A multicenter phase II randomized trial of docetaxel/gemcitabine versus docetaxel/capecitabine as first-line treatment for advanced breast cancer: A gruppo oncologico italia meridionale study

P. Vici, F. Giotta, L. Di Lauro, D. Sergi, E. Vizza, L. Mariani, A. Latorre, L. Pizzuti, C. D'Amico, D. Giannarelli, G. Colucci

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Abstract

Objective: To evaluate two docetaxel-based regimens as first-line treatment in advanced breast cancer patients. Methods: Patients were randomly assigned to docetaxel/gemcitabine (arm A: docetaxel 75 mg/m 2 on day 1, gemcitabine 1,000 mg/m 2 on days 1 and 8) or docetaxel/capecitabine (arm B: docetaxel 75 mg/m 2 on day 1, capecitabine 1,250 mg/m 2 twice daily on days 1-14); both chemotherapy regimens were repeated every 21 days. The primary objective of the study was to evaluate the response rate. Results: Seventy-two patients were enrolled (36 each in arms A and B). Responses according to intention-to-treat analysis were as follows: arm A, 41.7% [95% confidence interval (CI) 25.6-57.8]; arm B, 38.9% (95% CI 23-54.8). Median progression-free survival was 10.9 months (95% CI 8.1-13.7) in arm A and 10 months (95% CI 8.8-11.2) in arm B. Overall survival was 26 months (95% CI 22.0-30.0) in arm A and 28 months (95% CI 23.4-32.6) in arm B. Both treatments were well tolerated; myelosuppression was the dose-limiting toxicity, with grade 3-4 neutropenia in 13.8 and 19.4% of the patients in arms A and B, respectively. No relevant differences in other toxicities were observed in the two arms, except for diarrhea (13.9%) and hand-foot syndrome (11.1%), which occurred only in arm B. Conclusions: Both regimens were active and well tolerated in advanced breast cancer.

Original languageEnglish
Pages (from-to)230-236
Number of pages7
JournalOncology
Volume81
Issue number3-4
DOIs
Publication statusPublished - Dec 2011

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docetaxel
gemcitabine
Confidence Intervals
Breast Neoplasms
Therapeutics
Hand-Foot Syndrome
Intention to Treat Analysis
Neutropenia
Disease-Free Survival
Capecitabine
Diarrhea

Keywords

  • Advanced breast cancer
  • Capecitabine
  • Docetaxel
  • Gemcitabine
  • Phase II trial

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

@article{7a5d1a53e1724ccdbe1322552614bd90,
title = "A multicenter phase II randomized trial of docetaxel/gemcitabine versus docetaxel/capecitabine as first-line treatment for advanced breast cancer: A gruppo oncologico italia meridionale study",
abstract = "Objective: To evaluate two docetaxel-based regimens as first-line treatment in advanced breast cancer patients. Methods: Patients were randomly assigned to docetaxel/gemcitabine (arm A: docetaxel 75 mg/m 2 on day 1, gemcitabine 1,000 mg/m 2 on days 1 and 8) or docetaxel/capecitabine (arm B: docetaxel 75 mg/m 2 on day 1, capecitabine 1,250 mg/m 2 twice daily on days 1-14); both chemotherapy regimens were repeated every 21 days. The primary objective of the study was to evaluate the response rate. Results: Seventy-two patients were enrolled (36 each in arms A and B). Responses according to intention-to-treat analysis were as follows: arm A, 41.7{\%} [95{\%} confidence interval (CI) 25.6-57.8]; arm B, 38.9{\%} (95{\%} CI 23-54.8). Median progression-free survival was 10.9 months (95{\%} CI 8.1-13.7) in arm A and 10 months (95{\%} CI 8.8-11.2) in arm B. Overall survival was 26 months (95{\%} CI 22.0-30.0) in arm A and 28 months (95{\%} CI 23.4-32.6) in arm B. Both treatments were well tolerated; myelosuppression was the dose-limiting toxicity, with grade 3-4 neutropenia in 13.8 and 19.4{\%} of the patients in arms A and B, respectively. No relevant differences in other toxicities were observed in the two arms, except for diarrhea (13.9{\%}) and hand-foot syndrome (11.1{\%}), which occurred only in arm B. Conclusions: Both regimens were active and well tolerated in advanced breast cancer.",
keywords = "Advanced breast cancer, Capecitabine, Docetaxel, Gemcitabine, Phase II trial",
author = "P. Vici and F. Giotta and {Di Lauro}, L. and D. Sergi and E. Vizza and L. Mariani and A. Latorre and L. Pizzuti and C. D'Amico and D. Giannarelli and G. Colucci",
year = "2011",
month = "12",
doi = "10.1159/000334432",
language = "English",
volume = "81",
pages = "230--236",
journal = "Oncology",
issn = "0030-2414",
publisher = "UBM Medica Healthcare Publications",
number = "3-4",

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TY - JOUR

T1 - A multicenter phase II randomized trial of docetaxel/gemcitabine versus docetaxel/capecitabine as first-line treatment for advanced breast cancer

T2 - A gruppo oncologico italia meridionale study

AU - Vici, P.

AU - Giotta, F.

AU - Di Lauro, L.

AU - Sergi, D.

AU - Vizza, E.

AU - Mariani, L.

AU - Latorre, A.

AU - Pizzuti, L.

AU - D'Amico, C.

AU - Giannarelli, D.

AU - Colucci, G.

PY - 2011/12

Y1 - 2011/12

N2 - Objective: To evaluate two docetaxel-based regimens as first-line treatment in advanced breast cancer patients. Methods: Patients were randomly assigned to docetaxel/gemcitabine (arm A: docetaxel 75 mg/m 2 on day 1, gemcitabine 1,000 mg/m 2 on days 1 and 8) or docetaxel/capecitabine (arm B: docetaxel 75 mg/m 2 on day 1, capecitabine 1,250 mg/m 2 twice daily on days 1-14); both chemotherapy regimens were repeated every 21 days. The primary objective of the study was to evaluate the response rate. Results: Seventy-two patients were enrolled (36 each in arms A and B). Responses according to intention-to-treat analysis were as follows: arm A, 41.7% [95% confidence interval (CI) 25.6-57.8]; arm B, 38.9% (95% CI 23-54.8). Median progression-free survival was 10.9 months (95% CI 8.1-13.7) in arm A and 10 months (95% CI 8.8-11.2) in arm B. Overall survival was 26 months (95% CI 22.0-30.0) in arm A and 28 months (95% CI 23.4-32.6) in arm B. Both treatments were well tolerated; myelosuppression was the dose-limiting toxicity, with grade 3-4 neutropenia in 13.8 and 19.4% of the patients in arms A and B, respectively. No relevant differences in other toxicities were observed in the two arms, except for diarrhea (13.9%) and hand-foot syndrome (11.1%), which occurred only in arm B. Conclusions: Both regimens were active and well tolerated in advanced breast cancer.

AB - Objective: To evaluate two docetaxel-based regimens as first-line treatment in advanced breast cancer patients. Methods: Patients were randomly assigned to docetaxel/gemcitabine (arm A: docetaxel 75 mg/m 2 on day 1, gemcitabine 1,000 mg/m 2 on days 1 and 8) or docetaxel/capecitabine (arm B: docetaxel 75 mg/m 2 on day 1, capecitabine 1,250 mg/m 2 twice daily on days 1-14); both chemotherapy regimens were repeated every 21 days. The primary objective of the study was to evaluate the response rate. Results: Seventy-two patients were enrolled (36 each in arms A and B). Responses according to intention-to-treat analysis were as follows: arm A, 41.7% [95% confidence interval (CI) 25.6-57.8]; arm B, 38.9% (95% CI 23-54.8). Median progression-free survival was 10.9 months (95% CI 8.1-13.7) in arm A and 10 months (95% CI 8.8-11.2) in arm B. Overall survival was 26 months (95% CI 22.0-30.0) in arm A and 28 months (95% CI 23.4-32.6) in arm B. Both treatments were well tolerated; myelosuppression was the dose-limiting toxicity, with grade 3-4 neutropenia in 13.8 and 19.4% of the patients in arms A and B, respectively. No relevant differences in other toxicities were observed in the two arms, except for diarrhea (13.9%) and hand-foot syndrome (11.1%), which occurred only in arm B. Conclusions: Both regimens were active and well tolerated in advanced breast cancer.

KW - Advanced breast cancer

KW - Capecitabine

KW - Docetaxel

KW - Gemcitabine

KW - Phase II trial

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U2 - 10.1159/000334432

DO - 10.1159/000334432

M3 - Article

C2 - 22094540

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VL - 81

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