Moderate Colitis Not Requiring Intravenous Steroids Is Associated with Improved Survival in Stage IV Melanoma after Anti-CTLA4 Monotherapy, But Not Combination Therapy.

In the monotherapy group, 25 patients developed colitis and a nonsignificant trend toward improved OS was observed in this group.

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We also looked at whether the observed difference in OS could be explained by differences in completion of all four cycles of ipilimumab or in whether any ICI was resumed after colitis and found no significant difference between moderate and severe colitis ( Table 3 ); however, given that there was a trend toward significance for both of these factors we conducted a multivariable Cox proportional hazards analysis (MVA) with completion of all four cycles of ipilimumab, resumption of ICI after colitis and severity of colitis, and only colitis severity was shown to have a significant effect on OS (HR 7.58, P = .002).

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