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Cancer Therapy: Clinical

Phase II Study of Cediranib in Patients with Advanced Gastrointestinal Stromal Tumors or Soft-Tissue Sarcoma

Ian Judson, Michelle Scurr, Kate Gardner, Elizabeth Barquin, Marcelo Marotti, Barbara Collins, Helen Young, Juliane M. Jürgensmeier and Michael Leahy
Ian Judson
Authors' Affiliations: Royal Marsden Hospital, London; AstraZeneca, Macclesfield; and Christie Hospital NHS Foundation Trust, Manchester, United Kingdom
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Michelle Scurr
Authors' Affiliations: Royal Marsden Hospital, London; AstraZeneca, Macclesfield; and Christie Hospital NHS Foundation Trust, Manchester, United Kingdom
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Kate Gardner
Authors' Affiliations: Royal Marsden Hospital, London; AstraZeneca, Macclesfield; and Christie Hospital NHS Foundation Trust, Manchester, United Kingdom
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Elizabeth Barquin
Authors' Affiliations: Royal Marsden Hospital, London; AstraZeneca, Macclesfield; and Christie Hospital NHS Foundation Trust, Manchester, United Kingdom
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Marcelo Marotti
Authors' Affiliations: Royal Marsden Hospital, London; AstraZeneca, Macclesfield; and Christie Hospital NHS Foundation Trust, Manchester, United Kingdom
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Barbara Collins
Authors' Affiliations: Royal Marsden Hospital, London; AstraZeneca, Macclesfield; and Christie Hospital NHS Foundation Trust, Manchester, United Kingdom
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Helen Young
Authors' Affiliations: Royal Marsden Hospital, London; AstraZeneca, Macclesfield; and Christie Hospital NHS Foundation Trust, Manchester, United Kingdom
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Juliane M. Jürgensmeier
Authors' Affiliations: Royal Marsden Hospital, London; AstraZeneca, Macclesfield; and Christie Hospital NHS Foundation Trust, Manchester, United Kingdom
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Michael Leahy
Authors' Affiliations: Royal Marsden Hospital, London; AstraZeneca, Macclesfield; and Christie Hospital NHS Foundation Trust, Manchester, United Kingdom
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DOI: 10.1158/1078-0432.CCR-13-1881
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Abstract

Purpose: Cediranib is a potent VEGF signaling inhibitor with activity against all three VEGF receptors and KIT. This phase II study evaluated the antitumor activity of cediranib in patients with metastatic gastrointestinal stromal tumor (GIST) resistant/intolerant to imatinib, or metastatic soft-tissue sarcomas (STS; ClinicalTrials.gov, NCT00385203).

Experimental Design: Patients received cediranib 45 mg/day. Primary objective was to determine the antitumor activity of cediranib according to changes in 2[18F]fluoro-2-deoxy-D-glucose positron emission tomography (18FDG-PET) tumor uptake in patients with GIST using maximum standardized uptake values (SUVmax). Secondary objectives included objective tumor response and tolerability in patients with GIST/STS.

Results: Thirty-four of 36 enrolled patients were treated (GIST n = 24; STS n = 10). At day 29, five patients had confirmed decreases in SUVmax (≥10% from day 8) and two had confirmed partial metabolic responses (≥25% decrease), but arithmetic mean percentage changes in SUVmax, averaged across the cohort, were not significant at day 8 [6.8%; 95% confidence interval (CI), 19.95–33.54) or day 29 (4.6%; 95% CI, 8.05–17.34). Eleven patients with GIST achieved a best objective tumor response of stable disease; eight achieved stable disease ≥16 weeks. In patients with STS, four of six with alveolar soft-part sarcoma (ASPS) achieved confirmed and durable partial responses. The commonest adverse events were diarrhea (85%), fatigue (74%), and hypertension (68%).

Conclusions: In patients progressing on imatinib/sunitinib, cediranib 45 mg/day demonstrated evidence of activity by 18FDG-PET, but did not reduce average SUVmax. Evidence of antitumor activity was seen in ASPS. Clin Cancer Res; 1–10. ©2014 AACR.

Footnotes

  • Note: Supplementary data for this article are available at Clinical Cancer Research Online (http://clincancerres.aacrjournals.org/).

  • Received July 9, 2013.
  • Revision received March 21, 2014.
  • Accepted April 4, 2014.
  • ©2014 American Association for Cancer Research.
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Published OnlineFirst May 29, 2014
doi: 10.1158/1078-0432.CCR-13-1881

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Phase II Study of Cediranib in Patients with Advanced Gastrointestinal Stromal Tumors or Soft-Tissue Sarcoma
Ian Judson, Michelle Scurr, Kate Gardner, Elizabeth Barquin, Marcelo Marotti, Barbara Collins, Helen Young, Juliane M. Jürgensmeier and Michael Leahy
Clin Cancer Res May 29 2014 DOI: 10.1158/1078-0432.CCR-13-1881

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Phase II Study of Cediranib in Patients with Advanced Gastrointestinal Stromal Tumors or Soft-Tissue Sarcoma
Ian Judson, Michelle Scurr, Kate Gardner, Elizabeth Barquin, Marcelo Marotti, Barbara Collins, Helen Young, Juliane M. Jürgensmeier and Michael Leahy
Clin Cancer Res May 29 2014 DOI: 10.1158/1078-0432.CCR-13-1881
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Clinical Cancer Research
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