Randomized, controlled, multicenter phase III trial of standard-dose fluorouracil-epirubicin-cyclophosphamide (FEC), compared with time-intensive FEC (FEC-G) and mitoxantrone-methotrexate-mitomycin C (MMM-G) in metastatic breast carcinoma.

The purpose of this multicenter phase III trial was to assess the impact of a time-intensification of FEC (fluorouracil, epirubicin, cyclophosphamide) and MMM (mitoxantrone, methotrexate, mitomycin C) regimens, supported by lenograstim (G-CSF) on the objective response rate, time to progression and survival of patients with chemotherapy-naive metastatic breast cancer (mbc). Women with mbc were randomized to receive as first-line chemotherapy either standard-dose FEC (all doses in mg/m2): arm A (500, 75, 500 every 21 days), or time-intensified FEC-G: arm B (500, 75, 500 every 14 days), or time-intensified MMM-G: arm C (mitoxantrone 10, methotrexate 35 every 14 days and mitomycin C 10 every 28 days), both with support of lenograstim (G-CSF 150 microg/m2/day s.c.

Efficacy of 51Cr-EDTA clearance to tailor a carboplatin therapeutic regimen in ovarian cancer patients.

Aim: The aim of this study was to evaluate the efficacy of 51Cr-EDTA clearance to tailor the carboplatin dose in two different therapeutic regimens of advanced epithelial ovarian cancer.

Materials And Methods: 14 patients entered the study, eight treated by carboplatin (C) alone and six by C and paclitaxel (P). The dose of C was calculated from the Calvert formula [DOSE(mg) = desired AUC x (GFR + 25)] based on the Glomerular filtration rate (GFR) figure; in our protocol desired Area under the curve (AUC) figure was 5 mg/ml x min.

Dose intensification of chemotherapy in advanced breast cancer: a feasibility phase II study.

Aims And Background: Dose intensification of chemotherapy is associated with increased response rates in advanced breast cancer. Achievement of dose incrementation is usually limited by drug-dependent bone marrow toxicity. The recent availability of recombinant human colony-stimulating factors (CSFs) have made it possible to evaluate their potential in ameliorating chemotherapy-induced myelosuppression.