Patients with advanced stage breast carcinoma immunoreactive to biotinylated Herceptin® are most likely to benefit from trastuzumab-based therapy

An hypothesis-generating study

Anna Sapino, F. Montemurro, C. Marchiò, G. Viale, J. Kulka, M. Donadio, A. Bottini, G. Botti, A. P. dei Tos, A. Bersiga, S. Di Palma, M. Truini, G. Sanna, M. Aglietta, G. Bussolati

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Background: Biotin-labeled trastuzumab (BiotHER) can be used to test for HER2 by immunohistochemistry. We previously showed that BiotHER immunoreactivity is highly correlated with HER2 amplification and indicated that it could be associated with better clinical outcome in advanced breast cancer patients receiving trastuzumab. Patients and methods: Tumor specimens and clinical information from 234 patients who received trastuzumab-based treatments were collected from 10 institutions. HER2 amplification and BiotHER immunoreactivity were assessed centrally. The effect of BiotHER positivity on response rate (RR), time to progression and survival were studied by univariate and multivariate analysis in patients presenting HER2-amplified breast cancer. The pathologic reviews of the assays were blinded to patient outcomes. Results: BiotHER was positive in 109/194 (56%) HER2-amplified breast cancers and in one not amplified tumor. RRs were 74% [95% (confidence interval) CI 64%-81%] and 47% (95% CI 36%-58%) in BiotHER-positive and -negative tumors, respectively (P <0.001). BiotHER immunoreactivity was independently associated with increased probability of tumor response (odds ratio 3.848; 95% CI 1.952-7.582), with reduced risk of disease progression [hazard ratio (HR) 0.438; 95% CI 0.303-0.633] and with reduced risk of death (HR 0.566; 95% CI 0.368-0.870) by multivariate analysis. Conclusion: The results support a role for BiotHER testing in better tailoring trastuzumab-based treatments in patients with advanced HER2-amplified breast cancers.

Original languageEnglish
Pages (from-to)1963-1968
Number of pages6
JournalAnnals of Oncology
Volume18
Issue number12
DOIs
Publication statusPublished - Dec 2007

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Breast Neoplasms
Neoplasms
Therapeutics
Multivariate Analysis
Biotin
Disease Progression
Trastuzumab
Immunohistochemistry
Odds Ratio
Confidence Intervals
Survival

Keywords

  • Biotin-labeled trastuzumab
  • Breast neoplasms
  • HER2

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Patients with advanced stage breast carcinoma immunoreactive to biotinylated Herceptin® are most likely to benefit from trastuzumab-based therapy : An hypothesis-generating study. / Sapino, Anna; Montemurro, F.; Marchiò, C.; Viale, G.; Kulka, J.; Donadio, M.; Bottini, A.; Botti, G.; dei Tos, A. P.; Bersiga, A.; Di Palma, S.; Truini, M.; Sanna, G.; Aglietta, M.; Bussolati, G.

In: Annals of Oncology, Vol. 18, No. 12, 12.2007, p. 1963-1968.

Research output: Contribution to journalArticle

Sapino, Anna ; Montemurro, F. ; Marchiò, C. ; Viale, G. ; Kulka, J. ; Donadio, M. ; Bottini, A. ; Botti, G. ; dei Tos, A. P. ; Bersiga, A. ; Di Palma, S. ; Truini, M. ; Sanna, G. ; Aglietta, M. ; Bussolati, G. / Patients with advanced stage breast carcinoma immunoreactive to biotinylated Herceptin® are most likely to benefit from trastuzumab-based therapy : An hypothesis-generating study. In: Annals of Oncology. 2007 ; Vol. 18, No. 12. pp. 1963-1968.
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abstract = "Background: Biotin-labeled trastuzumab (BiotHER) can be used to test for HER2 by immunohistochemistry. We previously showed that BiotHER immunoreactivity is highly correlated with HER2 amplification and indicated that it could be associated with better clinical outcome in advanced breast cancer patients receiving trastuzumab. Patients and methods: Tumor specimens and clinical information from 234 patients who received trastuzumab-based treatments were collected from 10 institutions. HER2 amplification and BiotHER immunoreactivity were assessed centrally. The effect of BiotHER positivity on response rate (RR), time to progression and survival were studied by univariate and multivariate analysis in patients presenting HER2-amplified breast cancer. The pathologic reviews of the assays were blinded to patient outcomes. Results: BiotHER was positive in 109/194 (56{\%}) HER2-amplified breast cancers and in one not amplified tumor. RRs were 74{\%} [95{\%} (confidence interval) CI 64{\%}-81{\%}] and 47{\%} (95{\%} CI 36{\%}-58{\%}) in BiotHER-positive and -negative tumors, respectively (P <0.001). BiotHER immunoreactivity was independently associated with increased probability of tumor response (odds ratio 3.848; 95{\%} CI 1.952-7.582), with reduced risk of disease progression [hazard ratio (HR) 0.438; 95{\%} CI 0.303-0.633] and with reduced risk of death (HR 0.566; 95{\%} CI 0.368-0.870) by multivariate analysis. Conclusion: The results support a role for BiotHER testing in better tailoring trastuzumab-based treatments in patients with advanced HER2-amplified breast cancers.",
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T1 - Patients with advanced stage breast carcinoma immunoreactive to biotinylated Herceptin® are most likely to benefit from trastuzumab-based therapy

T2 - An hypothesis-generating study

AU - Sapino, Anna

AU - Montemurro, F.

AU - Marchiò, C.

AU - Viale, G.

AU - Kulka, J.

AU - Donadio, M.

AU - Bottini, A.

AU - Botti, G.

AU - dei Tos, A. P.

AU - Bersiga, A.

AU - Di Palma, S.

AU - Truini, M.

AU - Sanna, G.

AU - Aglietta, M.

AU - Bussolati, G.

PY - 2007/12

Y1 - 2007/12

N2 - Background: Biotin-labeled trastuzumab (BiotHER) can be used to test for HER2 by immunohistochemistry. We previously showed that BiotHER immunoreactivity is highly correlated with HER2 amplification and indicated that it could be associated with better clinical outcome in advanced breast cancer patients receiving trastuzumab. Patients and methods: Tumor specimens and clinical information from 234 patients who received trastuzumab-based treatments were collected from 10 institutions. HER2 amplification and BiotHER immunoreactivity were assessed centrally. The effect of BiotHER positivity on response rate (RR), time to progression and survival were studied by univariate and multivariate analysis in patients presenting HER2-amplified breast cancer. The pathologic reviews of the assays were blinded to patient outcomes. Results: BiotHER was positive in 109/194 (56%) HER2-amplified breast cancers and in one not amplified tumor. RRs were 74% [95% (confidence interval) CI 64%-81%] and 47% (95% CI 36%-58%) in BiotHER-positive and -negative tumors, respectively (P <0.001). BiotHER immunoreactivity was independently associated with increased probability of tumor response (odds ratio 3.848; 95% CI 1.952-7.582), with reduced risk of disease progression [hazard ratio (HR) 0.438; 95% CI 0.303-0.633] and with reduced risk of death (HR 0.566; 95% CI 0.368-0.870) by multivariate analysis. Conclusion: The results support a role for BiotHER testing in better tailoring trastuzumab-based treatments in patients with advanced HER2-amplified breast cancers.

AB - Background: Biotin-labeled trastuzumab (BiotHER) can be used to test for HER2 by immunohistochemistry. We previously showed that BiotHER immunoreactivity is highly correlated with HER2 amplification and indicated that it could be associated with better clinical outcome in advanced breast cancer patients receiving trastuzumab. Patients and methods: Tumor specimens and clinical information from 234 patients who received trastuzumab-based treatments were collected from 10 institutions. HER2 amplification and BiotHER immunoreactivity were assessed centrally. The effect of BiotHER positivity on response rate (RR), time to progression and survival were studied by univariate and multivariate analysis in patients presenting HER2-amplified breast cancer. The pathologic reviews of the assays were blinded to patient outcomes. Results: BiotHER was positive in 109/194 (56%) HER2-amplified breast cancers and in one not amplified tumor. RRs were 74% [95% (confidence interval) CI 64%-81%] and 47% (95% CI 36%-58%) in BiotHER-positive and -negative tumors, respectively (P <0.001). BiotHER immunoreactivity was independently associated with increased probability of tumor response (odds ratio 3.848; 95% CI 1.952-7.582), with reduced risk of disease progression [hazard ratio (HR) 0.438; 95% CI 0.303-0.633] and with reduced risk of death (HR 0.566; 95% CI 0.368-0.870) by multivariate analysis. Conclusion: The results support a role for BiotHER testing in better tailoring trastuzumab-based treatments in patients with advanced HER2-amplified breast cancers.

KW - Biotin-labeled trastuzumab

KW - Breast neoplasms

KW - HER2

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