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Clinical outcomes of patients with advanced gastrointestinal stromal tumors: safety and efficacy in a worldwide treatment-use trial of sunitinib.

Publication ,  Journal Article
Reichardt, P; Kang, Y-K; Rutkowski, P; Schuette, J; Rosen, LS; Seddon, B; Yalcin, S; Gelderblom, H; Williams, CC; Fumagalli, E; Biasco, G ...
Published in: Cancer
May 1, 2015

BACKGROUND: The objectives of this study were to provide sunitinib to patients with gastrointestinal stromal tumor (GIST) who were otherwise unable to obtain it and to collect broad safety and efficacy data from a large population of patients with advanced GIST after imatinib failure. (ClinicalTrials.gov identifier NCT00094029). METHODS: Imatinib-resistant/intolerant patients with advanced GIST received sunitinib on an initial dosing schedule of 50 mg daily in 6-week cycles (4 weeks on treatment, 2 weeks off treatment). Tumor assessment frequency was according to local practice, and response was assessed by investigators according to Response Evaluation Criteria in Solid Tumors version 1.0. Overall survival (OS) and safety were assessed regularly. Post hoc analyses evaluated different patterns of treatment management. RESULTS: At final data cutoff, 1124 patients comprised the intent-to-treat population, and 15% of these patients had a baseline Eastern Cooperative Oncology Group performance status ≥2. The median treatment duration was 7.0 months. The median time to tumor progression was 8.3 months (95% confidence interval [CI], 8.0-9.4 months), the median OS was 16.6 months (95% CI, 14.9-18.0 months), and 36% of patients were alive at the time of analysis. Patients for whom the initial dosing schedule was modified exhibited longer median OS (23.5 months) than those who were treated strictly according to the initial dosing schedule (11.1 months). The most common treatment-related grade 3 and 4 adverse events were hand-foot syndrome (11%), fatigue (9%), neutropenia (8%), hypertension (7%), and thrombocytopenia (6%). Treatment-related adverse events associated with cardiac function (eg, congestive heart failure and myocardial infarction) were reported at frequencies of ≤1% each. CONCLUSIONS: This treatment-use study confirms the long-term safety and efficacy of sunitinib in a large international population of patients with advanced GIST after imatinib failure.

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Published In

Cancer

DOI

EISSN

1097-0142

Publication Date

May 1, 2015

Volume

121

Issue

9

Start / End Page

1405 / 1413

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Sunitinib
  • Sarcoma
  • Pyrroles
  • Proportional Hazards Models
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
 

Citation

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Reichardt, P., Kang, Y.-K., Rutkowski, P., Schuette, J., Rosen, L. S., Seddon, B., … Demetri, G. D. (2015). Clinical outcomes of patients with advanced gastrointestinal stromal tumors: safety and efficacy in a worldwide treatment-use trial of sunitinib. Cancer, 121(9), 1405–1413. https://doi.org/10.1002/cncr.29220
Reichardt, Peter, Yoon-Koo Kang, Piotr Rutkowski, Jochen Schuette, Lee S. Rosen, Beatrice Seddon, Suayib Yalcin, et al. “Clinical outcomes of patients with advanced gastrointestinal stromal tumors: safety and efficacy in a worldwide treatment-use trial of sunitinib.Cancer 121, no. 9 (May 1, 2015): 1405–13. https://doi.org/10.1002/cncr.29220.
Reichardt P, Kang Y-K, Rutkowski P, Schuette J, Rosen LS, Seddon B, et al. Clinical outcomes of patients with advanced gastrointestinal stromal tumors: safety and efficacy in a worldwide treatment-use trial of sunitinib. Cancer. 2015 May 1;121(9):1405–13.
Reichardt, Peter, et al. “Clinical outcomes of patients with advanced gastrointestinal stromal tumors: safety and efficacy in a worldwide treatment-use trial of sunitinib.Cancer, vol. 121, no. 9, May 2015, pp. 1405–13. Pubmed, doi:10.1002/cncr.29220.
Reichardt P, Kang Y-K, Rutkowski P, Schuette J, Rosen LS, Seddon B, Yalcin S, Gelderblom H, Williams CC, Fumagalli E, Biasco G, Hurwitz HI, Kaiser PE, Fly K, Matczak E, Chen L, Lechuga MJ, Demetri GD. Clinical outcomes of patients with advanced gastrointestinal stromal tumors: safety and efficacy in a worldwide treatment-use trial of sunitinib. Cancer. 2015 May 1;121(9):1405–1413.
Journal cover image

Published In

Cancer

DOI

EISSN

1097-0142

Publication Date

May 1, 2015

Volume

121

Issue

9

Start / End Page

1405 / 1413

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Sunitinib
  • Sarcoma
  • Pyrroles
  • Proportional Hazards Models
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate