作为美国国家癌症中心NSABP临床试验主席,主持全美80家癌症中心和医疗机构参与的NSABP FB-7试验:比较Neratinib联合紫杉醇周疗序贯多柔比星和环磷酰胺(AC)方案与曲妥珠单抗联合紫杉醇周疗序贯AC方案作为HER2阳性的局部进展期乳腺癌妇女的新辅助化疗的II期,多中心随机研究。
[科研]
以课题主任身份主持了多项科研课题,题目为: 1.PACCT-1:为早期乳腺癌制定的个体化基因治疗方案。美国东部癌症临床试验工作组(ECOG)。
2.NSABP B35:一项在接受了乳房肿瘤切除术和放射治疗的绝经后导管原位癌(DCIS)患者中比较阿那曲唑和他莫昔芬的临床试验。
3.NSABP B-38:一项在淋巴结阴性的乳腺癌女性患者中的比较三种化疗方案:多西紫杉醇/多柔比星/环磷酰胺(TAC);密集剂量(DD)的多柔比星/环磷酰胺序贯密集剂量的紫杉醇(DD AC→P);DD AC序贯DD 紫杉醇和吉西他滨(DD AC→PG)的III期辅助药物试验。
4.NSABP B42:在患有激素受体阳性乳腺癌的绝经后女性中,对于以芳香化酶抑制剂(AI)或他莫昔芬完成了5年内分泌治疗并序贯一种AI的患者,5年来曲唑与安慰剂对延长无病生存期的疗效比较。
5.NSABP B46:一项在淋巴结阳性或淋巴结阴性,HER2阴性的高危组乳腺癌妇女中比较TC加贝伐单抗联合用药方案与单纯TC方案和TAC方案的III期临床试验。
6.NSABP FB-4:评价在局部晚期乳腺癌的妇女中,术前贝伐单抗(BEV),多柔比星,和环磷酰胺,序贯BEV,多西紫杉醇,和卡培他滨,术后序贯BEV单药的治疗方案。
7.NASBP FB-5:一项评价表柔比星和环磷酰胺序贯多西紫杉醇与赫赛汀和Avastin作为局部晚期乳腺癌的新辅助治疗的II期研究。
8.NSABP FB-6:一项评价在局部晚期乳腺癌妇女术后的帕唑帕尼治疗后,使用4周期多柔比星和环磷酰胺序贯紫杉醇周疗与帕唑帕尼同时给药新辅助治疗的II期临床试验。
9.ECOG 5103:评价淋巴结阳性或淋巴结阴性高危组乳腺癌中AC方案序贯紫杉醇和Avastin或安慰剂的III期临床试验。
10.ALTTO试验:拉帕替尼和/或曲妥珠单抗辅助治疗的优化。美国东部癌症临床试验工作组(ECOG)。
11.比较T-DM1与曲妥珠单抗和多西紫杉醇在转移性乳腺癌中的作用的II期试验。罗氏公司。
12.循环肿瘤细胞(CTC)在个体化癌症治疗中的研究。
[论文/论著]
代表性文章: 1.Hurviz, Dirix, Lu MJ et al., Trastuzumab Emtansine (T-DM1) Versus Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer (MBC): Primary Results of a Randomized, Multicenter, Open-Label Phase II Study (TDM4450g/BO21976). ESMO, 2011.
2.Lu MJ, Fan T, Zhao Q, Zaslavsky E, Frohman M, Madajewicz S, Chen J, Golightly M and Chen WT. Prognostic value of invasive circulating tumor cells in early stage breast cancer patients. Int J of Cancer. 1; 126(3): 669-83. 2010.
3.Perez E, Dirix L, Kocsis J, Gianni L, Lu MJ et al., Efficacy and safety of Trastuzumab-DM1 versus Trastuzumab plus Docetaxel in Her2-positive metastatic breast cancer patients with no prior chemotherapy for metastatic disease. ESMO, Berlin, 2010.
4.Chu D and Lu MJ. Novel Therapies in Breast Cancer: What is New from ASCO 2008. J Hematology Oncology, 1:16, 2008.
5.Hochester H, Chen T, Lu MJ, Hills D, Sorich J, Escalon J, Ivy P, Liebes L and Muggia F. Gynecologic Oncology, 2008. Tolerance and activity of oxaliplatin with protracted topotecan infusion in patients with previously treated ovarian cancer. A phase I study. Gynecol Oncol. 108:500-504, 2008.
6.Wu SH, Kudelka A, Chen J, Lu MJ and Zhu X. Incidence and risk of hypertension with Sorefenib in patients with cancer; a systemic review and meta-analysis. Lancet Oncology 2008; 9: 117-23.
7.S. Madajewicz, T. Fan, W. Zeng, M. H. Zarrabi, S. Zucker, Q. Zhao, Lu MJ. M. Seibel, W.-T. Chen. Gene expression signature of circulating tumor cells (CTC) in patients (pts) with colorectal carcinoma (CRC). ASCO, Chicago. June 2008.
8.Lu MJ, Fan T, Zaslavsky E, Zhao C and Chen WT. Circulating tumor cells and their signature in breast cancer. San Antonio Breast Cancer Symposium, San Antonio, TX. December 2007.
9.Lu MJ, Fan T, Zhao C and Chen WT. Circulating tumor cells in breast cancer. San Antonio Breast Cancer Symposium, San Antonio, TX. December 2006.
10.Lin EH, Lozano R, Karp DD, Lu MJ, et., Color-Matrix Cancer Staging and Treatment Handbook, MD Anderson Cancer Center, 3rd edition, 2004.
11.Lu MJ, Sorich J, Hazarika M, Kim M, Del Priore G, Jacobs AJ, Chiang C, Liu PC, Fusco E, Curtin J, and Muggia FM. Intraperitoneal therapy as consolidation for patients with ovarian cancer and negative reassessment following platinum-based chemotherapy. Clinics of North America, Hematology and Oncology, vol 17, no 4. 2003.
12.Lu MJ, Liebes L, Fry D, Buckley M, Jacobs A, Liu P, Fusco E, Sorich J, Hochster H, Muggia F. Phase I and pharmacologic study of intraperitoneal (IP) topotecan and cisplatin. American Association of Cancer Research, Toronto, Canada. April 2003.
13.Muggia F and Lu MJ. Emerging drugs of ovarian cancer. Expert Opinion on Emerging Drugs, 8(1): 203-16, 2003 |