SUSTOL—proven 5-day prevention of CINV

SUSTOL was noninferior to palonosetron for control of acute and delayed CINV after MEC and AC-based HEC regimens
  • All patients were concomitantly administered intravenous dexamethasone.
  • As measured by the primary endpoint of complete response, SUSTOL was noninferior to palonosetron for control of acute and delayed CINV after MEC and AC-based HEC regimens1
  • Trial 1 did not show a significant difference in delayed phase CINV in HEC; however, there was a trend favoring SUSTOL1
  • Because a 2-drug study is not the current recommendation for CINV prevention in patients receiving HEC, as a next step, Heron conducted a 3-drug vs 3-drug superiority trial1
SUSTOL demonstrated full 5-day efficacy in the prevention of acute and delayed CINV1
The most common chemotherapy regimens were carboplatin-based regimens (n=235; 27%), AC-based chemotherapy (n=224; 26%), and cisplatin (n=106; 12%)
Due to the number of cisplatin-treated patients in SUSTOL Phase 3 clinical trials (n=358; 26% of HEC-treated patients), efficacy in this population has not been established. SUSTOL is not indicated in patients treated with cisplatin.2,3
Palonosetron is not approved for the treatment of delayed CINV due to HEC. The endpoint of superiority in the delayed phase following HEC was not achieved.1
  • The most common chemotherapy regimens were carboplatin-based regimens (n=235; 27%), AC-based chemotherapy (n=224; 26%), and cisplatin (n=106; 12%)
  • Complete response was defined as no emetic episodes, including retching, and no use of rescue medications3,5
AC=anthracycline/cyclophosphamide; CINV=chemotherapy-induced nausea and vomiting; HEC=highly emetogenic chemotherapy; IV=intravenous; MEC=moderately emetogenic chemotherapy; SC=subcutaneous.

References:

  1. SUSTOL [prescribing information]. Heron Therapeutics, Inc., 2017.
  2. Raftopoulos et al. Future Oncol. 2015.
  3. Data on File [C2006-01]. Heron Therapeutics, Inc.
  4. Raftopoulos et al. Support Care Cancer. 2015.
  5. Data on File [C2013-01]. Heron Therapeutics, Inc., San Diego, CA.
  6. Schnadig et al. Future Oncol. 2016.
  7. Zhou et al. Ther Clin Risk Manag. 2015.