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L Frontini

Publications and source records attributed to L Frontini.

17 recordsLinked to original sources

High-versus low-dose levo-leucovorin as a modulator of 5-fluorouracil in advanced colorectal cancer: a 'GISCAD' phase III study. Italian Group for the Study of Digestive Tract Cancer.

BACKGROUND: Although leucovorin (LV) + 5-fluorouracil (5-FU) is considered the treatment of choice for advanced colorectal cancer in most countries, the optimal schedule of this combination has not yet been established. Low-dose LV appears to be as active as high-dose LV in the daily-times-five regimen, but no randomized study of the levorotatory stereoisomer (6S-LV) given at two different dose levels has been published. PATIENTS AND METHODS: Between November 1991 and June 1994, 422 patients (all with measurable disease previously untreated with chemotherapy) were randomized to 6S-LV (100 mg/sqm/i.v.) + 5-FU (370 mg sqm/15 min i.v. infusion), both administered for 5 days every 28 days (arm A), or to 6S-LV (10 mg/sqm/i.v./5-FU (doses as above), also given for 5 days every 28 days (arm B). The primary endpoint of the study was the comparison of response rates (WHO criteria): the secondary endpoint was the assessment of survival and tolerability. No evaluation of the quality of life or the symptomatic effect of treatment was planned. RESULTS: The response rate was 9.3% in arm A (95% CI: 5.4-13.1), with 2 CR and 18 PR, and 10.7% in arm B (95% CI: 6.5-14.9), with 3 CR + 19 PR, without any significant difference (P = 0.78). The median time to progression was eight months in both groups and overall survival was 11 months, with no difference between treatments. Toxicity mainly consisted of gastrointestinal side effects (mucositis and diarrhoea), which were rarely severe (grade 3-4: 5%-10% of patients) and similar in the two groups. CONCLUSIONS: In this large-scale multicentre trial, the low and high doses of 6S-LV appeared to be equivalent in terms of the biochemical modulation of 5-FU in advanced colorectal cancer although, for several reasons (including the timing and the strict criteria of response evaluation, the high number of patients with unfavourable prognostic factors, the multi-institutional nature of the study, the dose and modality of 5-FU administration), the response rate was lower than that reported in some of the other published studies. Given the considerable difference in economic cost between the two dosages, the use of high-dose 6S-LV in the daily-times-five regimen is not recommended in clinical practice.

Adult

Prediction of survival of patients terminally ill with cancer. Results of an Italian prospective multicentric study.

BACKGROUND: The individualization of prognostic factors in the various stages of cancer facilitates the planning of a therapeutic assistance program aimed at various subsets of patients. The prognostic factors for survival in patients terminally ill with cancer have been investigated in case studies that are often retrospective, monocentric and/or include a mixture of patients in advanced disease stages. The aim of this prospective multicentric study was to verify those clinical factors predictive of survival in a population of patients with terminal cancer. METHODS: This prospective and multicentric study was performed on 540 patients with solid tumors in the disseminated phase, no longer subject to specific therapy. Patients were evaluated at study entry and every 4 weeks thereafter. The analysis was performed for 23 clinical parameters. RESULTS: Of 530 assessable patients with a median survival of 32 days, 15 factors were found to be statistically significant prognostic factors. By univariate analysis, 13 factors were found to be indicators of a worse survival: age older than 65 years (P = 0.05); palliative corticosteroid treatment (P < 0.001), anorexia (P < 0.001); dry mouth (P < 0.001); dysphagia (P < 0.001); hospitalization (P < 0.001); transfusion (P < 0.001); weight loss greater than or equal to 10% (P = 0.001); dyspnea (P = 0.01); pain (P = 0.006); increasing amount of pain-killer treatment (P = 0.01); increasing number of symptoms (P < 0.001); and worse clinical prediction of survival (P < 0.001). Two factors that correlated with a better survival rate were palliative progestin treatment (P = 0.03) and a higher Karnofsky performance status (P < 0.001). Multiple regression analysis revealed that only clinical prediction of survival, anorexia, dyspnea, palliative steroidal treatment, Karnofsky performance status, and hospitalization were independent predictors of survival. CONCLUSIONS: The importance of certain clinical parameters as prognostic indicators for patients with terminal cancer (clinical experience, physical activity level, clinical symptoms relating to and unrelated to nutritional state) were confirmed; some others possible factors, such as treatment with corticosteroids and hospitalization, also were noted. These may be useful factors in the therapeutic, assistance decision-making process and may eliminate overtreatment and undertreatment resulting from philosophically preconceived attitudes, rather than from considering the patient's true pathologic condition.

Adrenal Cortex Hormones

Oral etoposide as second-line chemotherapy for colorectal cancer: a GISCAD study. Gruppo Italiano Studio Carcinomi Apparato Digerente.

Twenty-one patients with advanced colorectal cancer, all previously pretreated with a fluoropyrimidine-based regimen, received oral etoposide: 100 mg/die for 21 consecutive days, every three weeks. No objective response was achieved; 6 pts had a short-lasting stabilization of their disease. Toxicity was substantial and mainly represented by myelosuppression and alopecia. Protracted administration of etoposide is inactive as second-line treatment of colorectal cancer.

Administration, Oral

Vinorelbine as single agent in pretreated patients with advanced breast cancer.

Vinorelbine is a new semisynthetic vinca alkaloid with high activity against breast cancer. In this multicenter clinical study we evaluated the activity and toxicity of vinorelbine as a single agent in 30 advanced breast cancer patients pretreated with anthracycline and/or mitoxantrone (24 with recurrent tumor, 6 with non operable cancers). Vinorelbine was given at a weekly dose of 20 mg/m2 for a minimum of 3 weeks. Treatment was continued until there was disease progression or evidence of serious toxicity. Predominant sites of metastasis were viscera (14 cases), soft tissue (11 cases) and bone (5 cases). A median number of 12 doses of vinorelbine (range 3-34) were administered to each patient. Objective responses were recorded in 11 of them and 15 had minimal responses or stable disease. Four patients showed progression of disease during vinorelbine chemotherapy. The median duration of response was 5 months (2-14). The median survival time was 7 months (2-20+): 9 months for responders and 5 months for those with stable or progressive disease. The most important and dose-limiting toxicity was represented by leukopenia. The compliance of patients was very good and the treatment was well accepted by them all including those with low performance status. In conclusion, this study provides further evidence that a weekly schedule with vinorelbine as a single agent is effective and well-tolerated also in pretreated advanced breast cancer patients.

Adult

Vinorelbine is an active antiproliferative agent in pretreated advanced breast cancer patients: a phase II study.

PURPOSE: To evaluate the efficacy and toxicity of single-agent vinorelbine (VNB), a semisynthetic vinca alkaloid, in patients with breast cancer previously treated with other chemotherapeutic regimens for metastatic disease. PATIENTS AND METHODS: Sixty-seven of 70 patients with assessable disease entered onto the study were assessable. The main characteristics were as follows: median age, 60 years (range, 41 to 77); median performance status (PS; Karnofsky score), 90 (range, 60 to 100); and number of previous chemotherapeutic regimens given--one in 17, two in 27, three in eight, four in two, and five in one patient. The dominant sites of metastasis were viscera in 40, bone in 16, and soft tissues in 11 patients. VNB was administered beginning with the dose of 20 mg/m2 by 60-minute intravenous (iv) infusion weekly, with a dose escalation up to 25 mg/m2 if the first four courses were well tolerated. The treatment was continued until disease progression. RESULTS: Overall, 845 courses of VNB were given (median, 10; range, eight to 33). Objective responses were as follows: complete response (CR) in three (4.5%), partial response (PR) in 21 (31.2%), stable disease (SD) in 20 (30%), and progressive disease (PD) in 23 patients (34.3%). Twenty-four of 67 assessable patients obtained a major objective response (CR or PR, 36%; 95% confidence interval [Cl], 24% to 47%). Thirty-three percent of patients had a > or = 33% reduction of dose-intensity (DI). The median time to progression was 18 weeks. The drug was active in patients pretreated with either cyclophosphamide, methotrexate, and fluorouracil (CMF) or anthracyclines. The most relevant toxicity observed was myelosuppression: 17 (25%) and 19 patients (28%) had World Health Organization grade III, and six (9%) and six patients (9%) had grade IV leukopenia and granulocytopenia, respectively; two (3%) and two patients (3%) had grade III and IV anemia, respectively. Nonhematologic toxicities were phlebitis (grade II or III in 15 patients), alopecia (grade I or II in 16), nausea and vomiting (grade II or III in 15), diarrhea (grade II in two), constipation (grade II or III in 16), stomatitis (grade II or III in 13), peripheral neuropathy (grade II in seven), and asthenia (grade II in five). CONCLUSION: This study shows that VNB is an effective and well-tolerated agent in pretreated patients with advanced breast cancer. This drug does not seem to present cross-resistance with previous CMF or anthracycline regimens. Future clinical trials should be designed to prove whether the inclusion of VNB in combination chemotherapy regimens, or whether an enhancement of its dose-intensity using bone marrow growth factors, is able to improve further the efficacy of this drug in breast carcinoma.

Adult

Cisplatin plus epirubicin and etoposide followed by irradiation plus lonidamine in stage III nonsmall cell lung cancer.

Forty-seven patients with stage III nonsmall cell lung cancer (NSCLC) were treated with the sequential administration of combination chemotherapy consisting of cisplatin, epirubicin and etoposide and of irradiation plus lonidamine. The response rate was 49% after chemotherapy with an improvement of 14% after radiation therapy and lonidamine. The median survival was around 15 months for responders and 9 months for nonresponders. Toxicity was moderate and acceptable. It is concluded that this schedule is active in the treatment of NSCLC.

Adenocarcinoma

[Postoperative hyperamylasemia in surgery of the biliary tract (clinical contribution)].

The Authors refer on the presence of hyperamylasemia in 46 patients subjected to surgery of the bile ducts. A rise in serum amylase values was found in 22,42 of the cases. In one case only, hyperamylasemia was accompanied by a clinical picture of acute pancreatitis. In the rest of the patients the increase of the amylasemid has not modified the postoperative course and its completely normalization. The negativity of the clinical picture appears to indicate that the hyperamylasemia is to be considered as an aspecific and only partly pancreatic response to a injuries over very delicate anatomical structures.

Adult

[Traumatic rupture of the diaphragm caused by closed injury].

Our experience with 26 Patients who sustained traumatic laceration of the diaphragm caused by blunt forces is described. Automobile accidents were the most frequent cause of rupture and young adult males the most vulnerable. The left hemidiaphragm is most frequently injured, but with sufficient force significant tears in the right hemidiaphragm will occur. Most of these patients sustained injury to multiple organ systems. The preoperative diagnosis of traumatic diaphragmatic hernia is based on a high index suspicion, close and continued observation of the patient, and correct interpretation of roentgenograms of the chest. The mortality rate is high owing to the magnitude of the injuries.

Adult

[Our experience in the treatment of inguinal hernia using a silastic-dacron prosthesis].

The Authors report their experience on 50 patients suffering from inguinal hernia and treated with a plastic surgery operation preceded by subfascial introduction of a Silastic-Dacron prothesis. They describe the reported complications and relate on the frequency of relapses within a period of 3 years, comparing them with the data reported by the existing literature on this subject.

Aged

[Early diagnostic laparotomy in patients with multiple injuries (apropos of 125 cases)].

Hundred twenty five patients with multiple areas of injury requiring surgical repair outside of the abdomen too were subjected to laparotomy. In patients with multiple areas of trauma the abdomen is almost always suspect. The proliferation of diagnostic tools to detect intraperitoneal damage have, in some ways, helped phisicians decide as to laparotomy. However, when multiple injuries are present, particularly of the central nervous system, classical findings of peritoneal damage are difficult to elicit. A diagnostic laparotomy does not add significantly to the overall morbidity or mortality, for that we think is still a place for diagnostic laparotomy in patients with multiple trauma.

Abdominal Injuries

Cisplatin-vinorelbine combination chemotherapy in locally advanced non-small cell lung cancer.

AIM: The North Milan Group presents the results of a phase II study on a cisplatin-vinorelbine combination schedule in the treatment of locally advanced non-small cell lung cancer to evaluate its activity and tolerability. METHODS: Seventy-six consecutive patients entered the study. Patients' characteristics were the following: males/females 69/7; median age, 61.4 years (range, 40-73); ECOG performance status, 0-1; 17 stage IIIa and 59 stage IIIb. There were 49 squamous cell carcinomas, 20 adenocarcinomas, and 7 large cell carcinomas. All patients had not been previously treated and showed measureable disease. Treatment consisted of vinorelbine, 25 mg/m2 on days 1 and 8, plus cisplatin, 80 mg/m2 on day 1, administered intravenously every 21 days for three standard courses. RESULTS: Seventy-four patients were evaluable for response. Objective responses were documented in 42/74 patients with an overall response rate (CR+PR) of 56.7%; 18/74 patients (24.3%) showed stable disease and the remaining 14/74 (18.9%) went into progression. Twelve patients (16.2%) were suitable for a subsequent surgery. The median duration of response was 13.3 months. Survival time ranged from 4 to 36 months; it was 14.6 months for PR patients, 8.6 months for NC and 5 months for PD. Mean survival time is presently 12.85 months (SE, 1.2 months). Toxicity evaluated on 222 cycles administered was acceptable, and it was necessary to use G-CSF or delay the treatment because of severe leukopenia in only a few cases. CONCLUSIONS: The regimen is active and safe: the slight survival increase is likely due to the small amenability to surgery achieved (16.2%). However, our results are fully comparable to others obtained with vinorelbine in two/three drug combination chemotherapy regimens.

Adult