Hilpert, F., Stahle, A., Tome, O., Burges, A., Rossner, D., Spatke, K., . . . du Bois, A. (2005). Neuroprotection with amifostine in the first-line treatment of advanced ovarian cancer with carboplatin/paclitaxel-based chemotherapy—A double-blind, placebo-controlled, randomized phase II study from the Arbeitsgemeinschaft Gynäkologische Onkologoie (AGO) Ovarian Cancer Study Group. Supportive Care in Cancer, 13, 797–805.

Women with ovarian cancer scheduled for treatment with carboplatin or paclitaxel-based chemotherapy were randomized to receive either IV premedication with amifostine 740 mg/m² or placebo for 30 minutes. Data were collected at baseline, after each cycle of chemotherapy, and at three and six months after completion of chemotherapy.

The sample consisted of 71 women with advanced ovarian cancer.

The study was a double-blind, randomized, placebo-controlled study.

• Measurements included vibration perception thresholds and vibration disappearance thresholds before cycle 4 and after the end of treatment. Secondary objectives were patella and Achilles tendon reflexes and two-point discrimination.
• Sensory symptoms, fine global motor activities, and quality of life were collected via questionnaire.
• Toxicity was reported according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE).

Thirty-seven women received amifostine and 34 received the placebo infusion. A significant protective effect of amifostine was found in vibration, two-point discrimination, and deep tendon reflexes. No significant differences were observed for single sensory or motor symptoms; however, amifostine improved sensory neuropathy according to the NCI-CTCAE criteria. Inconsistent results were reported in regard to quality of life.

• The study sample size may have been too small to detect group differences.
• Inconsistencies were present regarding the assessment of sensory neurotoxicity, the neurologic assessment of vibration thresholds, and quality of life.
• There were inter-observer variances with vibration sense measurement.