优化卵巢癌Ⅰ期临床研究管理中国专家经验
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摘要
卵巢癌是中国妇科恶性肿瘤主要的死亡原因之一。随着国际上抗肿瘤治疗的迅速发展,国内的抗肿瘤新药也不断涌现,高效地开展相关临床研究将为患者带来极大的获益。基于中国尼拉帕尼的卵巢癌Ⅰ期临床研究(编号为ZL-2306-002),中国专家从患者知情同意、入排审核、临床用药随访、数据管理、不良反应处理和患者关爱等维度进行了总结和讨论,并对国内开展的卵巢癌Ⅰ期临床研究进行了分析,旨在为国内抗肿瘤新药临床研究的开展提供参考与经验。
Ovarian cancer is one of the main causes of death among gynecological malignancies in China. With the rapid development of antineoplastic therapies worldwide, new drugs are emerging one afrer another in China. Carrying out the relevant clinical studies scientifically and efficiently will bring great benefits to the patients. Based on the stage Ⅰ clinical study of niraparib in China(No. ZL-2306-002), Chinese experts summarized and discussed it from the perspectives of getting informed consent, auditing patient recruitment, follow-up of clinical medication, data management, adverse reaction management and patient care. Meanwhile, the present condition of stage Ⅰ study of ovarian cancer in China was analyzed, aiming to provide reference and experience for the development of clinical study of novel antineoplastic drugs in China.
Ovarian cancer is one of the main causes of death among gynecological malignancies in China. With the rapid development of antineoplastic therapies worldwide, new drugs are emerging one afrer another in China. Carrying out the relevant clinical studies scientifically and efficiently will bring great benefits to the patients. Based on the stage Ⅰ clinical study of niraparib in China(No. ZL-2306-002), Chinese experts summarized and discussed it from the perspectives of getting informed consent, auditing patient recruitment, follow-up of clinical medication, data management, adverse reaction management and patient care. Meanwhile, the present condition of stage Ⅰ study of ovarian cancer in China was analyzed, aiming to provide reference and experience for the development of clinical study of novel antineoplastic drugs in China.
引文
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[7]BRAHMER J R,TYKODI S S,CHOW L Q,et al.Safety and activity of anti-PD-L1 antibody in patients with advanced cancer[J].N Engl J Med,2012,366(26):2455-2465.
[8]HAMANISHI J,MANDAI M,IKADA T,et al.Safety and antitumor activity of anti-PD-1 antibody,nivolumab,in patients with platinum-resistant ovarian cancer[J].J Clin Oncol,2015,33(34):4015-4022.
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[10]BUISSON R,DIONC?TéA M,YAN C,et al.Cooperation of breast cancer proteins PALB2 and piccolo BRCA2 in stimulating homologous recombination[J].Nat Struct Mol Biol,2010,17(10):1247-1254.
[11]SABATUCCI I,LORUSSO D.The role of niraparib in the treatment of ovarian cancer:actuality and perspectives[J].Recenti Prog Med,2017,108(6):265-268.
[12]MIRZA M R,MONK B J,HERRSTEDT J,et al.Niraparib maintenance therapy in platinum-sensitive,recurrent ovarian cancer[J].N Engl J Med,2016,375(22):2154-2164.
[2]WEI K,LI Y,ZHENG R,et al.Ovary cancer incidence and mortality in China,2011[J].Chin J Cancer Res,2015,27(1):38-43.
[3]PICCART M J,BERTELSEN K,STUART G,et al.Long‐term follow‐up confirms a survival advantage of the paclitaxelcisplatin regimen over the cyclophosphamide-cisplatin combination in advanced ovarian cancer[J].Int J Gynecol Cancer,2010,13(Suppl 2):144-148.
[4]LEDERMANN J A,KRISTELEIT R S.Optimal treatment for relapsing ovarian cancer[J].Ann Oncol,2010,21(Suppl 7):vii218-vii222.
[5]FOTOPOULOU C.Limitations to the use of carboplatin-based therapy in advanced ovarian cancer[J].Eur J Cancer,2014,12(Suppl 2):13-16.
[6]PERREN T J,SWART A M,PFISTERER J,et al.A phase 3trial of bevacizumab in ovarian cancer[J].N Engl J Med,2011,365(26):2484-2496.
[7]BRAHMER J R,TYKODI S S,CHOW L Q,et al.Safety and activity of anti-PD-L1 antibody in patients with advanced cancer[J].N Engl J Med,2012,366(26):2455-2465.
[8]HAMANISHI J,MANDAI M,IKADA T,et al.Safety and antitumor activity of anti-PD-1 antibody,nivolumab,in patients with platinum-resistant ovarian cancer[J].J Clin Oncol,2015,33(34):4015-4022.
[9]MCGLYNN P,LLOYD R G.Recombinational repair and restart of damaged replication forks[J].Nat Rev Mol Cell Biol,2002,3(11):859-870.
[10]BUISSON R,DIONC?TéA M,YAN C,et al.Cooperation of breast cancer proteins PALB2 and piccolo BRCA2 in stimulating homologous recombination[J].Nat Struct Mol Biol,2010,17(10):1247-1254.
[11]SABATUCCI I,LORUSSO D.The role of niraparib in the treatment of ovarian cancer:actuality and perspectives[J].Recenti Prog Med,2017,108(6):265-268.
[12]MIRZA M R,MONK B J,HERRSTEDT J,et al.Niraparib maintenance therapy in platinum-sensitive,recurrent ovarian cancer[J].N Engl J Med,2016,375(22):2154-2164.