A phase IB/IL study of gemcitabine and docetaxel in combination with pazopanib for the neoadjuvant treatment of soft tissue sarcomas

Rodrigo R. Munhoz, Sandra P. D’Angelo, Mrinal M. Gounder, Mary L. Keohan, Ping Chi, Richard D. Carvajal, Samuel Singer, Aimee M. Crago, Jonathan Landa, John H. Healey, Li Xuan Qin, Meera Hameed, Mariettao Ezeoke, Arun S. Singh, Mark Agulnik, Bartosz Chmielowski, Jason J. Luke, Brian A. Vantine, Gary K. Schwartz, William D. TapMark A. Dickson*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

20 Scopus citations

Abstract

Background. For extremity soft tissue sarcomas (STS), surgical resection remains the standard of care, and the addition of chemotherapy is controversial. This was a phase Ib/II trial of neoadjuvant therapy for patients with STS. Methods. Patients with high grade, extremity STS of >8cm and amenable to definitive resection were treated with up to four 21-day cycles of 900 mg/m2 gemcitabine on days 1 and 8, 75 mg/m2 docetaxel on day 8, and 400 mg of pazopanib daily (GDP), followed by surgery and, if indicated, radiation therapy. Primary and secondary endpoints (phase Ib portion) were the safety and rate of pathologic response. Results. The trial was discontinued because of slow accrual after inclusion of five patients (leiomyosarcoma: two; undifferentiated pleomorphic sarcoma: three). Two patients completed four treatment cycles: one underwent surgery and one had insufficient response and received additional therapies. Three patients discontinued treatment because of toxicity. Grade 3 adverse events included hypertension, fatigue, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation, hoarseness, and myelotoxicity. There were no complete or partial responses. One patient had $90% pathologic response. Among four patients who underwent resection, three remain free of disease, and one patient eventually relapsed. Conclusion. GDP combination used in the neoadjuvant setting resulted in significanttoxicity; despite pathologic responses, no objective responses occurred.

Original languageEnglish (US)
Pages (from-to)1245-1246
Number of pages2
JournalOncologist
Volume20
Issue number11
DOIs
StatePublished - Oct 8 2015

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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