Reduced incidence of severe palmar-plantar erythrodysesthesia and mucositis in a prospective multicenter phase II trial with pegylated liposomal doxorubicin at 40 mg/m2 every 4 weeks in previously treated patients with metastatic breast cancer.
OBJECTIVE
The aim of this study was to assess whether the reduction in the total dose of pegylated liposomal doxorubicin (PLD) per cycle from 50 mg/m(2) every 4 weeks to 40 mg/m(2) every 4 weeks can effectively lower the incidence of treatment-related palmar-plantar erythrodysesthesia (PPE) and mucositis.


METHODS
Patients received PLD 40 mg/m(2) every 4 weeks, and were evaluated for toxicity prior to each treatment and for response every 8 weeks.


RESULTS
All patients were previously treated with at least one chemotherapy regimen for metastatic disease, and 72% of the patients had a prior exposure to an anthracycline. Forty-six evaluable patients received a median of four PLD cycles, with a median dose intensity of 10 mg/m(2)/week and a median cumulative dose of 160 mg/m(2). No National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade 3 or 4 PPE was observed in these patients. NCI-CTC grade 3 or 4 mucositis occurred in 4.3% of patients, only. Response rates and survival results observed here were comparable to those observed with PLD 50 mg/m(2) every 4 weeks in a matched patient population. However, patients treated with PLD 40 mg/m(2) every 4 weeks experienced less PPE and mucositis and required clearly less dose reductions and treatment delays.


CONCLUSIONS
The favorable safety profile observed in this study leads us to recommend the use of PLD 40 mg/m(2) every 4 weeks for patients with advanced breast cancer.
Al-Batran
Salah-Eddin
SE
Krankenhaus Nordwest, Frankfurt, Deutschland. albatran@aol.com
Meerpohl
Hans-Gerd
HG
von Minckwitz
Gunter
G
Atmaca
Akin
A
Kleeberg
Ulrich
U
Harbeck
Nadia
N
Lerbs
Werner
W
Hecker
Detlef
D
Sehouli
Jalid
J
Knuth
Alexander
A
Jager
Elke
E
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D004890:Erythema / Q000139:chemically induced / Q000453:epidemiology*; D005260:Female; D005528:Foot; D006225:Hand; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D052016:Mucositis / Q000139:chemically induced / Q000453:epidemiology*; D010292:Paresthesia / Q000139:chemically induced / Q000453:epidemiology*; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects*; D011446:Prospective Studies
D000903:Antibiotics, Antineoplastic; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin