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Cancer. 2017 Jan 1;123(1):90-97. doi: 10.1002/cncr.30379. Epub 2016 Oct 3.

Phase 2 study of dasatinib in patients with alveolar soft part sarcoma, chondrosarcoma, chordoma, epithelioid sarcoma, or solitary fibrous tumor.

Author information

1
University of Michigan, Ann Arbor, Michigan.
2
Cancer Research and Biostatistics, Seattle, Washington.
3
Massachussetts General Hospital, Boston, Massachusetts.
4
Stanford University, Palo Alto, California.
5
University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
6
City of Hope Medical Center, Duarte, California.
7
The University of Texas MD Anderson Cancer Center, Houston, Texas.
8
Northwest Oncology, Post Falls, Idaho.
9
Fox Chase Cancer Center, Philadelphia, Pennsylvania.
10
Georgia Cancer Specialists, Sandy Springs, Georgia.
11
Nebraska Cancer Specialists, Omaha, Nebraska.
12
Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland.
13
Cedars-Sinai Medical Center, Los Angeles, California.
14
University of Iowa, Iowa City, Iowa.
15
Indiana University, Indianapolis, Indiana.
16
Sarcoma Alliance Through Research and Collaboration, Ann Arbor, Michigan.

Abstract

BACKGROUND:

Alveolar soft part sarcoma (ASPS), chondrosarcoma (CS), chordoma, epithelioid sarcoma, and solitary fibrous tumor (SFT) are malignant tumors that are relatively resistant to chemotherapy and for which more effective drug therapy is needed.

METHODS:

The 5 listed subtypes were enrolled into a single indolent sarcoma cohort in a phase 2 study of dasatinib using a Bayesian continuous monitoring rule for enrollment. The primary objective was to estimate the 6-month progression-free survival (PFS) rate according to the Choi criteria with a target of ≥50%. Cross-sectional imaging was performed before the start of treatment, every 2 months for 6 months, and then every 3 months during treatment. The 2- and 5-year survival rates were determined.

RESULTS:

One hundred sixteen patients were enrolled within 45 months, and 109 began treatment with dasatinib. The 6-month PFS rate and the median PFS were 48% and 5.8 months, respectively. The PFS rate at 6 months was highest with ASPS (62%) and lowest with SFT (30%). More than 10% of the patients with ASPS, CS, or chordoma had stable disease for more than 1 year. Collectively, for all 5 subtypes, the 2- and 5-year overall survival rates were 44% and 13%, respectively. An objective response was observed in 18% of the patients with CS or chordoma.

CONCLUSIONS:

Dasatinib failed to achieve control of sarcoma growth for at least 6 months in more than 50% of the patients in this trial according to the Choi tumor response criteria. An objective tumor response and prolonged stable disease was observed in >10% of patients with CS or chordoma. Cancer 2017;90-97. © 2016 American Cancer Society.

KEYWORDS:

Bayesian; Choi; chemotherapy; chondrosarcoma; chordoma; dasatinib; phase 2; sarcoma

PMID:
27696380
DOI:
10.1002/cncr.30379
[Indexed for MEDLINE]
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