Table 4.

Impact of serum cholesterol, triglyceride, and glucose levels on treatment effects for PFS and OS

PFSOS
Treatment (temsirolimus vs. IFN)HRa (95% CI)PHRa (95% CI)P
Unadjusted analysis0.70 (0.58–0.86)0.0010.76 (0.60–0.95)0.02
Adjusted for on-study change and baseline cholesterol only0.88 (0.67–1.15)0.351.14 (0.85–1.53)0.37
Adjusted for on-study change and baseline cholesterol and other baseline factorsb0.86 (0.65–1.16)0.331.11 (0.81–1.52)0.51
Adjusted on-study change and baseline triglyceride only0.73 (0.60–0.90)0.0030.80 (0.64–1.02)0.07
Adjusted on-study change and baseline triglyceride and other baseline factorsb0.68 (0.54–0.85)0.0010.79 (0.61–1.03)0.08
Adjusted for on-study change and baseline glucose only0.71 (0.57–0.88)0.0020.83 (0.65–1.06)0.13
Adjusted for on-study change and baseline glucose and other baseline factorsb0.63 (0.50–0.80)<0.00010.78 (0.60–1.02)0.07
  • aHR is for comparison of treatment of temsirolimus versus IFN.

  • bAnalysis unadjusted (univariate) or adjusted (multivariate) for baseline and on-study change in marker level. Other baseline factors refer to trial prespecified factors: age; sex; geographic region; nephrectomy status; tumor histologic type; time from metastasis to randomization; Karnofsky performance score; and levels of hemoglobin, serum lactate dehydrogenase, and corrected serum calcium.