A phase II trial of sunitinib (S) in previously-treated pancreas adenocarcinoma (PAC), CALGB 80603.

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2008 ASCO Annual Meeting

Abstract No: 4515 J Clin Oncol 26: 2008 (May 20 suppl; abstr 4515) Author(s):

E. M. O'Reilly, D. Niedzwiecki, D. R. Hollis, T. S. Bekaii-Saab, T.
Pluard, A. Duffy, F. Overcash, S. P. Ivy, R. M. Goldberg
S is an oral broad-spectrum tyrosine kinase (TK) inhibitor with
potential utility in PAC given the perturbation of multiple signaling
pathways and stromal alterations noted in PAC. CALGB conducted an
NCI-sponsored phase II study of S in patients (pts) with
previously-treated PAC.
Methods: Eligibility included: PAC
previously treated with front-line gemcitabine (gem) therapy, or
progression of disease (PD) during or within 3-months of completion of
adjuvant therapy, or newly metastatic disease following therapy for
locally advanced PAC; performance status 0-2; measurable disease by
RECIST; no prior anti-VEGF therapy; no evidence of duodenal invasion on
CT. S was dosed at 50 mg daily for 28 days followed by 14 days of rest
(1 cycle). Re-staging was performed after each of the first 4 cycles of
therapy. Study design: Single-arm, multi-center cooperative group,
3-stage design, with response criteria of at least stable disease (SD)
in 1/19, 2/39, for expansion. Planned accrual was 64. Primary endpoint:
Response rate (RECIST). Secondary endpoints: Duration of response,
toxicity, PFS, and survival.
Results: From 11/06 to 11/07, 77
pts were accrued with the criteria met for full accrual (1 withdrew
consent). Pt characteristics were: male 54%, female 46%, age: median 65
yrs, range 42- 87, and PS 0/1/2 45%/48%/7%. Prior therapy included: gem
61%, gem-based combination 37%, TK inhibitor 14%, radiation therapy
14%. Sites of disease were: liver 84%, lung 30%, other 19%. As of
12/07, 52 pts are evaluable for response. Response criteria for
continuation were met at the two interim analyses. SD occurred in 7 pts
[13%, 95% CI (3.6%, 22%)] and PD in 29 (56%). Number of cycles received
was: 1- 86%; 2- 12%, 3- 2%. Dose modification was needed in 21%. Median
PFS was 41 days (CI 37-57d), and median OS 97 days (CI 79-127d). Grade
3-5 toxicities included: hematologic 13% (G3), fatigue 12%, bleeding 6%
(G3), nausea 4% (G3), Thrombosis/embolism 2% (G3), TTP/renal failure
2%, GI perforation 2% (G5).
Conclusions: Preliminary analysis
of a large cooperative group phase II study of S in previously-treated
PAC suggests modest single agent activity and no new safety signals in
this patient population. Final results will be presented.