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Combined high dose radiation and pazopanib in metastatic renal cell carcinoma : a phase I dose escalation trial

Katrien De Wolf, Sylvie Rottey (UGent) , Karim Vermaelen (UGent) , Karel Decaestecker (UGent) , Nora Sundahl (UGent) , Lizzy De Lobel (UGent) , Els Goetghebeur (UGent) , Gert De Meerleer (UGent) , Nicolaas Lumen (UGent) , Valerie Fonteyne (UGent) , et al.
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Abstract
Background: The primary objective was to determine maximum tolerated radiation dose in patients with metastatic renal cell carcinoma on pazopanib treatment. Methods: Treatment-naive patients received pazopanib according to standard of care. Stereotactic body radiotherapy (SBRT) was delivered concurrently to the largest metastatic lesion at day 8, 10 and 12. SBRT doses were escalated in 3 dose levels (24 Gy/3, 30 Gy/3 and 36 Gy/3). Dose level was assigned using Time-to-Event Continual Reassessment Method with the target dose-limiting toxicity rate set to 0.25. Results: Thirteen patients were included. One patient experienced dose limiting toxicity (DLT) at dose level 3 (grade 4 hypoglycemia). Maximum tolerated dose was not reached with a recommended dose of 36 Gy/3 having a probability of DLT of 11%. One-year local control was 83% (95% confidence interval 61-100) and 1-year progression-free survival was 28% (95% confidence interval 1-55). Conclusions: SBRT in combination with pazopanib is well tolerated with good local control and response rates outside the radiation field. Trial registration: This trial was retrospectively registered on clinicaltrials. gov(NCT02334709) on January 6th, 2015.
Keywords
STEREOTACTIC BODY RADIOTHERAPY, T(H)17 CELLS, SBRT, OLIGOMETASTASES, RADIOSURGERY, INHIBITORS, THERAPIES, SUNITINIB, CRITERIA, CANCER, Tyrosine kinase inhibitors, Stereotactic body radiotherapy, Renal cell, carcinoma, Immune monitoring

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Chicago
De Wolf, Katrien, Sylvie Rottey, Karim Vermaelen, Karel Decaestecker, Nora Sundahl, Lizzy De Lobel, Els Goetghebeur, et al. 2017. “Combined High Dose Radiation and Pazopanib in Metastatic Renal Cell Carcinoma : a Phase I Dose Escalation Trial.” Radiation Oncology 12.
APA
De Wolf, Katrien, Rottey, S., Vermaelen, K., Decaestecker, K., Sundahl, N., De Lobel, L., Goetghebeur, E., et al. (2017). Combined high dose radiation and pazopanib in metastatic renal cell carcinoma : a phase I dose escalation trial. RADIATION ONCOLOGY, 12.
Vancouver
1.
De Wolf K, Rottey S, Vermaelen K, Decaestecker K, Sundahl N, De Lobel L, et al. Combined high dose radiation and pazopanib in metastatic renal cell carcinoma : a phase I dose escalation trial. RADIATION ONCOLOGY. 2017;12.
MLA
De Wolf, Katrien, Sylvie Rottey, Karim Vermaelen, et al. “Combined High Dose Radiation and Pazopanib in Metastatic Renal Cell Carcinoma : a Phase I Dose Escalation Trial.” RADIATION ONCOLOGY 12 (2017): n. pag. Print.
@article{8540477,
  abstract     = {Background: The primary objective was to determine maximum tolerated radiation dose in patients with metastatic renal cell carcinoma on pazopanib treatment. 
Methods: Treatment-naive patients received pazopanib according to standard of care. Stereotactic body radiotherapy (SBRT) was delivered concurrently to the largest metastatic lesion at day 8, 10 and 12. SBRT doses were escalated in 3 dose levels (24 Gy/3, 30 Gy/3 and 36 Gy/3). Dose level was assigned using Time-to-Event Continual Reassessment Method with the target dose-limiting toxicity rate set to 0.25. 
Results: Thirteen patients were included. One patient experienced dose limiting toxicity (DLT) at dose level 3 (grade 4 hypoglycemia). Maximum tolerated dose was not reached with a recommended dose of 36 Gy/3 having a probability of DLT of 11\%. One-year local control was 83\% (95\% confidence interval 61-100) and 1-year progression-free survival was 28\% (95\% confidence interval 1-55). 
Conclusions: SBRT in combination with pazopanib is well tolerated with good local control and response rates outside the radiation field. 
Trial registration: This trial was retrospectively registered on clinicaltrials. gov(NCT02334709) on January 6th, 2015.},
  articleno    = {157},
  author       = {De Wolf, Katrien and Rottey, Sylvie and Vermaelen, Karim and Decaestecker, Karel and Sundahl, Nora and De Lobel, Lizzy and Goetghebeur, Els and De Meerleer, Gert and Lumen, Nicolaas and Fonteyne, Valerie and De Maeseneer, Daan and Ost, Piet},
  issn         = {1748-717X},
  journal      = {RADIATION ONCOLOGY},
  keyword      = {STEREOTACTIC BODY RADIOTHERAPY,T(H)17 CELLS,SBRT,OLIGOMETASTASES,RADIOSURGERY,INHIBITORS,THERAPIES,SUNITINIB,CRITERIA,CANCER,Tyrosine kinase inhibitors,Stereotactic body radiotherapy,Renal cell,carcinoma,Immune monitoring},
  language     = {eng},
  pages        = {8},
  title        = {Combined high dose radiation and pazopanib in metastatic renal cell carcinoma : a phase I dose escalation trial},
  url          = {http://dx.doi.org/10.1186/s13014-017-0893},
  volume       = {12},
  year         = {2017},
}

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