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BIOGRAPHICAL SKETCH
NAME
Ronald B. Natale, M.D.
INSTITUTION AND LOCATION
POSITION TITLE
Medical Oncology Attending Staff Physician III,
Director, Lung Cancer Research Program,
Samuel Oschin Comprehensive Cancer Instit
Cedars-Sinai Medical Center
DEGREE
YEAR(s)
FIELD OF STUDY
(if applicable)
Education & Training
University of Michigan, Ann Arbor, MI
Wayne State University School of Medicine
Wayne State University Affiliated Hospitals
Program, Hutzel Hospital Medical Unit.
Memorial Sloan-Kettering Cancer Center, NY
BS
MD
Internship
Residency
Clin Fellowship
Sloan Kettering Institute for Cancer Research,
1970
1974
Biology
Medicine
1974-77
Internal Mediine
1977-80
Medical Oncology
Res Fellowship
1977-80
Clinical Instructor
NIH (Bethesda)
Res Fellowship
1987-88
(Sabbatical)
Academic Appointments (prior to current position)
University of Michigan Medical School, Division
of Hematology/Oncology, Ann Arbor, Michigan
University of Michigan Comp Cancer Center
Univ of Southern Cal, Keck School of Medicine
USC Kenneth Norris Jr. Comp Cancer Center
Position
Assist Prof
Assoc Prof
Assoc Dir
Professor
Professor
Years
1980-84
1984-93
1984-1993
1993-97
1993-97
Department
Int Medicine, Med Onc
Int Medicine, Med Onc
Int Medicine, Med Onc
Director, Lung Cancer &
Clinical Res Programs
A. Personal Statement: My major area of interest is in translational clinical trials (Phase I-III) with
investigational agents in patients with lung cancer. I have had over 30 years of experience with
clinical trials and with their continuous evolution over that time period driven by advances in
molecular biology and technology. My experiences began with rationally designed empiric trials in
the 1980s and 1990s that resulted in my development or co-development of some of the most
widely used treatment regimens for lung cancer including cisplatin and etoposide for small cell lung
cancer (with Robert Wittes at MSKCC) and carboplatin and paclitaxel for non small cell lung
cancer. During that time I also co-developed the MVAC regimen for bladder cancer (with Alan
Yagoda at MSKCC) and went on to serve as PI of the SWOG and national high priority
neoadjuvant MVAC trial in patients with locally advanced bladder cancer (ASCO Plenary
presentation, 2001; NEJM publication, 2003). In 2001 I was one of the first investigators involved
in the clinical development of the breakthrough EGFR tyrosine kinase inhibitor, gefitinib. I served
as co-PI of the registrational trial and was selected to present results at the FDA ODAC meeting at
which gefitinib was first approved in 2003. I have been continuously involved in clinical trials of
new targeted agents in lung cancer since that time with almost all current studies requiring archival
or freshly biopsied tumor tissue for laboratory translational studies.
B. Peer-Reviewed Publications: (Selected from over 200)
1. Natale RB and Wittes RE: Combination cis-platinum and etoposide in small cell lung cancer.
CANCER TREAT REVIEWS 9 (Supplement A):91-94, 1982.
2. Stya M, Wahl RL, Natale RB and Beierwaltes WH: Radioimmunoimaging of human small cell lung
carcinoma xenografts in nude mice receiving several monoclonal antibodies. NCI Monographs
3:19-23, 1987.
3. Natale RB, Shank B, Hilaris BS, and Wittes RE: Combination cyclophosphamide, adriamycin and
vincristine (CAV) rapidly alternating with combination cisplatin and VP-16 (PVP) in the treatment of
small cell lung cancer. AM J MED 79:303-308, 1985.
4. Nakanishi Y, Mulshine JL, Kasprzyk PG, Natale RB, Maneckjee R, Avis I, Treston AM, Gazdar AF,
Minna JD, and Cuttitta F: Small cell lung cancer cells autostimulate their growth via an insulin-like
growth factor-I activity: evaluation of four cell lines. J Clin Invest 82: 1988.
5. Trepel JB, Moyer JD, Cuttitta F, Frucht H, Coy DH, Natale RB, Mulshine JL, Gardner JD, Jensen
RT, and Sausville EA: Inhibition of autocrine growth signals by a novel bombesin receptor
antagonist. Biochemical and Biophysical Research Communications 156:1383-1389, 1988.
6. Mulshine JL, Natale RB, Avis I, Treston AM, Kasprzyk PG, Nakanish, Y, Sausville EA, Trepel JB,
Cutitta, F: Autocrine growth factors and lung cancer. Cancer Treat. Res., 1989; 45:107-122.
7. Weick JD, Crowley J, Natale RB, Hom BL, Rivkin S, Coltma, CA, Taylor SA, and Livingston RB: A
Randomized trial of five cisplatin-containing treatments in patients with metastatic non-small cell
lung cancer: A Southwest Oncology Group study. J Clin Oncol, 1991; 9:1152-1162.
8. Natale RB: Preliminary results of a phase I/II clinical trial of paclitaxel and carboplatin in non-small
cell lung cancer. Seminars in Oncology 23 (Suppl 12):2-6, 1996 .
9. Miller TP, Crowley JJ, Mira J, Schwartz JG, Hutchins L, Baker L, Natale R, Chase EM, and
Livingston RB: A randomized trial of chemotherapy and radiotherapy for stage III non-small cell
lung cancer. Cancer Therapeutics 1:230-236, 1998.
10. Grossman HB, Natale RB, Tangen CM, et al. Neoadjuvant chemotherapy plus cystectomy
compared with cystectomy alone for locally advanced bladder cancer. NEJM 349:859-866, 2003.
11. Kris MG, Natale RB, Herbst RS, Lynch TJ Jr, Prager D, Belani CP, Schiller JH, Kelly K,
Spiridonidis H, Sandler A, Albain KS, Cella D, Wolf MK, Averbuch SD, Achs JJ, Kay AC. Efficacy
of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic
patients with non-small cell lung cancer: a randomized trial. JAMA 290(16):2149-2158, 2003.
12. Natale RB. Effects of ZD1839 (Iressa, gefitinib) treatment on symptoms and quality of life in
patients with advanced non-small cell lung cancer. Seminars in Oncology 31:23-30, 2004
13. Belani CP, Lee JS, Socinski MA, Robert F, Waterhouse D, Rowland K, Ansari R, Lilenbaum R, &
Natale RB. Randomized phase III trial comparing cisplatin-etoposide to carboplatin –paclitaxel in
advanced or metastatic non-small cell lung cancer. Annals of Oncology 16:1069-1075, 2005.
14. Jain A, Tindell CA, Laux I, Hunter JB, Curran J, Galkin A, Afar DE, Aronson N,Shak S, Natale RB
and Agus DB. Epithelial membrane protein-1 is a biomarker of gefitinib resistance. Proc Natl
Academy of Sciences 102:11858-11863, 2005.
15. Natale R. A ten-year review of progress in the treatment of non-small cell lung cancer with
gemcitabine. Lung Cancer 50 (Suppl 1):S2-4, 2005.
16. Langer CJ, Natale RB: The emerging role of vascular endothelial growth factor receptor tyrosine
kinase inhibitors. Seminars in Oncology 32 (6 Suppl 10):S23-9, 2005.
17. Lara PN Jr, Gandara DR, and Natale RB. Randomized phase III trial of cisplatin/irinotecan versus
cisplatin/etoposide in patients with extensive-stage small cell lung cancer. Clin Lung Ca 7 (5):3536, 2006.
18. Herbst RS, Davies AM, Natale RB, et.al. Efficacy and safety of single-agent pertuzumab, a human
epidermal receptor dimerization inhibitor, in patients with non small cell lung cancer. Clinical
Cancer Res 13(20):6175-81, 2007.
19. Natale RB. Dual targeting of the vascular endothelial growth factor receptor and epidermal growth
factor receptor pathways with vandetinib (ZD6474) in patients with advanced or metastatic nonsmall cell lung cancer. Journal of Thoracic Oncology: Official Publication of the International
Association for the Study of Lung Cancer. 3(6 Suppl 2):S128-30, 2008 Jun.
20. Natale RB, Bodkin D, Govindan R, Sleckman BG, Rizvi NA, Capó A, Germonpré P, Eberhardt
WEE, Stockman PK, Kennedy SJ, and Ranson M. Vandetanib Versus Gefitinib in Patients With
Advanced Non–Small-Cell Lung Cancer: Results From a Two-Part, Double-Blind, Randomized
Phase II Study. Journal of Clinical Oncology. 27(15):2523-9, 2009 May 20.
21. Sequist, LV. Gettinger, S. Senzer, NN. Martins, RG. Janne, PA. Lilenbaum, R. Gray, JE. Iafrate,
AJ. Katayama, Ri. Hafeez, N. Sweeney, J. Walker, JR. Fritz, C. Ross, RW. Grayzel, D. Engelman,
JA. Borger, DR. Paez, G. Natale, R. Activity of IPI-504, a novel heat-shock protein 90 inhibitor, in
patients with molecularly defined non-small-cell lung cancer. J Clin Oncol. 28(33):4953-60, 2010.
22. Natale RB. Thongprasert S. Greco FA. Thomas M. Tsai CM. Sunpaweravong P. Ferry D. Mulatero
C. Whorf R. Thompson J. Barlesi F. Langmuir P. Gogov S. Rowbottom JA. Goss GD. Phase III trial
of vandetanib compared with erlotinib in patients with previously treated advanced non-small-cell
lung cancer. J Clin Oncol. 29(8):1059-66, 2011 Mar 10.