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The DOI matches its Crossref record; 4 of the 4 references it cites were found in a registry or an index.

A Randomized, Double-Blind, Placebo-Controlled, Phase II Study Comparing the Tolerability and Efficacy of Ipilimumab Administered with or without Prophylactic Budesonide in Patients with Unresectable Stage III or IV Melanoma

Open access
Weber, Jeffrey, Thompson, John A., Hamid, Omid, Minor, David, Amin, Asim, Ron, Ilan, Ridolfi, Ruggero, Assi, Hazem, Maraveyas, Anthony, Berman, David, Siegel, Jonathan, O'Day, Steven J.·2009·Clinical Cancer Research
DOI 10.1158/1078-0432.ccr-09-1024
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Abstract

Purpose: Diarrhea (with or without colitis) is an immune-related adverse event (irAE) associated with ipilimumab. A randomized, double-blind, placebo-controlled, multicenter, multinational phase II trial was conducted to determine whether prophylactic budesonide (Entocort EC), a nonabsorbed oral steroid, reduced the rate of grade ≥2 diarrhea in ipilimumab-treated patients with advanced melanoma. Experimental Design: Previously treated and treatment-naïve patients (N = 115) with unresectable stage III or IV melanoma received open-label ipilimumab (10 mg/kg every 3 weeks for four doses) with daily blinded budesonide (group A) or placebo (group B) through week 16. The first scheduled tumor evaluation was at week 12; eligible patients received maintenance treatment starting at week 24. Diarrhea was assessed using Common Terminology Criteria for Adverse Events (CTCAE) 3.0. Patients kept a diary describing their bowel habits. Results: Budesonide did not affect the rate of grade ≥2 diarrhea, which occurred in 32.7% and 35.0% of patients in groups A and B, respectively. There were no bowel perforations or treatment-related deaths. Best overall response rates were 12.1% in group A and 15.8% in group B, with a median overall survival of 17.7 and 19.3 months, respectively. Within each group, the disease control rate was higher in patients with grade 3 to 4 irAEs than in patients with grade 0 to 2 irAEs, although many patients with grade 1 to 2 irAEs experienced clinical benefit. Novel patterns of response to ipilimumab were observed. Conclusions: Ipilimumab shows activity in advanced melanoma, with encouraging survival and manageable adverse events. Budesonide should not be used prophylactically for grade ≥2 diarrhea associated with ipilimumab therapy. (Clin Cancer Res 2009;15(17):5591–8)

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Metadata

Authors
Weber, J., Thompson, J. A., Hamid, O., Minor, D., Amin, A., Ron, I., Ridolfi, R., Assi, H., Maraveyas, A., Berman, D., Siegel, J., & O'Day, S. J.
Venue
Clinical Cancer Research
Publisher
American Association for Cancer Research (AACR)
Published
2009-08-31
Volume
15
Issue
17
Pages
5591-5598
ISSN
  • 1078-0432 (ISSN-L)
  • 1557-3265
DOI
10.1158/1078-0432.ccr-09-1024
OpenAlex
W2119198740
Cited by
568
References
4
FWCI
18.35
Type
journal article
Language
en
Open access
green

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