Abstract
This multicentre phase II study was aimed at investigating the activity and safety of pegylated liposomal doxorubicin (PLD) and gemcitabine (GEM) as front-line therapy in a large series of chemotherapy-naïve recurrent/metastatic breast cancer patients. From June 2003 to December 2006, a total of 71 recurrent/metastatic breast cancer patients were enrolled. Median age was 63 years (range=37-79), and 31 patients (43.7%) were ≥65 years old. Patients received PLD, 25 mg m -2, day 1, followed by GEM, 800 mg m -2, days 1 and 8, q21. Response was evaluable in 64 cases. Eight complete (12.5%) and 17 partial responses (26.6%) were registered, with an overall response rate of 39.1%. Thirty patients (46.9%) experienced stable disease, with an overall clinical benefit of 85.9%. Median time to progression (TTP) was 11 months, whereas median overall survival (OS) was not reached. The rate of 1- and 2-year OS was 79 and 61%, respectively. A total of 443 courses were evaluable for toxicity: grade 3 and 4 neutropaenia affected 14 patients (20.3%) and 3 patients (4.3%), respectively. Grade 3 and 4 palmar-plantar erythrodysesthesia syndrome was documented in five cases (7.2%) and one case (1.4%), whereas grade 3 and 4 mucositis occurred in six cases (8.7%) and two cases (2.9%), respectively. Grade 2 cardiac toxicity was observed in only one case. Interestingly enough, there was no difference in the percentage and severity of either haematological or non-haematological toxicity according to the age of the patients (
| Original language | English |
|---|---|
| Pages (from-to) | 1916-1921 |
| Number of pages | 6 |
| Journal | British Journal of Cancer |
| Volume | 98 |
| Issue number | 12 |
| DOIs | |
| Publication status | Published - Jun 17 2008 |
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Keywords
- Gemcitabine
- Metastatic breast cancer
- Pegylated liposomal doxorubicin
ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
Pegylated liposomal doxorubicin and gemcitabine in the front-line treatment of recurrent/metastatic breast cancer : A multicentre phase II study. / Adamo, V.; Lorusso, V.; Rossello, R.; Adamo, B.; Ferraro, G.; Lorusso, D.; Condemi, G.; Priolo, D.; Di Lullo, L.; Paglia, A.; Pisconti, S.; Scambia, G.; Ferrandina, G.
In: British Journal of Cancer, Vol. 98, No. 12, 17.06.2008, p. 1916-1921.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Pegylated liposomal doxorubicin and gemcitabine in the front-line treatment of recurrent/metastatic breast cancer
T2 - A multicentre phase II study
AU - Adamo, V.
AU - Lorusso, V.
AU - Rossello, R.
AU - Adamo, B.
AU - Ferraro, G.
AU - Lorusso, D.
AU - Condemi, G.
AU - Priolo, D.
AU - Di Lullo, L.
AU - Paglia, A.
AU - Pisconti, S.
AU - Scambia, G.
AU - Ferrandina, G.
PY - 2008/6/17
Y1 - 2008/6/17
N2 - This multicentre phase II study was aimed at investigating the activity and safety of pegylated liposomal doxorubicin (PLD) and gemcitabine (GEM) as front-line therapy in a large series of chemotherapy-naïve recurrent/metastatic breast cancer patients. From June 2003 to December 2006, a total of 71 recurrent/metastatic breast cancer patients were enrolled. Median age was 63 years (range=37-79), and 31 patients (43.7%) were ≥65 years old. Patients received PLD, 25 mg m -2, day 1, followed by GEM, 800 mg m -2, days 1 and 8, q21. Response was evaluable in 64 cases. Eight complete (12.5%) and 17 partial responses (26.6%) were registered, with an overall response rate of 39.1%. Thirty patients (46.9%) experienced stable disease, with an overall clinical benefit of 85.9%. Median time to progression (TTP) was 11 months, whereas median overall survival (OS) was not reached. The rate of 1- and 2-year OS was 79 and 61%, respectively. A total of 443 courses were evaluable for toxicity: grade 3 and 4 neutropaenia affected 14 patients (20.3%) and 3 patients (4.3%), respectively. Grade 3 and 4 palmar-plantar erythrodysesthesia syndrome was documented in five cases (7.2%) and one case (1.4%), whereas grade 3 and 4 mucositis occurred in six cases (8.7%) and two cases (2.9%), respectively. Grade 2 cardiac toxicity was observed in only one case. Interestingly enough, there was no difference in the percentage and severity of either haematological or non-haematological toxicity according to the age of the patients (
AB - This multicentre phase II study was aimed at investigating the activity and safety of pegylated liposomal doxorubicin (PLD) and gemcitabine (GEM) as front-line therapy in a large series of chemotherapy-naïve recurrent/metastatic breast cancer patients. From June 2003 to December 2006, a total of 71 recurrent/metastatic breast cancer patients were enrolled. Median age was 63 years (range=37-79), and 31 patients (43.7%) were ≥65 years old. Patients received PLD, 25 mg m -2, day 1, followed by GEM, 800 mg m -2, days 1 and 8, q21. Response was evaluable in 64 cases. Eight complete (12.5%) and 17 partial responses (26.6%) were registered, with an overall response rate of 39.1%. Thirty patients (46.9%) experienced stable disease, with an overall clinical benefit of 85.9%. Median time to progression (TTP) was 11 months, whereas median overall survival (OS) was not reached. The rate of 1- and 2-year OS was 79 and 61%, respectively. A total of 443 courses were evaluable for toxicity: grade 3 and 4 neutropaenia affected 14 patients (20.3%) and 3 patients (4.3%), respectively. Grade 3 and 4 palmar-plantar erythrodysesthesia syndrome was documented in five cases (7.2%) and one case (1.4%), whereas grade 3 and 4 mucositis occurred in six cases (8.7%) and two cases (2.9%), respectively. Grade 2 cardiac toxicity was observed in only one case. Interestingly enough, there was no difference in the percentage and severity of either haematological or non-haematological toxicity according to the age of the patients (
KW - Gemcitabine
KW - Metastatic breast cancer
KW - Pegylated liposomal doxorubicin
UR - http://www.scopus.com/inward/record.url?scp=44949259900&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=44949259900&partnerID=8YFLogxK
U2 - 10.1038/sj.bjc.6604409
DO - 10.1038/sj.bjc.6604409
M3 - Article
VL - 98
SP - 1916
EP - 1921
JO - British Journal of Cancer
JF - British Journal of Cancer
SN - 0007-0920
IS - 12
ER -