caa a22 4500 467953740 CHVBK 20180405193745.0 cr unu---uuuuu 170328e20040101xx s 000 0 eng 10.1007/s00280-003-0669-x doi (NATIONALLICENCE)springer-10.1007/s00280-003-0669-x (NATIONALLICENCE)springer-10.1007/BF02665349 Biweekly docetaxel-irinotecan with filgrastim support in pretreated breast and non-small-cell lung cancer patients. A phase I study [Elektronische Daten] [Giuseppe Frasci, Pasquale Comella, Renato Thomas, Maurizio Di Bonito, Liliana Lapenta, Immacolata Capasso, Gerardo Botti, Paolo Vallone, Vincenzo De Rosa, Giuseppe D'Aiuto, Giuseppe Comella] Background: Docetaxel (DTX) has been shown to be a very active drug in both breast cancer (BC) and non-small-cell lung cancer (NSCLC). Irinotecan (CPT-11) is also active in NSCLC, and has shown promising antitumor activity in pretreated BC. Purpose: To define the MTDs of these two drugs given together every other week with the use of filgrastim support in pretreated BC and NSCLC patients. Patients and methods: Patients (aged 18-70years, performance status ≤2) with advanced NSCLC or BC who had received at least one prior chemotherapy regimen were candidates for this phase I study. The starting DTX and CPT-11 doses were 60mg/m2 and 80mg/m2. Doses were alternately escalated at each step by 10mg/m2 for both drugs. Filgrastim 300μg/day was given subcutaneously from days 4 through 7 of each cycle. Results: From April 2000, 41 patients were included in the trial (27 BC, 14 NSCLC). All BC patients had received epirubicin plus paclitaxel (with or without cisplatin) as first-line treatment. Of the 14 NSCLC patients, 12 had received cisplatin-based first-line therapy, and 8 patients had been pretreated with paclitaxel. The dose escalation proceeded through five dose levels up to DTX and CPT-11 doses of 80mg/m2 and 100mg/m2, respectively. Overall, ten patients showed dose-limiting toxicity during the first cycle, diarrhea in seven and neutropenia in the remaining three. Considering all 218 cycles delivered, grade 3 or 4 neutropenia occurred in 14 patients (34%), with only one episode of neutropenic fever, while severe diarrhea was observed in 9 patients (23%). A total of 21 objective responses were registered (four complete) for an overall response rate of 51% [95% CI 35-67]. A major response was seen in 16 of the 27 BC patients (59%) and in 5 of the 14 NSCLC patients (36%). Conclusions: DTX and CPT-11 can be safely given together biweekly at adequate doses, with filgrastim support. In view of the promising activity data in both groups, phase II studies testing this combination in pretreated BC and NSCLC patients are ongoing. Springer-Verlag, 2003 Docetaxel nationallicence Irinotecan nationallicence Breast cancer nationallicence Non-small-cell lung cancer nationallicence Frasci Giuseppe SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut Comella Pasquale SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut Thomas Renato SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut Di Bonito Maurizio SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut Lapenta Liliana SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut Capasso Immacolata SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut Botti Gerardo SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut Vallone Paolo SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut De Rosa Vincenzo SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut D'Aiuto Giuseppe SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut Comella Giuseppe SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut Cancer Chemotherapy and Pharmacology Springer-Verlag 53/1(2004-01-01), 25-32 0344-5704 53:1<25 2004 53 280 https://doi.org/10.1007/s00280-003-0669-x text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s00280-003-0669-x text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Frasci Giuseppe SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut NATIONALLICENCE 700 1- Comella Pasquale SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut NATIONALLICENCE 700 1- Thomas Renato SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut NATIONALLICENCE 700 1- Di Bonito Maurizio SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut NATIONALLICENCE 700 1- Lapenta Liliana SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut NATIONALLICENCE 700 1- Capasso Immacolata SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut NATIONALLICENCE 700 1- Botti Gerardo SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut NATIONALLICENCE 700 1- Vallone Paolo SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut NATIONALLICENCE 700 1- De Rosa Vincenzo SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut NATIONALLICENCE 700 1- D'Aiuto Giuseppe SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut NATIONALLICENCE 700 1- Comella Giuseppe SICOG, c/o National Tumor Institute, Via M Semmola 80131, Naples, Italy aut NATIONALLICENCE 773 0- Cancer Chemotherapy and Pharmacology Springer-Verlag 53/1(2004-01-01), 25-32 0344-5704 53:1<25 2004 53 280 NATIONALLICENCE 700 1- Frasci Giuseppe SICOG, c/o National Tumor Institute, Via M Semmola, 80131, Naples, Italy aut NATIONALLICENCE 700 1- Comella Pasquale SICOG, c/o National Tumor Institute, Via M Semmola, 80131, Naples, Italy aut NATIONALLICENCE 700 1- Thomas Renato SICOG, c/o National Tumor Institute, Via M Semmola, 80131, Naples, Italy aut NATIONALLICENCE 700 1- Di Bonito Maurizio SICOG, c/o National Tumor Institute, Via M Semmola, 80131, Naples, Italy aut NATIONALLICENCE 700 1- Lapenta Liliana SICOG, c/o National Tumor Institute, Via M Semmola, 80131, Naples, Italy aut NATIONALLICENCE 700 1- Capasso Immacolata SICOG, c/o National Tumor Institute, Via M Semmola, 80131, Naples, Italy aut NATIONALLICENCE 700 1- Botti Gerardo SICOG, c/o National Tumor Institute, Via M Semmola, 80131, Naples, Italy aut NATIONALLICENCE 700 1- Vallone Paolo SICOG, c/o National Tumor Institute, Via M Semmola, 80131, Naples, Italy aut NATIONALLICENCE 700 1- De Rosa Vincenzo SICOG, c/o National Tumor Institute, Via M Semmola, 80131, Naples, Italy aut NATIONALLICENCE 700 1- D'Aiuto Giuseppe SICOG, c/o National Tumor Institute, Via M Semmola, 80131, Naples, Italy aut NATIONALLICENCE 700 1- Comella Giuseppe SICOG, c/o National Tumor Institute, Via M Semmola, 80131, Naples, Italy aut NATIONALLICENCE 856 40 https://doi.org/10.1007/BF02665349 text/html Onlinezugriff via DOI Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE NATIONALLICENCE NL-springer