- A phase 3 study involving >300 patients with lung cancer has demonstrated the efficacy of combination aprepitant, palonosetron, and dexamethasone in curbing chemotherapy-induced nausea and vomiting (CINV).
Why this matters
- Chemotherapy is a common treatment for lung cancer.
- The treatment can cause nausea and vomiting.
- The adverse effects can result in treatment discontinuation.
- Randomized, placebo-controlled study.
- 324 patients with locally advanced or metastatic lung cancer screened.
- Patients had received full-dose, single-day, cisplatin-based chemotherapy.
- 244 patients randomly assigned 1:1 to aprepitant+palonosetron+dexamethasone (n=122) or placebo+palonosetron+dexamethasone (n=122).
- Primary endpoint: complete response of nausea and vomiting in first cycle of treatment (2 cycles total).
- Secondary endpoints: prevalence of nausea and vomiting, rescue antiemetic medication, response of cross-over patients, safety.
- Cross-over allowed after cycle 2 of treatment for patients in placebo group.
- Significance at P<.05>
- Funded internally.
- Groups balanced at baseline
- Complete response in 92.6% and 79.5% of patients in the treatment and control groups, respectively (P<.01>
- Resolution of nausea in 75.4% and 71.3% of patients in the treatment and control groups, respectively (P>.05)
- Continued nausea and vomiting second cycle in the treatment group, at 37.5% and 25%, respectively; both were 100% in control (P<.05 for nausea and vomiting>
- Rescue medications were used for 14.7% and 36.1% of patients in the treatment and control groups, respectively (P<.001>
- Cross-over of 32 patients in the placebo group for rescue treatment for vomiting (n=16) or nausea (n=16)
- Study groups comparable for adverse events, including decreased appetite, fatigue, diarrhea, and abdominal pain
- "Aprepitant plus palonosetron and dexamethasone proved to be effective and well tolerated in preventing chemotherapy-induced nausea and vomiting after administration of full-dose, single-day cisplatin-based combination chemotherapy," said presenter Fang Wu, MS, Hunan Cancer Hospital, Xiangya School of Medicine, Changshu, China.