Methylprednisolone in cis-platinum induced nausea and emesis: A placebo-controlled trial

Abstract

In a double-blind, placebo-controlled trial, the antiemetic efficacy of a total of 1–2 g methylprednisolone sodium succinate (MPSS) alone versus placebo was evaluated over the first three courses of chemotherapy in a group of 27 women receiving moderate to high-dose cis-platinum (50–118 mg/m2) for ovarian or cervical carcinomas. Antiemetic protection was classified as total (no emesis), major (one or two bouts), minor (three to five bouts), or minimal (six or more bouts). Total or major protection occurred in 1026 (38.5%) of the MPSS cycles and in 624 (25%) of the placebo cycles (NS). A significant number of placebo patients (714 placebo versus 113 MPSS, P = 0.02) dropped out of the study due to lack of efficacy. Patient evaluations completed 24 hr before and after each course of chemotherapy indicated no treatment effect on pain, appetite, nausea, drowsiness, anxiety, sense of well-being, or sleep. Physician and patient global evaluations of antiemetic efficacy favored treatment with MPSS. Evidence of the efficacy of single-drug MPSS antiemetic therapy during non-cis-platinum or low-dose cis-platinum (<50 mg/m2) chemotherapy can be found in the literature. The results of this study, however, do not support the use of MPSS alone with high-dose cis-platinum chemotherapy.