A phase II study of paclitaxel, carboplatin, and gemcitabine in previously untreated patients with epithelial ovarian cancer FIGO stage IC-IV (AGO-OVAR protocol OVAR-8)
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A phase II study of paclitaxel, carboplatin, and gemcitabine in previously untreated patients with epithelial ovarian cancer FIGO stage IC-IV (AGO-OVAR protocol OVAR-8). / du Bois, A; Belau, A; Wagner, U; Pfisterer, J; Schmalfeldt, B; Richter, B; Staehle, A; Jackisch, C; Lueck, H J; Schroeder, W; Burges, A; Olbricht, S; Elser, G; Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group (AGO-OVAR).
in: GYNECOL ONCOL, Jahrgang 96, Nr. 2, 02.2005, S. 444-51.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - A phase II study of paclitaxel, carboplatin, and gemcitabine in previously untreated patients with epithelial ovarian cancer FIGO stage IC-IV (AGO-OVAR protocol OVAR-8)
AU - du Bois, A
AU - Belau, A
AU - Wagner, U
AU - Pfisterer, J
AU - Schmalfeldt, B
AU - Richter, B
AU - Staehle, A
AU - Jackisch, C
AU - Lueck, H J
AU - Schroeder, W
AU - Burges, A
AU - Olbricht, S
AU - Elser, G
AU - Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group (AGO-OVAR)
PY - 2005/2
Y1 - 2005/2
N2 - PURPOSE: A multicenter, nonrandomized, phase II study was initiated to evaluate the tolerability, toxicity, and activity of paclitaxel, carboplatin, and gemcitabine combination in previously untreated ovarian cancer.PATIENTS AND METHODS: Chemonaive patients who had radical debulking surgery for primary epithelial ovarian cancer International Federation of Gynecology and Obstetrics (FIGO) IC-IV received sequentially paclitaxel 175 mg/m(2), carboplatin AUC 5, and gemcitabine 800 mg/m(2) on day 1 and gemcitabine 800 mg/m(2) on day 8, every 3 weeks.RESULTS: From October 2001 to July 2002, 55 patients were treated and evaluated. Main toxicities were hematological with NCI-CTC grade 3/4 anemia 12.7%, leukopenia 70.9%, neutropenia 76.3%, and thrombocytopenia 45.5. However, febrile neutropenia occurred only in 1.8%. Grade 3/4 nonhematological toxicities were rare and occurred in less than 10% of patients. Toxicity-induced treatment delays occurred in 3.1% of cycles and resulted in early treatment cessation in four patients. Dose intensity reached 90.8% for carboplatin and paclitaxel, and 73.3% for gemcitabine. Objective response was observed in 10 of 14 patients with measurable disease.CONCLUSIONS: The triplet combination of paclitaxel-carboplatin-gemcitabine is feasible and active, with manageable hematological toxicity and no unexpected nonhematological toxicity. This regimen has proceeded to phase III evaluation.
AB - PURPOSE: A multicenter, nonrandomized, phase II study was initiated to evaluate the tolerability, toxicity, and activity of paclitaxel, carboplatin, and gemcitabine combination in previously untreated ovarian cancer.PATIENTS AND METHODS: Chemonaive patients who had radical debulking surgery for primary epithelial ovarian cancer International Federation of Gynecology and Obstetrics (FIGO) IC-IV received sequentially paclitaxel 175 mg/m(2), carboplatin AUC 5, and gemcitabine 800 mg/m(2) on day 1 and gemcitabine 800 mg/m(2) on day 8, every 3 weeks.RESULTS: From October 2001 to July 2002, 55 patients were treated and evaluated. Main toxicities were hematological with NCI-CTC grade 3/4 anemia 12.7%, leukopenia 70.9%, neutropenia 76.3%, and thrombocytopenia 45.5. However, febrile neutropenia occurred only in 1.8%. Grade 3/4 nonhematological toxicities were rare and occurred in less than 10% of patients. Toxicity-induced treatment delays occurred in 3.1% of cycles and resulted in early treatment cessation in four patients. Dose intensity reached 90.8% for carboplatin and paclitaxel, and 73.3% for gemcitabine. Objective response was observed in 10 of 14 patients with measurable disease.CONCLUSIONS: The triplet combination of paclitaxel-carboplatin-gemcitabine is feasible and active, with manageable hematological toxicity and no unexpected nonhematological toxicity. This regimen has proceeded to phase III evaluation.
KW - Adult
KW - Aged
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Carboplatin
KW - Deoxycytidine
KW - Disease-Free Survival
KW - Epithelial Cells
KW - Female
KW - Humans
KW - Middle Aged
KW - Neoplasm Staging
KW - Ovarian Neoplasms
KW - Paclitaxel
U2 - 10.1016/j.ygyno.2004.10.020
DO - 10.1016/j.ygyno.2004.10.020
M3 - SCORING: Journal article
C2 - 15661234
VL - 96
SP - 444
EP - 451
JO - GYNECOL ONCOL
JF - GYNECOL ONCOL
SN - 0090-8258
IS - 2
ER -