Abstract
We conducted a phase II study to determine the activity and tolerability of weekly paclitaxel, 5-fluorouracil (5-FU) and folinic acid plus granulocyte colony-stimulating factor (G-CSF) support in anthracycline-pre-treated or -resistant metastatic breast cancer patients. The phase II study was designed following the Simon optimal-two stage method. Patients received paclitaxel 80 mg/m, folinic acid 10 mg/m and bolus infusion of 5-FU 300 mg/m every week plus G-CSF on day 3 for 24 consecutive weeks in the absence of disease progression. From May 1998 to May 2000, 51 patients entered the study. Patients received a median relative dose intensity of 97.5% (range 81-100%). No severe toxicities were observed. Seven patients (14%) experienced neutropenia grade 2. Seven patients (14%) experienced grade 2 anemia. Two patients (4%) experienced severe asthenia. Three out of 50 evaluable patients [6%, 95% confidence interval (CI) 2-12.6%] showed a complete response, whereas 23 (46%, 95% CI 32.2-59.8%) had a partial response, with an overall response rate of 52% (95% CI 38.2-65.8%). In addition, eight patients (15.7%) had stable disease. In the 13 patients untreated for metastatic disease, the overall response rate was 92.3% (CI 77.8-100), wit...Continue Reading
References
Mar 15, 1989·Cancer·C L Loprinzi
Jul 1, 1989·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·S M SwainC J Allegra
Mar 1, 1989·Controlled Clinical Trials·R Simon
Jan 1, 1981·Cancer·A B MillerA Winkler
May 1, 1995·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·A D SeidmanP Forsythe
Oct 1, 1995·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·A D SeidmanJ Crown
Aug 2, 1995·Journal of the National Cancer Institute·L GianniA Laffranchi
Sep 1, 1996·British Journal of Cancer·Y KanoK Adachi
May 30, 1998·Annals of Oncology : Official Journal of the European Society for Medical Oncology·U KlaassenS Seeber
Oct 21, 1998·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·A D SeidmanL Norton
Oct 21, 1998·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·R FossatiA Liberati
Jul 29, 1999·Biochemical Pharmacology·J L GremF J Geoffroy
Oct 6, 1999·Annals of Oncology : Official Journal of the European Society for Medical Oncology·C NisticòE Terzoli
Nov 16, 2001·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·E A PerezR Patel
Jan 30, 2002·CA: a Cancer Journal for Clinicians·Ahmedin JemalMichael Thun
Jun 18, 2002·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Joyce O'ShaughnessyRobert Leonard
Dec 31, 2002·Critical Reviews in Oncology/hematology·Paolo MarchettiCorrado Ficorella
Feb 27, 2003·Breast Cancer Research and Treatment·David M LoeschNicholas J Robert
Apr 2, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Martine J Piccart-Gebhart
Mar 19, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Alphonse G TaghianSimon N Powell
Mar 23, 2005·Cancer Research·Eddy PasquierDiane Braguer
Jun 22, 2005·The Oncologist·Larry Norton
Jul 16, 2005·Oncology·Cecilia NisticòEdmondo Terzoli
Aug 10, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Marjorie C GreenGabriel N Hortobagyi
Aug 10, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Andrew D Seidman
Sep 1, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Paola PapaldoFederico Calabresi
Citations
Jan 15, 2008·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Christoph C ZielinskiMatti Aapro
Sep 1, 2007·Anti-cancer Drugs·Cecilia NisticòEdmondo Terzoli
Sep 16, 2011·Expert Review of Anticancer Therapy·Marco DanovaGiovanni L Pappagallo