title: Pegylated liposomal doxorubicin (Doxil) for metastatic breast cancer: the Cancer Research Network, Inc., experience.
abstract: Pegylated liposomal doxorubicin (Doxil) was formulated to improve the safety profile of doxorubicin. The major toxicities, mucositis and palmar-plantar erythrodysesthesia, are dose and schedule dependent, respectively. Anecdotal experience suggests that a dosage of 40 mg/m2 every 4 weeks is well tolerated. To evaluate the safety and efficacy of this regimen in women with metastatic breast cancer, we performed a retrospective chart review at a private practice. Forty women received a median initial dose of 42.5 mg/m2 usually every 4 weeks and a median cumulative dose of 135 mg/m2 (range: 40-595 mg/m2). There were 10 partial responses and seven patients with stable disease for more than 6 months resulting in a clinical benefit rate of 43% in the intent-to-treat analysis. The median time to progression was 4 months in all patients, 6.5 months in patients who had partial responses, and 10 months in patients who had stable disease for more than 6 months. There was no grade 4 toxicity. The only grade 3 toxicities were leukopenia in seven (18%) patients, mucositis in one (3%), and palmar-plantar erythrodysesthesia in one (3%). More studies are warranted to confirm our findings, which suggest that pegylated liposomal doxorubicin at a dosage of 40-45 mg/m2 every 4 weeks is clinically active in, and well tolerated by, women with metastatic breast cancer.
authors.affiliation: Cancer Research Network, Inc., Plantation, Florida, USA. alejandratp@netscape.net
authors.forename: Alejandra T
authors.initials: AT
authors.lastname: Perez
authors.forename: Gabriel H
authors.initials: GH
authors.lastname: Domenech
authors.forename: Cynthia
authors.initials: C
authors.lastname: Frankel
authors.forename: Charles L
authors.initials: CL
authors.lastname: Vogel
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy / Q000473:pathology; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006331:Heart Diseases / Q000139:chemically induced; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008081:Liposomes; D008593:Menopause; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011092:Polyethylene Glycols / Q000008:administration & dosage; D012189:Retrospective Studies; D016879:Salvage Therapy; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D008081:Liposomes; D011092:Polyethylene Glycols; D004317:Doxorubicin