Treatment of palmar-plantar erythrodysesthesia (PPE) with topical sildenafil: a pilot study.

Journal Article (Journal Article)

PURPOSE: Palmar-plantar erythrodysesthesia (PPE) is a common chemotherapy and anti-VEGF multi-kinase inhibitor class-related toxicity that often results in debilitating skin changes and often limits the use of active anti-cancer regimens. Mechanistic and anecdotal clinical evidence suggested that topical application of sildenafil cream may help reduce the severity of PPE. Therefore, we conducted a randomized, double-blind, placebo-controlled pilot study to evaluate the feasibility, safety and efficacy of topical sildenafil cream for the treatment of PPE. METHODS: Eligible subjects were required to have grade 1-3 PPE associated with either capecitabine or sunitinib. Subjects were randomized to receive 1 % topical sildenafil cream to the left extremities or right extremities and placebo cream on the opposite extremity. Two times per day, 0.5 mL of cream was applied to each affected hand/foot. The primary endpoint was improvement in PPE grading at any point on study. Clinical assessments were evaluated by NCI-CTC 4.0 grading and patient self-reported pain. RESULTS: Ten subjects were enrolled, nine were evaluable for safety and efficacy. Five of nine subjects reported some improvement in foot pain and three of eight subjects for hand pain improvement. One of these subjects noted specific improvement in tactile function. No treatment-related toxicities were observed. CONCLUSIONS: In this limited, single-center study, topical cream containing 1 % sildenafil is feasible to administer, is well-tolerated, and may mitigate PPE-related symptoms due to anti-cancer therapeutic agents. Further validation is necessary.

Full Text

Duke Authors

Cited Authors

  • Meadows, KL; Rushing, C; Honeycutt, W; Latta, K; Howard, L; Arrowood, CA; Niedzwiecki, D; Hurwitz, HI

Published Date

  • May 2015

Published In

Volume / Issue

  • 23 / 5

Start / End Page

  • 1311 - 1319

PubMed ID

  • 25341548

Pubmed Central ID

  • PMC4973630

Electronic International Standard Serial Number (EISSN)

  • 1433-7339

Digital Object Identifier (DOI)

  • 10.1007/s00520-014-2465-z


  • eng

Conference Location

  • Germany