Efficacy and tolerance of vinorelbine and fluorouracil combination as first-line chemotherapy of advanced breast cancer: results of a phase II study using a sequential group method.

Purpose: To assess the antitumor efficacy and safety profile of the combination of Fluorouracil (5FU) and vinorelbine given as first-line therapy to patients with advanced breast cancer.

Patients And Methods: As defined in the seven consecutive steps of a phase II group sequential design, 63 patients received 5FU 750 mg/m2/d for 5 consecutive days as a continuous infusion and vinorelbine 30 mg/ m2 on days 1 and 5 as a short intravenous (I/V) infusion every 3 weeks.

Results: Forty-one of 63 patients achieved an objective response, which allowed us to discontinue the study and reject a response rate less than 50% with a statistical power of 90%.

Rationale for the dosage and schedule of CPT-11 (irinotecan) selected for phase II studies, as determined by European phase I studies.

Background: CPT-11 (irinotecan), a camptothecin-derived anticancer agent with DNA topoisomerase 1 inhibitory activity, has demonstrated a broad spectrum of in vitro and in vivo activity in solid tumour models including multidrug-resistant tumours. This review details the rationale for the dosage schedule of CPT-11 selected for phase II studies, based on the results of 3 European phase I dose-escalating trials in patients with solid tumours.

Patients And Methods: CPT-11 was administered as a 30-minute intravenous infusion once every 3 weeks (schedule 1), once daily for 3 consecutive days every 3 weeks (schedule 2) or once weekly every 3 out of 4 weeks (schedule 3).

The Lck tyrosine kinase is expressed in brain neurons.

The lck gene product, p56lck, is a member of the src-related family of protein tyrosine kinases. It is known as lymphocyte specific and involved in thymocyte development and in the immune response mediated by the T cell receptor. We report that the lck gene is also expressed in adult mouse CNS and that brain p56lck is similar to the thymus protein.

A spontaneously immortalized mouse microglial cell line expressing CD4.

We have derived a microglial clone, named C8-B4, from the 8-day mouse cerebellum organ culture which gave rise to distinct astroglial cell lines as previously reported. Indeed, the C8-B4 clone expresses classical microglial markers (MAC1, F4/80, 2-4G2) and appears to be derived from a committed microglial precursor since it does not express differentiation antigens present during the early stage of the monocytic lineage. This microglial clone expresses two characteristics not previously reported for microglial cell lines: it synthesizes the CD4 molecule and produces and releases large amounts of glutamate.

Two consecutive phase II studies of oxaliplatin (L-OHP) for treatment of patients with advanced colorectal carcinoma who were resistant to previous treatment with fluoropyrimidines.

Background: Oxaliplatin (L-OHP) is a platinum complex that possesses activity against human and murine cells in vitro and in vivo, including colorectal carcinoma-derived cell lines, and cells that have been selected for resistance to cisplatin. We report two consecutive phase II trials of L-OHP for treatment of patients with advanced colorectal carcinoma.

Patients And Methods: Fifty-eight patients were entered in study I, and 51 patients in study II.

Adjuvant cyclophosphamide, methotrexate, and fluorouracil versus fluorouracil, epirubicin, and cyclophosphamide chemotherapy in premenopausal women with axillary node-positive operable breast cancer: results of a randomized trial. The International Collaborative Cancer Group.

Purpose: To determine whether a combination chemotherapy regimen that contains epirubicin (fluorouracil, epirubicin, and cyclophosphamide [FEC]) is superior to the standard cyclophosphamide, methotrexate, and fluorouracil (CMF) combination in premenopausal women with axillary node-positive operable breast cancer.

Patients And Methods: The International Collaborative Cancer Group (ICCG) conducted a large randomized trial in which two alternative schedules were used according to participating center: CMF1 versus FEC1 and CMF2 versus FEC2.

Results: Seven hundred fifty-nine patients were entered onto the trial.

Phase I-II and pharmacokinetic study of a new fotemustine schedule in advanced non-small cell lung cancer.

Unlabelled: Fotemustine, a new nitrosourea derivative has already demonstrated activity in non-small cell lung cancer (NSCLC). In order to improve its therapeutic index, we designed a protocol in which Fotemustine was delivered with dose escalation on 3 consecutive days as induction therapy followed by a 5-week rest period. Maintenance therapy consisted of 100 mg/m2 once every 3 weeks.

Phase II randomized study of paclitaxel versus mitomycin in advanced breast cancer.

Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) has been shown to be an effective agent in the treatment of metastatic breast carcinoma. This multicenter randomized study compared paclitaxel 175 mg/m2 given as a 3-hour infusion every 3 weeks with mitomycin 12 mg/m2 given as an intravenous infusion every 6 weeks. Eighty-one patients have been randomized, and preliminary results of a planned analysis of the first 36 evaluable patients per arm are reported.

[Immunohematologic study in 112 patients with myelodysplastic syndromes: 10-year analysis].

Purpose: To describe the immunohematological response after multiple red blood cells transfusions in 112 patients with myelodysplastic syndromes (MDS).

Patients And Methods: From 1982 to 1992 every patient with MDS entered the study. Immunohematological studies consisted of an antibody screening test (AST) and a direct antiglobulin test (DAT) at diagnosis and after every four transfused units of red blood cell concentrates.

[Knee joint arthroscopy in the growth years].

An increasing number of children and adolescents are complaining about knee pain. Because of unspecific patient history and the difficulty of clinical examination a correct diagnosis can be made in only half of the patients. The importance of the diagnostic and therapeutic knee arthroscopy has therefore increased.

[Amyloidosis of the gallbladder. An unusual localization].

We report a rare case of amyloidosis of the gallbladder in a 60-year-old man. This amyloidosis was associated with hepatic amyloidosis and pancreatic adenocarcinoma. To our knowledge, this is the second case reported in the literature and the first associated with neoplastic pathology.

Is Navoban (tropisetron) as effective as Zofran (ondansetron) in cisplatin-induced emesis? The French Navoban Study Group.

The purpose of this study was to evaluate and compare the antiemetic effectiveness and tolerability of Navoban (tropisetron) and Zofran (ondansetron) following high-dose (> or = 50 mg/m2) cisplatin chemotherapy. In a randomised, multi-centre, double-blind, double-dummy, parallel group study, 117 evaluable chemotherapy-naive patients who received Navoban were compared with 114 who received Zofran. Patient diary cards were used to assess both acute (Day 1) and delayed (Days 2-6) nausea and vomiting.

Cancer risk assessment for crystalline silica to implement California's hot spots act.

Crystalline silica has been identified as a probable human carcinogen. To assess the potential for adverse health effects due to environmental exposures to respirable crystalline silica, a quantitative estimate of carcinogenicity has been made using incidence data from three studies in which long-term silica inhalation caused lung tumors in rats. The uncertainties in risk assessment in general and in the risk assessment for silica in particular are discussed.

Phase II study of a new vinca alkaloid derivative, S12363, in advanced breast cancer.

Vinca alkaloids are widely used in the medical treatment of breast cancer. Our study aimed to evaluate the therapeutic activity of a new vinca alkaloid derivative, S12363 (vinfosiltine), which is 36 and 72 times more cytotoxic in vitro than vincristine and vinblastine, respectively. Because phase I studies did not allow a choice of the best treatment schedule, a randomization was performed between two schedules with the same dose intensity, that is, 0.

[Inflammatory cancer of the breast: review and experience at Saint-Louis hospital].

Inflammatory breast cancer represents about 1 to 6% of all breast cancers. It has a sudden onset and affects women of the same age as other breast cancers. Its particular feature is the almost constant development of metastases.

Population pharmacokinetics of docetaxel during phase I studies using nonlinear mixed-effect modeling and nonparametric maximum-likelihood estimation.

Docetaxel, a novel anticancer agent, was given to 26 patients by short i.v. infusion (1-2 h) at various dose levels (70-115 mg/m2, the maximum tolerated dose) during 2 phase I studies.

Can we still hear the call? What it means to be Catholic.

Despite the drastic changes occurring in the world today, certain elements of the Catholic tradition and communion can make the transition into a world colored by merger and shaped by governmental concerns for the general, not the particular. If Catholic particularism to many degrees and in many ways has been lost, the "loss" occurred before, apart from, alongside, and in many ways independent of merger and governmental contexts. "We gave it away.

Methylprednisolone enhances the efficacy of ondansetron in acute and delayed cisplatin-induced emesis over at least three cycles. Ondansetron Study Group.

This double-blind multicentre study has been carried out in order to confirm the improvement of ondansetron's antiemetic efficacy when combined with a corticosteroid and to determine whether this increased efficacy is maintained over three chemotherapy courses. One hundred and two patients receiving their first course of cisplatin (50-120 mg m-2)-containing chemotherapy were randomised to receive one of the two following treatments: 8 mg OND i.v.

Dysgerminoma in a pure 45,X Turner syndrome: report of a case and review of the literature.

There is a high risk of neoplasm in dysgenetic gonads. Classically, in Turner syndrome, only patients with 45, X/46, XY mosaicism karyotype or with a fragment of Y chromosome (45, X+mar) are at risk of developing gonadal tumor. A case of a dysgerminoma arisen on the dysgenetic gonad of a 45, X Turner patient in the absence of Y chromosome material at cytogenetic and molecular biology analysis is reported.

[Radio-chemotherapy combinations: from biology to clinics].

Combination of radiotherapy and chemotherapy (CRC) is actually one important way of research in oncology. Theoretical advantages are: 1) Spatial cooperation; 2) Additivity, which is only obtained if the toxicity of each modality are different; 3) Supra-additivity, which needs a rigorous in vitro definition; the only way to prove it is to make an isobologram analysis. This model has however, some limitations: qualitative variable could not be used, results could be different, depending on the cell line and isoeffect chosen.

[Adamantinoma of the proximal end of the tibia. A case].

Adamantinoma is a rare primary tumour of long bones containing mesenchymatous and epithelial cells. There has been some controversy over the pathogenesis. We observed a localization in the right tibia.