Neoadjuvant concurrent paclitaxel and radiation in stage II/III breast cancer

A. Bapsi Chakravarthy, Mark C. Kelley, Bernadette McLaren, Cristina I. Truica, Dean Billheimer, Ingrid A. Mayer, Ana M. Grau, David H. Johnson, Jean F. Simpson, R. Daniel Beauchamp, Catherine Jones, Jennifer A. Pietenpol

Research output: Contribution to journalArticle

Abstract

Purpose: The aim of this study was to determine the safety and pathologic response rates following neoadjuvant paclitaxel and radiation in patients with stage II/III breast cancer and to evaluate the use of sequential biopsies to allow an in vivo assessment of biological markers as potential predictive markers of response to this regimen. Patients and Methods: Patients with high-risk, operable breast cancer were treated with three cycles of paclitaxel 175 mg/m2 every 3 weeks, followed by twice-weekly paclitaxel 30 mg/m2 and concurrent radiation. Core biopsies were obtained at baseline and 24 to 72 hours after the first cycle of paclitaxel. After completing neoadjuvant treatment, patients underwent definitive surgery. The primary end point was pathologic complete response, which is defined as the absence of any invasive cancer at surgery. Potential markers of therapeutic response were evaluated including markers of proliferation, apoptosis, p21, HER2, estrogen receptor, and progesterone receptor status. Results: Of the 38 patients enrolled, 13 (34%) had a pathologic complete response. There was no significant difference in baseline Ki-67 between responders (35%) and nonresponders (28%; P = 0.45). There was also no significant change in Ki-67 following paclitaxel administration. Despite this lack of immunohistologic change in proliferative activity, baseline mitotic index was higher for patients with pathologic complete response over nonresponders (27 versus 10, P = 0.003). Moreover, the increase in mitotic index following paclitaxel administration was associated with pathologic complete response. Conclusions: Neoadjuvant paclitaxel/radiation is effective and well tolerated. Tumor proliferation at baseline and response to chemotherapy as measured by mitotic activity may serve as an important indicator of pathologic response to neoadjuvant paclitaxel/radiation.

Original languageEnglish (US)
Pages (from-to)1570-1576
Number of pages7
JournalClinical Cancer Research
Volume12
Issue number5
DOIs
StatePublished - Mar 1 2006
Externally publishedYes

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Paclitaxel
Radiation
Breast Neoplasms
Mitotic Index
Biopsy
Neoadjuvant Therapy
Progesterone Receptors
Estrogen Receptors
Neoplasms
Biomarkers
Apoptosis
Safety
Drug Therapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Chakravarthy, A. B., Kelley, M. C., McLaren, B., Truica, C. I., Billheimer, D., Mayer, I. A., ... Pietenpol, J. A. (2006). Neoadjuvant concurrent paclitaxel and radiation in stage II/III breast cancer. Clinical Cancer Research, 12(5), 1570-1576. https://doi.org/10.1158/1078-0432.CCR-05-2304

Neoadjuvant concurrent paclitaxel and radiation in stage II/III breast cancer. / Chakravarthy, A. Bapsi; Kelley, Mark C.; McLaren, Bernadette; Truica, Cristina I.; Billheimer, Dean; Mayer, Ingrid A.; Grau, Ana M.; Johnson, David H.; Simpson, Jean F.; Beauchamp, R. Daniel; Jones, Catherine; Pietenpol, Jennifer A.

In: Clinical Cancer Research, Vol. 12, No. 5, 01.03.2006, p. 1570-1576.

Research output: Contribution to journalArticle

Chakravarthy, AB, Kelley, MC, McLaren, B, Truica, CI, Billheimer, D, Mayer, IA, Grau, AM, Johnson, DH, Simpson, JF, Beauchamp, RD, Jones, C & Pietenpol, JA 2006, 'Neoadjuvant concurrent paclitaxel and radiation in stage II/III breast cancer', Clinical Cancer Research, vol. 12, no. 5, pp. 1570-1576. https://doi.org/10.1158/1078-0432.CCR-05-2304
Chakravarthy AB, Kelley MC, McLaren B, Truica CI, Billheimer D, Mayer IA et al. Neoadjuvant concurrent paclitaxel and radiation in stage II/III breast cancer. Clinical Cancer Research. 2006 Mar 1;12(5):1570-1576. https://doi.org/10.1158/1078-0432.CCR-05-2304
Chakravarthy, A. Bapsi ; Kelley, Mark C. ; McLaren, Bernadette ; Truica, Cristina I. ; Billheimer, Dean ; Mayer, Ingrid A. ; Grau, Ana M. ; Johnson, David H. ; Simpson, Jean F. ; Beauchamp, R. Daniel ; Jones, Catherine ; Pietenpol, Jennifer A. / Neoadjuvant concurrent paclitaxel and radiation in stage II/III breast cancer. In: Clinical Cancer Research. 2006 ; Vol. 12, No. 5. pp. 1570-1576.
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abstract = "Purpose: The aim of this study was to determine the safety and pathologic response rates following neoadjuvant paclitaxel and radiation in patients with stage II/III breast cancer and to evaluate the use of sequential biopsies to allow an in vivo assessment of biological markers as potential predictive markers of response to this regimen. Patients and Methods: Patients with high-risk, operable breast cancer were treated with three cycles of paclitaxel 175 mg/m2 every 3 weeks, followed by twice-weekly paclitaxel 30 mg/m2 and concurrent radiation. Core biopsies were obtained at baseline and 24 to 72 hours after the first cycle of paclitaxel. After completing neoadjuvant treatment, patients underwent definitive surgery. The primary end point was pathologic complete response, which is defined as the absence of any invasive cancer at surgery. Potential markers of therapeutic response were evaluated including markers of proliferation, apoptosis, p21, HER2, estrogen receptor, and progesterone receptor status. Results: Of the 38 patients enrolled, 13 (34{\%}) had a pathologic complete response. There was no significant difference in baseline Ki-67 between responders (35{\%}) and nonresponders (28{\%}; P = 0.45). There was also no significant change in Ki-67 following paclitaxel administration. Despite this lack of immunohistologic change in proliferative activity, baseline mitotic index was higher for patients with pathologic complete response over nonresponders (27 versus 10, P = 0.003). Moreover, the increase in mitotic index following paclitaxel administration was associated with pathologic complete response. Conclusions: Neoadjuvant paclitaxel/radiation is effective and well tolerated. Tumor proliferation at baseline and response to chemotherapy as measured by mitotic activity may serve as an important indicator of pathologic response to neoadjuvant paclitaxel/radiation.",
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T1 - Neoadjuvant concurrent paclitaxel and radiation in stage II/III breast cancer

AU - Chakravarthy, A. Bapsi

AU - Kelley, Mark C.

AU - McLaren, Bernadette

AU - Truica, Cristina I.

AU - Billheimer, Dean

AU - Mayer, Ingrid A.

AU - Grau, Ana M.

AU - Johnson, David H.

AU - Simpson, Jean F.

AU - Beauchamp, R. Daniel

AU - Jones, Catherine

AU - Pietenpol, Jennifer A.

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N2 - Purpose: The aim of this study was to determine the safety and pathologic response rates following neoadjuvant paclitaxel and radiation in patients with stage II/III breast cancer and to evaluate the use of sequential biopsies to allow an in vivo assessment of biological markers as potential predictive markers of response to this regimen. Patients and Methods: Patients with high-risk, operable breast cancer were treated with three cycles of paclitaxel 175 mg/m2 every 3 weeks, followed by twice-weekly paclitaxel 30 mg/m2 and concurrent radiation. Core biopsies were obtained at baseline and 24 to 72 hours after the first cycle of paclitaxel. After completing neoadjuvant treatment, patients underwent definitive surgery. The primary end point was pathologic complete response, which is defined as the absence of any invasive cancer at surgery. Potential markers of therapeutic response were evaluated including markers of proliferation, apoptosis, p21, HER2, estrogen receptor, and progesterone receptor status. Results: Of the 38 patients enrolled, 13 (34%) had a pathologic complete response. There was no significant difference in baseline Ki-67 between responders (35%) and nonresponders (28%; P = 0.45). There was also no significant change in Ki-67 following paclitaxel administration. Despite this lack of immunohistologic change in proliferative activity, baseline mitotic index was higher for patients with pathologic complete response over nonresponders (27 versus 10, P = 0.003). Moreover, the increase in mitotic index following paclitaxel administration was associated with pathologic complete response. Conclusions: Neoadjuvant paclitaxel/radiation is effective and well tolerated. Tumor proliferation at baseline and response to chemotherapy as measured by mitotic activity may serve as an important indicator of pathologic response to neoadjuvant paclitaxel/radiation.

AB - Purpose: The aim of this study was to determine the safety and pathologic response rates following neoadjuvant paclitaxel and radiation in patients with stage II/III breast cancer and to evaluate the use of sequential biopsies to allow an in vivo assessment of biological markers as potential predictive markers of response to this regimen. Patients and Methods: Patients with high-risk, operable breast cancer were treated with three cycles of paclitaxel 175 mg/m2 every 3 weeks, followed by twice-weekly paclitaxel 30 mg/m2 and concurrent radiation. Core biopsies were obtained at baseline and 24 to 72 hours after the first cycle of paclitaxel. After completing neoadjuvant treatment, patients underwent definitive surgery. The primary end point was pathologic complete response, which is defined as the absence of any invasive cancer at surgery. Potential markers of therapeutic response were evaluated including markers of proliferation, apoptosis, p21, HER2, estrogen receptor, and progesterone receptor status. Results: Of the 38 patients enrolled, 13 (34%) had a pathologic complete response. There was no significant difference in baseline Ki-67 between responders (35%) and nonresponders (28%; P = 0.45). There was also no significant change in Ki-67 following paclitaxel administration. Despite this lack of immunohistologic change in proliferative activity, baseline mitotic index was higher for patients with pathologic complete response over nonresponders (27 versus 10, P = 0.003). Moreover, the increase in mitotic index following paclitaxel administration was associated with pathologic complete response. Conclusions: Neoadjuvant paclitaxel/radiation is effective and well tolerated. Tumor proliferation at baseline and response to chemotherapy as measured by mitotic activity may serve as an important indicator of pathologic response to neoadjuvant paclitaxel/radiation.

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