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Table 5 Effect of total-drug* exposure on antitumor activity

From: Sunitinib in combination with trastuzumab for the treatment of advanced breast cancer: activity and safety results from a phase II study

 

C3D1

C5D1

Efficacy parameter†

No. of evaluable patients

No. with parameter (%)

No. of evaluable patients

No. with parameter (%)

Objective response

 < Median trough concentation

14

4 (29)

9

3 (33)

 ≥ Median trough concentation

15

10 (67)

9

7 (78)

Stable disease

 < Median trough concentation

14

8 (57)

9

6 (67)

 ≥ Median trough concentation

15

3 (20)

9

2 (22)

Clinical benefit‡

 < Median trough concentation

14

11 (79)

9

9 (100)

 ≥ Median trough concentation

15

13 (87)

9

9 (100)

Median PFS (95% CI), months

 < Median trough concentation

14

6.6 (4.9–9.5)

9

7.2 (6.0–7.3)

 ≥ Median trough concentation

15

7.3 (6.4–10.2)§

9

9.5 (8.1–10.7)¶

  1. Abbreviations: C cycle, D day, PFS progression-free survival.
  2. *Sunitinib + SU12662.
  3. †By trough concentration of total drug on C3D1 or C5D1 as indicated.
  4. ‡Patients with objective responses or stable disease ≥ 12 weeks.
  5. §Log-rank p = 0.879.
  6. ¶Log-rank p = 0.013.
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BMC Cancer

ISSN: 1471-2407

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