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Hu X.,Fudan University | Zhang J.,Fudan University | Xu B.,Chinese Academy of Sciences | Jiang Z.,Affiliated Hospital of Academy of Military Medical science | And 13 more authors.
International Journal of Cancer | Year: 2014

Apatinib is an oral, highly potent tyrosine-kinase inhibitor targeting VEGFR2. Phase I study showed the recommended dose of 750 mg/day with substantial antitumor activity. This phase II study aims to evaluate the optimum dose level for the efficacy and safety of apatinib monotherapy in heavily pretreated patients with metastatic triple negative breast cancer (mTNBC) in China. Phase IIa was first performed among 25 patients previously treated with anthracycline and/or taxane. All patients received apatinib 750 mg/day p.o. in a 4-week cycle. Subsequently, a phase IIb study of 59 patients was activated, with the endpoint progression-free survival (PFS). The dosage of drug for the Phase IIb was determined according to safety, tolerability and efficacy from the phase IIa study. As a result of toxicity associated with the 750 mg dose in phase IIa, the recommended initial dose of apatinib in the phase IIb was 500 mg/day. In phase IIb, grade 3/4 hematologic toxicities were thrombocytopenia (13.6%), leukopenia (6.8%), neutropenia (3.4%) and anemia (1.7%). The most frequent grade 3/4 nonhematologic toxicities were hand-foot syndrome, proteinuria, hypertension, and increased ALT. In the 56 evaluable patients, overall response rate and clinical benefit rate (CBR) were 10.7 and 25.0%, respectively. Median PFS and overall survival were 3.3 (95% CI 1.7-5.0) and 10.6 (95% CI 5.6-15.7) months, respectively. Our results indicate that apatinib dose of 500 mg rather than 750 mg is the recommended starting dose for the heavily pretreated mTNBC patients with measurable rate of partial response and PFS. © 2014 UICC.


Wang W.,Foshan No 1 Peoples Hospital | Feng F.,Foshan No 1 Peoples Hospital | Zhao L.,Foshan No 1 Peoples Hospital | Lin X.,Foshan No 1 Peoples Hospital
Chinese Journal of Clinical Oncology | Year: 2013

Objective: The clinical features, risk factors, and outcomes of coma were analyzed in patients treated with bevacizumab combined with chemotherapy This study also aims to increase the awareness on the toxicity of this regimen. Methods: Two cases of coma induced by bevacizumab combined with chemotherapy were reported. Diagnosis, treatment, and relevant literature were reviewed and discussed. Results: Inadequate blood pressure (BP) control was one of the risk factors leading to coma in patients treated with this therapy. The clinical feature of these patients was reversible posterior leukoencephalopathy syndrome (RLPS). Imaging results showed no typical finding. Reinforced supportive treatment including intensive BP control showed satisfactory outcomes. Conclusion: Coma is common in patients treated with bevacizumab combined with chemotherapy. This regimen should be used cautiously in patients with a history of hypertension. BP should be monitored closely and managed promptly during the combination therapy to prevent coma. RLPS-related coma is reversible after appropriate treatment.

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