Efficacy and safety of apatinib monotherapy in advanced bone and soft tissue sarcoma: An observational study.

Abstract

Sarcomas are rare but malignant tumors with high risks of local recurrence and distant metastasis. Anti-angiogenic therapy is a potential strategy against un-controlled and not-organized tumor angiogenesis. We aimed to assess the safety and efficacy of apatinib, an oral tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2, in patients with advanced sarcoma. Thirty-one patients who received initial apatinib between September 2015 and August 2016 were retrospectively reviewed. Among them, 19 (61.3%) patients were heavily pretreated with two or more lines of cytotoxic chemotherapy. Apatinib was given at a start-dose of 425 mg qd. During therapy, 9 (29.0%) patients required dose interruption and 7 (22.6%) needed dose reduction, and the mean dosage of apatinib was 372.9 ± 68.4 mg/day. In the study cohort, one patient was treated as adjunctive therapy and 6 patients stopped treatment before radiographic response assessment. Thus, 24 patients were eligible for tumor response evaluation. The objective response rate was 33.3% and clinical benefit rate was as high as 75.0%. The progression free survival was 4.25 (95% confidence interval [CI], 2.22-5.11) months, whereas the overall survival was 9.43 (95% CI, 6.64-18.72) months. Compared with other histological subtypes, leiomyosarcoma did not show significant survival benefits. Most of the adverse events (AEs) were at grade 1 or 2. The main grade 3 AEs were hypertension (6.5%), hand foot skin reaction (6.5%), and diarrhea (3.2%). In conclusion, apatinib showed promising efficacy and acceptable safety profile in metastatic or recurrent sarcoma, giving rationale clinical evidence to conduct clinical trials.

• Authors: Baorang Zhu, Jing Li, Qiaosheng Xie, Liyan Diao, Lvhua Gai, Wuwei Yang
• Journal: Cancer biology & therapy (Cancer Biol Ther) Vol. 19 Issue 3 Pg. 198-204 (03 04 2018) ISSN: 1555-8576 [Electronic] United States
• PMID: 29261005 (Publication Type: Journal Article, Observational Study)

Chemical References

• Antineoplastic Agents
• Pyridines
• apatinib
• KDR protein, human
• Vascular Endothelial Growth Factor Receptor-2

Topics

• Adolescent
• Adult
• Aged
• Antineoplastic Agents (pharmacology, therapeutic use)
• Bone Neoplasms (diagnostic imaging, drug therapy, mortality, pathology)
• Child
• Child, Preschool
• Diarrhea (chemically induced, epidemiology)
• Female
• Hand-Foot Syndrome (epidemiology, etiology)
• Humans
• Hypertension (chemically induced, epidemiology)
• Kaplan-Meier Estimate
• Leiomyosarcoma (diagnostic imaging, drug therapy, mortality, pathology)
• Magnetic Resonance Imaging
• Male
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy, mortality, pathology)
• Osteosarcoma (drug therapy, mortality, pathology)
• Progression-Free Survival
• Pyridines (pharmacology, therapeutic use)
• Response Evaluation Criteria in Solid Tumors
• Retrospective Studies
• Tomography, X-Ray Computed
• Vascular Endothelial Growth Factor Receptor-2 (antagonists & inhibitors)
• Young Adult