Intravenous antiemetic combination is well tolerated

An intravenous combination of fosnetupitant and palonosetron is as well tolerated as is the oral combination for the management of chemotherapy-induced nausea and vomiting, according to a double-blind phase 3 study.

Researchers randomized 404 chemotherapy-naive patients undergoing highly emetogenic chemotherapy for solid tumors to receive a single intravenous dose of 235 mg fosnetupitant and 0.25 mg palonosetron (NEPA) 30 minutes before chemotherapy, or an oral formulation 60 minutes before chemotherapy, with matching placebos.

After a mean of 3.3 doses of intravenous formulation or 3.2 doses of oral formulation, there were similar numbers of treatment-emergent adverse events in the intravenous and oral groups (83.3% vs. 86.6%) but no serious treatment-related adverse events, the investigators wrote. The report was published in Annals of Oncology.

Nearly half of patients in both groups experienced severe adverse events over the course of the study, the most common being neutropenia, anemia, and leukopenia. The most common overall adverse events that occurred during the course of treatment were constipation and increased alanine aminotransferase.

There were very few infusion site treatment-emergent adverse events and none of these were judged to be related to the intravenous infusion of the drug combination.

“Infusion site reactions have been reported for fosaprepitant and IV rolapitant and the product labeling for both includes precaution/warning statements regarding the potential for hypersensitivity reactions/anaphylaxis; in addition, marketed distribution of IV rolapitant was recently suspended as a result of anaphylaxis/anaphylactic shock and hypersensitivity reactions reported in the post-marketing setting,” wrote Lee Schwartzberg, MD, of West Cancer Center, Germantown, Tenn., and his coauthors.

“In light of this, it is noteworthy that there were no injection site reactions considered to be related to IV NEPA over repeated cycles and no instance of anaphylaxis with either formulation of NEPA,” they wrote.

Overall, complete response rates for cycle 1 of treatment were 76.8% in the intravenous group and 84.1% in the oral treatment group, and no emesis rates were also similar (84.2% vs. 88.6%). However, the authors noted that the study was not powered to compare the efficacy of the two formulations.

Helsinn Healthcare sponsored the study and provided the drugs. Two authors were employees of the company, and four were consultants for the company. Two authors declared research support, advisory roles, and honoraria from pharmaceutical companies including Helsinn Healthcare. Three authors declared no conflicts of interest.

SOURCE: Schwartzberg L et al. Ann Oncol. 2018 May 10. doi: 10.1093/annonc/mdy169/4990798.

An intravenous combination of fosnetupitant and palonosetron is as well tolerated as is the oral combination for the management of chemotherapy-induced nausea and vomiting, according to a double-blind phase 3 study.

Researchers randomized 404 chemotherapy-naive patients undergoing highly emetogenic chemotherapy for solid tumors to receive a single intravenous dose of 235 mg fosnetupitant and 0.25 mg palonosetron (NEPA) 30 minutes before chemotherapy, or an oral formulation 60 minutes before chemotherapy, with matching placebos.

After a mean of 3.3 doses of intravenous formulation or 3.2 doses of oral formulation, there were similar numbers of treatment-emergent adverse events in the intravenous and oral groups (83.3% vs. 86.6%) but no serious treatment-related adverse events, the investigators wrote. The report was published in Annals of Oncology.

Nearly half of patients in both groups experienced severe adverse events over the course of the study, the most common being neutropenia, anemia, and leukopenia. The most common overall adverse events that occurred during the course of treatment were constipation and increased alanine aminotransferase.

There were very few infusion site treatment-emergent adverse events and none of these were judged to be related to the intravenous infusion of the drug combination.

“Infusion site reactions have been reported for fosaprepitant and IV rolapitant and the product labeling for both includes precaution/warning statements regarding the potential for hypersensitivity reactions/anaphylaxis; in addition, marketed distribution of IV rolapitant was recently suspended as a result of anaphylaxis/anaphylactic shock and hypersensitivity reactions reported in the post-marketing setting,” wrote Lee Schwartzberg, MD, of West Cancer Center, Germantown, Tenn., and his coauthors.

“In light of this, it is noteworthy that there were no injection site reactions considered to be related to IV NEPA over repeated cycles and no instance of anaphylaxis with either formulation of NEPA,” they wrote.

Overall, complete response rates for cycle 1 of treatment were 76.8% in the intravenous group and 84.1% in the oral treatment group, and no emesis rates were also similar (84.2% vs. 88.6%). However, the authors noted that the study was not powered to compare the efficacy of the two formulations.

Helsinn Healthcare sponsored the study and provided the drugs. Two authors were employees of the company, and four were consultants for the company. Two authors declared research support, advisory roles, and honoraria from pharmaceutical companies including Helsinn Healthcare. Three authors declared no conflicts of interest.

SOURCE: Schwartzberg L et al. Ann Oncol. 2018 May 10. doi: 10.1093/annonc/mdy169/4990798.

An intravenous combination of fosnetupitant and palonosetron is as well tolerated as is the oral combination for the management of chemotherapy-induced nausea and vomiting, according to a double-blind phase 3 study.

Researchers randomized 404 chemotherapy-naive patients undergoing highly emetogenic chemotherapy for solid tumors to receive a single intravenous dose of 235 mg fosnetupitant and 0.25 mg palonosetron (NEPA) 30 minutes before chemotherapy, or an oral formulation 60 minutes before chemotherapy, with matching placebos.

After a mean of 3.3 doses of intravenous formulation or 3.2 doses of oral formulation, there were similar numbers of treatment-emergent adverse events in the intravenous and oral groups (83.3% vs. 86.6%) but no serious treatment-related adverse events, the investigators wrote. The report was published in Annals of Oncology.

Nearly half of patients in both groups experienced severe adverse events over the course of the study, the most common being neutropenia, anemia, and leukopenia. The most common overall adverse events that occurred during the course of treatment were constipation and increased alanine aminotransferase.

There were very few infusion site treatment-emergent adverse events and none of these were judged to be related to the intravenous infusion of the drug combination.

“Infusion site reactions have been reported for fosaprepitant and IV rolapitant and the product labeling for both includes precaution/warning statements regarding the potential for hypersensitivity reactions/anaphylaxis; in addition, marketed distribution of IV rolapitant was recently suspended as a result of anaphylaxis/anaphylactic shock and hypersensitivity reactions reported in the post-marketing setting,” wrote Lee Schwartzberg, MD, of West Cancer Center, Germantown, Tenn., and his coauthors.

“In light of this, it is noteworthy that there were no injection site reactions considered to be related to IV NEPA over repeated cycles and no instance of anaphylaxis with either formulation of NEPA,” they wrote.

Overall, complete response rates for cycle 1 of treatment were 76.8% in the intravenous group and 84.1% in the oral treatment group, and no emesis rates were also similar (84.2% vs. 88.6%). However, the authors noted that the study was not powered to compare the efficacy of the two formulations.

Helsinn Healthcare sponsored the study and provided the drugs. Two authors were employees of the company, and four were consultants for the company. Two authors declared research support, advisory roles, and honoraria from pharmaceutical companies including Helsinn Healthcare. Three authors declared no conflicts of interest.

SOURCE: Schwartzberg L et al. Ann Oncol. 2018 May 10. doi: 10.1093/annonc/mdy169/4990798.