Published

In the Phase 3 SPOTLIGHT and GLOW trials, mFOLFOX6 or CAPOX could be given the next day if zolbetuximab dosing was prolonged.

In SPOTLIGHT and GLOW, if zolbetuximab administration was not completed on the scheduled dosing day due to infusion interruptions or infusion rate reductions, the following guidance was provided in the clinical trial protocols:1

  • ≥ 75% of the zolbetuximab dose given: no additional zolbetuximab needed, mFOLFOX6 or CAPOX could be given the same day or next day.
  • < 75% and > 10% of the zolbetuximab dose given: a new infusion preparation equaling the remaining zolbetuximab dose prepared and administered the next day, followed by mFOLFOX6 or CAPOX.
  • ≤ 10% of the zolbetuximab dose given: a new infusion preparation equaling the full zolbetuximab dose prepared and administered next day, followed by mFOLFOX6 or CAPOX.

If the zolbetuximab infusion time exceeded the recommended storage time, the infusion bag was discarded and a new infusion bag was prepared to continue the infusion.1

Consensus Guidance and Recommendations2

  • An international RAND/UCLA Modified Delphi Panel was formed to determine consensus guidance for preventing and managing nausea and vomiting associated with zolbetuximab + chemotherapy.
  • Overall, the panel concluded zolbetuximab infusions can be slowed and completed within a maximum window of six hours; if the zolbetuximab infusion has been slowed to the point at which chemotherapy cannot be completed on the same day, chemotherapy can be provided the following day.
  • The panel advises against planning to stagger zolbetuximab and chemotherapy regimens (i.e. give them one day to one week apart), unless the patient has experienced repeated vomiting during prior zolbetuximab infusions, in which case it may be considered.

  1. Data on File.
  2. Klempner SJ, Pazo-Cid RA, Lonardi S, et al. Consensus guidance for prevention and management of nausea and vomiting in patients treated with zolbetuximab + chemotherapy: a RAND/UCLA modified Delphi panel study. ESMO Gastrointest. Oncol. 2025;7100131. Available at: https://doi.org/10.1016/j.esmogo.2024.100131.
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