BACKGROUND: To determine the activity and safety of the combination of paclitaxel and pegylated liposomal doxorubicin (Caelyx) in patients with locally advanced breast cancer. PATIENTS AND METHODS: This was a multicenter phase II study. Thirty-five newly diagnosed patients with locally advanced breast cancer were included in the study. Histological or cytological diagnosis was necessary for inclusion. Median age was 54 years (range 26-73 years). Fifteen patients were premenopausal and 20 postmenopausal. Paclitaxel was administered at a dose of 175 mg/m(2) and pegylated liposomal doxorubicin 35 mg/m(2) every 3 weeks for six cycles. RESULTS: Twenty-five patients (71%) responded. Six (17%) had a complete response, 19 (54%) had a partial response, four remained stable, two progressed and four were not evaluated for response due to discontinuation of chemotherapy. Three patients had a pathologically complete response. A total of 173 cycles were administered. The primary toxicity observed was skin toxicity. Grade 3 skin toxicity was noted in four patients (11%). Palmar-plantar erythrodysesthesia (PPE) grade 3 was experienced by three (9%). Two patients presented with PPE and skin toxicity. Hematological toxicities included grade 3 leukopenia in four patients (3%). Other grade 3 toxicities were uncommon and included only alopecia in 29 patients (83%). Grade 3 or 4 neurotoxicity was not observed in any patient. Dose reduction was necessary in seven patients; in six due to skin toxicity and in one due to neutropenia. Four patients discontinued treatment due to skin toxicity. There were no treatment-related deaths. CONCLUSIONS: The combination of pegylated liposomal doxorubicin and paclitaxel was active in locally advanced breast cancer. The primary toxicity was cutaneous toxicity and it was manageable.
BACKGROUND: To determine the activity and safety of the combination of paclitaxel and pegylated liposomal doxorubicin (Caelyx) in patients with locally advanced breast cancer. PATIENTS AND METHODS: This was a multicenter phase II study. Thirty-five newly diagnosed patients with locally advanced breast cancer were included in the study. Histological or cytological diagnosis was necessary for inclusion. Median age was 54 years (range 26-73 years). Fifteen patients were premenopausal and 20 postmenopausal. Paclitaxel was administered at a dose of 175 mg/m(2) and pegylated liposomal doxorubicin 35 mg/m(2) every 3 weeks for six cycles. RESULTS: Twenty-five patients (71%) responded. Six (17%) had a complete response, 19 (54%) had a partial response, four remained stable, two progressed and four were not evaluated for response due to discontinuation of chemotherapy. Three patients had a pathologically complete response. A total of 173 cycles were administered. The primary toxicity observed was skin toxicity. Grade 3 skin toxicity was noted in four patients (11%). Palmar-plantar erythrodysesthesia (PPE) grade 3 was experienced by three (9%). Two patients presented with PPE and skin toxicity. Hematological toxicities included grade 3 leukopenia in four patients (3%). Other grade 3 toxicities were uncommon and included only alopecia in 29 patients (83%). Grade 3 or 4 neurotoxicity was not observed in any patient. Dose reduction was necessary in seven patients; in six due to skin toxicity and in one due to neutropenia. Four patients discontinued treatment due to skin toxicity. There were no treatment-related deaths. CONCLUSIONS: The combination of pegylated liposomal doxorubicin and paclitaxel was active in locally advanced breast cancer. The primary toxicity was cutaneous toxicity and it was manageable.
Authors: David Sarid; Ilan G Ron; Fani Sperber; Yona Stadler; Perry Kahan; Felix Kovner; Rami Ben-Yosef; Sylvia Marmor; Yulia Grinberg; Natalie Maimon; Juliana Weinstein; Neora Yaal-Hahoshen Journal: Clin Drug Investig Date: 2006 Impact factor: 2.859
Authors: P Schmid; J Krocker; G Morack; V Heilmann; J-U Blohmer; K Michniewicz; G Köhler; T Schaller-Kranz; K Possinger; D Elling Journal: J Cancer Res Clin Oncol Date: 2004-08-20 Impact factor: 4.553
Authors: Patrizia Vici; Laura Pizzuti; Teresa Gamucci; Domenico Sergi; Francesca Conti; Germano Zampa; Pietro Del Medico; Roy De Vita; Marcello Pozzi; Claudio Botti; Simona Di Filippo; Federica Tomao; Isabella Sperduti; Luigi Di Lauro Journal: J Cancer Date: 2014-04-25 Impact factor: 4.207
Authors: Juan Lao; Julia Madani; Teresa Puértolas; María Alvarez; Alba Hernández; Roberto Pazo-Cid; Angel Artal; Antonio Antón Torres Journal: J Drug Deliv Date: 2013-03-26
Authors: D Bafaloukos; C Papadimitriou; H Linardou; G Aravantinos; P Papakostas; D Skarlos; P Kosmidis; G Fountzilas; H Gogas; C Kalofonos; A M Dimopoulos Journal: Br J Cancer Date: 2004-11-01 Impact factor: 7.640