CN107456456A - 伊立替康或其可药用盐在制备治疗乳腺癌的药物中的用途 - Google Patents
伊立替康或其可药用盐在制备治疗乳腺癌的药物中的用途 Download PDFInfo
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- CN107456456A CN107456456A CN201710408211.2A CN201710408211A CN107456456A CN 107456456 A CN107456456 A CN 107456456A CN 201710408211 A CN201710408211 A CN 201710408211A CN 107456456 A CN107456456 A CN 107456456A
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- irinotecan
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Abstract
本发明涉及伊立替康或其可药用盐在制备治疗乳腺癌的药物中的用途。具体而言，本发明涉及伊立替康脂质体在制备治疗乳腺癌的药物中的用途。
Description
技术领域
本发明涉及伊立替康或其可药用盐在制备治疗乳腺癌的药物中的用途。
背景技术
乳腺癌是女性最常见的恶性肿瘤之一，具有发病率高，颇具侵袭性，但病程进展缓慢，中国人口协会2010年2月1日在北京发布了《中国乳腺疾病调查报告》，报告显示，我国城市地区乳腺癌的死亡率增长了38.91％，乳腺癌已经成为对妇女健康威胁最大的疾病，目前在研和上市的乳腺癌药物至少有156种，其中68％为靶向治疗药物。
伊立替康是喜树碱的半合成衍生物。喜树碱可特异性地与拓扑异构酶I结合，后者诱导可逆性单链断裂，从而使DNA双链结构解旋；伊立替康及其活性代谢物SN-38可与拓扑异构酶I-DNA复合物结合，从而阻止断裂单链的再连接。现有研究提示，伊立替康的细胞毒作用归因于DNA合成过程中，复制酶与拓扑异构酶I-DNA-伊立替康(或SN-38)三联复合物相互作用，从而引起DNA双链断裂。
目前，伊立替康在临床上主要用于晚期大肠癌患者的治疗。虽然有伊立替康用于治疗其它癌症，或者伊立替康与其它药物联合使用治疗乳腺癌的报导，但并未发现伊立替康单独使用可以治疗乳腺癌。特别是BEACON研究(NCT01492101)使用伊立替康改良后的长效拓扑异构酶抑制剂Etirinotecan Pegol用于晚期乳腺癌的二线以上治疗并未带来生存获益。
CN103120645A和CN102271659A公开了一种伊立替康脂质体组合物及其制备方法，并证实其对人结肠癌Ls-174细胞有很好的抑制作用，但该文献也未公开伊立替康脂质体用于治疗乳腺癌的用途。
发明内容
本发明惊奇地发现，伊立替康或其可药用盐能够用于治疗乳腺癌，并且取得了良好的疗效。
因此，本发明提供了伊立替康或其盐在制备治疗乳腺癌的药物中的用途。优选的，其中所述的伊立替康或其可药用盐单独使用，即不需要与其它药物联合使用即可以产生良好的疗效。
在本发明优选的实施方案中，所述的伊立替康或其盐以脂质体的形式施用。优选的伊立替康脂质体含有伊立替康或其盐，中性磷脂以及胆固醇，其中所述胆固醇与中性磷脂的重量比为1：3～5，优选为1：3.5～4.5，最优选为1：4。
伊立替康或其与中性膦脂的重量比为1：2～5，优选1：2.5-4，最优选为1：4。
在优选的实施方案中，所述中性磷脂选自氢化大豆磷脂酰胆碱、磷脂酰乙醇胺、卵磷脂、心磷脂中的一种或几种，优选氢化大豆磷脂。
在优选的实施方案中，所述脂质体还含有亲水性高分子的脂质衍生物，优选是培化磷脂酰乙醇胺DSPE-PEG2000。
在本发明中，所述的乳腺癌可以是晚期乳腺癌，例如可以是转移性乳腺癌。本发明的乳腺癌患者可以是经过系统治疗，包括化疗、放疗、内分泌或靶向治疗失败的患者，此处治疗失败是指经过这些治疗后疾病得不到控制，仍然继续进展的情况。这些患者所接受的系统治疗可以是经过本领域各种常规药物中的一种或多种进行治疗。其中所述的化疗可以是使用各种常规的化疗药物治疗，例如蒽环类(包括但不限于多柔比星、表柔比星、多柔比星脂质体)；紫杉类(包括但不限于紫杉醇、多西他赛、白蛋白结合型紫杉醇)；抗代谢类(包括但不限于卡培他滨、吉西他滨)；微管抑制剂类(包括但不限于长春瑞滨、长春氟宁、艾日布林)；以及其他不属于上述分类的化疗药物(包括但不限于环磷酰胺、米托蒽醌、顺铂、卡铂、依托泊苷、长春花碱、氟尿嘧啶、奥沙利铂、替吉奥、伊沙匹隆)。所述的内分泌治疗所使用的药物包括但不限于阿那曲唑、来曲唑、依西美坦、氟维司群、依维莫司、Palbociclib、他莫昔芬、托瑞米芬、醋酸甲地孕酮、甲羟孕酮、乙炔雌二醇、氟甲睾酮等。所述的靶向治疗可以使用多种靶向药物，例如HER2抑制剂(包括但不限于曲妥珠单抗、帕妥珠单抗、拉帕替尼、来那替尼等)；血管生成抑制剂(包括但不限于贝伐单抗、赛伐珠单抗、舒布替尼、阿帕替尼、舒尼替尼、雷珠单抗、ramucirumab等)；EGFR抑制剂(包括但不限于吉非替尼、厄洛替尼或埃克替尼)；以及其它靶向药物，例如索拉非尼等。
本发明中，所述的伊立替康或其盐、以及它们的脂质体，以盐酸伊立替康计，以40～200mg/m2的剂量施用，优选以80～120mg/m2的剂量施用，更优选100～120mg/m2，最优选以100mg/m2的剂量施用。每一名乳腺癌病人按照前述剂量每三周一个给药周期，每周期给药一次。
经过实际的临床试验，证实伊立替康或其盐，特别是在以脂质体的形式给药时，对于乳腺癌病人具有很好的疗效，且毒副作用处于可承受的范围内。
具体实施方式
以下结合实施例用于进一步描述本发明，但这些实施例并非限制本发明的范围。
试验药物及给药方案：按照CN103120645A公开的方法依下表中处方制备成伊立替康脂质体冻干粉针。
表1：伊立替康脂质体处方
注：a 40mg用量以不含结晶水的盐酸伊立替康(C33H38N4O6·HCl)计，b终产品中基本去除，c终产品中基本去除,d为折算无水磷酸二氢钠用量，实际使用为一水磷酸二氢钠，因盐酸伊立替康有结晶水，且投料后有约8％的损失，实际投料时按照盐酸伊立替康：氢化大豆磷脂酰胆碱酰胆碱＝3:10的比例投料。
实施例1：一项伊立替康脂质体治疗乳腺癌的临床试验
试验方法：使用250ml 0.9％氯化钠注射液将伊立替康脂质体稀释，然后静脉滴注，90±5min内完成滴注。每3周一个给药周期，每周期给药一次。2个周期的给药试验结束后，按RECIST1.1标准评价疗效，初次评价为CR、PR、SD的受试者可以继续接受同一方案的治疗，初次评价为CR、PR的受试者在首次评价后4周进行疗效确认。
截至2017年3月3日乳腺癌入组15例，完成疗效评价的有11例，其中5例PR(45.4％)，3例SD(27.3％)，3例PD(27.3％)，即ORR(客观缓解率)为45.4％，DCR(疾病控制率)为72.7％。目前仍然在组用药的有0例。对于晚期乳腺癌患者，伊立替康脂质体在100mg/m2和120mg/m2安全性、耐受性良好，临床可控，且抗肿瘤疗效显著。
已有疗效评估的患者详细信息如下表。其中，各个英文缩写的含义如下。
PD：疾病进展，直径和比靶病灶直径之和的最小值增加至少20％且直径和的绝对值增加至少5mm(出现一个或多个新病灶也视为疾病进展)；SD：疾病稳定，靶病灶最大径之和缩小未达PR，或增大未达PD PR：部分缓解，靶病灶直径之和比基线水平减少至少30％，至少维持4周。ER:雌激素受体。PR:孕激素受体。HER-2:人表皮生长因子受体2。C是cycle英文简写，代表试验周期。
Claims (19)
1.伊立替康或其可药用盐在制备治疗乳腺癌的药物中的用途，所述的可药用盐优选为盐酸盐。
2.根据权利要求1所述的用途，其中所述的伊立替康或其可药用盐单独使用。
3.根据权利要求1所述的用途，其中所述的伊立替康或其其可药用盐以脂质体的形式施用。
4.根据权利要求2所述的用途，其中所述的伊立替康脂质体含有伊立替康或其可药用盐，中性磷脂以及胆固醇。
5.根据权利要求4所述的用途，其中所述胆固醇与中性磷脂的重量比为1：3～5，优选1：3.5～4.5，最优选为1：4。
6.根据权利要求4所述的用途，其中所述的伊立替康或其可药用盐与中性膦脂的重量比为1：2～5，优选1：2.5-4，最优选为1：4。
7.根据权利要求4所述的用途，其中所述中性磷脂选自氢化大豆磷脂酰胆碱、磷脂酰乙醇胺、卵磷脂、心磷脂中的一种或几种，优选氢化大豆磷脂。
8.根据权利要求4所述的用途，其中，所述脂质体还含有亲水性高分子的脂质衍生物，优选是培化磷脂酰乙醇胺DSPE-PEG2000。
9.根据权利要求1所述的用途，其中所述乳腺癌是晚期乳腺癌。
10.根据权利要求1所述的用途，其中所述乳腺癌是转移性乳腺癌。
11.根据权利要求1所述的用途，其中所述乳腺癌是HER-2阳性乳腺癌、或者PR阳性、或者ER阳性乳腺癌、或者三阴乳腺癌。
12.根据权利要求1所述的用途，其中所述乳腺癌是经过选自化疗、放疗、内分泌或靶向治疗的治疗手段后继续进展的乳腺癌。
13.根据权利要求12所述的用途，其中所述的化疗是使用例如蒽环类、紫杉类、抗代谢类微管抑制剂类药物进行的化疗。
14.根据权利要求12所述的用途，其中所述的化疗是使用选自环磷酰胺、米托蒽醌、顺铂、卡铂、依托泊苷、长春花碱、氟尿嘧啶、奥沙利铂、替吉奥和伊沙匹隆的药物进行的化疗。
15.根据权利要求13所述的用途，其中所述的蒽环类药物选自多柔比星、表柔比星、多柔比星脂质体；所述的紫杉类药物选自紫杉醇、多西他赛、白蛋白结合型紫杉醇；所述的抗代谢类药物选自卡培他滨、吉西他滨；所述的微管抑制剂类药物选自长春瑞滨、长春氟宁、艾日布林。
16.根据权利要求12所述的用途，其中所述的内分泌治疗所使用的药物选自阿那曲唑、来曲唑、依西美坦、氟维司群、依维莫司、Palbociclib、他莫昔芬、托瑞米芬、醋酸甲地孕酮、甲羟孕酮、乙炔雌二醇、氟甲睾酮中的一种或几种。
17.根据权利要求12所述的用途，其中所述的靶向治疗选自HER2抑制剂、血管生成抑制剂和EGFR抑制剂的靶向药物。
18.根据权利要求17所述的用途，其中所述的HER2抑制剂选自曲妥珠单抗、帕妥珠单抗、拉帕替尼、来那替尼；所述的血管生成抑制剂选自贝伐单抗、赛伐珠单抗、舒布替尼、阿帕替尼、舒尼替尼、雷珠单抗、ramucirumab；所述的EGFR抑制剂选自吉非替尼、厄洛替尼和埃克替尼。
19.根据权利要求1所述的用途，其中所述的伊立替康或其可药用盐、以及它们的脂质体，以盐酸伊立替康计，以40～200mg/m2的剂量施用，优选以80～120mg/m2的剂量施用，更优选100～120mg/m2，最优选以100mg/m2的剂量施用。
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