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

Scott M. Schuetze, Vanessa Bolejack, Edwin Choy, Kristen N. Ganjoo, Arthur P. Staddon, Warren A. Chow, Hussein A. Tawbi, Brian L. Samuels, Shreyaskumar R. Patel, Margaret von Mehren, Gina D'Amato, Kirsten M. Leu, David M. Loeb, Charles A. Forscher, Mohammed M. Milhem, Daniel A. Rushing, David R. Lucas, Rashmi Chugh, Denise K. Reinke, Laurence H. Baker

Research output: Contribution to journalArticle

29 Citations (Scopus)

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.

Original languageEnglish (US)
JournalCancer
DOIs
StateAccepted/In press - 2016

Fingerprint

Alveolar Soft Part Sarcoma
Solitary Fibrous Tumors
Chordoma
Chondrosarcoma
Sarcoma
Survival Rate
Disease-Free Survival
Drug Therapy
Neoplasms
Therapeutics
Dasatinib
Growth

Keywords

  • Bayesian
  • Chemotherapy
  • Choi
  • Chondrosarcoma
  • Chordoma
  • Dasatinib
  • Phase 2
  • Sarcoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Schuetze, S. M., Bolejack, V., Choy, E., Ganjoo, K. N., Staddon, A. P., Chow, W. A., ... Baker, L. H. (Accepted/In press). Phase 2 study of dasatinib in patients with alveolar soft part sarcoma, chondrosarcoma, chordoma, epithelioid sarcoma, or solitary fibrous tumor. Cancer. https://doi.org/10.1002/cncr.30379

Phase 2 study of dasatinib in patients with alveolar soft part sarcoma, chondrosarcoma, chordoma, epithelioid sarcoma, or solitary fibrous tumor. / Schuetze, Scott M.; Bolejack, Vanessa; Choy, Edwin; Ganjoo, Kristen N.; Staddon, Arthur P.; Chow, Warren A.; Tawbi, Hussein A.; Samuels, Brian L.; Patel, Shreyaskumar R.; von Mehren, Margaret; D'Amato, Gina; Leu, Kirsten M.; Loeb, David M.; Forscher, Charles A.; Milhem, Mohammed M.; Rushing, Daniel A.; Lucas, David R.; Chugh, Rashmi; Reinke, Denise K.; Baker, Laurence H.

In: Cancer, 2016.

Research output: Contribution to journalArticle

Schuetze, SM, Bolejack, V, Choy, E, Ganjoo, KN, Staddon, AP, Chow, WA, Tawbi, HA, Samuels, BL, Patel, SR, von Mehren, M, D'Amato, G, Leu, KM, Loeb, DM, Forscher, CA, Milhem, MM, Rushing, DA, Lucas, DR, Chugh, R, Reinke, DK & Baker, LH 2016, 'Phase 2 study of dasatinib in patients with alveolar soft part sarcoma, chondrosarcoma, chordoma, epithelioid sarcoma, or solitary fibrous tumor', Cancer. https://doi.org/10.1002/cncr.30379
Schuetze, Scott M. ; Bolejack, Vanessa ; Choy, Edwin ; Ganjoo, Kristen N. ; Staddon, Arthur P. ; Chow, Warren A. ; Tawbi, Hussein A. ; Samuels, Brian L. ; Patel, Shreyaskumar R. ; von Mehren, Margaret ; D'Amato, Gina ; Leu, Kirsten M. ; Loeb, David M. ; Forscher, Charles A. ; Milhem, Mohammed M. ; Rushing, Daniel A. ; Lucas, David R. ; Chugh, Rashmi ; Reinke, Denise K. ; Baker, Laurence H. / Phase 2 study of dasatinib in patients with alveolar soft part sarcoma, chondrosarcoma, chordoma, epithelioid sarcoma, or solitary fibrous tumor. In: Cancer. 2016.
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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.",
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T1 - Phase 2 study of dasatinib in patients with alveolar soft part sarcoma, chondrosarcoma, chordoma, epithelioid sarcoma, or solitary fibrous tumor

AU - Schuetze, Scott M.

AU - Bolejack, Vanessa

AU - Choy, Edwin

AU - Ganjoo, Kristen N.

AU - Staddon, Arthur P.

AU - Chow, Warren A.

AU - Tawbi, Hussein A.

AU - Samuels, Brian L.

AU - Patel, Shreyaskumar R.

AU - von Mehren, Margaret

AU - D'Amato, Gina

AU - Leu, Kirsten M.

AU - Loeb, David M.

AU - Forscher, Charles A.

AU - Milhem, Mohammed M.

AU - Rushing, Daniel A.

AU - Lucas, David R.

AU - Chugh, Rashmi

AU - Reinke, Denise K.

AU - Baker, Laurence H.

PY - 2016

Y1 - 2016

N2 - 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.

AB - 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.

KW - Bayesian

KW - Chemotherapy

KW - Choi

KW - Chondrosarcoma

KW - Chordoma

KW - Dasatinib

KW - Phase 2

KW - Sarcoma

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U2 - 10.1002/cncr.30379

DO - 10.1002/cncr.30379

M3 - Article

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