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Biomedical subjects

M Sassi

Publications and source records attributed to M Sassi.

At least 19 recordsLinked to original sources
PubMed2000

Gemcitabine, ifosfamide, cisplatin (GIP) for the treatment of advanced non-small cell lung cancer: a phase II study of the italian oncology group for clinical research (GOIRC).

The purpose of this study was to evaluate the activity and the toxicity of the combination of gemcitabine with ifosfamide and cisplatin (GIP) in chemonaive patients with advanced non small cell lung cancer (NSCLC). Eighty chemonaive patients with Stage IIIB-IV NSCLC were treated with the combination of gemcitabine 1 g/m(2) on Days 1 and 8, ifosfamide 2 g/m(2) on Day 1 and cisplatin 80 mg/m(2) on Day 2. Cycles were administered on an outpatient basis every 3 weeks. Hematologic toxicity was the main side effect; Grade III-IV thrombocytopenia was observed in 54 (67%) patients and Grade III-IV leucopenia in 44 (55%) patients, with 4 episodes of febrile neutropenia and 1 toxic death. Thirteen patients received platelet transfusions and 38 were transfused with packed red cells. All patients were evaluable for response. The overall response rate was 54% (95% confidence interval 43 to 65%) with 1 complete response. In patients with Stage IIIB and IV disease, response rates were 58% and 52%, respectively. Median time to progression was 40 weeks (range 0-114) and median overall survival was 12 months (16.6 months for stage IIIB and 10.4 months for stage IV). Median and minimum follow-up were 19 and 12 months, respectively. The GIP combination shows a response rate and overall survival of clinical interest. Hematologic toxicity was the main toxic effect, especially in patients with low performance status. This regimen will be tested in a Phase III randomized trial.

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

Italian Breast Cancer Adjuvant Chemo-Hormone Therapy Cooperative Group Trials. GROCTA Trials.

The first GROCTA trial compared 5-year tamoxifen treatment to ten chemotherapy cycles in a group of 504 pre-/post-menopausal, node-positive, ER-positive breast cancer patients. This study also included an arm combining tamoxifen with chemotherapy. Fifteen-year results showed no difference between tamoxifen and tamoxifen plus chemotherapy, while both treatments were significantly superior to chemotherapy alone. A confirmatory study (GROCTA 02) was performed in 244 pre-/perimenopausal patients by comparing 5 years of tamoxifen treatment (plus 2 years of goserelin) to six CMF cycles. No difference has emerged so far between the tamoxifen and CMF arms at a median follow-up time of 62 months. Post-menopausal women were scheduled to receive 3 years of tamoxifen treatment and then to be randomly allocated to further 2 years of tamoxifen or to 2 years of low-dose aminoglutethimide (GROCTA 04B). So far 662 patients have been entered, 375 of whom have been randomized to tamoxifen (n = 188) or aminoglutethimide (n = 187). Preliminary results (median follow-up time 32 months) show no major difference in patients' outcome. A new trial (ITA trial) with a similar design but employing anastrozole in place of aminoglutethimide has been activated in 1998. The GROCTA 03 study investigated the potential superiority of alternating adjuvant chemotherapy over standard CMF. This study, which included 107 node-positive ER-negative pre-menopausal women, was prematurely closed because more patients allocated to the triple alternated chemotherapy appeared to have relapsed and died at the first interim analysis. The use of high-dose chemotherapy (HDC) was explored by the GROCTA 06 trial which included 53 patients with ten or more involved nodes and a maximum age of 55 years. These patients were scheduled to receive three standard CEF cycles followed by one cycle of HDC (cyclophosphamide 5 g/m2; etoposide 1.5 g/m2; cisplatin 150 mg/m2) without any form of bone marrow rescue. This HDC program proved to be feasible but was not superior to CMF-based chemotherapy we had previously employed in a comparable group of patients in previous GROCTA trials. These findings prompted us to explore new HDC programmes with the use of peripheral stem cell support and in addition the possible value of new drugs such as Taxol and vinorelbine. New-generation trials will also explore the value of new prognostic indicators such as tumor proliferative activity, which are prospectively used to allocate patients to different treatment options.

Antineoplastic Agents, Hormonal↗
PubMed1998

Bolus versus 5-day continuous infusion of cisplatin with mitomycin and vindesine in the treatment of advanced non-small cell lung cancer (NSCLC): a phase III prospective randomised trial of the Italian Oncology Group for Clinical Research (GOIRC).

The aim of this randomised trial was to compare the efficacy of bolus versus continuous infusion cisplatin combined with mitomycin C and vindesine (MVP) for chemotherapy-naive patients with stage IIIB-IV non-small cell lung cancer (NSCLC). 97 patients (49 given bolus cisplatin-arm A and 48 given continuous infusion cisplatin--arm B) were evaluable for response. In arm A, 2 patients achieved a complete response (CR), 21 achieved a partial response (PR), whilst in arm B, 14 patients achieved a PR (29%) (P = 0.07). Median survival was 8 months in both arms. Myelosuppression was the most frequent and severe toxicity, with a higher incidence of grade 3-4 leucopenia in arm A when compared with arm B (44% versus 25%). In conclusion, there is no advantage for a cisplatin 5 day infusion in the MVP regimen.

Adult↗
PubMed1993

[Prophylactic antibiotherapy using cefapirin in the surgery of duodenal ulcer: a randomized clinical trial].

A randomized clinical trial of antibiotic prophylaxis in patients undergoing gastroduodenal surgery for stenosing or bleeding duodenal ulcer was carried out from February 1990 to February 1991. Seventy-two patients were randomly assigned to either Group I (n = 33) and given 1 g of cefapirine intravenously every eight hours, four times, starting at induction of anaesthesia; or to Group II (n = 39), and not given any antibiotic. The surgical dressing was changed on the third postoperative day, and thereafter every two days in patients with fever. The efficiency of prophylaxis was assessed on the incidence of superficial or deep primary infection, and the length of hospital stay. Primary wound sepsis occurred in 7 Group II patients, and in none in Group I (n = 0.01). The results for those patients with stenosing ulcer (n = 53) were also significant: there was no primary wound infection in Group I (n = 25), whereas five occurred in Group II (n = 28) (p = 0.03). Hospital stay was shorter in Group I than in Group II (7 vs 9.5 days). Antibiotic prophylaxis also seemed to be efficient in patients with bleeding duodenal ulcers (n = 19), but their group was too small to reach levels of statistical significance. Again hospital stay was shorter in Group I than in Group II (8.5 vs 12.2 days). The efficiency of antibiotic prophylaxis was therefore confirmed for patients undergoing gastroduodenal surgery for stenosing duodenal ulcer.

Adult↗
PubMed1993

Ondansetron.

Ondansetron is the first selective antagonist of the 5-hydroxytryptamine receptors (type 3) marketed for the prevention of emesis induced by antineoplastic agents. Ondansetron has been shown to be more active and less toxic than high-dose metoclopramide in patients submitted to cisplatin chemotherapy. Furthermore, when dexamethasone was added to ondansetron, its antiemetic efficacy increased significantly. In the prevention of emesis induced by a high single dose of cisplatin or by repeated low doses, ondansetron combined with dexamethasone has been shown to be the more efficacious and less toxic antiemetic treatment. However, in the prevention of delayed emesis from cisplatin, its role is still to be defined. In patients submitted to moderately emetogenic chemotherapeutic agents, ondansetron has shown an efficacy superior or equal to standard doses of metoclopramide, but is less toxic. Moreover, when compared with dexamethasone, its antiemetic efficacy and tolerability is similar; in this group of patients ondansetron should be used only when steroids fail. Ondansetron toxicity is generally mild; in particular, it does not induce extrapyramidal reactions. The most frequent side-effects are headache and constipation.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1992

Antiemetic activity of two different high doses and schedules of metoclopramide in dacarbazine-treated cancer patients.

The antiemetic activity of two different high doses and schedules of metoclopramide in dacarbazine-treated cancer patients was compared in a double-blind crossover study. Regimen A consisted of metoclopramide [2 mg/kg x 4 intravenously (i.v.)] plus methylprednisolone (250 mg x 2 i.v.) plus diphenhydramine (50 mg x 2 i.v.). Regimen B consisted of metoclopramide (3 mg/kg x 2 i.v.) plus dexamethasone (20 mg i.v.) and diphenhydramine (50 mg i.v.). Both treatments were administered for the first 2 days of 5-day dacarbazine chemotherapy. Thirty-two patients (13 men and 19 women) affected by melanoma and sarcoma were entered in the study. Complete protection against nausea and vomiting for the first 2 days of chemotherapy in both antiemetic regimens was not significantly different. Patient preference and tolerance of the two antiemetic treatments were similar. Regimen B, employing a lower dosage of metoclopramide and steroids and using a more simple schedule of administration should be the preferred treatment.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1991

Double-blind crossover trial of single vs. divided dose of metoclopramide in a combined regimen for treatment of cisplatin-induced emesis.

In a double-blind crossover antiemetic study in cisplatin-treated cancer patients, metoclopramide 4 mg/kg as a single intravenous dose (regimen A) was compared with 3 mg/kg in two doses (regimen B). In both regimens, metoclopramide was combined with dexamethasone and diphenhydramine. 65 consecutive, chemotherapy-naïve inpatients (45 males and 20 females) treated with high doses (at least 50 mg/m2) of cisplatin entered the study and 54 completed both treatments. Complete protection from vomiting and nausea, mean number of emetic episodes, mean maximum intensity of nausea and mean duration of emesis or nausea were similar with the two antiemetic regimens. 23 patients (43%) did not express a treatment preference, while 16 (30%) preferred regimen B and 15 (28%) preferred regimen A. Side-effects were similar with the two metoclopramide schedules. A combined antiemetic regimen of a single high dose of metoclopramide (4 mg/kg) can preserve efficacy and tolerability and thus should be preferred.

Cisplatin↗
PubMed1991

Intra and interobserver variability in cancer patients' performance status assessed according to Karnofsky and ECOG scales.

The Karnofsky (K) and ECOG (E) performance status (PS) scales are widely used to evaluate the functional status of cancer patients to determine their eligibility for clinical trials and their prognosis, but knowledge of inter and intraobserver variability of these scales is scarse. We therefore planned a prospective study on 209 consecutive cancer patients to evaluate this critical point. Two independent observers evaluated the KPS and EPS of each patient by interviewing them on the same day. After their interviews the patients were asked to fill in, again on the same day, a self-evaluation scale concerning their ability to perform the routine activities of daily life. The 209 patient self-evaluation scales were presented twice, randomly and blinded, to the two observers who had participated in the evaluation of PS as well as to one other observer who had not. The interobserver correlation for both scales was very high (K = 0.921 for KPS and K = 0.914 for EPS) as was the intraobserver correlation (for KPS: K = 0.993, K = 0.960, and K = 0.959 and, respectively, for EPS: K = 0.982, K = 0.970, and K = 0.920). On the basis of these results, it appears that evaluation of PS made by a clinical oncologist using K or E scales can be very reliable and is a guarantee of optimal selection of cancer patients for inclusion in clinical trials.

Aged↗
PubMed1990

Etoposide versus etoposide plus high-dose cisplatin in the management of advanced non-small cell lung cancer. Results of a prospective randomized FONICAP trial. Italian Lung Cancer Task Force.

Two hundred sixteen patients with unresectable non-small cell lung carcinoma were randomly allocated to receive etoposide (120 mg/m2, days 1-3) either alone or in combination with high-dose cisplatin (60 mg/m2, days 1-2). The patients' distribution and characteristics were similar in the two treatment arms. The objective response rate for etoposide was 7% versus 25.8% for etoposide plus cisplatin (P less than 0.005). Median progression-free survival in etoposide arm was 3.5 months versus 5 months in the combination arm (P = 0.43). The median survival time for etoposide was 6 months compared with 8 months for etoposide combined with cisplatin (P = 0.87). Significantly more nausea/vomiting (P less than 0.005), serum creatinine elevation (P less than 0.005), hearing loss and/or tinnitus (P less than 0.005), peripheral neuropathy (P less than 0.005), leukopenia (P less than 0.025), and anemia (P less than 0.005) occurred in the etoposide plus cisplatin arm. No statistically significant difference was recorded between the two arms in terms of performance status changes. In conclusion the addition of high-dose cisplatin to single-agent etoposide significantly increases the chance of obtaining tumor response in advanced non-small cell lung cancer at the cost of an increased toxicity without any significant long-term impact on survival and progression-free survival.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1986

[Blood transfusion practices in elective surgery at the Ospedale Maggiore di Parma: proposal for a table for maximum blood ordering].

In elective surgery the preoperative blood order goes beyond the real need. This excess results important problems in a Blood Bank management about blood aging and outdating, availability of particular groups and phenotypes, unnecessary laboratory work and extra-costs. The introducing of a Maximum Surgical Blood Order Schedule seems to be helpful in auto-reduction of blood request. The MSBOS is the maximum number of blood units which is transfused in 90% of cases during surgical procedures and within 72 hours postoperatively. This optimal blood order reflects a realistic hemotherapy in elective surgery. For those procedures which rarely required hemotherapy, a ABO-Rh typing and screening for unexpected antibodies (Type and Screen) is appropriate. The Authors have realised a MSBOS for 24 surgical procedures of General Surgery, Urology and Orthopaedy performed in the General Hospital of Parma during six month. The results compared with other data obtained from Literature suggest that there is not excess in blood use for elective surgery in the General Hospital of Parma.

Blood Banks↗
PubMed1986

An in vitro model of erythroid egress in bone marrow.

An in vitro system has been developed that mimics the passage of erythrocytes from the bone marrow to the circulation. Bone marrow egress and its proper regulation are vital physiologic processes. However, because of the inaccessibility of the marrow, it is difficult to evaluate the various factors important in controlling these processes or even to define the precise mechanism by which egress occurs. The in vitro system has been designed to evaluate the importance of different physical parameters in regulating egress. It consists of a thin silicon wafer (thickness approximately equal to 1.0 micron) cemented over the tip of a large (15.0 micron ID) micropipette. The wafer contains a single circular pore. Cells were observed under the microscope as they passed through the pore under controlled pressures. The rate and duration of passage were obtained from videorecordings of the experiment. The measured passage times agreed well with the predictions of a simple analytical model of a cell passing through a thin aperture. The experimental results confirm the conclusion reached from the analysis that the pressures needed to drive a cell through the pore are well within the physiologic range, and the time needed to complete egress is typically less than 1.0 seconds. These results support the hypothesis that erythrocyte egress may be driven by a hydrostatic pressure difference across the pore.

Bone Marrow↗
PubMed1985

[Errors in blood transfusion. Causes and prevention].

Authors, analyzed the possible sources of errors resulting in the administration of incompatible blood and of the specific professional responsibilities connected to that error, point out the precautions to minimize it and the therapy which is to be followed in the cases of serious haemolytic transfusion reactions.

Anemia, Hemolytic↗
PubMed1985

[Blood filtration for the prevention of microaggregate damage: various critical aspects].

Recent studies shown that patients receiving more than 20% of their total blood volume through 170 mu standard blood filters, may occur in severe organic damage such as pulmonary, cerebral, renal embolism due to microaggregates contained in stored blood. Microaggregate size varies from 10-200 mu; they are composed of platelets, leucocytes, red cells debris and fibrin strands, which take form few hours after blood storage begins and whose number progressively increases. In this study we analyzed microaggregate composition, factors causing their formation, side effects due to massive transfusion and blood filtration techniques capable to prevent a direct blood infusion. There is a variety of available filters, but screen filters seem to offer more important and practical advantages than depth filters do. The use fine pore filters is recommended when more than three blood units are to be infused during only one administration.

Anticoagulants↗