title: Phase 2 study of dasatinib in patients with alveolar soft part sarcoma, chondrosarcoma, chordoma, epithelioid sarcoma, or solitary fibrous tumor.
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.
authors.affiliation: University of Michigan, Ann Arbor, Michigan.
authors.forename: Scott M
authors.initials: SM
authors.lastname: Schuetze
authors.affiliation: Cancer Research and Biostatistics, Seattle, Washington.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Bolejack
authors.affiliation: Massachussetts General Hospital, Boston, Massachusetts.
authors.forename: Edwin
authors.initials: E
authors.lastname: Choy
authors.affiliation: Stanford University, Palo Alto, California.
authors.forename: Kristen N
authors.initials: KN
authors.lastname: Ganjoo
authors.affiliation: University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
authors.forename: Arthur P
authors.initials: AP
authors.lastname: Staddon
authors.affiliation: City of Hope Medical Center, Duarte, California.
authors.forename: Warren A
authors.initials: WA
authors.lastname: Chow
authors.affiliation: The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Hussein A
authors.initials: HA
authors.lastname: Tawbi
authors.affiliation: Northwest Oncology, Post Falls, Idaho.
authors.forename: Brian L
authors.initials: BL
authors.lastname: Samuels
authors.affiliation: The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Shreyaskumar R
authors.initials: SR
authors.lastname: Patel
authors.affiliation: Fox Chase Cancer Center, Philadelphia, Pennsylvania.
authors.forename: Margaret
authors.initials: M
authors.lastname: von Mehren
authors.affiliation: Georgia Cancer Specialists, Sandy Springs, Georgia.
authors.forename: Gina
authors.initials: G
authors.lastname: D'Amato
authors.affiliation: Nebraska Cancer Specialists, Omaha, Nebraska.
authors.forename: Kirsten M
authors.initials: KM
authors.lastname: Leu
authors.affiliation: Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland.
authors.forename: David M
authors.initials: DM
authors.lastname: Loeb
authors.affiliation: Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Charles A
authors.initials: CA
authors.lastname: Forscher
authors.affiliation: University of Iowa, Iowa City, Iowa.
authors.forename: Mohammed M
authors.initials: MM
authors.lastname: Milhem
authors.affiliation: Indiana University, Indianapolis, Indiana.
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Rushing
authors.affiliation: University of Michigan, Ann Arbor, Michigan.
authors.forename: David R
authors.initials: DR
authors.lastname: Lucas
authors.affiliation: University of Michigan, Ann Arbor, Michigan.
authors.forename: Rashmi
authors.initials: R
authors.lastname: Chugh
authors.affiliation: Sarcoma Alliance Through Research and Collaboration, Ann Arbor, Michigan.
authors.forename: Denise K
authors.initials: DK
authors.lastname: Reinke
authors.affiliation: University of Michigan, Ann Arbor, Michigan.
authors.forename: Laurence H
authors.initials: LH
authors.lastname: Baker
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001499:Bayes Theorem; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000401:mortality; D002813:Chondrosarcoma / Q000188:drug therapy* / Q000401:mortality; D002817:Chordoma / Q000188:drug therapy* / Q000401:mortality; D000069439:Dasatinib / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D018234:Sarcoma, Alveolar Soft Part / Q000188:drug therapy* / Q000401:mortality; D054364:Solitary Fibrous Tumors / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate; D055815:Young Adult
chemical_list: D000069439:Dasatinib
keywords: Bayesian; Choi; chemotherapy; chondrosarcoma; chordoma; dasatinib; phase 2; sarcoma