TY - JOUR
T1 - Phase II trial of concurrent sunitinib and image-guided radiotherapy for oligometastases
AU - Tong, Charles C.L.
AU - Ko, Eric C.
AU - Sung, Max W.
AU - Cesaretti, Jamie A.
AU - Stock, Richard G.
AU - Packer, Stuart H.
AU - Forsythe, Kevin
AU - Genden, Eric M.
AU - Schwartz, Myron
AU - Lau, K. H.Vincent
AU - Galsky, Matthew
AU - Ozao-Choy, Junko
AU - Chen, Shu hsia
AU - Kao, Johnny
N1 - Funding Information:
JK received the Pfizer investigator initiated award #2005-1082 and the Ellen Katz Foundation Award. MG served as an advisory board member for Pfizer. The authors have declared that no competing interests exist and adhere to all the PLoS ONE policies on sharing data and materials.
PY - 2012/6/27
Y1 - 2012/6/27
N2 - Background: Preclinical data suggest that sunitinib enhances the efficacy of radiotherapy. We tested the combination of sunitinib and hypofractionated image-guided radiotherapy (IGRT) in a cohort of patients with historically incurable distant metastases. Methods: Twenty five patients with oligometastases, defined as 1-5 sites of active disease on whole body imaging, were enrolled in a phase II trial from 2/08 to 9/10. The most common tumor types treated were head and neck, liver, lung, kidney and prostate cancers. Patients were treated with the recommended phase II dose of 37.5 mg daily sunitinib (days 1-28) and IGRT 50 Gy (days 8-12 and 15-19). Maintenance sunitinib was used in 33% of patients. Median follow up was 17.5 months (range, 0.7 to 37.4 months). Results: The 18-month local control, distant control, progression-free survival (PFS) and overall survival (OS) were 75%, 52%, 56% and 71%, respectively. At last follow-up, 11 (44%) patients were alive without evidence of disease, 7 (28%) were alive with distant metastases, 3 (12%) were dead from distant metastases, 3 (12%) were dead from comorbid illness, and 1 (4%) was dead from treatment-related toxicities. The incidence of acute grade ≥ 3 toxicities was 28%, most commonly myelosuppression, bleeding and abnormal liver function tests. Conclusions: Concurrent sunitinib and IGRT achieves major clinical responses in a subset of patients with oligometastases. Trial Registration: ClinicalTrials.gov NCT00463060.
AB - Background: Preclinical data suggest that sunitinib enhances the efficacy of radiotherapy. We tested the combination of sunitinib and hypofractionated image-guided radiotherapy (IGRT) in a cohort of patients with historically incurable distant metastases. Methods: Twenty five patients with oligometastases, defined as 1-5 sites of active disease on whole body imaging, were enrolled in a phase II trial from 2/08 to 9/10. The most common tumor types treated were head and neck, liver, lung, kidney and prostate cancers. Patients were treated with the recommended phase II dose of 37.5 mg daily sunitinib (days 1-28) and IGRT 50 Gy (days 8-12 and 15-19). Maintenance sunitinib was used in 33% of patients. Median follow up was 17.5 months (range, 0.7 to 37.4 months). Results: The 18-month local control, distant control, progression-free survival (PFS) and overall survival (OS) were 75%, 52%, 56% and 71%, respectively. At last follow-up, 11 (44%) patients were alive without evidence of disease, 7 (28%) were alive with distant metastases, 3 (12%) were dead from distant metastases, 3 (12%) were dead from comorbid illness, and 1 (4%) was dead from treatment-related toxicities. The incidence of acute grade ≥ 3 toxicities was 28%, most commonly myelosuppression, bleeding and abnormal liver function tests. Conclusions: Concurrent sunitinib and IGRT achieves major clinical responses in a subset of patients with oligometastases. Trial Registration: ClinicalTrials.gov NCT00463060.
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U2 - 10.1371/journal.pone.0036979
DO - 10.1371/journal.pone.0036979
M3 - Article
C2 - 22761653
AN - SCOPUS:84862997356
SN - 1932-6203
VL - 7
JO - PloS one
JF - PloS one
IS - 6
M1 - e36979
ER -
