Openshaw, H., Beamon, K., Synold, T.W., Longmate, J., Slatkin, N.E., Doroshow, J.H., . . . Somlo, G. (2004). Neurophysiological study of peripheral neuropathy after high-dose paclitaxel: Lack of neuroprotective effect of amifostine. Clinical Cancer Research, 10, 461–467.

DOI Link

Intervention Characteristics/Basic Study Process

Women with breast cancer receiving high-dose infusional paclitaxel (725 mg/m2 for 24 hours) in combination with doxorubicin (165 mg/m2 for 96 hours) and cyclophosphamide (ACT) (100 mg/kg for two hours) were studied on two autologous peripheral blood stem cell transplant protocols—one with and one without amifostine (740 mg/m2 administered over 10 minutes before and 12 hours after initiation of the paclitaxel infusion).

Sample Characteristics

  • N = 31
  • KEY DISEASE CHARACTERISTICS: Women with high-risk breast cancer eligible to receive ACT with or without amifostine, and stable patients with stage IV breast cancer eligible to receive ACT with amifostine

Study Design

Women in each group were evaluated before ACT and 20–40 days later with neurologic examination, a composite peripheral neuropathy score, peroneal and sural nerve conduction studies, and quantitative sensory testing. The same technologist performed all nerve conduction studies.

Results

No significant effect was seen of amifostine on chemotherapy-induced peripheral neuropathy after high-dose paclitaxel in regard to nerve conduction parameters, quantitative sensory testing, or composite neuropathy scores.

Limitations

  • The study’s small sample size and lack of randomization to treatment with amifostine may bias results.