A DGOG open-label multicenter phase II study of pazopanib in metastatic and locally advanced hormone-resistant endometrial cancer

Date

08 Oct 2016

Session

Gynaecological cancers

Presenters

L.E. Boom

Citation

Annals of Oncology (2016) 27 (6): 296-312. 10.1093/annonc/mdw374

Authors

L.E. Boom1, P.B. Ottevanger2, A. Reyners3, J.R. Kroep4, P. Witteveen5, R. Lalisang6, A.M. Westermann1

Author affiliations

  • 1 Medical Oncology F4-224, Academic Medical Center (AMC), 1105AZ - Amsterdam/NL
  • 2 Medical Oncology, Radboud University Medical Centre Nijmegen, 6500 HB - Nijmegen/NL
  • 3 Medical Oncology, University Hospital Groningen (UMCG), 9700 RB - Groningen/NL
  • 4 Medical Oncology, Leiden University Medical Center (LUMC), Leiden/NL
  • 5 Medical Oncology, University Medical Center Utrecht, 3584 CX - Utrecht/NL
  • 6 Medical Oncology, Maastricht University Medical Center (MUMC), Maastricht/NL
More

Resources

Background

There is a pressing need for second-line systemic treatment for metastatic, recurrent and/or locally advanced endometrial cancer (AEC) after hormonal therapy or chemotherapy. We studied the effect of the selective multi-targeted receptor tyrosine kinase inhibitor pazopanib on progression free survival (PFS) at three months for patients with AEC.

Methods

In this prospective phase II open label study, patients were recruited from six oncology departments in the Netherlands. Eligible patients had histologically or cytologically confirmed AEC, documented progressive disease and a WHO performance status of ≤ 2. All participants received treatment with pazopanib 800 mg once daily until progression, unacceptable toxicity or patient refusal. Dose reductions for toxicity were allowed. Patients were evaluable for the primary endpoint of PFS at three months if they had received pazopanib for at least four weeks. All participants were analysed for toxicity and overall survival (OS). The study was powered to demonstrate 50% PFS at 3 months (vs

Results

Between January 2011 and February 2016, 60 eligible patients were included. Median age was 68 years (range 53-85). Previous treatment included pelvic radiotherapy (58%), chemotherapy (90%) and hormonal therapy (43%). Forty-five out of sixty patients were treated for at least four weeks, and were thus evaluable for the primary endpoint. Twenty-six of the evaluable patients (58%) had no progression at three months, with median PFS and OS of 5.3 and 9.5 months, respectively. The most common severe adverse events were gastrointestinal toxicity in 21% of 60 participants, including 2 patients with a gut perforation, one fatal gastrointestinal hemorrhage, one enterocutaneous fistula and one fatal enterovaginal fistula. Peritoneal disease existed in 80% of patients with severe gastrointestinal toxicity. A definite correlation with previous radiotherapy could not be established.

Conclusions

Pazopanib showed encouraging 3 months PFS in AEC. There may be a correlation between previous treatments and/or disease site with rare but severe gastrointestinal toxicity that has yet to be elucidated.

Clinical trial identification

NTR3139 (Dutch Trial Register); Registration date 15-NOV-2011

Legal entity responsible for the study

Academic Medical Center Amsterdam for Dutch Gynaecologic Oncology Group

Funding

Dutch Gynaecologic Oncology Group and Novartis Oncology

Disclosure

All authors have declared no conflicts of interest.

Resources from the same session

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings