Efficacy of triplet regimen antiemetic therapy for chemotherapy-induced nausea and vomiting (CINV) in bone and soft tissue sarcoma patients receiving highly emetogenic chemotherapy, and an efficacy comparison of single-shot palonosetron and consecutive-day granisetron for CINV in a randomized, single-blinded crossover study

Cancer Med. 2015 Mar;4(3):333-41. doi: 10.1002/cam4.373. Epub 2014 Dec 23.

Abstract

The first aim of this study was to evaluate combination antiemetic therapy consisting of 5-HT3 receptor antagonists, neurokinin-1 receptor antagonists (NK-1RAs), and dexamethasone for multiple high emetogenic risk (HER) anticancer agents in bone and soft tissue sarcoma. The second aim was to compare the effectiveness of single-shot palonosetron and consecutive-day granisetron in a randomized, single-blinded crossover study. A single randomization method was used to assign eligible patients to the palonosetron or granisetron arm. Patients in the palonosetron arm received a palonosetron regimen during the first and third chemotherapy courses and a granisetron regimen during the second and fourth courses. All patients received NK-1RA and dexamethasone. Patients receiving the palonosetron regimen were administered 0.75 mg palonosetron on day 1, and patients receiving the granisetron regimen were administered 3 mg granisetron twice daily on days 1 through 5. All 24 patients in this study received at least 4 chemotherapy courses. A total of 96 courses of antiemetic therapy were evaluated. Overall, the complete response CR rate (no emetic episodes and no rescue medication use) was 34%, while the total control rate (a CR plus no nausea) was 7%. No significant differences were observed between single-shot palonosetron and consecutive-day granisetron. Antiemetic therapy with a 3-drug combination was not sufficient to control chemotherapy-induced nausea and vomiting (CINV) during chemotherapy with multiple HER agents for bone and soft tissue sarcoma. This study also demonstrated that consecutive-day granisetron was not inferior to single-shot palonosetron for treating CINV.

Keywords: Antiemetic therapy; bone and soft tissue sarcoma; chemotherapy-induced nausea and vomiting; crossover trial; granisetron; palonosetron.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antiemetics / administration & dosage
  • Antiemetics / therapeutic use*
  • Antineoplastic Agents / adverse effects
  • Aprepitant
  • Bone Neoplasms / drug therapy
  • Cross-Over Studies
  • Dexamethasone / administration & dosage
  • Dexamethasone / therapeutic use*
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Granisetron / administration & dosage
  • Granisetron / therapeutic use
  • Humans
  • Isoquinolines / administration & dosage
  • Isoquinolines / therapeutic use
  • Male
  • Middle Aged
  • Morpholines / administration & dosage
  • Morpholines / therapeutic use
  • Nausea / chemically induced
  • Nausea / drug therapy*
  • Neurokinin-1 Receptor Antagonists / administration & dosage
  • Neurokinin-1 Receptor Antagonists / therapeutic use*
  • Palonosetron
  • Quinuclidines / administration & dosage
  • Quinuclidines / therapeutic use
  • Sarcoma / drug therapy
  • Serotonin 5-HT3 Receptor Antagonists / administration & dosage
  • Serotonin 5-HT3 Receptor Antagonists / therapeutic use*
  • Treatment Outcome
  • Vomiting / chemically induced
  • Vomiting / drug therapy*
  • Young Adult

Substances

  • Antiemetics
  • Antineoplastic Agents
  • Isoquinolines
  • Morpholines
  • Neurokinin-1 Receptor Antagonists
  • Quinuclidines
  • Serotonin 5-HT3 Receptor Antagonists
  • Aprepitant
  • Palonosetron
  • Dexamethasone
  • Granisetron