Skin toxic effects of polyethylene glycol-coated liposomal doxorubicin.
OBJECTIVE
To record the profile of toxic effects of polyethylene glycol-coated liposomal doxorubicin hydrochloride (Doxil) to the skin, and to evaluate whether the long circulation pattern and enhanced accumulation of liposomes in specific skin sites will result in any unique presentations.


METHODS
Patients were accrued in the frame of dose-range-finding studies that examine the toxic effects and antitumor activity of Doxil therapy in metastatic breast and prostate cancers. All patients receiving Doxil were instructed to report any skin eruption or discomfort. Skin examination was performed on a regular basis at every cycle of Doxil therapy and after specific complaints.


METHODS
Outpatient day care unit of the oncology institute of a secondary-referral medical center.


METHODS
Sixty patients (45 women and 15 men).


METHODS
A basic severity scale of I through IV was adopted for toxic effects to the skin, based on National Cancer Institute common toxicity criteria.


RESULTS
The following 4 patterns of skin eruptions were encountered: hand-foot syndrome (n = 24), diffuse follicular rash (n = 6), intertrigolike eruption (n = 5), and new formation of melanotic macules (n = 3). Another major toxic effect of Doxil was stomatitis, which was found to be the dose-limiting factor for the maximal single dose. Alopecia and extravasation injuries did not occur.


CONCLUSIONS
The profile of toxic effects of Doxil to the skin reflects its unique pharmacokinetics and tissue distribution. These skin reactions vary significantly from those associated with doxorubicin in non-liposome-encapsulated form.
Lotem
M
M
Sharett Institute of Oncology, Hadassah Hebrew University Medical Center, Kiryat Hadassah, PO Box 12000, Jerusalem 91120, Israel. lotem@isdn.net.il
Hubert
A
A
Lyass
O
O
Goldenhersh
M A
MA
Ingber
A
A
Peretz
T
T
Gabizon
A
A
D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects*; D016503:Drug Delivery Systems; D003875:Drug Eruptions / Q000209:etiology* / Q000473:pathology; D005076:Exanthema / Q000139:chemically induced* / Q000473:pathology; D005260:Female; D005528:Foot; D006225:Hand; D006801:Humans; D007262:Infusions, Intravenous; D008081:Liposomes; D008297:Male; D011092:Polyethylene Glycols; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D012720:Severity of Illness Index; D013280:Stomatitis / Q000209:etiology
D000970:Antineoplastic Agents; D008081:Liposomes; D011092:Polyethylene Glycols; D004317:Doxorubicin