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Biomedical subjects

A Ravaioli

Publications and source records attributed to A Ravaioli.

At least 37 records · Page 2Linked to original sources
PubMed1999

Paclitaxel efficacy and tolerability in second-line treatment of refractory and relapsed ovarian cancer patients.

Nineteen patients with recurrent or refractory ovarian carcinoma after a first-line platinum-based chemotherapy were treated with a 3-hour i.v. infusion of paclitaxel 175 mg/m2 every 3 weeks from November 1992 to October 1996. The major hematologic toxicity was neutropenia (63.2%). No febrile neutropenia was observed. Other hematologic effects were leukopenia (47.4%) and anemia (47.4%). The main non-hematologic toxicities were as follows: neuropathy (52.6%), nausea and vomiting (36.8%), myalgia (36.8%), cardiac toxicity (15.8%) and mucositis (10.5%). Alopecia was observed in the majority of cases. The overall response rate was 47.4%, with 5 (26.3%) complete responses (CRs) and 4 (21.1%) partial responses (PRs). The median duration of response was 7 months (range: 3-19), with a median follow-up of 17 months (range: 3-61). Quality of life of responding patients was good. Our results confirm that paclitaxel as second-line therapy in relapsed and refractory ovarian cancer patients is an acceptable treatment with a good safety profile, and can be safely administered at the dose of 175 mg/m2. In our study paclitaxel was more active in relapsed than in refractory patients. Consequently, further studies are needed to identify more effective drugs for the refractory subset.

Adult↗
PubMed1999

Gemcitabine and cisplatin versus mitomycin, ifosfamide, and cisplatin in advanced non-small-cell lung cancer: A randomized phase III study of the Italian Lung Cancer Project.

PURPOSE: To compare gemcitabine and cisplatin (GC) with mitomycin, ifosfamide, and cisplatin (MIC) chemotherapy in patients with stage IIIB (limited to T4 for pleural effusion and N3 for supraclavicular lymph nodes) or stage IV non-small-cell lung cancer (NSCLC). The end points were the evaluation of quality of life (QoL), response rates, survival, and toxicity. PATIENTS AND METHODS: Three hundred seven patients were randomized to receive either gemcitabine 1,000 mg/m(2) on days 1, 8, and 15 plus cisplatin 100 mg/m(2) on day 2, every 28 days, or mitomycin 6 mg/m(2), ifosfamide 3,000 mg/m(2), and mesna on day 1 plus cisplatin 100 mg/m(2) on day 2, every 28 days. The whole-blood cell count was repeated on day 1 in both arms and weekly in the GC arm before each gemcitabine administration. RESULTS: No major differences in changes in QoL were observed between the two treatment arms. The objective response rate was 38% in the GC arm compared with 26% in the MIC arm (P =.029). The median survival time was 8.6 months in the GC arm and 9.6 months in the MIC arm (P =.877, log-rank test). Grade 3 and 4 thrombocytopenia was significantly worse in the GC arm (64% v 28%, P <.001), whereas grade 3 and 4 alopecia was reported more commonly in the MIC arm (39% v 12%, P <. 001). CONCLUSION: We report an increased response rate without changes in QoL and a similar overall survival, time to progression, and time to treatment failure for the GC when compared with the MIC regimen in the treatment of advanced NSCLC.

Adult↗
PubMed1998

Staging of breast cancer: what standards should be used in research and clinical practice?

BACKGROUND: Bone scan (BS), chest X-rays (CXR), liver ultrasonography (LUS) and laboratory parameters (LP) are frequently used as routine staging procedures for breast cancer patients. These procedures are not always appropriate in either clinical or research settings, regardless of the stage. The aim of this study was to identify groups of patients with differing risks for metastases in order to select more precise standard staging procedures. PATIENTS AND METHODS: The staging data relating to 406 breast cancer patients consecutively referred to our institution between November 1989 and October 1996 were analysed including pathological TNN grading and biological parameters. All of the cases with a positive or suspicious pre-operatory staging and who proved to have metastatic disease before surgery or during the first six months of follow-up were considered true-positive; all of the other cases with a positive or suspicious initial staging but with no evidence of distant metastasis before surgery and with a disease-free survival longer then six months were considered false-positive. In the same way all cases with negative initial staging who relapsed during the first six months of follow-up were considered false-negative and those with negative initial staging and with a disease-free survival longer then six months were considered true-negative. Statistical analysis was performed using Fisher's exact test. RESULTS: BS, CXR and LUS, 388, 399 and 398 examinations respectively, were considered available, and 17 (4.38%), six (1.5%) and four (1%), respectively, proved to be true-positive. A statistically significant difference was observed when our cases were grouped according to T status (T4 vs. T1-T2-T3, P < 0.01) and nodal status (N0-N1 cases with less than three involved nodes and N1 with more than three positive lymph nodes N2 patients, P < 0.01). CONCLUSIONS: The present study suggests that breast cancer patients can be divided into three subgroups with different detection rates for distant metastases at staging (0.59%, 2.94% and 15.53%), and that the standard practice should be changed. In the first (T1N0 and T1N1 patients with < or = 3 positive lymph nodes--41.13% of the patients) and the second group (T2N0, T2N1 with < or = 3 positive lymph nodes, T3N0 and T3N1 patients with < or = 3 positive lymph nodes--33.49% of the patients) there is no need for a complete set of staging procedures, whereas full procedural staging is needed in the third group of patients (T4, N1 with > 3 lymph nodes and N2, 25.37% of the patients).

Adult↗
PubMed1997

Vinorelbine chemotherapy in non small cell lung cancer: experience in elderly patients.

This study involved 25 elderly (> 65 years old) patients (pts) with unresectable non small cell lung cancer (NSCLC) who were not eligible for polychemotherapy. The diagnosis of NSCLC was histologically or cytologically documented, and all of them had measurable or evaluable disease. The median age of the patients was 71 (range 65-77); 9 had been pretreated. The pts received 25 mg/m2 of vinorelbine weekly or bi-weekly depending on the results of blood tests. The treatment continued until disease progression or tolerance. No complete response was achieved: 3 pts (12%) had a partial response (RP) (8-12-14 months), 13 (52%) stable disease (SD) with an improvement in symptoms, such as cough and/or pain, and 9 pts (36%) progressed. Compliance with the therapy was acceptable. The main toxicity was hematological: neutropenia was observed in 16 pts, with only 1 case of grade 4 neutropenia without sepsis; grade 1-2 anemia occurred in 8 patients. The other toxicities included grade 1-2 neurotoxicity in 8 pts, chemical phlebitis in 2 pts and grade 3 cardiotoxicity reversible with medical treatment in 1 patient. The median survival time was 10 months (lower quartile 5 months, upper quartile 23 months) (Kaplan and Meyer method). Vinorelbine can be considered a rational choice in elderly pts with advanced NSCLC who are not suitable for aggressive polychemotherapy, with the aim of improving their quality of life in terms of symptoms and outpatient treatment.

Aged↗
PubMed1997

Doxorubicin and paclitaxel (sequential combination) in the treatment of advanced breast cancer.

Based on preclinical data, we designed a phase I/II clinical trial to determine the efficacy and toxicity of doxorubicin followed by paclitaxel in the treatment of advanced breast cancer (either untreated or relapsed after adjuvant therapy). In the phase I dose-finding study, 19 enrolled patients received bolus doxorubicin (50 mg/m2) and, after a 16-hour interval, a three-hour infusion of paclitaxel in escalating doses from 130 to 250 mg/m2, increased by 30-mg/m2 increments for each dose-level group. The first dose level group (paclitaxel 130 mg/m2) included three patients. The other dose level groups included four patients. Treatment was repeated every three weeks for a maximum of eight cycles. The paclitaxel dose was escalated to 250 mg/m2 without reaching the maximum tolerated dose. In the 128 cycles assessable for toxicity, there were no relevant clinical signs or symptoms of cardiotoxicity. This absence of significant cardiotoxicity required confirmation in a phase II trial. Since a maximum tolerated dose of paclitaxel had not been reached during the first study and an increasing risk of neutropenia and peripheral neurotoxicity was feared if doses continued to escalate, a phase II confirmatory study was begun to evaluate treatment with fixed doses of doxorubicin (50 mg/m2) and paclitaxel (220 mg/m2), using the same schedule and interval as in phase I. The 13 patients enrolled in phase II received a total of 95 cycles of therapy; in 10 cycles (three patients) dose reductions were necessary because of toxicity. However, no significant clinical cardiotoxicity was observed in 12 of the 13 patients. One patient experienced an asymptomatic, transient decrease in left ventricular ejection fraction at a cumulative doxorubicin dose of 400 mg/m2. Overall clinical responses included 10 complete remissions (31.3%) and 15 partial remissions (46.9%) for an objective response rate of 78.1%. At 16 months' median follow-up, the median time to progression for all patients is nine months. The high response rate obtained in the phase I/II studies and, in particular, the absence of significant cardiotoxicity require confirmation in further clinical trials. To date, two confirmatory phase II trials are ongoing in our institutions.

Antibiotics, Antineoplastic↗
PubMed1997

[Regression of primary gastric lymphoma after treatment with ranitidine].

In a 60 years old patient affected by primary gastric MALT lymphoma stage IE, we observed a complete regression after aspecific treatment with ranitidine 150 mg x 2/day; after regression we treated the patient with anti-Helicobacter pylori therapy for 30 days. Nowadays, after 3 years of clinical and endoscopical follow-up we observe no relapse of disease. The elimination of antigenic stimulation of Helicobacter pylori, stopping T-lymphocytes' effect on B-lymphocytes, stopped neoplastic proliferation, causing the complete regression of neoplastic lesion. This clinical case, according to biological data about primary gastric lymphomas, suggests different ways of treatment for primary gastric lymphomas at the lowest stage of disease.

Follow-Up Studies↗
PubMed1996

Assessment of the RSCL quality of life instrument during chemotherapy in an Italian setting.

Evaluation of the quality of life of oncological patients is now perceived as a major element of cancer treatment, and various instruments for measuring it have been proposed. However, whatever instrument is used must be capable of reflecting the different ways in which different contexts and cultures respond to cancer. We administered the Italian version of the Rotterdam Symptom Checklist (RSCL) to 60 patients with advanced disease attending five oncological centres in Romagna (central Italy). The RSCL was found to be able to measure both psychological and physical well-being and to detect a difference between patients on low/medium and those on high-burden chemotherapy. The Italian version of the RSCL is an adequate scale that is capable of capturing patient perceptions and could be used for monitoring the quality of life of Italian patients participating in clinical trials.

Adult↗
PubMed1996

A Phase I/II study of paclitaxel and doxorubicin in the treatment of advanced breast cancer.

We designed a clinical study in which fixed doses of doxorubicin were infused by intravenous bolus 16 hours before escalating doses of paclitaxel (Taxol; Bristol-Myers Squibb Company, princeton, NJ) for the treatment of patients with advanced breast cancer, an interval selected to allow systemic clearance of doxorubicin before administration of paclitaxel in an outpatient setting. Courses of fixed-dose doxorubicin 50 mg/m2 by intravenous bolus and paclitaxel (doses escalated from 130 mg/m2 to 250 mg/m2 via dose escalation of 30 mg/m2) were repeated every 21 days, to a maximum of eight cycles. Maximum tolerated dose was reached if two or more of six patients at a given dose level were affected by the following events: absolute neutrophil count less than 500/microliter for > or = 7 days, absolute neutrophil count less than 100/microliter for > or = 3 days, insufficient hematopoietic recovery with absolute neutrophil count less than 1,500/microliter on day 21, febrile neutropenia, grade 4 thrombocytopenia, any World Health Organization grade 3 nonhematologic toxicity for more than 7 days. There were 19 patients enrolled; the patients received a total of 128 treatment courses. Grade 4 neutropenia was the main side effect, occurring in 20% of courses but generally not associated with clinical events. No relevant clinical cardiac toxicity or alteration of left ventricular ejection fraction was observed. Other toxicities included complete alopecia, mild peripheral neuropathy, and mild myalgia. There was a reduction of one dose level for moderate myalgia in one patient (190 mg/m2 level). Complete alopecia was always present. Maximum tolerated dose was not reached at paclitaxel 250 mg/m2. Ultimately, the introduction of this combination in the adjuvant setting is warranted.

Adult↗
PubMed1996

A phase I/II study of sequential doxorubicin and paclitaxel in the treatment of advanced breast cancer.

Based on preclinical data, we designed a phase I/II clinical trial to determine the efficacy and toxicity of doxorubicin followed by paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) in the treatment of patients with advanced breast cancer (either untreated or relapsed after adjuvant therapy). In the phase I study, 19 enrolled patients received bolus doxorubicin (50 mg/m2) and, after a 16-hour interval, escalating doses of paclitaxel (from 130 to 250 mg/m2 in 30-mg/ m2 increments) by 3-hour infusion every 3 weeks for a maximum of eight cycles. Paclitaxel doses were increased if the maximum tolerated dose (MTD; defined by dose-limiting toxicities) had not been reached. Analysis of the 128 cycles assessable for toxicity demonstrated neutropenia (< 500/microL) in 20% of cycles with no significant clinical events. No relevant clinical cardiotoxicity was observed. Other toxicities included mild peripheral neuropathy and mild myalgia/arthralgia (In 37.5% and 30.4% of cycles, respectively). The maximum tolerated paclitaxel dose was not reached at the 250 mg/m2 dose level. In the second phase, 13 patients were treated with fixed doses of both drugs (doxorubicin 50 mg/m2 and paclitaxel 220 mg/m2, the dose level immediately preceding the highest paclitaxel dose used in phase I). Grade 4 neutropenia occurred in 36 of the 87 cycles but was complicated by fever in only eight cycles (9%); three patients needed granulocyte colony-stimulating factor. Peripheral neuropathy (grades 1 and 2 in 41.3% and 5.7% of cycles, respectively) and a myalgic syndrome (grades 1 and 2 in 24.1% and 17.2% of cycles, respectively) were observed. No significant clinical cardiotoxicity was observed in 12 of the 13 patients. One patient experienced a decrease in left ventricular ejection fraction (from 60% to 43%) at a cumulative doxorubicin dose of 400 mg/m2. Antitumor efficacy was evaluated in both phase I and phase II. Overall clinical responses included 10 complete (31.3%) and 15 partial (46.9%) responses, for an objective response rate of 78.1%. Six patients (18.8%) had stable disease. The median durations of objective and complete response were 9 and 7 months, respectively. The 78.9% objective response rate in the phase I trial (31.6% complete and 47.3% partial responses) suggests a dose response relationship: at paclitaxel dose > or = 190 mg/m2, all patients had an objective response (six complete and nine partial responses). These results confirm that doxorubicin followed by paclitaxel is active and should be tested as adjuvant treatment and in patients treated previously with anthracyclines.

Adult↗
PubMed1996

The sequential administration of combined doxorubicin and paclitaxel in the treatment of advanced breast cancer.

In phase I and II studies we administered fixed doses of doxorubicin by intravenous bolus 16 hours before escalating doses of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) for the treatment of patients with advanced breast cancer who had received no prior treatment or who had relapsed after adjuvant therapy. Nineteen patients were entered in the study from April 1994 to February 1995. The median age of participants was 54 years; the median disease-free interval was 328 days. Eleven patients had undergone prior adjuvant chemotherapy, seven had undergone prior hormonal therapy, and six had undergone chest radiotherapy. A total of 128 courses of fixed-dose doxorubicin 50 mg/m2 by intravenous bolus and paclitaxel (doses escalated from 130 to 250 mg/m2, through dose escalations of 30 mg/m2 if maximum tolerated dose was not reached) were repeated every 21 days for a median of seven cycles per patient. Toxicities encountered in this trial included grade 4 neutropenia (20% of courses) and grade 4 thrombocytopenia (3% of courses). No grade 3 or 4 nonhematologic toxicities were observed (World Health Organization grade I peripheral neuropathies and mild myalgias in 37.5% and 30% of courses, respectively). No cardiac toxicity was observed. Responses included six complete responses (31.6%), nine partial responses (47.2%), and three stable disease (15.8%), for an overall response rate of 78.8%. Median duration of overall and complete response was 8+ months and 7+ months, respectively. At dose levels > or = 190 mg/m2, all patients had achieved a response (six complete responses and six partial responses). A phase II trial using fixed doses of doxorubicin (50 mg/m2) and paclitaxel (220 mg/m2) is ongoing. Preliminary data on 71 courses report no cardiac toxicity. Treatment with paclitaxel has been well tolerated at each dose level. The maximum tolerated dose was not reached at 250 mg/m2. No cardiac toxicity was reported. The dosing sequence of doxorubicin followed by paclitaxel is a highly active regimen and needs to be tested in anthracycline patients and in an adjuvant setting.

Adult↗
PubMed1995

Atypical absorption of morphine sulphate through oral mucosa: an unusual case of acute opioid poisoning.

An unusual case of probable opioid poisoning due to atypical absorption of morphine sulphate through the oral mucosa is reported. A patient with advanced laryngeal cancer, who was unable to swallow, became stuporous, bradypneic, and cyanotic and had pinpoint pupils 1 hour after taking a controlled-release tablet of morphine sulphate 30 mg. Intravenous naloxone 0.4 mg induced prompt reversal of the clinical picture. The tablet of morphine, in advanced stage of decomposition, was found in the patient's mouth, the mucosa of which was inflamed and extensively ulcerated because of the long-standing stagnation of food residuals. Usually morphine is not amenable to transmucosal absorption, because of its low lipid solubility. In this case, the retention of the tablet of morphine in the mouth and the breakdown of oral mucosa integrity could have provoked a quick transmucosal absorption of the drug, with by-pass of hepatic first-pass metabolism. This may have induced a peak in drug concentration much higher than that usually resulting from the enteric absorption of controlled-release tablets of morphine.

Absorption↗
PubMed1994

Etoposide, doxorubicin and cisplatin (EAP regimen) in advanced gastric cancer.

The treatment of advanced gastric cancer is unsatisfactory. The response rates for single chemotherapy agents: 5-fluorouracil, mitomycin-c, methotrexate, cisplatin, adriamycin, nitrosoureas and etoposide are approximately 10-25% and response duration ranges from 3 to 6 months. Complete responses with single agents are rare. Combination chemotherapy produces higher response rates, but these responses are short. Recently the combination of etoposide, adriamycin and cisplatin (EAP regimen) has been reported to produce results superior to what have been previously reported with other regimens. Twenty-four consecutive patients with locally advanced or metastatic gastric cancer (stage III-IV) were treated between June 1990 and December 1992 with the EAP regimen at our Department. Twenty-two patients were evaluable for response and toxicity. Objective responses were observed in 8 of 22 patients (response rate 36%; 95% confidence interval 17% to 59%). No clinical complete response was found. The median duration of the response was 7 months (range 2 to 22). Myelosuppression represented the primary toxicity associated with the EAP regimen. Grade 4 leukopenia was observed in 4 patients (18%). Grade 3-4 thrombocytopenia was registered in two patients, and grade 3 anemia was detected in 4 patients (18%). The median survival for all patients was 8 months and 12 months for the 8 responding patients. The EAP regimen seems to be an effective chemotherapeutic regimen, but cannot be considered the standard therapy for patients with locally advanced or metastatic gastric cancer, because of the high incidence of moderate to severe myelotoxicity and a response rate and duration of survival similar, but not superior, to those obtained using a less toxic schedule.

Aged↗