The American Society of Clinical Oncology (ASCO) updated their antiemetic guideline to include the use of a novel antiemetic combination for cancer patients.
The American Society of Clinical Oncology (ASCO) has updated their antiemetic guideline to include the use of a novel antiemetic combination for cancer patients. The update was published in the Journal of Clinical Oncology.
Based on results of a phase III clinical trial, the guideline authors now recommend the use of the oral combination of the neurokinin 1 (NK1) receptor antagonist netupitant, the 5-hydroxytryptamine-3 (5-HT3) receptor antagonist palonosetron, and dexamethasone to prevent acute and delayed nausea and vomiting for patients being treated with highly emetogenic chemotherapy regimens.
This combination is one such option according to the guideline. The combination of netupitant and palonosetron (NEPA) was approved by the US Food and Drug Administration in October 2014 for use as an antiemetic during initial and subsequent chemotherapy cycles.
Two phase III clinical trials and one phase II trial provided the evidence for the addition of the triple combination to the guideline.
In a phase III trial of 1,449 patients, NEPA was associated with higher rates of no emesis or need for rescue medication-defined as a complete response-compared with palonosetron alone in patients treated with anthracycline plus cyclophosphamide chemotherapy. The complete response rates were 74% in the NEPA arm vs 67% in the control arm (P = .001).
A separate phase III trial demonstrated that the combination was safe and decreased vomiting and nausea in patients treated with moderately or highly emetogenic chemotherapy across multiple cycles of treatment. Treatment-emergent adverse events-most of which were mild or moderate-occurred in 86% of patients in the NEPA arm and 91.3% of patients in the second trial arm of aprepitant plus palonosetron.
A phase II dose-ranging trial enrolled 694 chemotherapy-naÃ¯ve patients with solid tumors who were receiving cisplatin-based chemotherapy. At the highest dose, patients in the NEPA arm had a statistically significantly higher rate of complete responses-defined as no emesis or rescue therapeutics-compared with patients in the palonosetron alone arm for both acute and delayed phases. Each additionally tested dose of NEPA resulted in a higher overall complete response rate compared with palonosetron alone.
Palonosetron is the preferred 5-HT3 receptor antagonist for patients undergoing moderately emetogenic chemotherapy regimens according to the guideline.
“All patients who receive highly emetogenic chemotherapy regimens should be offered a three-drug combination of an NK1 receptor antagonist, a 5-HT3 receptor antagonist, and dexamethasone,” concluded Mark G. Kris, MD, a medical oncologist who specializes in lung cancer at Memorial Sloan Kettering Cancer Center in New York, and coauthors.
The other recommendations from the 2011 update were not changed.