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1.
Bhavana Pothuri Allison L. Brodsky Joseph A. Sparano Stephanie V. Blank Mimi Kim Dawn L. Hershman Amy Tiersten Brian F. Kiesel Jan H. Beumer Leonard Liebes Franco Muggia 《Cancer chemotherapy and pharmacology》2020,85(4):741-751
Poly(ADP-ribosyl) polymerases (PARPs) are nuclear enzymes with roles in DNA damage recognition and repair. PARP1 inhibition enhances the effects of DNA-damaging agents like doxorubicin. We sought to determine the recommended phase two dose (RP2D) of veliparib with pegylated liposomal doxorubicin (PLD) in breast and recurrent gynecologic cancer patients. Veliparib and PLD were administered in a standard phase 1, 3 + 3 dose-escalation design starting at 50 mg veliparib BID on days 1–14 with PLD 40 mg/mg2 on day 1 of a 28-day cycle. Dose escalation proceeded in two strata: A (prior PLD exposure) and B (no prior PLD exposure). Patients underwent limited pharmacokinetic (PK) sampling; an expansion PK cohort was added. 44 patients with recurrent ovarian or triple negative breast cancer were enrolled. Median age 56 years; 23 patients BRCA mutation carriers; median prior regimens four. Patients received a median of four cycles of veliparib/PLD. Grade 3/4 toxicities were observed in 10% of patients. Antitumor activity was observed in both sporadic and BRCA-deficient cancers. Two BRCA mutation carriers had complete responses. Two BRCA patients developed oral squamous cell cancers after completing this regimen. PLD exposure was observed to be higher when veliparib doses were > 200 mg BID. The RP2D is 200 mg veliparib BID on days 1–14 with 40 mg/m2 PLD on day 1 of a 28-day cycle. Anti-tumor activity was seen in both strata. However, given development of long-term squamous cell cancers and the PK interaction observed, efforts should focus on other targeted combinations to improve efficacy. 相似文献
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Freda Cooner Margaret Gamalo-Siebers Amy Xia Aijun Gao Shiling Ruan Tony Jiang 《Statistics In Biopharmaceutical Research》2020,12(2):210-223
AbstractChildren are considered a vulnerable group and as such are granted additional protection as research subjects. Research projects using children as research subjects are justifiable if the answer to the scientific question of the study cannot be obtained by enrolling adult subjects (cf. scientific necessity). Thus, there is an ethical obligation to explore innovative analytical strategies that seek balance between the feasibility of conducting a trial and maximizing the utilization of data on efficacy and safety. On this note, there is enthusiasm for implementing some less popular but efficient alternative designs for confirmatory pediatric trials. Within the pediatric extrapolation paradigm, examples of such designs, other than purely based on pharmacokinetic/pharmacodynamic data, are described in this article along with their advantages and disadvantages. This article will also discuss how to incorporate alternative data sources in the analysis of pediatric clinical trials. A discussion of existing approaches and a road-map to their utilization will be provided. Real case examples on the use of the approaches are provided. 相似文献
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Emarene Kalaw Malcolm Lim Jamie R. Kutasovic Anna Sokolova Lucinda Taege Kate Johnstone James Bennett Jodi M. Saunus Colleen Niland Kaltin Ferguson Irma Gresshoff Mark Bettington Nirmala Pathmanathan Gary M. Tse David Papadimos Rajadurai Pathmanathan Gavin Harris Rin Yamaguchi Puay Hoon Tan Stephen Fox Sandra A. O’Toole Peter T. Simpson Sunil R. Lakhani Amy E. McCart Reed 《British journal of cancer》2020,123(11):1665
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Ashton A. Connor Robert E. Denroche Gun Ho Jang Mathieu Lemire Amy Zhang Michelle Chan-Seng-Yue Gavin Wilson Robert C. Grant Daniele Merico Ilinca Lungu John M.S. Bartlett Dianne Chadwick Sheng-Ben Liang Jenna Eagles Faridah Mbabaali Jessica K. Miller Paul Krzyzanowski Heather Armstrong Steven Gallinger 《Cancer cell》2019,35(2):267-282.e7
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Phantana-angkool April Voci Amy E. Warren Yancey E. Livasy Chad A. Beasley Lakesha M. Robinson Myra M. Hadzikadic-Gusic Lejla Sarantou Terry Forster Meghan R. Sarma Deba White Richard L. 《Annals of surgical oncology》2019,26(12):3874-3882
Annals of Surgical Oncology - The role of sentinel lymph node biopsy (SLNB) when ductal carcinoma in situ with microinvasion (DCISM) is identified on core biopsy is unclear. Our aim was to assess... 相似文献
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