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Biomedical subjects

P De Besi

Publications and source records attributed to P De Besi.

16 recordsLinked to original sources

Risk factors for bacterial vaginosis.

OBJECTIVE: To analyse risk factors for bacterial vaginosis (BV). STUDY DESIGN: We conducted a case-control study on risk factors for BV, in several first-level gynecological centers in Italy. Cases were women aged 18-70 years with confirmed diagnosis of BV (using test for proline iminopeptidase (PIP) activity). Control were the first patients observed in the same center without any symptom suggesting vaginal infection, and a negative PIP activity test. A total of 476 cases and 450 controls entered the study. RESULTS: The number of sexual partners in the month before interview, but not the number of intercourses, was associated with an increased risk of BV. The risk of BV with vaginal douching or tight jeans/trousers once or more a week was 2.0 (95% CI 1.0-3.9) and 1.5 (95% CI 1.0-2.2), respectively, compared to never users. CONCLUSION: The findings are consistent with previous data and suggest that daily habits play an important role in risk of BV.

Adult↗

Randomised phase II study of cisplatin and 5-fluorouracil (5-FU) versus cisplatin alone in advanced squamous cell oesophageal cancer.

Patients with measurable or evaluable locally advanced or metastatic squamous cell carcinoma of the oesophagus were treated with cisplatin (CDDP), 100 mg/m2, combined with 5-fluorouracil (5-FU) at a dose of 1000 mg/m2 as a continuous infusion from days 1-5 (Arm A) or with CDDP alone (Arm B). Cycles were repeated every 3 weeks. 92 patients were randomised centrally, 88 were eligible. The response rate was 35% (95% CI (confidence interval), 20-54%) in Arm A and 19% (95% CI, 8-35%) in Arm B. One complete response was observed in each arm. The median duration of survival was 33 weeks and 28 weeks for Arm A and Arm B, respectively. Haematological and non-haematological toxicities were more frequent and more severe in Arm A. The most prominent toxicities were grade 4 aplasia and septicaemia (2), meningeal haemorrhage (1), cerebrovascular accident (3) and ischaemia of the lower limbs (1) all occurring in Arm A. Overall, seven treatment-related deaths (16%) were observed in Arm A, none in Arm B. The severe side-effects induced by the combination suggest that, currently, no standard chemotherapy can be recommended for patients with advanced squamous cell oesophageal cancer.

Adult↗

Deflazacort and fluoximesterone in advanced, pretreated breast cancer.

A very simple, low dose, orally administered regime (10 to 15 mg of fluoximesterone + 6 mg of deflazacort daily for periods of 1 to several months) resulting in mild-acceptable toxicity (essentially some weight gain) determined subjective improvement in 2/3 of 34 evaluable patients (out of 36 treated) and an objective measurable tumor reduction in 1/3, although most patients had been previously treated with chemotherapy and hormone treatment and proved primarily or secondarily refractory. The receptor status at the beginning of fluoximesterone+deflazacort treatment was not known, except in one negative-receptor patient, who responded to the combination after becoming resistant to tamoxifen (see photo). In some patients the condition of hormone refractoriness would suggest a no-treatment policy, but a trial with this regime is always convenient as it may improve both duration and quality of life.

Adult↗

Differentiated thyroid carcinoma in the elderly.

Prognostic factors and therapeutic results in a group of 268 patients with differentiated thyroid cancer (DTC) aged over 60 years are reported. These cases were selected from a total of 1457 DTC-patients seen at our Center from 1967 to 1987. All elderly patients underwent total thyroidectomy, and were treated with 131I therapy and suppressive hormonal therapy. Moreover, external radiotherapy was performed in 20% and chemotherapy in 3.8% of all cases. Follow-up included periodical clinical examination, serum Thyroglobulin (Tg) determination, 131I total body scan (TBS), and echographic and radiologic survey. Several unfavorable prognostic factors were identified in elderly patients with DTC. In comparison with data obtained in a group of patients under 60 years of age, 1) the follicular histologic type was increased, papillary/follicular ratio was 1.1 vs 2.6; 2) the F/M ratio was decreased, 1.5 vs 2.8 for papillary tumors, and 1.7 vs 3.6 for follicular tumors; 3) the rate of cases with local extrathyroid tumor growth and distant metastases was higher, and 4) rates of metastases to bone and metastases with low 131I uptake were increased. Moreover, the 10-year survival rate in elderly patients with lymph node and distant metastases was significantly reduced compared to younger patients, both for papillary and follicular cancer. The finding of detectable serum Tg levels was well correlated with the presence of metastatic disease. Moreover, Tg sensitivity was higher than TBS in showing the presence of metastatic foci. DTC in elderly people must be considered an aggressive tumor both for follicular and papillary histologic types. A radical approach is recommended: total thyroidectomy, 131I administration, and suppressive hormonal therapy.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Second and third responses to the same induction regimen in relapsing patients with multiple myeloma.

From September 1975 to December 1986, 115 consecutive previously untreated patients with multiple myeloma (MM) were treated with combination chemotherapy consisting of BCNU, cyclophosphamide, melphalan, vincristine, and prednisone (M-2). No patients were excluded or lost during follow-up. Forty-three percent of the patients were Stage I plus II, and 57% were Stage III. Thirty-eight patients (33%) had blood urea nitrogen greater than or equal to 40 mg/dl (substage B). Reaching an objective response treatment was stopped, generally after 1 year, and restarted at relapse. After induction therapy, 94 patients (82%) responded and had a median duration of response (MDR) of 22 months. After first relapse, 26 of 38 patients (69%) responded again to the same regimen and had an MDR of 11 months. This response rate and MDR are significantly lower than the ones achieved in induction chemotherapy. After second relapse, 7 of 16 patients (44%) again responded with an MDR of 3.5 months. The median survival time (MST) was 50.5 months for all patients. The most relevant side effect was leukopenia. No case of secondary leukemia was noticed. The authors conclude that patients with MM can be treated safely without maintenance therapy after reaching remission because a high response rate can be obtained in first and even second relapse. The planned treatment pause at remission does not adversely affect the survival time. Secondary leukemia is infrequent after this policy. Quality of life improves during the treatment pause.

Adult↗

Combined chemotherapy with bleomycin, adriamycin, and platinum in advanced thyroid cancer.

Twenty-two advanced consecutive thyroid cancer patients with varying histologies were treated with the so called BAP regime which consisted of bleomycin (B) 30 mg a day for three days, adriamycin (A) 60 mg/m2 iv in day 5, and cisplatinum (P) 60 to mg/m2 iv in day 5. Patients with progressive, symptomatic recurrent or disseminated disease unresponsive to hormonal and/or isotopic treatment were eligible. Nine patients had an objective response: two long-lasting complete and seven partial responses were observed out of 21 evaluable patients. Stable disease was observed in four additional patients. The median duration of response was 12 months (range, 6-29). The total series experienced a median survival of 11 months (range, 1 to 57), with 2 patients actually disease free. Several histologic types of thyroid carcinoma responded, but the best responses were observed in medullary and anaplastic giant-cell carcinomas. Toxicity was reversible in all but one patient. Of the patients failing on BAP chemotherapy three responded to a four drug second line combination containing vincristine, fluorouracil, BCNU and methotrexate. BAP regime can achieve reasonable palliation, and probably increases survival, in poor-prognosis thyroid cancers.

Adenocarcinoma↗

Response and toxicity of cisplatin and 120-h 5-fluorouracil infusion in pretreated and untreated patients with advanced epidermoid cancer of the head and neck.

Eighty-two patients with advanced or recurrent squamous cell carcinoma of the head and neck were treated with bolus cisplatin and 120-h infusion of 5-fluorouracil. Among 49 pretreated patients, there were 9 complete and 12 partial responses, for an overall response rate of 43% and a median estimated survival of 8 months. Hematologic toxicity in this group was relevant, with 4 early deaths and 30% of cases with moderate to severe leukopenia; mucosal and renal toxicities were also important. Among 33 patients with no prior therapy, there were 8 complete and 17 partial responses, for an overall response rate of 76%. Fifteen of the 25 responding patients received subsequent locoregional treatment. The median estimated survival in this group was 29 months. Hematologic, mucosal, and renal toxicities were only mild to moderate. Episodes of possible 5-fluorouracil-related cardiotoxicity were recorded in both pretreated and untreated patients. Twelve of 41 partial responses observed after the second cycle of therapy were converted to complete responses with a third (8 cases) and also a fourth (4 cases) course. This study confirmed that cisplatin plus 5-fluorouracil is a first-choice combination in previously untreated patients. Definitive evidence that chemotherapy can favorable influence survival awaits confirmation by randomized trials, using a control arm with conventional locoregional treatment. In previously treated patients with recurrent disease, less intensive regimens not requiring hospitalization seem more useful for the quality of life.

Adult↗

Cisplatin plus vindesine versus cisplatin plus VP16 versus doxorubicin plus cytoxan in non-small-cell carcinoma of the lung. A randomized study.

From March 1981 to January 1984, 116 patients with advanced non-small-cell carcinoma of the lung (NSCCL) were randomly assigned to 3 combinations as follows: CDDP + DVA, CDDP + VP16 and DXR + CTX. 94 patients were evaluable for response, 106 for toxicity and survival. Of 31 patients, 15 (48%; 3 CRs and 12 PRs) responded to CDDP + DVA; of 33 patients, 12 (36%, 2 CRs and 10 PRs) responded to CDDP + VP16; of 30 patients, 3 (10%) obtained a PR with DXR + CTX (CDDP + DVA vs DXR + CTX, P less than 0.005; CDDP + VP16 vs DXR + CTX, P less than 0.05; CDDP + DVA vs CDDP + VP16, P = NS). The median duration of response was 22 weeks in the CDDP-DVA group, 17 weeks in the CDDP-VP16 group, and 16 weeks in the DXR + CTX group. No significant difference in survival was observed among the 3 groups (median: 43, 47, 41 weeks, respectively). Hematologic and neurologic toxicities were significantly higher in the DVA-containing regimen. Despite the lack of improvement of overall survival with the CDDP-containing combinations over the DXR + CTX control group, the good response rate makes them suitable to be used in combined therapeutic strategies.

Adult↗

Peptichemio in pretreated patients with plasmacell neoplasms.

Twenty-one patients with alkylator-resistant plasmacell neoplasms were treated with Peptichemio (PTC) at a dose of 40 mg/m2 for 3 days every 3 weeks or, in the case of persistent leukopenia and/or thrombocytopenia, at the single dose of 70 mg/m2 every 2-3 weeks according to haematological recovery. Seventeen patients, 10 with multiple myeloma and seven with extramedullary plasmacytoma (EMP), were fully evaluable. Six of 17 patients (35%) responded: three of seven EMP patients had a complete remission and 3 of 10 multiple myeloma patients had an objective response greater than 50%. The median duration of response was 8.5 months. An EMP patient obtained a complete response lasting for 16 months. The most frequent toxic effect were phlebosclerosis, occurring in all the patients, and myelosuppression, which was severe in only one case. PTC appears to be an active drug in patients with plasmacell neoplasms even if resistant to alkylating agents.

Adult↗

Phase II study of cisplatin, 5-FU, and allopurinol in advanced esophageal cancer.

Forty patients with advanced squamous cell carcinoma of the esophagus were treated with a combination of cisplatin, 5-FU (by continuous 5-day infusion), and allopurinol; 37 are evaluable for response. Thirteen remissions (35%) were obtained, including three complete and ten partial, with a median duration of 9 months. After chemotherapy, seven responding patients underwent a surgical procedure, which was radical in four. The most frequent side effects were nausea and vomiting. This regimen is effective and can be included in a multimodality approach.

Adult↗

Vindesine in plasma cell tumors.

Twenty-one patients with plasma cell tumors received vindesine (VDS) at the dose of 3 mg/m2 i.v. on day 1 plus prednisone at the dose of 100 mg p.o. from day 1 to 5, recycling every 8 days 3 times and then every 10-12 days. In 3 patients with gastric or duodenal ulcer prednisone was not administered. All but one patient were heavily pretreated and resistant to M-2 regimen. Overall there were 4 objective responses (19%): 2 among 15 patients (13%) with multiple myeloma and 2 among 6 patients (33%) with extramedullary plasmacytoma (EMP). The responses lasted for 2, 12, 15 and 48+ months. One previously untreated EMP patient received VDS without prednisone and obtained a complete long-lasting remission. The association of VDS with high-dose prednisone seems to have some activity in plasma cell tumors; probably in multiple myeloma the objective responses are due to the high dose of cortisone rather than to VDS. On the contrary, in EMP patients, VDS may be an active agent, even if administered without cortisone.

Adult↗

Urinary hydroxyproline in multiple myeloma: correlation with clinical stages and bone disease.

Twenty-four-hour urinary hydroxyproline excretion (HOP) (normal values: 6-22 mg/day/m2) was measured by the Hypronosticon test in 50 untreated patients with plasma cell myeloma. At diagnosis, HOP was elevated in 36 of 50 patients (72%) with a mean value of 35.9 mg/day/m2. Extent of bone lesions and clinical stage were accurately assessed in all patients. Higher HOP values were found in patients with a higher degree of bone lesions (multiple lytic areas and/or destruction of skeletal segments). According to clinical stages, HOP was very elevated only in stage III (mean value: 43.7); in stages I and II the mean value (25.2) was just above the normal range. Our data indicate that HOP in multiple myeloma at diagnosis is closely related to the extension of skeletal lesions and that during the clinical course it may be useful in the follow-up of bone disease.

Adult↗

Cisplatin, bleomycin and methotrexate in the treatment of advanced oesophageal cancer.

From February 1981 to September 1982, 34 patients with metastatic or locally advanced (inoperable) epidermoid carcinoma of the oesophagus were treated with a combination of cisplatin, bleomycin and methotrexate. Thirty-one patients are now evaluable for response: 16 of 31 (52%) experienced some improvement, but only eight (26%) obtained major responses (one complete and seven partial). Responses were obtained rapidly within the first two courses. The median duration of responses was 5 months. The median survival from start of therapy was 8 months for responsive and 5 months for non-responsive patients. Gastrointestinal toxicity (cisplatin-related) and mild myelosuppression were the most prominent side-effects. This combination chemotherapy proved to be only of small efficacy in the long-term control of advanced oesophageal cancer. However, because the responses were obtained rapidly, it is conceivable that a similar regimen (with increased dosage of cisplatin) applied before surgery to patients with limited disease could obtain a reduction of the bulky tumour, with a possible increase of the resectability rate and destruction of micrometastases.

Adult↗

Tamoxifen in disseminated breast cancer.

86 postmenopausal women with disseminated breast cancer have been treated orally with 30 mg of Tamoxifen per day (ICI 46474, Nolvadex) for periods of 2 months or more. The overall responders were 28/86 (32.5%) with a median remission duration of 9 months. In 30 patients already shown to be resistant to cytotoxic chemotherapy. Tamoxifen was used as first hormonal agent; the remission rate in this group was 12/30 (40%), while it was 28.5% (16/56) in the others who had already received different hormonal treatments. In 6 early menopausal cases, the treatment had to be stopped for a dangerous "worsening syndrome". Other side effects were trivial. In 28/35 cases (80%), we have found the reappearance of a pattern of estrogenic activity in vaginal smears during treatment. Hence a "simil-estrogen", more than an "anti-estrogen" mechanism of action is postulated and a selection of patients for treatment in the "mid postmenopausal age" is recommended.

Breast Neoplasms↗