Lorusso, D., Ferrandina, G., Greffi, S., Gadducci, A., Pignata, S., Tateo, S. … Scambia, G. (2003). Phase III multicenter randomized trial of amifostine as cytoprotectant in first-line chemotherapy in ovarian cancer patients. Annals of Oncology, 14, 1086–1093.

DOI Link

Intervention Characteristics/Basic Study Process

Patients receiving carboplatin (area under the curve [AUC] 5 mg per minute/ml) and 175 mg/m2 paclitaxel were randomly assigned to receive 910 mg/m2 IV amifostine 30 minutes prior to carboplatin.

Sample Characteristics

  • Patients were diagnosed with stage 2–4 ovarian cancer.
  • The study reported on a sample of 187 patients (93 in the amifostine group and 94 in the control group).

Setting

The study was conducted between April 1999 and July 2001.

Study Design

This was a phase III, multicenter, randomized trial.

Measurement Instruments/Methods

  • Grade 3-4 toxicity was reported.
  • The National Cancer Institute (NCI) Common Terminology Criteria (CTC) was used.

Results

A significant difference was found in grade 3-4 mucositis (4.7% in the amifostine group versus 15.4% in the control group, p < 0.0001).

Limitations

  • The study was not double blinded.
  • The authors did not indicate clearly how mucositis was measured.
  • The data in the article was not clear and specific.