Abstract
Background: Pegylated liposomal doxorubicin (PLD) was shown as active but less toxic compared to doxorubicin in advanced breast cancer. Given its low cardiotoxicity, the combination of PLD and trastuzumab appears most attractive in the treatment of human epidermal factor receptor 2 (HER2)-positive breast cancer. Patients and Methods: We investigated the activity of 8 courses of PLD in combination with cisplatin and infusional 5-fluorouracil (CCF) plus 3-week trastuzumab in patients with primary or recurrent cT2-T4 a-d, N0-3, M0 any estrogen receptor (ER), HER2-positive breast cancer. Patients with ER and/or progesterone receptor (PgR) ? 10% tumors received also letrozole (plus triptorelin if premenopausal). The principal endpoint was clinical response rate; secondary endpoints were the pathologic complete response rate (pCR) and the cardiac safety of the combination. Results: Thirty-two patients were enrolled in the study and all are evaluable for response and toxicity. Fifteen patients (47%) had ER-positive tumors, 15 patients and 2 patients had ER absent and ER poor tumors, respectively. Thirteen patients (41%) had inflammatory breast cancer (IBC) and 84% of patients had clinically positive nodes. A clinical response rate of 94% (95% CI, 79%-99%) and a pCR rate of 41% (95% CI, 24%-59%) were observed. Fifty-four percent of patients with IBC obtained a pCR. Eleven patientsdiscontinued treatment before completing 8 courses as planned. No patient developed relevant cardiac toxicity. Conclusion: In this series of very locally advanced breast cancer, the combination of CCF and trastuzumab was very active obtaining an impressive rate of pCR, particularly in IBC, which merits further investigation in larger series.
| Original language | English |
|---|---|
| Pages (from-to) | 483-488 |
| Number of pages | 6 |
| Journal | Clinical Breast Cancer |
| Volume | 10 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - 2010 |
Fingerprint
Keywords
- HER2 positivity
- Left ventricular ejection fraction
ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
Phase II trial of combination of pegylated liposomal doxorubicin, cisplatin, and infusional 5-fluorouracil (CCF) plus trastuzumab as preoperative treatment for locally advanced and inflammatory breast cancer. / Torrisi, Rosalba; Cardillo, Anna; Cancello, Giuseppe; Dellapasqua, Silvia; Balduzzi, Alessandra; Ghisini, Raffaella; Luini, Alberto; Veronesi, Paolo; Viale, Giuseppe; Goldhirsch, Aron; Colleoni, Marco.
In: Clinical Breast Cancer, Vol. 10, No. 6, 2010, p. 483-488.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Phase II trial of combination of pegylated liposomal doxorubicin, cisplatin, and infusional 5-fluorouracil (CCF) plus trastuzumab as preoperative treatment for locally advanced and inflammatory breast cancer
AU - Torrisi, Rosalba
AU - Cardillo, Anna
AU - Cancello, Giuseppe
AU - Dellapasqua, Silvia
AU - Balduzzi, Alessandra
AU - Ghisini, Raffaella
AU - Luini, Alberto
AU - Veronesi, Paolo
AU - Viale, Giuseppe
AU - Goldhirsch, Aron
AU - Colleoni, Marco
PY - 2010
Y1 - 2010
N2 - Background: Pegylated liposomal doxorubicin (PLD) was shown as active but less toxic compared to doxorubicin in advanced breast cancer. Given its low cardiotoxicity, the combination of PLD and trastuzumab appears most attractive in the treatment of human epidermal factor receptor 2 (HER2)-positive breast cancer. Patients and Methods: We investigated the activity of 8 courses of PLD in combination with cisplatin and infusional 5-fluorouracil (CCF) plus 3-week trastuzumab in patients with primary or recurrent cT2-T4 a-d, N0-3, M0 any estrogen receptor (ER), HER2-positive breast cancer. Patients with ER and/or progesterone receptor (PgR) ? 10% tumors received also letrozole (plus triptorelin if premenopausal). The principal endpoint was clinical response rate; secondary endpoints were the pathologic complete response rate (pCR) and the cardiac safety of the combination. Results: Thirty-two patients were enrolled in the study and all are evaluable for response and toxicity. Fifteen patients (47%) had ER-positive tumors, 15 patients and 2 patients had ER absent and ER poor tumors, respectively. Thirteen patients (41%) had inflammatory breast cancer (IBC) and 84% of patients had clinically positive nodes. A clinical response rate of 94% (95% CI, 79%-99%) and a pCR rate of 41% (95% CI, 24%-59%) were observed. Fifty-four percent of patients with IBC obtained a pCR. Eleven patientsdiscontinued treatment before completing 8 courses as planned. No patient developed relevant cardiac toxicity. Conclusion: In this series of very locally advanced breast cancer, the combination of CCF and trastuzumab was very active obtaining an impressive rate of pCR, particularly in IBC, which merits further investigation in larger series.
AB - Background: Pegylated liposomal doxorubicin (PLD) was shown as active but less toxic compared to doxorubicin in advanced breast cancer. Given its low cardiotoxicity, the combination of PLD and trastuzumab appears most attractive in the treatment of human epidermal factor receptor 2 (HER2)-positive breast cancer. Patients and Methods: We investigated the activity of 8 courses of PLD in combination with cisplatin and infusional 5-fluorouracil (CCF) plus 3-week trastuzumab in patients with primary or recurrent cT2-T4 a-d, N0-3, M0 any estrogen receptor (ER), HER2-positive breast cancer. Patients with ER and/or progesterone receptor (PgR) ? 10% tumors received also letrozole (plus triptorelin if premenopausal). The principal endpoint was clinical response rate; secondary endpoints were the pathologic complete response rate (pCR) and the cardiac safety of the combination. Results: Thirty-two patients were enrolled in the study and all are evaluable for response and toxicity. Fifteen patients (47%) had ER-positive tumors, 15 patients and 2 patients had ER absent and ER poor tumors, respectively. Thirteen patients (41%) had inflammatory breast cancer (IBC) and 84% of patients had clinically positive nodes. A clinical response rate of 94% (95% CI, 79%-99%) and a pCR rate of 41% (95% CI, 24%-59%) were observed. Fifty-four percent of patients with IBC obtained a pCR. Eleven patientsdiscontinued treatment before completing 8 courses as planned. No patient developed relevant cardiac toxicity. Conclusion: In this series of very locally advanced breast cancer, the combination of CCF and trastuzumab was very active obtaining an impressive rate of pCR, particularly in IBC, which merits further investigation in larger series.
KW - HER2 positivity
KW - Left ventricular ejection fraction
UR - http://www.scopus.com/inward/record.url?scp=79952278668&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79952278668&partnerID=8YFLogxK
U2 - 10.3816/CBC.2010.n.064
DO - 10.3816/CBC.2010.n.064
M3 - Article
C2 - 21147693
AN - SCOPUS:79952278668
VL - 10
SP - 483
EP - 488
JO - Clinical Breast Cancer
JF - Clinical Breast Cancer
SN - 1526-8209
IS - 6
ER -