Neomycin

Neomycin

PEP Topic 
Chemotherapy-Induced Diarrhea
Description 

Neomycin is an aminoglycoside broad-spectrum antibiotic that is typically used as a topical treatment but also is available as an oral medication for use in reducing bacteria in the gastrointestinal tract. Neomycin has been evaluated for the management of chemotherapy-induced diarrhea.

Benefits Balanced With Harm

Research Evidence Summaries

De Jong, F.A., Kehrer, D.F., Mathijssen, R.H., Creemers, G.J., de Bruijn, P., van Schaik, R.H., … De Jong, M.J. (2006). Prophylaxis of irinotecan-induced diarrhea with neomycin and potential role for UGT1A1*28 genotype screening: A double-blind, randomized, placebo-controlled study. Oncologist, 11, 944–954.

doi: 10.1634/theoncologist.11-8-944
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Intervention Characteristics/Basic Study Process:

Patients were treated with 350 mg/m2 irinotecan during their first cycle of chemotherapy combined with 660 mg neomycin (n = 28; 45%) administered three times daily for three consecutive days starting two days before irinotecan or combined with placebo (n = 34; 55%). 

Sample Characteristics:

The two groups were balanced for demographic parameters, hematologic function, bilirubin, and liver enzyme values. The administered dose of irinotecan did not differ significantly between groups (mean dose of 640 mg versus 679 mg, p = 0.9).

Study Design:

This was a double-blind, randomized, placebo-controlled study.

Measurement Instruments/Methods:

  • The National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2, was used for diarrhea, nausea, and vomiting up to three weeks following administration of irinotecan. 
  • Duration of diarrhea (in days) was scored.

Results:

  • Overall incidence and severity of delayed-type diarrhea did not differ significantly between study groups (p = 0.33).
  • The neomycin group experienced a 45% lower incidence of grade 3 diarrhea compared to the placebo group (17.9% versus 32.4%; p = 0.19). However, no difference was found between study groups when combining grade 2 and 3 incidence (46.4% versus 50.0%; p = 0.78).
  • Treatment with neomycin did not result in significantly shorter duration of diarrhea (4.0 versus 4.9 days; p = 0.32).

Limitations:

  • Patients receiving neomycin had a 4.5 times higher risk for grade 2 nausea than those receiving placebo (39.9% versus 8.8%; p < 0.01). 
  • A larger trial is warranted.

Kehrer, D.F., Sparreboom, A., Verweij, J., de Bruijn, P., Nierop, C.A., van de Schraaf, J., … De Jonge, M.J. (2001). Modulation of irinotecan-induced diarrhea by cotreatment with neomycin in cancer patients. Clinical Cancer Research, 7(5), 1136–1141.

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Study Purpose:

To evaluate irinotecan disposition and pharmacodynamics in the presence and absence of the broad-spectrum antibiotic neomycin

Intervention Characteristics/Basic Study Process:

Patients experiencing grade 2 or higher diarrhea after receiving irinotecan alone (350 mg/m2 every 3 weeks) received the same dose combined with 1,000 mg oral neomycin three times per day continuously from 2 days prior to 5 days after the second course.

Sample Characteristics:

The study reported on 20 patients with advanced colorectal cancer receiving CPT-11 (350 mg/m2 every 3 weeks).

Study Design:

This was a nonrandomized trial. Patients acted as their own controls.

Measurement Instruments/Methods:

Presence of more than 4 stools per day and duration (measured in days) of diarrhea were recorded.

Results:

  • Nine patients developed grade 2 diarrhea in the first chemotherapy course and were then given neomycin as cotreatment in the second course of chemotherapy.
  • No significant effect was found on hematological toxicity (p > 0.05), but diarrhea improved in six out of seven patients (p = 0.033).

Conclusions:

Findings indicate that bacterial B-glucorinidase plays a crucial role in irinotecan-induced diarrhea without affecting enterocycling and systemic SN-38 levels.
 

Limitations:

This was an extremely small pilot study.


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