Drake, R.D., Lin, W.M., King, M., Farrar, D., Miller, D.S., & Coleman, R.L. (2004). Oral dexamethasone attenuates Doxil®-induced palmar-plantar erythrodysesthesias in patients with recurrent gynecologic malignancies. Gynecologic Oncology, 94, 320–324.

To evaluate the effectiveness of oral dexamethasone in attenuating or eliminating ​palmar-plantar erythrodysesthesias (PPE) induced by pegylated liposomal doxorubicin (PLD) (Doxil^®) in patients with recurrent gynecologic malignancies.

Patients were initially treated with PLD without dexamethasone (median number of cycles = 5). Patients who experienced grade 2 to 4 PPE had treatment delayed until symptom resolution, and then were retreated without dose reduction.

Patients in group 1 received a tapering oral dexamethasone regimen (8 mg BID) starting one day before infusion for five days, 4 mg BID on day 6, and 4 mg on day 7.

In group 2, patients who were not receiving dexamethasone and experienced grade 2 to 4 PPE had a weekly dose delay for up to two weeks until symptom resolution. If resolution occurred within three weeks of the delay, a 25% dose reduction was made. Patients who had persistent grade 3 or 4 PPE had PLD withdrawn.

• The study reported on a sample of 23 patients with recurrent gynecologic malignancies who received PLD 50 mg/m² on a 28-day cycle from January 1998 to December 2000.
• Sixteen patients had ovarian cancer, and seven had uterine cancer.

University of Texas Southwestern Medical Center in Dallas

This was a prospective, observational trial.

National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) was used to assess PPE (grades 1–4).

• Nine patients (39%) who received more than five cycles of PLD (50 mg/m²) developed grade 2 to 4 PPE. Median time to PPE was three cycles, and drug treatment was withheld until PPE symptoms resolved.
• On restarting treatment, six of nine patients who developed PPE received a scheduled tapering dose of oral dexamethasone. All six had complete or near complete resolution of PPE, and all continued treatment without subsequent dose modification or delay for an average of seven cycles.
• In group 2, three of the nine patients with PPE who did not receive dexamethasone required treatment delays, and doses were reduced.

Oral dexamethasone appears to be effective in attenuating or eliminating PLD-induced PPE in patients with recurrent gynecologic malignancies.

The sample size was small.