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First-line treatment of ovarian cancer FIGO stages IIb-IV with paclitaxel/epirubicin/carboplatin versus paclitaxel/carboplatin

Kristensen, GB ; Vergote, I ; Stuart, G ; Del Campo, JM ; Kaern, J ; Lopez, AB ; Eisenhauer, E ; Aavall-Lundquist, E ; Ridderheim, Mona LU and Havsteen, H , et al. (2003) In International Journal of Gynecological Cancer 13. p.172-177
Abstract
The objective of this study was to compare the safety and efficacy of carboplatin plus epirubicin and paclitaxel (TEC) to carboplatin and paclitaxel (TC), in the treatment of epithelial ovarian, peritoneal, or tubal carcinoma.. Between March 1999 and August 2001, 887 patients were randomized to receive six to nine cycles of paclitaxel (175 mg/m(2), 3 h intravenously) followed by carboplatin (AUC 5, Calvert formula) with or without epirubicin (75 mg/m2 intravenously prior to paclitaxel), on a 3-weekly schedule. The primary endpoint was progression-free survival. Demographic information: Residual disease <1 cm was reported on 41% of patients. At the end of treatment, 65% in the TEC and 55% in the TC arm had achieved a clinical complete... (More)
The objective of this study was to compare the safety and efficacy of carboplatin plus epirubicin and paclitaxel (TEC) to carboplatin and paclitaxel (TC), in the treatment of epithelial ovarian, peritoneal, or tubal carcinoma.. Between March 1999 and August 2001, 887 patients were randomized to receive six to nine cycles of paclitaxel (175 mg/m(2), 3 h intravenously) followed by carboplatin (AUC 5, Calvert formula) with or without epirubicin (75 mg/m2 intravenously prior to paclitaxel), on a 3-weekly schedule. The primary endpoint was progression-free survival. Demographic information: Residual disease <1 cm was reported on 41% of patients. At the end of treatment, 65% in the TEC and 55% in the TC arm had achieved a clinical complete response, and 18 and 25% a clinical partial response resulting in an overall response rate of 83% in the TEC and 80% in the TC arm, whereas 7 and 9% had progressive disease, respectively. The three-drug combination produced a markedly higher myelotoxicity, resulting in a higher frequency of febrile neutropenia (12.5% of the TEC and 1.5% of the TC patients) and a higher number of dose reductions and treatment delays. Cycle prolongation above seven days was seen in 7 and 5% of cycles in the TEC and TC arm, respectively. Stomatitis &GE; grade 3 was also higher with TEC (4% TEC and 0.5% TC). Reductions in left ventricular ejection fraction of more than 15% after six courses were slightly more common with the TEC regimen (3% versus 1.5%), but the difference was not statistically significant (P=0.2). In conclusion, treatment with the TEC combination produced a higher rate of complete responses than treatment with the TC combination. Toxicity was manageable. Long-term survival data are awaited. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
ovarian carcinoma, anthracycline, chemotherapy
in
International Journal of Gynecological Cancer
volume
13
pages
172 - 177
publisher
BMJ Publishing Group
external identifiers
  • wos:000187712100008
  • scopus:10744231732
ISSN
1048-891X
DOI
10.1111/j.1525-1438.2003.13363.x
language
English
LU publication?
yes
id
ff464704-2bd6-493b-b51b-84e41dd3b3db (old id 291040)
date added to LUP
2016-04-01 12:02:21
date last changed
2022-09-16 09:44:26
@article{ff464704-2bd6-493b-b51b-84e41dd3b3db,
  abstract     = {{The objective of this study was to compare the safety and efficacy of carboplatin plus epirubicin and paclitaxel (TEC) to carboplatin and paclitaxel (TC), in the treatment of epithelial ovarian, peritoneal, or tubal carcinoma.. Between March 1999 and August 2001, 887 patients were randomized to receive six to nine cycles of paclitaxel (175 mg/m(2), 3 h intravenously) followed by carboplatin (AUC 5, Calvert formula) with or without epirubicin (75 mg/m2 intravenously prior to paclitaxel), on a 3-weekly schedule. The primary endpoint was progression-free survival. Demographic information: Residual disease &lt;1 cm was reported on 41% of patients. At the end of treatment, 65% in the TEC and 55% in the TC arm had achieved a clinical complete response, and 18 and 25% a clinical partial response resulting in an overall response rate of 83% in the TEC and 80% in the TC arm, whereas 7 and 9% had progressive disease, respectively. The three-drug combination produced a markedly higher myelotoxicity, resulting in a higher frequency of febrile neutropenia (12.5% of the TEC and 1.5% of the TC patients) and a higher number of dose reductions and treatment delays. Cycle prolongation above seven days was seen in 7 and 5% of cycles in the TEC and TC arm, respectively. Stomatitis &amp;GE; grade 3 was also higher with TEC (4% TEC and 0.5% TC). Reductions in left ventricular ejection fraction of more than 15% after six courses were slightly more common with the TEC regimen (3% versus 1.5%), but the difference was not statistically significant (P=0.2). In conclusion, treatment with the TEC combination produced a higher rate of complete responses than treatment with the TC combination. Toxicity was manageable. Long-term survival data are awaited.}},
  author       = {{Kristensen, GB and Vergote, I and Stuart, G and Del Campo, JM and Kaern, J and Lopez, AB and Eisenhauer, E and Aavall-Lundquist, E and Ridderheim, Mona and Havsteen, H and Mirza, MR and Scheistroen, M and Vrdoljak, E}},
  issn         = {{1048-891X}},
  keywords     = {{ovarian carcinoma; anthracycline; chemotherapy}},
  language     = {{eng}},
  pages        = {{172--177}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{International Journal of Gynecological Cancer}},
  title        = {{First-line treatment of ovarian cancer FIGO stages IIb-IV with paclitaxel/epirubicin/carboplatin versus paclitaxel/carboplatin}},
  url          = {{http://dx.doi.org/10.1111/j.1525-1438.2003.13363.x}},
  doi          = {{10.1111/j.1525-1438.2003.13363.x}},
  volume       = {{13}},
  year         = {{2003}},
}