range 1-20). Only mild toxicities were observed. We concluded that the mitoxantrone and mitomycin C combination has limited toxicity but low activity and only brief disease palliation in advanced breast cancer.

Adult↗

[Electronic podometry--2-year experience: preliminary report].

The authors relate their experience with the EMED system for the dynamic assessment of plantar pressure used in clinical practice for 2 years: how the measurement device was chosen; how the examination is performed; the usefulness of this type of examination in foot surgery. They discuss the specific problems related to the application of this new diagnostic tool in clinical practice.

Biomechanical Phenomena↗

Ifosfamide and etoposide salvage treatment in advanced ovarian cancer.

Twelve FIGO stage III-IV ovarian cancer patients progressing or relapsing after primary cisplatin-containing combination chemotherapy were treated with ifosfamide and etoposide. Only patients with clinically evaluable disease entered the trial. The 12 patients received a median number of 3 courses (range 1-6). No complete or partial response and two disease stabilizations were observed. Ten patients progressed on therapy. The combination of ifosfamide and etoposide does not appear to be an effective salvage treatment for advanced ovarian cancer.

Adult↗

Tamoxifen and alpha interferon in advanced breast cancer.

Thirteen pretreated advanced breast cancer patients received a combination of alpha interferon 5 million IU every 2 days, subcutaneously, plus tamoxifen 10 mg 3 times daily, until disease progression. The objective response rate was 15.4%: 1 patient achieved a complete response, 1 a partial response and 11 demonstrated stable disease; half of the patients were receptor negative and/or pretreated with hormonotherapy. Durations of response were 16 and 26 months for the CR and PR patients respectively; median progression-free survival was 4 months (range 0-26). Toxicities were registered according to WHO criteria: 4 patients stopped the treatment with interferon because of severe flu-like symptoms, while in the others the combination was generally accepted with good tolerance.

Adult↗

Low-glycemic-index starchy foods in the diabetic diet.

Eight patients with noninsulin-dependent diabetes underwent two 2-wk study periods in random order during which they were provided with carbohydrate foods with either a high or low glycemic index (GI). Over both high-GI and low-GI periods there were significant reductions in body weight, serum fructosamine, and cholesterol. Reductions in fasting blood glucose, HbA1c, and urinary c-peptide-to-creatinine ratio were significant only over the low-GI period despite a smaller mean weight loss. Reductions in triglyceride were significant only over the high-GI diet. Inclusion of low-GI foods into diets of patients with diabetes may be an additional measure that favorably influences carbohydrate metabolism without increasing insulin demand.

Aged↗