Table 2 Summary of individual AE models for the associations between adverse events and survival end points for mRCC patients receiving sunitinib

From: Sunitinib-associated hypertension and neutropenia as efficacy biomarkers in metastatic renal cell carcinoma patients

      

6-week landmark

 

12-week landmark

 

Efficacy end point

Median time to progression/survival event, months

P-value

Multivariate analysis,a HR (P-value)

Time-dependent covariate analysis, HR (P-value)

Median time to progression/survival event, months (n)

P-value

Median time to progression/survival event, months (n)

P-value

Hypertension during treatment ( Rini et al, 2011)

 

SBP⩾140 mm Hg (n=442)

SBP <140 mm Hg (n=92)

 

SBP⩾/<140 mm Hg

SBP⩾/<140 mm Hg

SBP⩾140 mm Hg

SBP <140 mm Hg

 

SBP⩾140 mm Hg

SBP <140 mm Hg

 

PFS

12.5

2.5

<0.001

0.241 (<0.001)

0.603 (<0.001)

13.4

10.8

0.031

13.6

10.8

0.015

OS

30.9

7.2

<0.001

0.284 (<0.001)

0.332 (<0.001)

32.2

20.3

<0.001

31.1

18.2

<0.001

Hand–foot syndrome during treatment

 

Yes (n=179)

No (n=591)

 

Yes/No

Yes/No

Yes

No

 

Yes

No

 

PFS

14.3

8.3

<0.0001

0.707 (0.001)

0.874 (0.211)

12.3

9.4

0.251

10.6

9.0

0.535

OS

38.2

18.9

<0.0001

0.519 (<0.001)

0.539 (<0.001)

43.8

21.6

0.007

37.4

20.3

<0.001

Asthenia/fatigue during treatment

 

Yes (n=583)

No (n=187)

 

Yes/no

Yes/no

Yes

No

 

Yes

No

 

PFS

10.9

6.4

<0.001

0.527 (<0.001)

0.941 (0.543)

9.6

9.3

0.197

9.2

8.4

0.821

OS

26.2

15.0

<0.001

0.634 (<0.001)

0.890 (0.296)

24.2

19.7

0.128

23.8

18.9

0.086

Neutropenia during treatment

 

Gr ⩾2 (n=366)

Gr <2 (n=404)

 

Gr ⩾/<2

Gr ⩾/<2

Gr ⩾2

Gr <2

 

Gr ⩾2

Gr <2

 

PFS

13.6

7.1

<0.0001

0.520 (<0.0001)

0.759 (0.0032)

9.7

9.4

0.615

11.0

8.0

0.005

OS

35.6

15.8

<0.0001

0.415 (<0.0001)

0.467 (<0.0001)

26.5

21.9

0.041

29.7

19.0

0.001

Thrombocytopenia during treatment

 

Gr ⩾2 (n=101)

Gr <2 (n=669)

 

Gr ⩾/<2

Gr ⩾/<2

Gr ⩾2

Gr <2

 

Gr ⩾2

Gr <2

 

PFS

13.7

8.8

0.001

0.658 (0.003)

0.767 (0.056)

12.4

9.4

0.224

11.1

8.5

0.395

OS

31.1

21.4

0.014

0.724 (0.038)

0.776 (0.088)

31.1

21.9

0.187

28.2

21.0

0.460

  1. Abbreviations: AE=adverse event; Gr=grade; HR=hazard ratio; mRCC=metastatic renal cell carcinoma; OS=overall survival; PFS=progression-free survival; SBP=systolic blood pressure.
  2. aThe multivariate analyses conducted for the individual AE models were similar to those conducted for the combined AE models; however, the covariates (i.e., prognostic factors) included in the full models differed as follows: the individual AE models included baseline vital characteristics (systolic blood pressure <140 vs ⩾140 mm Hg and diastolic blood pressure <90 vs ⩾90 mm Hg), whereas the combined AE models did not, and as outlined in Supplementary Tables 1 and 2, the combined AE models included prior nephrectomy, prior cytokine therapy, histology, baseline neutrophils, platelets, bone metastases, and any dose reduction during treatment, whereas the individual AE models did not; otherwise, all other covariates were the same in both models.
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