Dosing targeted and cytotoxic two-drug combinations: Lessons learned from analysis of 24,326 patients reported 2010 through 2013

International Journal of Cancer

Volumn 139, Issue 9, 2016, Pages 2135-2141

  Nikanjam, Mina ^a   Liu, Sariah ^b   Kurzrock, Razelle ^c  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b KAISER PERMANENTE   (United States)

^c UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

Author keywords

cytotoxic chemotherapy; maximum tolerated dose; precision medicine; recommended Phase 2 dose; targeted therapy

Indexed keywords

ALEMTUZUMAB; ATRASENTAN; BEVACIZUMAB; BRYOSTATIN 1; CAPECITABINE; CENERSEN; CHLORAMBUCIL; CISPLATIN; CLADRIBINE; CLOFARABINE; COMBRETASTATIN A4 PHOSPHATE; CYCLOPHOSPHAMIDE; DACARBAZINE; DECITABINE; DOCETAXEL; DOXORUBICIN; EVEROLIMUS; FLUDARABINE; GEMTUZUMAB OZOGAMICIN; IDARUBICIN; IMATINIB; NAVELBINE; OBATOCLAX; OLAPARIB; PANOBINOSTAT; RITUXIMAB; TOPOTECAN; UNINDEXED DRUG; VELIPARIB; VORINOSTAT;

ARTICLE; CLINICAL TRIAL (TOPIC); DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FOOD AND DRUG ADMINISTRATION; HUMAN; MAXIMUM TOLERATED DOSE; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PUBLICATION; SYSTEMATIC REVIEW;

EID: 84983084682     PISSN: 00207136     EISSN: 10970215     Source Type: Journal    
DOI: 10.1002/ijc.30262     Document Type: Article

References (21)

1. Kurzrock R, Giles FJ. Precision oncology for patients with advanced cancer: the challenges of malignant snowflakes. Cell Cycle 2015;14:2219–21.
2. Gerlinger M, Rowan AJ, Horswell S, et al. Intratumor heterogeneity and branched evolution revealed by multiregion sequencing. N Engl J Med 2012;366:883–92.
3. Kandoth C, McLellan MD, Vandin F, et al. Mutational landscape and significance across 12 major cancer types. Nature 2013;502:333–9.
4. Wheler JJ, Parker BA, Lee JJ, et al. Unique molecular signatures as a hallmark of patients with metastatic breast cancer: implications for current treatment paradigms. Oncotarget 2014;5:2349–54.
5. Wheler J, Lee JJ, Kurzrock R. Unique molecular landscapes in cancer: implications for individualized, curated drug combinations. Cancer Res 2014;74:7181–4.
6. Tsimberidou AM, Iskander NG, Hong DS, et al. Personalized medicine in a phase I clinical trials program: the MD Anderson Cancer Center initiative. Clin Cancer Res 2012;18:6373–83.
7. DeVita VT Jr., Chu E. A history of cancer chemotherapy. Cancer Res 2008;68:8643–53.
8. Borad MJ, Curtis KK, Babiker HM, et al. The impact of concomitant medication use on patient eligibility for phase I cancer clinical trials. J Cancer 2012;3:345–53.
9. Liu S, Kurzrock R. Toxicity of targeted therapy: implications for response and impact of genetic polymorphisms. Cancer Treat Rev 2014;40:883–91.
10. Averbuch SD, Wolf MK, El-Rayes BF, et al. Clinical development issues. In: Prendergast GC, eds. Molecular cancer therapeutics: strategies for drug discovery and development. Hoboken, NJ: Wiley-LSS, 2004. 287–306.
11. Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004;350:2335–42.
12. Sehn LH, Donaldson J, Chhanabhai M, et al. Introduction of combined CHOP plus rituximab therapy dramatically improved outcome of diffuse large B-cell lymphoma in British Columbia. J Clin Oncol 2005;23:5027–33.
13. Baselga J. Herceptin alone or in combination with chemotherapy in the treatment of HER2-positive metastatic breast cancer: pivotal trials. Oncology 2001;61: 14–21.
14. Drew Y, Plummer R. PARP inhibitors in cancer therapy: two modes of attack on the cancer cell widening the clinical applications. Drug Resist Updates 2009;12:153
15. Xu WS, Parmigiani RB, Marks PA. Histone deacetylase inhibitors: molecular mechanisms of action. Oncogene 2007;26:5541–52.
16. Underhill C, Toulmonde M, Bonnefoi H. A review of PARP inhibitors: from bench to bedside. Ann Oncol 2011;22:268–79.
17. Liu S, Nikanjam M, Kurzrock R. Dosing de novo combinations of two targeted drugs: towards a customized precision medicine approach to advanced cancers. Oncotarget 2016;7:11310–20.
18. Gupta S, Hunsberger S, Boerner SA, et al. Meta-analysis of the relationship between dose and benefit in phase I targeted agent trials. J Natl Cancer Inst 2012;104:1860–6.
19. Jain RK, Lee JJ, Hong D, et al. Phase I oncology studies: evidence that in the era of targeted therapies patients on lower doses do not fare worse. Clin Cancer Res 2010;16:1289–97.
20. Hamberg P, Verweij J. Phase I drug combination trial design: walking the tightrope. J Clin Oncol 2009;27:4441–3.
21. Hamberg P, Ratain MJ, Lesaffre E, et al. Dose-escalation models for combination phase I trials in oncology. Eur J Cancer 2010;46:2870–8.