PubMed Health⌕ Search

Biomedical subjects

S Chiara

Publications and source records attributed to S Chiara.

At least 55 records · Page 3Linked to original sources
PubMed1987

Cisplatin and cyclophosphamide in early epithelial ovarian carcinoma.

Toxicity and efficacy of adjuvant cisplatin-based chemotherapy were assessed in 41 patients with FIGO stage I-II ovarian carcinoma. Chemotherapy consisted of cisplatin 50 mg/m2 and cyclophosphamide 600 mg/m2 administered on a one-day schedule q 28 d for six courses. Inclusion criteria were based on appropriate staging procedures and absence of macroscopic disease after primary surgery; patients with stage IAi G1-G2 or with borderline tumors were excluded from the study. Second look laparotomy was performed 2 months after termination of chemotherapy. At 60 months the actuarial survival is 77.5%. Recurrences were observed in 8 patients; in 1 case relapse was diagnosed at second look laparotomy. Toxicity was acceptable with only 1 treatment drop-out due to reversible neurotoxicity. Our results demonstrate that short-term chemotherapy including cisplatin is a safe and effective regimen and is suitable for administration on a outpatient basis. In our experience second-look laparotomy has limited value for early detection of relapses.

Adult↗
PubMed1987

4-Demethoxydaunorubicin (IMI-30) in refractory epithelial ovarian cancer: a pilot study.

Fifteen patients with advanced epithelial ovarian cancer were treated with 4-demethoxydaunorubicin (IMI-30) after platinum failure. A total of 33 courses of IMI-30 15 mg/m2, per os, daily for 3 consecutive days every 3 weeks were performed. Three patients experienced severe hematologic toxicity (WHO grade greater than or equal to 3), while gastroenteric toxicity was acceptable and no cardiotoxicity was observed. One minor response, 4 stabilization of disease and 7 progression were observed in 12 evaluable patients. In conclusion, IMI-30, at this scheduling, is inactive in our small series of heavily pretreated epithelial ovarian cancer patients.

Aged↗
PubMed1986

A randomized trial comparing cisplatin plus cyclophosphamide versus cisplatin, doxorubicin, and cyclophosphamide in advanced ovarian cancer.

After primary surgery, 125 patients with epithelial ovarian cancer (International Federation of Gynaecology and Obstetrics [FIGO] 1c + IIb + IIc = 22 patients, FIGO III = 82 patients, FIGO IV = 21 patients) were randomly allocated to receive PC (cisplatin 50 mg/m2 + cyclophosphamide 600 mg/m2 on day 1 every 28 days) (corrected) or PAC (PC + doxorubicin 45 mg/m2). After six cycles, patients clinically disease-free or with resectable residual disease were submitted to second-look surgery. After restaging, patients in surgical complete response (CR) stopped treatment while those responding partially (PR) received six more courses; patients whose disease progressed were excluded from the study. Among patients with measurable disease, the following clinical response rates were observed: PC = 20% CR, 34.3% PR, 14.3% stable disease, and 31.4% progression; PAC = 40.6% CR, 15.6% PR, 12.5% stable disease, and 31.3% progression. In the 75 patients submitted to second look, the results have been the following: PC = 39.5% CR, 36.8% PR, 7.9% stable disease, and 15.8% progression; PAC = 62.2% CR, 18.9% PR, 10.8% stable disease, and 8.1% progression. The difference in surgical complete response in favor of the PAC regimen is significant (P less than .05). Median survival and progression-free survival were 800 and 400 days, respectively, for PAC arm; median survival and progression-free survival were 680 and 380 days, respectively, for PC. These differences are not significant. Probability of survival was affected by FIGO stage, amount of residual disease, histology, performance status, and response at second look, while no influence was observed according to grade of tumor differentiation and age. Our results demonstrate the usefulness of doxorubicin in terms of surgical CR.

Adult↗
PubMed1986

Evaluation of the cochleovestibular function in patients treated with carboplatin for ovarian carcinoma.

Carboplatin (JM8), a new cisdiamminodichloroplatin (CDDP) analogue, has exhibited the same antitumor as CDDP. In our pilot study, aiming at optimizing the dosage of this drug in a combination regimen with other chemotherapics, we planned to evaluate the existence of drug related damage on cochleo-vestibular structures. The study was performed on 9 patients suffering from advanced ovarian carcinoma. The results obtained in our study showed that patients undergoing carboplatin chemotherapy do not require an audiometric check-up. In order to assess definitely the existence of vestibular toxicity of this drug, larger studies planned to test JM8 in a high-dosage regimen are desirable.

Aged↗
PubMed1985

The antiemetic efficacy of methylprednisolone compared with metoclopramide in outpatients receiving adjuvant CMF chemotherapy for breast cancer: a randomized trial.

A randomized trial was performed comparing the antiemetic efficacy of methylprednisolone (MPN) and metoclopramide (MCP) in 60 breast cancer patients eligible for outpatient adjuvant chemotherapy with cyclophosphamide, methotrexate, and 5-FU (CMF). At the time of their first chemotherapy course patients were randomized to receive either MPN 375 mg or MCP 1 mg/kg both administered in 3 equal doses, IV just prior to chemotherapy and then IM 6 and 12 hours after treatment. Patients receiving MPN experienced significantly less nausea (p less than 0.0005) and vomiting (p less than 0.0005) and antiemetic protection was maintained in patients receiving multiple chemotherapy courses. Complete protection (0 emesis) was observed in 58% of patients receiving MPN as compared with 20% of patients treated with MCP (p less than 0.005). The most frequent side effects were facial flush in 38% of patients and somnolence in 15% of patients receiving MPN and MCP, respectively. Complete protection from CMF-induced gastrointestinal side effects was observed in two-thirds of our patients receiving antiemetic MPN treatment. In these patients administration of the maximum cumulative CMF dose was possible without impairing their quality of life. MPN, at the dose and schedule reported, is an affective antiemetic drug suitable for use in breast cancer outpatients receiving adjuvant CMF therapy.

Adult↗
PubMed1985

High dose cisplatin after failure of polychemotherapy containing cisplatin in ovarian cancer. Preliminary results.

A substantial percentage of patients with advanced ovarian cancer will progress or relapse after platinum-based front therapies and will require salvage chemotherapy. In order to evaluate feasibility and effectiveness of high dose platinum (HD-CDDP) nine patients with ovarian cancer were treated with HD-CDDP while progressing after conventional doses of the same drug. Cisplatin 40 mg/M2 d. 1----5 q. 28 days, was administered with forced chloruresis for a total of fifteen cycles. Preliminary results show a promising 44.4% response rate with acceptable toxicity: only one patient had to discontinue treatment because of severe combined toxicity including infection, mucositis, shaking tremors, ototoxicity and palmar hyperkeratosis.

Adult↗
PubMed1984

Low-dose metoclopramide versus methylprednisolone in controlling chemotherapy induced nausea and vomiting.

Ninety outpatients with histologically confirmed malignancy receiving chemotherapy entered a randomized crossover trial to assess the antiemetic efficacy of low-dose metoclopramide versus methylprednisolone. Treatment consisted of either metoclorpramide (MCP) 60 mg or methylprednisolone (MPN) 375 mg administered in 3 equal doses just prior to chemotherapy and 6 and 12 hours after treatment. Patients receiving MPN had significantly less nausea (p less than 0.001) and fewer episodes of vomiting (p less than 0.0003) than patients receiving MCP. MPN also proved to be the more effective agent in cross-over trials. Both MPN and MCP were well tolerated. No important side effects were observed. MPN is a safe, effective, antiemetic treatment suitable for use in the outpatient.

Adult↗
PubMedDate not supplied

Sucralfate in the treatment of chemotherapy-induced stomatitis: a double-blind, placebo-controlled pilot study.

BACKGROUND: The study was a double-blind, placebo-controlled, randomised pilot study to assess the efficacy of sucralfate gel in the treatment of chemotherapy-induced mucositis. PATIENTS AND METHODS: At the onset of stomatitis, forty patients received sucralfate gel (1 gr.) or placebo and were instructed to apply the gel over oral mucosas, 3 times daily. RESULTS: Objective response was observed in 14 patients (11 complete response+3 partial response) and in 15 patients (10 CR+5 PR), in the sucralfate and placebo arms, respectively; (p = NS). Analysis of VAS (visual analogue scale) scoring of pain did not detect any statistical difference between the two groups. No important side-effects were observed. Twelve out 21 patients who obtained a complete resolution of stomatitis (5 out of 11 and 7 out of 10 in the sucralfate and in placebo arms, respectively) received further treatment at the subsequent course of chemotherapy; prevention of mucositis was observed in 4 patients in the sucralfate arm and in 6 patients in the placebo arm, respectively. CONCLUSION: In the present pilot study, sucralfate did not demonstrate a significant advantage in comparison to the placebo in the treatment of chemotherapy-induced stomatitis.

Adult↗
PubMedDate not supplied

Clinical stage I and II endometrial carcinoma: multivariate analysis of prognostic factors.

In 221 patients with FIGO stage I and II endometrial carcinoma, the impact on survival of age at diagnosis, menopausal status, FIGO stage, myometrial invasion, tumor grade and histology was evaluated by univariate and multivariate analysis. At a median follow-up of 50 months (range 45-210), 42 patients had died, and therefore overall survival was 81% (179/221). Univariate analysis showed that age, menopausal status and histology did not influence survival, whereas FIGO stage, myometrial invasion and tumor grade were important prognostic factors. Multivariate analysis showed that tumor grade had a significant and independent impact on survival and confirmed that FIGO stage is the most important parameter influencing survival.

Actuarial Analysis↗
PubMedDate not supplied

Phase II study of weekly oxaliplatin and high-dose infusional 5-fluorouracil plus leucovorin in pretreated patients with metastatic colorectal cancer.

BACKGROUND: Chemotherapy with oxaliplatin, fluorouracil (5-FU) and leucovorin (LV) has proven efficacy in patients with advanced colorectal carcinoma (CRC), although the optimal dosage and administration schedule are still unclear. This phase II trial investigated the tolerability and activity of weekly oxaliplatin, high-dose infusional 5-FU and LV in pretreated patients with metastatic CRC. MATERIALS AND METHODS: Patients received weekly courses of i.v. oxaliplatin 50 mg/m2 (1-h infusion), LV 100 mg/m2 (1-h infusion) and 5-FU 2100 mg/m2 (24-h infusion) until disease progression or unacceptable toxicity. NCI-CTC criteria were used for assessment of side-effects (at each cycle) and WHO criteria for assessment of tumour response (every 8 cycles). For descriptive purposes, time to progression, overall survival and duration of objective response were also calculated. RESULTS: Forty-four patients were enrolled and received a total of 606 cycles (median 13/patient, range 4-33), and 70% of courses (421/606) were delivered at 100% of the planned dose. The most frequent side-effects were gastrointestinal and neurological and incidence rates were: diarrhoea 66% (grade III: 29%), nausea/vomiting 54%, neurotoxicity 34% (grade III: 2%), fatigue 27%, mucositis 22%, leucopenia 14%. No grade IV toxicity was observed. Objective response rates were: partial response 23% (10 patients), stable disease 59% (26) and progressive disease 11% (5). Median time to progression was 7 months, overall survival 13 months and the duration of partial response and stable disease were 9 and 6 months, respectively. CONCLUSION: The study demonstrated that this regimen has a favourable tolerability profile and is an active combination in the pretreated metastatic CRC patient, deserving further evaluation in phase III trials.

Aged↗
PubMedDate not supplied

Intraperitoneal chemotherapy with carboplatin and interferon alpha in the treatment of relapsed ovarian cancer: a pilot study.

In ovarian cancer patients intraperitoneal chemotherapy confers pharmacokinetic advantages and appears an attractive way to improve the efficacy of certain antineoplastic agents. Intraperitoneal carboplatin and interferon alpha have been separately evaluated in ovarian cancer "with promising results". We report a phase I-II pilot trial of intraperitoneal carboplatin 400 mg/sqm plus interferon alpha 25 x 10(6) U q 28 d in 16 patients (pts) previously treated with intravenous cisplatin based chemotherapy. All the patients had relapsed (11 pts) or refractory (5 pts) disease; residual tumors were less than 2 cm in 10 pts and greater than 2 cm in 6 pts. Local and general toxicities were moderate, with neither WHO grade 4, nor neurotoxicity and ototoxicity. Myelotoxicity was the most frequent side effect. Among 14 evaluable pts, objective responses were observed in 6 pts (42.8%) including 3 pts with pathologically confirmed complete response (21.4%); six more pts presented prolonged disease-free survival. Response occurred in both categories of pts with greater than or less than 2 cm residual disease, also in pts refractory to prior intravenous cisplatin. The proper role of intraperitoneal treatment cannot be exactly defined without large randomized trials designed to compare intraperitoneal to intravenous drug administrations.

Antineoplastic Combined Chemotherapy Protocols↗
PubMedDate not supplied

CA-125 monitoring in the management of ovarian cancer.

In 100 ovarian cancer patients serum CA-125 was monitored during treatment and follow-up to verify the prognostic value of its pre-surgery marker level and the usefulness of the test for disease monitoring. A low pre-operative CA-125 was not associated with improved survival or progression-free survival. A significant survival advantage was evident for patients in whom the marker had decreased during treatment, compared to patients in whom the antigen remained unchanged or increased. In 40 patients CA-125 was measured before second look laparotomy: the marker was negative in 100% of patients in, pathological complete response and in 53.5% of patients with residual disease at second look. A marker increase was evident in 32 of 41 patients with either progressive or recurrent disease, and in 17 patients the CA-125 increase was documented from 1 to 9 months before clinical evidence of progression. The pre-operative level of CA-125 did not appear to be of prognostic value. However, the monitoring of CA-125 during treatment and follow-up can provide a reliable method of assessing response and prognosis. CA-125 monitoring is particularly useful for early detection of recurrence.

Adult↗
PubMedDate not supplied

Serial determination of platinum, protein content and free sulfhydryl levels in plasma of patients treated with cisplatin or carboplatin.

We report here the results of serial determinations of free-sulfhydryl, protein content and platinum levels in plasma of cancer patients following either cisplatin (cis-DDP, 3 patients, 60 mg/m2) or carboplatin (JM-8, 3 patients, 300 mg/m2) i.v. administration. After treatment with cis-DDP, significant platinum binding to plasma components with MW greater than 25 kD was observed; the ratio free-sulfhydryls/protein content decreased during the first two hours, returning to normal values at 24 hours after injection. In contrast, no evidence of platinum binding to plasma components with MW greater than 25 kD was noted after JM-8 i.v. administration, and the ratio free sulfhydryls/protein content did not change significantly after treatment. In vitro experiments show that at a molar ratio cis-DDP:JM-8 1:10, the two compounds bind to low MW thiols with the same kinetics. These data seems to suggest different interactions at the plasma level of these drugs, which may be correlated with their different toxicity.

Antineoplastic Combined Chemotherapy Protocols↗
PubMedDate not supplied

Prevention of delayed emesis with metoclopramide and dexamethasone in patients receiving moderately emetogenic cytotoxic treatment.

Forty-three untreated cancer patients receiving moderately emetogenic polychemotherapy entered a phase II trial in order to evaluate the effectiveness of the combination of metoclopramide (40 mg every 6 hrs) and dexamethasone (8 mg every 12 hrs) in the prevention of delayed emesis (days 2-3). For the control of acute emesis all patients received on day 1 ondansetron 8 mg for 3 times. Results of antiemetic treatment were as follows: complete/major protection from acute emesis (day 1) was observed in 72%/88% of patients. Worst day analysis of delayed emesis (days 2 and 3) showed that complete/major protection was obtained in 93%/95% of cases, respectively. Delayed nausea was not as well controlled: complete/major protection was observed in 44%/79% of patients. Extrapyramidal reactions occurred in 3 patients and moderate epigastric pain was reported by 3 patients. Since control of acute emesis could be one of the most important factors influencing delayed emesis, the absence of acute symptoms in 72% of our patients may be partially responsible for the excellent control of delayed emesis. The combination of metoclopramide and dexamethasone is a feasible and effective treatment for delayed emesis in outpatients receiving moderately emetogenic chemotherapy.

Adult↗
PubMedDate not supplied

Treatment of metastatic colorectal carcinoma with lymphoblastoid interferon and 5-fluorouracil: data of a phase II study.

Many clinical trials have tested the combination of 5-fluorouracil and recombinant alpha-interferons in metastatic colorectal carcinoma. The efficacy of 5-fluorouracil and lymphoblastoid interferon was evaluated in a phase II study in which 31 patients with advanced colorectal carcinoma were enrolled. 5-Fluorouracil was administered at the dose of 600 mg/sqm bolus weekly and lymphoblastoid interferon was given intramuscularly at 3 million units every two days. All patients were evaluable for toxicity. Thirty patients were available for response: no complete response was recorded, three patients reached a partial response (10%), three a minor response (10%) and 18 progressed (59.4%). Overall median survival was 8 months. No grade IV toxicity was observed: in 2 patients grade III occurred and in 8 patients grade III fever and fatigue attributable to interferon developed. It appears that this combination does not yield better results than 5-fluorouracil alone.

Adult↗