PMID- 35849782
OWN - NLM
STAT- MEDLINE
DCOM- 20220721
LR  - 20220729
IS  - 0890-9091 (Print)
IS  - 0890-9091 (Linking)
VI  - 36
IP  - 7
DP  - 2022 Jul 11
TI  - A Pilot Study of Omalizumab to Treat Oxaliplatin-Induced Hypersensitivity 
      Reaction.
PG  - 414-419
LID - 10.46883/2022.25920965 [doi]
AB  - BACKGROUND: Oxaliplatin hypersensitivity reactions (HSRs) are immunoglobulin E 
      (IgE)-mediated and prevent maximum benefit from this drug. This study was 
      designed to determine whether oxaliplatin HSRs could be prevented or reduced with 
      omalizumab (Xolair), an anti-IgE antibody. PATIENTS/METHODS: This was a 
      single-arm prospective pilot study. Patients receiving oxaliplatin-based 
      chemotherapy for gastrointestinal cancers who were experiencing grade 1/2 HSRs 
      were eligible. Patients received omalizumab 300 mg subcutaneously every 2 weeks, 
      alternating with oxaliplatin-based chemotherapy. Nine patients enrolled. The 
      primary end point was reduction of repeat HSR over the next 2 cycles. The sample 
      size of 12 patients would achieve 79% power to detect a decrease from HSR rate of 
      70% (the null hypothesis) to 35% using a 1-sided binomial test. The study would 
      be considered positive if fewer than 6 HSR events over 2 cycles occurred on 
      omalizumab. RESULTS: Nine patients received 58 cycles of omalizumab. The mean 
      number of treatments was 6 (range, 1-12). Eight of 9 patients (88%) completed 2 
      or more cycles and 7 (78%) completed 4 or more cycles; the overall rate of HSR 
      was 12%. Five of 7 evaluable patients had stable disease, including 1 with near 
      partial response. CONCLUSIONS: Omalizumab reduces or abrogates oxaliplatin HSRs 
      and allows months of additional therapy with apparent clinical benefit.
FAU - Stein, Stacy
AU  - Stein S
FAU - Dooley, Kirsten
AU  - Dooley K
FAU - Ubohla, Nataliya V
AU  - Ubohla NV
FAU - Hochster, Howard S
AU  - Hochster HS
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Oncology (Williston Park)
JT  - Oncology (Williston Park, N.Y.)
JID - 8712059
RN  - 04ZR38536J (Oxaliplatin)
RN  - 2P471X1Z11 (Omalizumab)
SB  - IM
MH  - *Drug Hypersensitivity/drug therapy/etiology
MH  - Humans
MH  - *Omalizumab/therapeutic use
MH  - Oxaliplatin/adverse effects
MH  - Pilot Projects
MH  - Prospective Studies
OTO - NOTNLM
OT  - gastrointestinal malignancies
OT  - hypersensitivity reaction omalizumab Trial registration: Role of Omalizumab in 
      Reducing the Incidence of Oxaliplatin-induced Hypersensitivity Reaction 
      ClinicalTrials.gov Identifier: NCT02266355.
OT  - oxaliplatin
EDAT- 2022/07/19 06:00
MHDA- 2022/07/22 06:00
CRDT- 2022/07/18 15:41
PHST- 2022/07/18 15:41 [entrez]
PHST- 2022/07/19 06:00 [pubmed]
PHST- 2022/07/22 06:00 [medline]
AID - 25920965 [pii]
AID - 10.46883/2022.25920965 [doi]
PST - ppublish
SO  - Oncology (Williston Park). 2022 Jul 11;36(7):414-419. doi: 
      10.46883/2022.25920965.