Sharma Ricky A, Decatris Marios P, Santhanam Sundar, Roy Rajarshi, Osman Ahmed E, Clarke Christine B, Khanna Subhash, O'Byrne Kenneth J
Department of Oncology, Leicester Royal Infirmary, University Hospitals of Leicester, Leicester, LE1 5WW, UK.
Cancer Chemother Pharmacol. 2003 Nov;52(5):367-70. doi: 10.1007/s00280-003-0679-8. Epub 2003 Jul 18.
The development of liver metastases from breast cancer is associated with a very poor prognosis, estimated at 4 months median survival. Since treatment with many chemotherapeutic agents is relatively contraindicated, we assessed the safety, tolerability and potential efficacy of combination chemotherapy with vinorelbine and cisplatin (ViP).
Pilot study in 11 patients with histologically confirmed breast carcinoma, radiological evidence of liver metastases and serum bilirubin greater than 1.5 times the upper limit of normal. Patients received up to six cycles of cisplatin (75 mg/m2) every 21 days and vinorelbine (20 mg/m2) on days 1 and 8 of every 21-day cycle. Measurement of liver lesions was performed on CT scan every 8 weeks into treatment.
The most frequently reported adverse event was myelosuppression. Other adverse effects included nausea, vomiting and mild neurotoxicity. Two patients died after one treatment with ViP, one of whom suffered an intracerebral haemorrhage that was possibly treatment-related. Improvement in liver function tests was observed in 10 patients, and mean time to normalization of bilirubin levels was 36 days. Partial responses were documented radiologically in 7 out of 11 patients treated. Median overall survival from trial entry was 6.5 months (range 11-364 days), with one patient alive 13 months from trial entry.
Normalization of liver function is possible with ViP treatment of metastatic breast cancer, offering the potential to prolong survival. Phase II clinical trials of this regimen in this patient group should include measurement of quality of life in order to assess risk versus benefit.
乳腺癌肝转移的发生与预后极差相关，中位生存期估计为4个月。由于使用多种化疗药物相对禁忌，我们评估了长春瑞滨和顺铂联合化疗（ViP）的安全性、耐受性及潜在疗效。
对11例经组织学确诊为乳腺癌、有肝转移影像学证据且血清胆红素高于正常上限1.5倍的患者进行了初步研究。患者每21天接受多达6个周期的顺铂（75mg/m²）治疗，并在每21天周期的第1天和第8天接受长春瑞滨（20mg/m²）治疗。治疗期间每8周进行一次肝脏病变的CT扫描测量。
最常报告的不良事件是骨髓抑制。其他不良反应包括恶心、呕吐和轻度神经毒性。2例患者在接受一次ViP治疗后死亡，其中1例发生脑出血，可能与治疗有关。10例患者肝功能检查有所改善，胆红素水平恢复正常的平均时间为36天。在接受治疗的11例患者中，有7例经影像学检查记录有部分缓解。从试验入组开始的中位总生存期为6.5个月（范围11 - 364天），1例患者从试验入组起存活了13个月。
ViP治疗转移性乳腺癌可使肝功能恢复正常，有可能延长生存期。该方案在该患者群体中的II期临床试验应包括生活质量测量，以评估风险与获益情况。
