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 language | English |
|---|---|
| Pages (from-to) | 230-236 |
| Number of pages | 7 |
| Journal | Oncology |
| Volume | 81 |
| Issue number | 3-4 |
| DOIs | |
| Publication status | Published - Dec 2011 |
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Keywords
- Advanced breast cancer
- Capecitabine
- Docetaxel
- Gemcitabine
- Phase II trial
ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
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. / Vici, P.; Giotta, F.; Di Lauro, L.; Sergi, D.; Vizza, E.; Mariani, L.; Latorre, A.; Pizzuti, L.; D'Amico, C.; Giannarelli, D.; Colucci, G.
In: Oncology, Vol. 81, No. 3-4, 12.2011, p. 230-236.Research output: Contribution to journal › Article
}
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
UR - http://www.scopus.com/inward/record.url?scp=81155145956&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=81155145956&partnerID=8YFLogxK
U2 - 10.1159/000334432
DO - 10.1159/000334432
M3 - Article
C2 - 22094540
AN - SCOPUS:81155145956
VL - 81
SP - 230
EP - 236
JO - Oncology
JF - Oncology
SN - 0030-2414
IS - 3-4
ER -