BACKGROUND: Taxanes are effective in treating metastatic breast cancer. Liposomal doxorubicin (LD) is as effective as doxorubicin but less toxic. PATIENTS AND METHODS: This phase II trial assessed the combination of LD and docetaxel (D). Between 12/2002 and 9/2005, 12 women received monthly LD (30 mg/m(2)) and weekly D (30 mg/m(2)). Cycles were continued until progression or toxicity. Primary outcome was time to progression. Secondary endpoints included response rate, time to treatment failure, duration of response, survival, and toxicity. RESULTS: Median age was 49 (31-60) years. 9 (75%) patients had estrogen receptor-positive or progesterone receptor-positive tumors. 5 (41.7%) women had her-2/neu-positive tumors. 4 women stopped participation due to toxicity, and 7 due to progression. 8 (67%) participants (95% confidence interval (CI) 51.6-94.5%) had a partial response, and 2 (16.7%) had stable disease. Median time to progression was 9.6 months (95% CI 4.7-12.2). Median time to treatment failure was 6.5 months (95% CI 4.4-10.5). Median survival was 22.1 months (95% CI 9.6-40.8). Median duration of partial response was 2.7 months (95% CI 2.4-10.5). 10 (83%) women experienced grade 3/4 toxicities: neutropenia 3 (25%), infection 3 (25%), stomatitis 5 (41.7%), nausea 2 (16.7%), vomiting 1 (8.3%), dyspnea 2 (16.7%), pericardial effusion 1 (8.3), and palmar-plantar erythrodysesthesia 1 (8.3%). CONCLUSIONS: LD and D resulted in an encouraging response and unacceptable toxicities.
BACKGROUND:Taxanes are effective in treating metastatic breast cancer. Liposomal doxorubicin (LD) is as effective as doxorubicin but less toxic. PATIENTS AND METHODS: This phase II trial assessed the combination of LD and docetaxel (D). Between 12/2002 and 9/2005, 12 women received monthly LD (30 mg/m(2)) and weekly D (30 mg/m(2)). Cycles were continued until progression or toxicity. Primary outcome was time to progression. Secondary endpoints included response rate, time to treatment failure, duration of response, survival, and toxicity. RESULTS: Median age was 49 (31-60) years. 9 (75%) patients had estrogen receptor-positive or progesterone receptor-positive tumors. 5 (41.7%) women had her-2/neu-positive tumors. 4 women stopped participation due to toxicity, and 7 due to progression. 8 (67%) participants (95% confidence interval (CI) 51.6-94.5%) had a partial response, and 2 (16.7%) had stable disease. Median time to progression was 9.6 months (95% CI 4.7-12.2). Median time to treatment failure was 6.5 months (95% CI 4.4-10.5). Median survival was 22.1 months (95% CI 9.6-40.8). Median duration of partial response was 2.7 months (95% CI 2.4-10.5). 10 (83%) women experienced grade 3/4 toxicities: neutropenia 3 (25%), infection 3 (25%), stomatitis 5 (41.7%), nausea 2 (16.7%), vomiting 1 (8.3%), dyspnea 2 (16.7%), pericardial effusion 1 (8.3), and palmar-plantar erythrodysesthesia 1 (8.3%). CONCLUSIONS:LD and D resulted in an encouraging response and unacceptable toxicities.
Authors: G Batist; G Ramakrishnan; C S Rao; A Chandrasekharan; J Gutheil; T Guthrie; P Shah; A Khojasteh; M K Nair; K Hoelzer; K Tkaczuk; Y C Park; L W Lee Journal: J Clin Oncol Date: 2001-03-01 Impact factor: 44.544
Authors: Marijke Bontenbal; Geert-Jan Creemers; Hans J Braun; Auke C de Boer; Jos Th Janssen; Rieneke B Leys; Jan B Ruit; Swan Hoo Goey; Paul C van der Velden; Leon G Kerkhofs; Kristel L Schothorst; Paul I Schmitz; Hansje J Bokma; Jaap Verweij; Caroline Seynaeve Journal: J Clin Oncol Date: 2005-10-01 Impact factor: 44.544
Authors: E Alba; N Ribelles; A Antón; R Pérez-Carrión; J M López-Vega; M Llanos; A Pelegri; J Florián; M Menéndez; M J Godes Journal: Breast Cancer Res Treat Date: 2003-01 Impact factor: 4.872
Authors: P M Ravdin; H A Burris; G Cook; P Eisenberg; M Kane; W A Bierman; J Mortimer; E Genevois; R E Bellet Journal: J Clin Oncol Date: 1995-12 Impact factor: 44.544
Authors: V Valero; F A Holmes; R S Walters; R L Theriault; L Esparza; G Fraschini; G A Fonseca; R E Bellet; A U Buzdar; G N Hortobagyi Journal: J Clin Oncol Date: 1995-12 Impact factor: 44.544
Authors: S Cresta; G Grasselli; M Mansutti; A Martoni; G Lelli; G Capri; F Buzzi; G Robustelli Della Cuna; A Jirillo; E Terzoli; L Frevola; E Tarenzi; C Sguotti; N Azli; M Murawsky; L Gianni Journal: Ann Oncol Date: 2004-03 Impact factor: 32.976
Authors: M E R O'Brien; N Wigler; M Inbar; R Rosso; E Grischke; A Santoro; R Catane; D G Kieback; P Tomczak; S P Ackland; F Orlandi; L Mellars; L Alland; C Tendler Journal: Ann Oncol Date: 2004-03 Impact factor: 32.976
Authors: E Tomiak; M J Piccart; J Kerger; S Lips; A Awada; D de Valeriola; C Ravoet; D Lossignol; J P Sculier; V Auzannet Journal: J Clin Oncol Date: 1994-07 Impact factor: 44.544
Authors: M E Trudeau; E A Eisenhauer; B P Higgins; F Letendre; W S Lofters; B D Norris; T A Vandenberg; F Delorme; A M Muldal Journal: J Clin Oncol Date: 1996-02 Impact factor: 44.544