Phase III Trial of Carboplatin Plus Paclitaxel With or Without Gemcitabine in First-Line Treatment of Epithelial Ovarian Cancer
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du Bois, AndreasHerrstedt, Jorn
Hardy-Bessard, Anne-Claire
Mueller, Hans-Helge
Harter, Philipp
Kristensen, Gunnar
Joly, Florence
Huober, Jens
Avall-Lundqvist, Elisabeth
Weber, Beatrice
Kurzeder, Christian
Jelić, Svetislav
Pujade-Lauraine, Eric
Burges, Alexander
Pfisterer, Jacobus
Gropp, Martina
Staehle, Anne
Wimberger, Pauline
Jackisch, Christian
Sehouli, Jalid
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Purpose One attempt to improve long-term survival in patients with advanced ovarian cancer was thought to be the addition of more non-cross-resistant drugs to platinum-paclitaxel combination regimens. Gemcitabine was among the candidates for a third drug. Patients and Methods We performed a prospective, randomized, phase III, intergroup trial to compare carboplatin plus paclitaxel (TC; area under the curve [AUC] 5 and 175 mg/m(2), respectively) with the same combination and additional gemcitabine 800 mg/m(2) on days 1 and 8 (TCG) in previously untreated patients with advanced epithelial ovarian cancer. TC was administered intravenously (IV) on day 1 every 21 days for a planned minimum of six courses. Gemcitabine was administered by IV on days 1 and 8 of each cycle in the TCG arm. Results Between 2002 and 2004, 1,742 patients were randomly assigned; 882 and 860 patients received TC and TCG, respectively. Grades 3 to 4 hematologic toxicity and fatigue occurred more frequently in the TCG ...arm. Accordingly, quality-of-life analysis during chemotherapy showed a disadvantage in the TCG arm. Although objective response was slightly higher in the TCG arm, this did not translate into improved progression-free survival (PFS) or overall survival (OS). Median PFS was 17.8 months for the TCG arm and 19.3 months for the TC arm (hazard ratio [HR], 1.18; 95% CI, 1.06 to 1.32; P = .0044). Median OS was 49.5 for the TCG arm and 51.5 months for the TC arm (HR, 1.05; 95% CI, 0.91 to 1.20; P = .5106). Conclusion The addition of gemcitabine to carboplatin plus paclitaxel increased treatment burden, reduced PFS time, and did not improve OS in patients with advanced epithelial ovarian cancer. Therefore, we recommend no additional clinical use of TCG in this population.
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Journal of Clinical Oncology, 2010, 28, 27, 4162-4169Funding / projects:
- Eli Lilly
DOI: 10.1200/JCO.2009.27.4696
ISSN: 0732-183X
PubMed: 20733132
WoS: 000281909700012
Scopus: 2-s2.0-77957950128
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VinčaTY - JOUR AU - du Bois, Andreas AU - Herrstedt, Jorn AU - Hardy-Bessard, Anne-Claire AU - Mueller, Hans-Helge AU - Harter, Philipp AU - Kristensen, Gunnar AU - Joly, Florence AU - Huober, Jens AU - Avall-Lundqvist, Elisabeth AU - Weber, Beatrice AU - Kurzeder, Christian AU - Jelić, Svetislav AU - Pujade-Lauraine, Eric AU - Burges, Alexander AU - Pfisterer, Jacobus AU - Gropp, Martina AU - Staehle, Anne AU - Wimberger, Pauline AU - Jackisch, Christian AU - Sehouli, Jalid PY - 2010 UR - https://vinar.vin.bg.ac.rs/handle/123456789/4110 AB - Purpose One attempt to improve long-term survival in patients with advanced ovarian cancer was thought to be the addition of more non-cross-resistant drugs to platinum-paclitaxel combination regimens. Gemcitabine was among the candidates for a third drug. Patients and Methods We performed a prospective, randomized, phase III, intergroup trial to compare carboplatin plus paclitaxel (TC; area under the curve [AUC] 5 and 175 mg/m(2), respectively) with the same combination and additional gemcitabine 800 mg/m(2) on days 1 and 8 (TCG) in previously untreated patients with advanced epithelial ovarian cancer. TC was administered intravenously (IV) on day 1 every 21 days for a planned minimum of six courses. Gemcitabine was administered by IV on days 1 and 8 of each cycle in the TCG arm. Results Between 2002 and 2004, 1,742 patients were randomly assigned; 882 and 860 patients received TC and TCG, respectively. Grades 3 to 4 hematologic toxicity and fatigue occurred more frequently in the TCG arm. Accordingly, quality-of-life analysis during chemotherapy showed a disadvantage in the TCG arm. Although objective response was slightly higher in the TCG arm, this did not translate into improved progression-free survival (PFS) or overall survival (OS). Median PFS was 17.8 months for the TCG arm and 19.3 months for the TC arm (hazard ratio [HR], 1.18; 95% CI, 1.06 to 1.32; P = .0044). Median OS was 49.5 for the TCG arm and 51.5 months for the TC arm (HR, 1.05; 95% CI, 0.91 to 1.20; P = .5106). Conclusion The addition of gemcitabine to carboplatin plus paclitaxel increased treatment burden, reduced PFS time, and did not improve OS in patients with advanced epithelial ovarian cancer. Therefore, we recommend no additional clinical use of TCG in this population. T2 - Journal of Clinical Oncology T1 - Phase III Trial of Carboplatin Plus Paclitaxel With or Without Gemcitabine in First-Line Treatment of Epithelial Ovarian Cancer VL - 28 IS - 27 SP - 4162 EP - 4169 DO - 10.1200/JCO.2009.27.4696 ER -
@article{ author = "du Bois, Andreas and Herrstedt, Jorn and Hardy-Bessard, Anne-Claire and Mueller, Hans-Helge and Harter, Philipp and Kristensen, Gunnar and Joly, Florence and Huober, Jens and Avall-Lundqvist, Elisabeth and Weber, Beatrice and Kurzeder, Christian and Jelić, Svetislav and Pujade-Lauraine, Eric and Burges, Alexander and Pfisterer, Jacobus and Gropp, Martina and Staehle, Anne and Wimberger, Pauline and Jackisch, Christian and Sehouli, Jalid", year = "2010", abstract = "Purpose One attempt to improve long-term survival in patients with advanced ovarian cancer was thought to be the addition of more non-cross-resistant drugs to platinum-paclitaxel combination regimens. Gemcitabine was among the candidates for a third drug. Patients and Methods We performed a prospective, randomized, phase III, intergroup trial to compare carboplatin plus paclitaxel (TC; area under the curve [AUC] 5 and 175 mg/m(2), respectively) with the same combination and additional gemcitabine 800 mg/m(2) on days 1 and 8 (TCG) in previously untreated patients with advanced epithelial ovarian cancer. TC was administered intravenously (IV) on day 1 every 21 days for a planned minimum of six courses. Gemcitabine was administered by IV on days 1 and 8 of each cycle in the TCG arm. Results Between 2002 and 2004, 1,742 patients were randomly assigned; 882 and 860 patients received TC and TCG, respectively. Grades 3 to 4 hematologic toxicity and fatigue occurred more frequently in the TCG arm. Accordingly, quality-of-life analysis during chemotherapy showed a disadvantage in the TCG arm. Although objective response was slightly higher in the TCG arm, this did not translate into improved progression-free survival (PFS) or overall survival (OS). Median PFS was 17.8 months for the TCG arm and 19.3 months for the TC arm (hazard ratio [HR], 1.18; 95% CI, 1.06 to 1.32; P = .0044). Median OS was 49.5 for the TCG arm and 51.5 months for the TC arm (HR, 1.05; 95% CI, 0.91 to 1.20; P = .5106). Conclusion The addition of gemcitabine to carboplatin plus paclitaxel increased treatment burden, reduced PFS time, and did not improve OS in patients with advanced epithelial ovarian cancer. Therefore, we recommend no additional clinical use of TCG in this population.", journal = "Journal of Clinical Oncology", title = "Phase III Trial of Carboplatin Plus Paclitaxel With or Without Gemcitabine in First-Line Treatment of Epithelial Ovarian Cancer", volume = "28", number = "27", pages = "4162-4169", doi = "10.1200/JCO.2009.27.4696" }
du Bois, A., Herrstedt, J., Hardy-Bessard, A., Mueller, H., Harter, P., Kristensen, G., Joly, F., Huober, J., Avall-Lundqvist, E., Weber, B., Kurzeder, C., Jelić, S., Pujade-Lauraine, E., Burges, A., Pfisterer, J., Gropp, M., Staehle, A., Wimberger, P., Jackisch, C.,& Sehouli, J.. (2010). Phase III Trial of Carboplatin Plus Paclitaxel With or Without Gemcitabine in First-Line Treatment of Epithelial Ovarian Cancer. in Journal of Clinical Oncology, 28(27), 4162-4169. https://doi.org/10.1200/JCO.2009.27.4696
du Bois A, Herrstedt J, Hardy-Bessard A, Mueller H, Harter P, Kristensen G, Joly F, Huober J, Avall-Lundqvist E, Weber B, Kurzeder C, Jelić S, Pujade-Lauraine E, Burges A, Pfisterer J, Gropp M, Staehle A, Wimberger P, Jackisch C, Sehouli J. Phase III Trial of Carboplatin Plus Paclitaxel With or Without Gemcitabine in First-Line Treatment of Epithelial Ovarian Cancer. in Journal of Clinical Oncology. 2010;28(27):4162-4169. doi:10.1200/JCO.2009.27.4696 .
du Bois, Andreas, Herrstedt, Jorn, Hardy-Bessard, Anne-Claire, Mueller, Hans-Helge, Harter, Philipp, Kristensen, Gunnar, Joly, Florence, Huober, Jens, Avall-Lundqvist, Elisabeth, Weber, Beatrice, Kurzeder, Christian, Jelić, Svetislav, Pujade-Lauraine, Eric, Burges, Alexander, Pfisterer, Jacobus, Gropp, Martina, Staehle, Anne, Wimberger, Pauline, Jackisch, Christian, Sehouli, Jalid, "Phase III Trial of Carboplatin Plus Paclitaxel With or Without Gemcitabine in First-Line Treatment of Epithelial Ovarian Cancer" in Journal of Clinical Oncology, 28, no. 27 (2010):4162-4169, https://doi.org/10.1200/JCO.2009.27.4696 . .