Tanyi, J.L., Smith, J.A., Ramos, L., Parker, C.L., Munsell, M.F., & Wolf, J.K. (2009). Predisposing risk factors for palmar-plantar erythrodysesthesia when using liposomal doxorubicin to treat recurrent ovarian cancer. Gynecologic Oncology, 114, 219–224.

DOI Link

Study Purpose

To evaluate the efficacy and safety profile of pegylated liposomal doxorubicin (PLD) (Doxil®) at different doses, as well as predictive factors of palmar-plantar erythrodysesthesia (PPE).

Intervention Characteristics/Basic Study Process

The regional cooling mechanism comprised application of ice packs to the wrists and ankles during PLD administration.

Sample Characteristics

  • The study reported on a sample of 330 women who received PLD as treatment for recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinomas.
  • Median patient age was 60 years.

Setting

University of Texas MD Anderson Cancer Center in Houston

Study Design

This was a retrospective chart review.

Measurement Instruments/Methods

National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE); version not specified

Results

  • The proportion of patients with PPE was significantly higher among those who used a cooling mechanism compared to those who did not (39% versus 26%, p = 0.0067).
  • Median overall survival and median progression-free survival did not differ between patients who received different doses of PLD.

Conclusions

Higher doses and additional cycles of PLD were associated with a higher incidence of adverse reactions, including PPE. Potential predictors of PPE were use of cooling mechanisms, higher numbers of PLD cycles given, occurrence of mucositis, neutropenia, and peripheral neuropathy.

Limitations

This was a retrospective study only.