Apatinib alone or combined with radiotherapy in metastatic prostate cancer: Results from a pilot, multicenter study
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Feng Zhao1,2, Wei Tian3,4, Ming Zeng2,4, Jianling Xia2, Honglin Hu2, Xinbao Hao5, Liangfu Han6, Hao Liu2, Yangke He2, Xueqiang Zhu2, Liang Liang2, Rui Ao2, Min Wei7, Lili Deng8 and Yuquan Wei1
1State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University, and Collaborative Innovation Center for Biotherapy, Chengdu, Sichuan, PR China
2Cancer Center Hospital of University of Electronic Science and Technology of China and Sichuan Provincial People’s Hospital, Chengdu, Sichuan, PR China
3Operations Management Department, Hospital of University of Electronic Science and Technology of China and Sichuan Provincial People’s Hospital, Chengdu, Sichuan, PR China
4School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan, PR China
5Sino-America Cancer Center, Hainan Medial University, Haikou, Hainan, PR China
6Department of Radiation Oncology, ChangAn Hospital, Xi’an, Shanxi, PR China
7Ziyang People’s Hospital, Sichuan, Ziyang, Sichuan, PR China
8Sichuan Friendship Hospital, Chengdu, Sichuan, PR China
Ming Zeng, email: firstname.lastname@example.org
Keywords: apatinib; radiotherapy; metastatic prostate cancer; adverse events; PSA
Received: March 01, 2017 Accepted: October 13, 2017 Published: November 28, 2017
Background: To study safety and efficacy of apatinib in combination of radiotherapy in patients with symptomatic bony disease prostate cancer(SBPC), based on the potential synergistic antitumor activity between apatinib and Radiation Therapy (RT).
Patients and methods: In phase I dose escalation part, 18 patients received apatinib dose at 250 mg every other day, 250 mg daily and 500 mg daily. In phase II part, the 250 mg daily cohorts were expanded to 20 patients in combination of RT (6 Gy/fraction, 5 fraction in total), one patient lost followed up and excluded the study, comparing with RT alone cohort with 10 patients, ratio of RT to RT + apatinib was 1 to 2. Evaluations included adverse events (AEs), prostate specific antigen (PSA) changes, radiographic evaluation and pain relief.
Results: In phase I study, common apatinib-related AEs (arAEs) were fatigue, anorexia, hand foot syndrome, proteinuria, and hypertension (HTN). Grade 3arAEs included HTN, proteinuria, liver dysfunction. In phase II study, combination apatinib with RT cohorts, AEs events increased comparing with either apatinib alone or RT alone; at the same time, combination cohorts showed PSA declines of ≥50% in 12 patients, and stable disease in 6 patients. Combination cohorts had pain control significantly improved in both level and duration comparing with RT alone.
Conclusions: In SBPC patients, apatinib at less than 500 mg daily dose as mono-therapy had tolerable toxicity. Apatinib at dose of 250 mg daily in combining with RT synergized pain control, the overall AEs were manageable. Further studies are needed in large sample size future trials.
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