Paclitaxel 175 or 225 mg per meters squared with carboplatin in advanced ovarian cancer

A randomized trial

Giorgio Bolis, Giovanna Scarfone, Gianpiero Polverino, Francesco Raspagliesi, Saverio Tateo, Giovanni Richiardi, Mauro Melpignano, Massimo Franchi, Giorgia Mangili, Mauro Presti, Antonella Villa, Enrico Conta, Paolo Guarnerio, Sonia Cipriani, Fabio Parazzini

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

Purpose: To analyze the effect of different doses of paclitaxel with fixed doses of carboplatin in the treatment of ovarian cancer. Patients and Methods: Patients with histologically confirmed epithelial ovarian cancer, International Federation of Gynecology and Obstetrics stages IlB to IV, were eligible for this randomized, multicenter study. Women were randomly assigned to treatment with (1) carboplatin at the dose (in milligrams) corresponding to the following formula: target area under the free carboplatin plasma concentration versus time curve (AUC) = 6 × (glomerular filtration rate + 25) mg/m2 (AUC6) plus paclitaxel 175 mg/m2 for six cycles every 21 days or (2) carboplatin AUC6 plus paclitaxel 225 mg/m2 for six cycles every 21 days. A total of 502 women entered the study. Results: Pathologic complete response was documented in 132 patients (63.8%) in the 175 mg/m2 group and in 127 cases (55.7%) in the 225 mg/m2 group (χ2 P = .090). The 4-year progression-free survival rate was 41.5% (SE = 3.5) in the 175-mg group and 39.2% (SE = 3.5) in the 225-mg group. The corresponding 4-year survival rates were 46.2% (based on 115 deaths) and 47.3% (based on 113 deaths), respectively. Conclusion: This randomized trial suggests that paclitaxel 175 mg/m2 plus carboplatin AUC6 is the schedule with a more favorable profile than paclitaxel 225 mg/m2 plus carboplatin AUC6.

Original languageEnglish
Pages (from-to)686-690
Number of pages5
JournalJournal of Clinical Oncology
Volume22
Issue number4
DOIs
Publication statusPublished - 2004

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Carboplatin
Paclitaxel
Ovarian Neoplasms
Survival Rate
Gynecology
Glomerular Filtration Rate
Obstetrics
Multicenter Studies
Disease-Free Survival
Area Under Curve
Appointments and Schedules
Therapeutics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Paclitaxel 175 or 225 mg per meters squared with carboplatin in advanced ovarian cancer : A randomized trial. / Bolis, Giorgio; Scarfone, Giovanna; Polverino, Gianpiero; Raspagliesi, Francesco; Tateo, Saverio; Richiardi, Giovanni; Melpignano, Mauro; Franchi, Massimo; Mangili, Giorgia; Presti, Mauro; Villa, Antonella; Conta, Enrico; Guarnerio, Paolo; Cipriani, Sonia; Parazzini, Fabio.

In: Journal of Clinical Oncology, Vol. 22, No. 4, 2004, p. 686-690.

Research output: Contribution to journalArticle

Bolis, Giorgio ; Scarfone, Giovanna ; Polverino, Gianpiero ; Raspagliesi, Francesco ; Tateo, Saverio ; Richiardi, Giovanni ; Melpignano, Mauro ; Franchi, Massimo ; Mangili, Giorgia ; Presti, Mauro ; Villa, Antonella ; Conta, Enrico ; Guarnerio, Paolo ; Cipriani, Sonia ; Parazzini, Fabio. / Paclitaxel 175 or 225 mg per meters squared with carboplatin in advanced ovarian cancer : A randomized trial. In: Journal of Clinical Oncology. 2004 ; Vol. 22, No. 4. pp. 686-690.
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abstract = "Purpose: To analyze the effect of different doses of paclitaxel with fixed doses of carboplatin in the treatment of ovarian cancer. Patients and Methods: Patients with histologically confirmed epithelial ovarian cancer, International Federation of Gynecology and Obstetrics stages IlB to IV, were eligible for this randomized, multicenter study. Women were randomly assigned to treatment with (1) carboplatin at the dose (in milligrams) corresponding to the following formula: target area under the free carboplatin plasma concentration versus time curve (AUC) = 6 × (glomerular filtration rate + 25) mg/m2 (AUC6) plus paclitaxel 175 mg/m2 for six cycles every 21 days or (2) carboplatin AUC6 plus paclitaxel 225 mg/m2 for six cycles every 21 days. A total of 502 women entered the study. Results: Pathologic complete response was documented in 132 patients (63.8{\%}) in the 175 mg/m2 group and in 127 cases (55.7{\%}) in the 225 mg/m2 group (χ2 P = .090). The 4-year progression-free survival rate was 41.5{\%} (SE = 3.5) in the 175-mg group and 39.2{\%} (SE = 3.5) in the 225-mg group. The corresponding 4-year survival rates were 46.2{\%} (based on 115 deaths) and 47.3{\%} (based on 113 deaths), respectively. Conclusion: This randomized trial suggests that paclitaxel 175 mg/m2 plus carboplatin AUC6 is the schedule with a more favorable profile than paclitaxel 225 mg/m2 plus carboplatin AUC6.",
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T1 - Paclitaxel 175 or 225 mg per meters squared with carboplatin in advanced ovarian cancer

T2 - A randomized trial

AU - Bolis, Giorgio

AU - Scarfone, Giovanna

AU - Polverino, Gianpiero

AU - Raspagliesi, Francesco

AU - Tateo, Saverio

AU - Richiardi, Giovanni

AU - Melpignano, Mauro

AU - Franchi, Massimo

AU - Mangili, Giorgia

AU - Presti, Mauro

AU - Villa, Antonella

AU - Conta, Enrico

AU - Guarnerio, Paolo

AU - Cipriani, Sonia

AU - Parazzini, Fabio

PY - 2004

Y1 - 2004

N2 - Purpose: To analyze the effect of different doses of paclitaxel with fixed doses of carboplatin in the treatment of ovarian cancer. Patients and Methods: Patients with histologically confirmed epithelial ovarian cancer, International Federation of Gynecology and Obstetrics stages IlB to IV, were eligible for this randomized, multicenter study. Women were randomly assigned to treatment with (1) carboplatin at the dose (in milligrams) corresponding to the following formula: target area under the free carboplatin plasma concentration versus time curve (AUC) = 6 × (glomerular filtration rate + 25) mg/m2 (AUC6) plus paclitaxel 175 mg/m2 for six cycles every 21 days or (2) carboplatin AUC6 plus paclitaxel 225 mg/m2 for six cycles every 21 days. A total of 502 women entered the study. Results: Pathologic complete response was documented in 132 patients (63.8%) in the 175 mg/m2 group and in 127 cases (55.7%) in the 225 mg/m2 group (χ2 P = .090). The 4-year progression-free survival rate was 41.5% (SE = 3.5) in the 175-mg group and 39.2% (SE = 3.5) in the 225-mg group. The corresponding 4-year survival rates were 46.2% (based on 115 deaths) and 47.3% (based on 113 deaths), respectively. Conclusion: This randomized trial suggests that paclitaxel 175 mg/m2 plus carboplatin AUC6 is the schedule with a more favorable profile than paclitaxel 225 mg/m2 plus carboplatin AUC6.

AB - Purpose: To analyze the effect of different doses of paclitaxel with fixed doses of carboplatin in the treatment of ovarian cancer. Patients and Methods: Patients with histologically confirmed epithelial ovarian cancer, International Federation of Gynecology and Obstetrics stages IlB to IV, were eligible for this randomized, multicenter study. Women were randomly assigned to treatment with (1) carboplatin at the dose (in milligrams) corresponding to the following formula: target area under the free carboplatin plasma concentration versus time curve (AUC) = 6 × (glomerular filtration rate + 25) mg/m2 (AUC6) plus paclitaxel 175 mg/m2 for six cycles every 21 days or (2) carboplatin AUC6 plus paclitaxel 225 mg/m2 for six cycles every 21 days. A total of 502 women entered the study. Results: Pathologic complete response was documented in 132 patients (63.8%) in the 175 mg/m2 group and in 127 cases (55.7%) in the 225 mg/m2 group (χ2 P = .090). The 4-year progression-free survival rate was 41.5% (SE = 3.5) in the 175-mg group and 39.2% (SE = 3.5) in the 225-mg group. The corresponding 4-year survival rates were 46.2% (based on 115 deaths) and 47.3% (based on 113 deaths), respectively. Conclusion: This randomized trial suggests that paclitaxel 175 mg/m2 plus carboplatin AUC6 is the schedule with a more favorable profile than paclitaxel 225 mg/m2 plus carboplatin AUC6.

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DO - 10.1200/JCO.2004.03.017

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SP - 686

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JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

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