Phase II study of neoadjuvant docetaxel/vinorelbine followed by surgery and adjuvant doxorubicin/cyclophosphamide in women with stage II/III breast cancer

Steven A. Limentani, Adam M. Brufsky, John K. Erban, Mohammad Jahanzeb, Deborah Lewis

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Background: The purpose of this study was to evaluate the combination of docetaxel plus vinorelbine as neoadjuvant chemotherapy for stage II/III locally advanced breast cancer. Patients and Methods: Eligible women wi th stage IIA-IIIB or locoregional stage IV breast cancer were treated before surgery with 6 cycles of docetaxel 60 mg/m2 and vinorelbine 45 mg/m2, repeated every 2 weeks with granulocyte colony-stimulating factor and quinolone prophylaxis. Pathologic complete response (pCR), viewed as an early surrogate for disease-free and overall survival, was the primary efficacy endpoint. Sixty patients were enrolled; 60% had T3 or T4 lesions, 67% had clinically palpable lymph nodes, and 52% were hormone receptor positive. Results: Fifty-nine patients were evaluable for path ologic response; 16 (27%) exhibited pCR in the breast alone (T0 Tis NX), 20% exhibited a pCR in the breast and lymph nodes (T0 Tis N0), 24 (41%) had < 5 mm of residual tumor, and 28 (47%) had node-negative disease at surgery. Relative dose intensity was 96% for docetaxel and 95% for vinorelbine. The clinical response rate was 98% (59 of 60 patients), including 38 complete responses (63%). Grade 3/4 neutropenia (95%), neutropenic fever (22%), mucositis (5%), and pulmonary toxicity (5%) occurred in ≥ 5% of patients. Constipation was seen early but became insignificant after incorporating a prophylactic laxative regimen. Other toxicities have been minimal. Conclusion: With a clinical response rate of 98% and an i n-breast pCR rate of 27%, docetaxel/vinorelbine is among the most active neoadjuvant regimens reported for locally advanced breast cancer. Docetaxel/ vinorelbine can be administered in a dose-dense fashion while maintaining relative dose intensity. However, there was a significant incidence of fever and neutropenia despite the use of prophylactic growth factors and quinolones, indicating that lower doses of docetaxel/ vinorelbine should be evaluated in future studies.

Original languageEnglish
Pages (from-to)511-517
Number of pages7
JournalClinical Breast Cancer
Volume6
Issue number6
DOIs
StatePublished - Jan 1 2006
Externally publishedYes

Fingerprint

docetaxel
Doxorubicin
Cyclophosphamide
Breast Neoplasms
Breast
Quinolones
Neutropenia
Fever
Lymph Nodes
Laxatives
Mucositis
Residual Neoplasm
Granulocyte Colony-Stimulating Factor
Constipation
Disease-Free Survival
vinorelbine
Intercellular Signaling Peptides and Proteins
Hormones

Keywords

  • Chemotherapy
  • Granulocyte colony-stimulating factor
  • Neutropenia
  • Quinolones

ASJC Scopus subject areas

  • Cancer Research

Cite this

Phase II study of neoadjuvant docetaxel/vinorelbine followed by surgery and adjuvant doxorubicin/cyclophosphamide in women with stage II/III breast cancer. / Limentani, Steven A.; Brufsky, Adam M.; Erban, John K.; Jahanzeb, Mohammad; Lewis, Deborah.

In: Clinical Breast Cancer, Vol. 6, No. 6, 01.01.2006, p. 511-517.

Research output: Contribution to journalArticle

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title = "Phase II study of neoadjuvant docetaxel/vinorelbine followed by surgery and adjuvant doxorubicin/cyclophosphamide in women with stage II/III breast cancer",
abstract = "Background: The purpose of this study was to evaluate the combination of docetaxel plus vinorelbine as neoadjuvant chemotherapy for stage II/III locally advanced breast cancer. Patients and Methods: Eligible women wi th stage IIA-IIIB or locoregional stage IV breast cancer were treated before surgery with 6 cycles of docetaxel 60 mg/m2 and vinorelbine 45 mg/m2, repeated every 2 weeks with granulocyte colony-stimulating factor and quinolone prophylaxis. Pathologic complete response (pCR), viewed as an early surrogate for disease-free and overall survival, was the primary efficacy endpoint. Sixty patients were enrolled; 60{\%} had T3 or T4 lesions, 67{\%} had clinically palpable lymph nodes, and 52{\%} were hormone receptor positive. Results: Fifty-nine patients were evaluable for path ologic response; 16 (27{\%}) exhibited pCR in the breast alone (T0 Tis NX), 20{\%} exhibited a pCR in the breast and lymph nodes (T0 Tis N0), 24 (41{\%}) had < 5 mm of residual tumor, and 28 (47{\%}) had node-negative disease at surgery. Relative dose intensity was 96{\%} for docetaxel and 95{\%} for vinorelbine. The clinical response rate was 98{\%} (59 of 60 patients), including 38 complete responses (63{\%}). Grade 3/4 neutropenia (95{\%}), neutropenic fever (22{\%}), mucositis (5{\%}), and pulmonary toxicity (5{\%}) occurred in ≥ 5{\%} of patients. Constipation was seen early but became insignificant after incorporating a prophylactic laxative regimen. Other toxicities have been minimal. Conclusion: With a clinical response rate of 98{\%} and an i n-breast pCR rate of 27{\%}, docetaxel/vinorelbine is among the most active neoadjuvant regimens reported for locally advanced breast cancer. Docetaxel/ vinorelbine can be administered in a dose-dense fashion while maintaining relative dose intensity. However, there was a significant incidence of fever and neutropenia despite the use of prophylactic growth factors and quinolones, indicating that lower doses of docetaxel/ vinorelbine should be evaluated in future studies.",
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AU - Jahanzeb, Mohammad

AU - Lewis, Deborah

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N2 - Background: The purpose of this study was to evaluate the combination of docetaxel plus vinorelbine as neoadjuvant chemotherapy for stage II/III locally advanced breast cancer. Patients and Methods: Eligible women wi th stage IIA-IIIB or locoregional stage IV breast cancer were treated before surgery with 6 cycles of docetaxel 60 mg/m2 and vinorelbine 45 mg/m2, repeated every 2 weeks with granulocyte colony-stimulating factor and quinolone prophylaxis. Pathologic complete response (pCR), viewed as an early surrogate for disease-free and overall survival, was the primary efficacy endpoint. Sixty patients were enrolled; 60% had T3 or T4 lesions, 67% had clinically palpable lymph nodes, and 52% were hormone receptor positive. Results: Fifty-nine patients were evaluable for path ologic response; 16 (27%) exhibited pCR in the breast alone (T0 Tis NX), 20% exhibited a pCR in the breast and lymph nodes (T0 Tis N0), 24 (41%) had < 5 mm of residual tumor, and 28 (47%) had node-negative disease at surgery. Relative dose intensity was 96% for docetaxel and 95% for vinorelbine. The clinical response rate was 98% (59 of 60 patients), including 38 complete responses (63%). Grade 3/4 neutropenia (95%), neutropenic fever (22%), mucositis (5%), and pulmonary toxicity (5%) occurred in ≥ 5% of patients. Constipation was seen early but became insignificant after incorporating a prophylactic laxative regimen. Other toxicities have been minimal. Conclusion: With a clinical response rate of 98% and an i n-breast pCR rate of 27%, docetaxel/vinorelbine is among the most active neoadjuvant regimens reported for locally advanced breast cancer. Docetaxel/ vinorelbine can be administered in a dose-dense fashion while maintaining relative dose intensity. However, there was a significant incidence of fever and neutropenia despite the use of prophylactic growth factors and quinolones, indicating that lower doses of docetaxel/ vinorelbine should be evaluated in future studies.

AB - Background: The purpose of this study was to evaluate the combination of docetaxel plus vinorelbine as neoadjuvant chemotherapy for stage II/III locally advanced breast cancer. Patients and Methods: Eligible women wi th stage IIA-IIIB or locoregional stage IV breast cancer were treated before surgery with 6 cycles of docetaxel 60 mg/m2 and vinorelbine 45 mg/m2, repeated every 2 weeks with granulocyte colony-stimulating factor and quinolone prophylaxis. Pathologic complete response (pCR), viewed as an early surrogate for disease-free and overall survival, was the primary efficacy endpoint. Sixty patients were enrolled; 60% had T3 or T4 lesions, 67% had clinically palpable lymph nodes, and 52% were hormone receptor positive. Results: Fifty-nine patients were evaluable for path ologic response; 16 (27%) exhibited pCR in the breast alone (T0 Tis NX), 20% exhibited a pCR in the breast and lymph nodes (T0 Tis N0), 24 (41%) had < 5 mm of residual tumor, and 28 (47%) had node-negative disease at surgery. Relative dose intensity was 96% for docetaxel and 95% for vinorelbine. The clinical response rate was 98% (59 of 60 patients), including 38 complete responses (63%). Grade 3/4 neutropenia (95%), neutropenic fever (22%), mucositis (5%), and pulmonary toxicity (5%) occurred in ≥ 5% of patients. Constipation was seen early but became insignificant after incorporating a prophylactic laxative regimen. Other toxicities have been minimal. Conclusion: With a clinical response rate of 98% and an i n-breast pCR rate of 27%, docetaxel/vinorelbine is among the most active neoadjuvant regimens reported for locally advanced breast cancer. Docetaxel/ vinorelbine can be administered in a dose-dense fashion while maintaining relative dose intensity. However, there was a significant incidence of fever and neutropenia despite the use of prophylactic growth factors and quinolones, indicating that lower doses of docetaxel/ vinorelbine should be evaluated in future studies.

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