A randomized trial of chemotherapy with or without estrogenic recruitment in locally advanced breast cancer

Editta Baldini, Giovanni Gardin, Piergiorgio Giannessi, Fulvio Brema, Alessandra Camorriano, Flavio Carnino, Cinzia Naso, Giuliana Pastorino, Paolo Pronzato, Riccardo Rosso, Alessandra Rubagotti, Giorgio Torretta, Pier Franco Conte

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

The present phase III trial was carried out to verify whether a kinetic recruitment induced by low doses of diethylstilbestrol (DES) could increase the killing efficacy of chemotherapy in patients with locally advanced breast cancer. One-hundred and seventeen untreated patients with locally advanced breast cancer (stage IIIA/IIIB) were randomized to receive 3 courses of primary chemotherapy consisting of cyclophosphamide (600 mg/m2 i.v.), doxorubicin (50 mg/m2 i.v.) and fluorouracil (600 mg/m2 i.v.) (CAF) on day 1, or DES-CAF (DES, 1 mg orally days 1-3, CAF on day 4). The courses were repeated every 3 weeks. The patients who achieved an objective response were submitted to mastectomy followed by 3 courses of CAF alternated with 3 courses of CMF (cyclophosphamide, 600 mg/m2 i.v.; methotrexate, 40 mg/m2 i.v.; fluorouracil, 600 mg/m2 i.v.), with or without DES. The two treatment arms were well balanced in terms of clinical and pathologic features. There was no significant difference in response rates to induction chemotherapy between the two treatment arms (objective response rate, 63.3% for CAF and 56.1% for DES-CAF). Median overall survival was 49 and 47 months and median progression-free survival was 24 and 21 months for CAF and DES-CAF patients, respectively. Toxicity was not significantly different in the two groups, with the exception of leukopenia: DES chemotherapy was significantly more myelotoxic than the standard treatment, which resulted in a significant reduction in the actual dose intensity. In spite of the attractive experimental evidence, we conclude that so far there is no clinical advantage in the combination of estrogen and chemotherapy. Further research is needed to investigate different schedules of chemotherapy and hormones, or to test the possibility of combining various mitogens.

Original languageEnglish
Pages (from-to)829-833
Number of pages5
JournalTumori
Volume83
Issue number5
Publication statusPublished - Sep 1997

Fingerprint

Diethylstilbestrol
Breast Neoplasms
Drug Therapy
Fluorouracil
Cyclophosphamide
Induction Chemotherapy
Mastectomy
Leukopenia
Combination Drug Therapy
Mitogens
Methotrexate
Doxorubicin
Disease-Free Survival
Appointments and Schedules
Estrogens
Therapeutics
Hormones
Survival
Research

Keywords

  • Breast cancer
  • Chemotherapy
  • Estrogenic recruitment

ASJC Scopus subject areas

  • Cancer Research

Cite this

Baldini, E., Gardin, G., Giannessi, P., Brema, F., Camorriano, A., Carnino, F., ... Conte, P. F. (1997). A randomized trial of chemotherapy with or without estrogenic recruitment in locally advanced breast cancer. Tumori, 83(5), 829-833.

A randomized trial of chemotherapy with or without estrogenic recruitment in locally advanced breast cancer. / Baldini, Editta; Gardin, Giovanni; Giannessi, Piergiorgio; Brema, Fulvio; Camorriano, Alessandra; Carnino, Flavio; Naso, Cinzia; Pastorino, Giuliana; Pronzato, Paolo; Rosso, Riccardo; Rubagotti, Alessandra; Torretta, Giorgio; Conte, Pier Franco.

In: Tumori, Vol. 83, No. 5, 09.1997, p. 829-833.

Research output: Contribution to journalArticle

Baldini, E, Gardin, G, Giannessi, P, Brema, F, Camorriano, A, Carnino, F, Naso, C, Pastorino, G, Pronzato, P, Rosso, R, Rubagotti, A, Torretta, G & Conte, PF 1997, 'A randomized trial of chemotherapy with or without estrogenic recruitment in locally advanced breast cancer', Tumori, vol. 83, no. 5, pp. 829-833.
Baldini E, Gardin G, Giannessi P, Brema F, Camorriano A, Carnino F et al. A randomized trial of chemotherapy with or without estrogenic recruitment in locally advanced breast cancer. Tumori. 1997 Sep;83(5):829-833.
Baldini, Editta ; Gardin, Giovanni ; Giannessi, Piergiorgio ; Brema, Fulvio ; Camorriano, Alessandra ; Carnino, Flavio ; Naso, Cinzia ; Pastorino, Giuliana ; Pronzato, Paolo ; Rosso, Riccardo ; Rubagotti, Alessandra ; Torretta, Giorgio ; Conte, Pier Franco. / A randomized trial of chemotherapy with or without estrogenic recruitment in locally advanced breast cancer. In: Tumori. 1997 ; Vol. 83, No. 5. pp. 829-833.
@article{672ffc21d33b4f6d82d19aff1601b27d,
title = "A randomized trial of chemotherapy with or without estrogenic recruitment in locally advanced breast cancer",
abstract = "The present phase III trial was carried out to verify whether a kinetic recruitment induced by low doses of diethylstilbestrol (DES) could increase the killing efficacy of chemotherapy in patients with locally advanced breast cancer. One-hundred and seventeen untreated patients with locally advanced breast cancer (stage IIIA/IIIB) were randomized to receive 3 courses of primary chemotherapy consisting of cyclophosphamide (600 mg/m2 i.v.), doxorubicin (50 mg/m2 i.v.) and fluorouracil (600 mg/m2 i.v.) (CAF) on day 1, or DES-CAF (DES, 1 mg orally days 1-3, CAF on day 4). The courses were repeated every 3 weeks. The patients who achieved an objective response were submitted to mastectomy followed by 3 courses of CAF alternated with 3 courses of CMF (cyclophosphamide, 600 mg/m2 i.v.; methotrexate, 40 mg/m2 i.v.; fluorouracil, 600 mg/m2 i.v.), with or without DES. The two treatment arms were well balanced in terms of clinical and pathologic features. There was no significant difference in response rates to induction chemotherapy between the two treatment arms (objective response rate, 63.3{\%} for CAF and 56.1{\%} for DES-CAF). Median overall survival was 49 and 47 months and median progression-free survival was 24 and 21 months for CAF and DES-CAF patients, respectively. Toxicity was not significantly different in the two groups, with the exception of leukopenia: DES chemotherapy was significantly more myelotoxic than the standard treatment, which resulted in a significant reduction in the actual dose intensity. In spite of the attractive experimental evidence, we conclude that so far there is no clinical advantage in the combination of estrogen and chemotherapy. Further research is needed to investigate different schedules of chemotherapy and hormones, or to test the possibility of combining various mitogens.",
keywords = "Breast cancer, Chemotherapy, Estrogenic recruitment",
author = "Editta Baldini and Giovanni Gardin and Piergiorgio Giannessi and Fulvio Brema and Alessandra Camorriano and Flavio Carnino and Cinzia Naso and Giuliana Pastorino and Paolo Pronzato and Riccardo Rosso and Alessandra Rubagotti and Giorgio Torretta and Conte, {Pier Franco}",
year = "1997",
month = "9",
language = "English",
volume = "83",
pages = "829--833",
journal = "Tumori",
issn = "0300-8916",
publisher = "SAGE Publications Ltd",
number = "5",

}

TY - JOUR

T1 - A randomized trial of chemotherapy with or without estrogenic recruitment in locally advanced breast cancer

AU - Baldini, Editta

AU - Gardin, Giovanni

AU - Giannessi, Piergiorgio

AU - Brema, Fulvio

AU - Camorriano, Alessandra

AU - Carnino, Flavio

AU - Naso, Cinzia

AU - Pastorino, Giuliana

AU - Pronzato, Paolo

AU - Rosso, Riccardo

AU - Rubagotti, Alessandra

AU - Torretta, Giorgio

AU - Conte, Pier Franco

PY - 1997/9

Y1 - 1997/9

N2 - The present phase III trial was carried out to verify whether a kinetic recruitment induced by low doses of diethylstilbestrol (DES) could increase the killing efficacy of chemotherapy in patients with locally advanced breast cancer. One-hundred and seventeen untreated patients with locally advanced breast cancer (stage IIIA/IIIB) were randomized to receive 3 courses of primary chemotherapy consisting of cyclophosphamide (600 mg/m2 i.v.), doxorubicin (50 mg/m2 i.v.) and fluorouracil (600 mg/m2 i.v.) (CAF) on day 1, or DES-CAF (DES, 1 mg orally days 1-3, CAF on day 4). The courses were repeated every 3 weeks. The patients who achieved an objective response were submitted to mastectomy followed by 3 courses of CAF alternated with 3 courses of CMF (cyclophosphamide, 600 mg/m2 i.v.; methotrexate, 40 mg/m2 i.v.; fluorouracil, 600 mg/m2 i.v.), with or without DES. The two treatment arms were well balanced in terms of clinical and pathologic features. There was no significant difference in response rates to induction chemotherapy between the two treatment arms (objective response rate, 63.3% for CAF and 56.1% for DES-CAF). Median overall survival was 49 and 47 months and median progression-free survival was 24 and 21 months for CAF and DES-CAF patients, respectively. Toxicity was not significantly different in the two groups, with the exception of leukopenia: DES chemotherapy was significantly more myelotoxic than the standard treatment, which resulted in a significant reduction in the actual dose intensity. In spite of the attractive experimental evidence, we conclude that so far there is no clinical advantage in the combination of estrogen and chemotherapy. Further research is needed to investigate different schedules of chemotherapy and hormones, or to test the possibility of combining various mitogens.

AB - The present phase III trial was carried out to verify whether a kinetic recruitment induced by low doses of diethylstilbestrol (DES) could increase the killing efficacy of chemotherapy in patients with locally advanced breast cancer. One-hundred and seventeen untreated patients with locally advanced breast cancer (stage IIIA/IIIB) were randomized to receive 3 courses of primary chemotherapy consisting of cyclophosphamide (600 mg/m2 i.v.), doxorubicin (50 mg/m2 i.v.) and fluorouracil (600 mg/m2 i.v.) (CAF) on day 1, or DES-CAF (DES, 1 mg orally days 1-3, CAF on day 4). The courses were repeated every 3 weeks. The patients who achieved an objective response were submitted to mastectomy followed by 3 courses of CAF alternated with 3 courses of CMF (cyclophosphamide, 600 mg/m2 i.v.; methotrexate, 40 mg/m2 i.v.; fluorouracil, 600 mg/m2 i.v.), with or without DES. The two treatment arms were well balanced in terms of clinical and pathologic features. There was no significant difference in response rates to induction chemotherapy between the two treatment arms (objective response rate, 63.3% for CAF and 56.1% for DES-CAF). Median overall survival was 49 and 47 months and median progression-free survival was 24 and 21 months for CAF and DES-CAF patients, respectively. Toxicity was not significantly different in the two groups, with the exception of leukopenia: DES chemotherapy was significantly more myelotoxic than the standard treatment, which resulted in a significant reduction in the actual dose intensity. In spite of the attractive experimental evidence, we conclude that so far there is no clinical advantage in the combination of estrogen and chemotherapy. Further research is needed to investigate different schedules of chemotherapy and hormones, or to test the possibility of combining various mitogens.

KW - Breast cancer

KW - Chemotherapy

KW - Estrogenic recruitment

UR - http://www.scopus.com/inward/record.url?scp=6844261173&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=6844261173&partnerID=8YFLogxK

M3 - Article

VL - 83

SP - 829

EP - 833

JO - Tumori

JF - Tumori

SN - 0300-8916

IS - 5

ER -