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Effect of adding gefitinib to neoadjuvant chemotherapy in estrogen receptor negative early breast cancer in a randomized phase II trial

Bernsdorf, Mogens; Ingvar, Christian LU ; Jorgensen, Leif; Tuxen, Malgorzata K.; Jakobsen, Erik H.; Saetersdal, Anna; Kimper-Karl, Marie Louise; Kroman, Niels; Balslev, Eva and Ejlertsen, Bent (2011) In Breast Cancer Research and Treatment 126(2). p.463-470
Abstract
Gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor, has shown both anti-proliferative and anti-tumoral activity in breast cancer. This study was designed to determine the effect of adding gefitinib to neoadjuvant epirubicin and cyclophosphamide (EC) on tumor response rates. Women with unilateral, primary operable, estrogen receptor negative invasive breast cancer a parts per thousand yen 2 cm were eligible for inclusion. Randomized patients were to receive four cycles of neoadjuvant EC plus 12 weeks of either gefitinib (250 mg daily) or placebo. Primary endpoint was pathologic complete response (pCR), and secondary endpoints were complete response (CR) and overall objective response (OR). 181 patients were randomized.... (More)
Gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor, has shown both anti-proliferative and anti-tumoral activity in breast cancer. This study was designed to determine the effect of adding gefitinib to neoadjuvant epirubicin and cyclophosphamide (EC) on tumor response rates. Women with unilateral, primary operable, estrogen receptor negative invasive breast cancer a parts per thousand yen 2 cm were eligible for inclusion. Randomized patients were to receive four cycles of neoadjuvant EC plus 12 weeks of either gefitinib (250 mg daily) or placebo. Primary endpoint was pathologic complete response (pCR), and secondary endpoints were complete response (CR) and overall objective response (OR). 181 patients were randomized. A pCR was observed in 17% (12/71) of patients treated with gefitinib and in 12% (9/73) of patients treated with placebo (4.57% difference, 95% CI -7.19 to 6.33; P = 0.44). CR was observed in 10% of patients in both the gefitinib (7/71) and the placebo group (7/73) (0.27% difference, 95% CI -9.6 to 10.2; P = 0.96). There was no significant difference in OR (5.96%; 95% CI -9.9 to 21.9; P = 0.45) between the two groups. Post hoc subgroup analysis showed a significant difference in pCR between triple negative breast cancer (TNBC) and non-TNBC tumors (P = 0.03). More patients in the gefitinib arm had hematological toxicity (P = 0.15) and discontinued treatment (9/94 vs. 2/86) because of adverse events (AE). Tumor response rates were similar in the two groups. A significantly higher pCR rate was observed post hoc in TNBC versus non-TNBC independent of treatment. More patients in the gefitinib group discontinued treatment because of AE. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Breast cancer, Neoadjuvant treatment, Gefitinib, Triple negative
in
Breast Cancer Research and Treatment
volume
126
issue
2
pages
463 - 470
publisher
Springer
external identifiers
  • wos:000288251000018
  • scopus:79958711331
ISSN
1573-7217
DOI
10.1007/s10549-011-1352-2
language
English
LU publication?
yes
id
b22d2daa-2725-4858-8267-775e285c257d (old id 1868592)
date added to LUP
2011-04-04 12:58:10
date last changed
2017-11-12 03:50:29
@article{b22d2daa-2725-4858-8267-775e285c257d,
  abstract     = {Gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor, has shown both anti-proliferative and anti-tumoral activity in breast cancer. This study was designed to determine the effect of adding gefitinib to neoadjuvant epirubicin and cyclophosphamide (EC) on tumor response rates. Women with unilateral, primary operable, estrogen receptor negative invasive breast cancer a parts per thousand yen 2 cm were eligible for inclusion. Randomized patients were to receive four cycles of neoadjuvant EC plus 12 weeks of either gefitinib (250 mg daily) or placebo. Primary endpoint was pathologic complete response (pCR), and secondary endpoints were complete response (CR) and overall objective response (OR). 181 patients were randomized. A pCR was observed in 17% (12/71) of patients treated with gefitinib and in 12% (9/73) of patients treated with placebo (4.57% difference, 95% CI -7.19 to 6.33; P = 0.44). CR was observed in 10% of patients in both the gefitinib (7/71) and the placebo group (7/73) (0.27% difference, 95% CI -9.6 to 10.2; P = 0.96). There was no significant difference in OR (5.96%; 95% CI -9.9 to 21.9; P = 0.45) between the two groups. Post hoc subgroup analysis showed a significant difference in pCR between triple negative breast cancer (TNBC) and non-TNBC tumors (P = 0.03). More patients in the gefitinib arm had hematological toxicity (P = 0.15) and discontinued treatment (9/94 vs. 2/86) because of adverse events (AE). Tumor response rates were similar in the two groups. A significantly higher pCR rate was observed post hoc in TNBC versus non-TNBC independent of treatment. More patients in the gefitinib group discontinued treatment because of AE.},
  author       = {Bernsdorf, Mogens and Ingvar, Christian and Jorgensen, Leif and Tuxen, Malgorzata K. and Jakobsen, Erik H. and Saetersdal, Anna and Kimper-Karl, Marie Louise and Kroman, Niels and Balslev, Eva and Ejlertsen, Bent},
  issn         = {1573-7217},
  keyword      = {Breast cancer,Neoadjuvant treatment,Gefitinib,Triple negative},
  language     = {eng},
  number       = {2},
  pages        = {463--470},
  publisher    = {Springer},
  series       = {Breast Cancer Research and Treatment},
  title        = {Effect of adding gefitinib to neoadjuvant chemotherapy in estrogen receptor negative early breast cancer in a randomized phase II trial},
  url          = {http://dx.doi.org/10.1007/s10549-011-1352-2},
  volume       = {126},
  year         = {2011},
}