Sai-Hong Ignatius Ou

Picture of Sai-Hong Ignatius Ou
Clinical Professor, Division of Hematology/Oncology, Medicine
School of Medicine
Hamoui Salous Endowed Chair in Thoracic Oncology Research
M.D., University of Texas Southwestern Medical Center, Dallas, TX, 1997, Medicine
Ph.D., University of Texas Southwestern Medical Center, Dallas, TX, 1997, Cellular and Molecular Biology
B.A., University of California, Berkeley, CA, 1988, Biochemistry
Phone: (714) 456-5153
Fax: (714) 456-2242
Email: ignatius.ou@uci.edu
University of California, Irvine
101 The City Drive South
Building 200, Room 407
Mail Code: 4061
Orange, CA 92868
Research Interests
Nasopharyngeal Carcinoma, Head and Neck Cancer, Thoracic malignancies, Esophageal carcinoma, Targeted therapy
Academic Distinctions
Phi Beta Kappa, UC Berkeley (1986)
National Golden Key Honor Society, UC Berkeley (1986)
American Heart Association Summer Research Fellowship (1987)
Medical Scientist Training Program Fellowship (1988-1997)
Certified, American Board of Internal Medicine, Internal Medicine (2000)
Certified, American Board of Internal Medicine, Medical Oncology (2003)
AACR-Methods in Clinical Cancer Research Fellowship (2003)
Certified, American Board of Internal Medicine, Hematology (2004)
SWOG Ortho Biotech-Hope Foundation Young Investigator Training Fellowship(March, 2004)
Appointments
Assistant Clinical Professor Medicine, School of Medicine (2003-2008)
Health Science Associate Clinical Professor Medicine, School of Medicine (2008-Present)
Adjunct Assistant Professor of Epidemiology, School of Medicine (2008-Present)
Research Abstract
My interests at UCI will be to incorporate novel and targeted therapies in the treatment of upper aero-digestive tract malignancies. I am especially interested in Lung cancer in never-smokers who harbor specific genetic alterations: activating mutations in the epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) translocation-fusion. I currently am the Principal Investigator in clinical trials that investigate second generation EGFR tyrosine kinase inhibitors (TKIs), acquired resistance to first generation EGFR TKIs, and inhibitor to the ALK (Crizotinib). Additionally, I have international collaboration with investigators in Asia to investigate the difference in lung cancer according to ethnicity, and the role of environmental tobacco smoke (ETS) and the occurrence in the genetic alterations in lung cancer patients who are never-smokers.

I am also interested in nasopharyngeal carcinoma (NPC). NPC is endemic in Southeast Asia with the highest incidence in Southern China. NPC has been closely associated with Epstein-Barr virus (EBV). Thus, EBV provided a potential target in the treatment of NPC which includes both radiation and chemotherapy. Measuring the actual EBV viral load in blood has also been shown to be useful in prognosis if treatment outcome and monitoring treatment of NPC and even surveillance. The radiation oncology group at UCI also has state of the art radiation treatment facilities including Intensity Modulated Radiation Therapy (IMRT) which can better spare normal tissues from radiation. Together with our excellent otolaryngology surgeons and radiation oncologist, we can plan to provide the state of the art treatment for head and neck cancers.

Patent:
Number # 5688511: Cellular protein TDP-43 and regulation of HIV-1 gene expression
Publications
1. Lalazar, A., Ou, S.-H. I., Mahley, R. W. Human apolipoprotein E: Receptor binding activity of truncated variants with carboxyl-terminal deletions. J Biol Chem 1989; 264: 8447-8450. PMID:2542277

2. Matsumine, H., Herbst, M. A., Ou, S.-H. I., Wilson, J. D., McPhaul, M. J. Aromatase mRNA in the extragonadal tissues of chicken with henny-feathering trait is derived from a distinctive promoter structure that contains a segment of a retroviral long terminal repeat. J Biol Chem 1991; 266: 19900-19907. PMID:1939054

3. Garcia, J. A., Ou, S.-H. I.,* Wu, F., Lusis, A. L., Sparkes, R. S., Gaynor, R. B. Cloning and chromosomal mapping of a human immunodeficiency virus 1 “TATA” element modulatory factor. Proc Natl Acad Sci 1992; 89: 9372-9376. *co-first author. PMID:1409643

4. Ou, S.-H. I., Garcia-Martinez, L. F., Paulssen, E. J., Gaynor, R. B. Role of flanking E box motifs in human immunodeficiency virus type 1 TATA element function. J Virol 1994; 68: 7188-7199.
PMID:7933101

5. Ou, S.-H. I., Wu, F., Harrich, D., Garcia-Martinez, L. F., Gaynor, R. B. Cloning and characterization of a novel cellular protein, TDP-43, that binds to human immunodeficiency virus type 1 TAR DNA sequence motifs. J Virol 1995; 69: 3584-3596. PMID:7745706

6. Mavankal, G., Ou, S.-H. I., Oliver, H., Sigman, D., Gaynor, R. G. Human immunodeficiency virus type 1 and 2 Tat proteins specifically interact with RNA polymerase II. Proc Natl Acad Sci 1996; 93: 2089-2094. PMID: 8700889

7. Zell, J. A., Ou, S.-H. I., Ziogas, A., Anton-Culver, H. Epidemiology of bronchioloalveolar carcinoma (BAC) in Southern California and impact of the 1999 WHO classification on survival. J Clin Oncol 2005; 23: 8396-8405. PMID:16293870

8. Zell, J. A., Ou, S.-H. I., Ziogas, A., Anton-Culver, H. Long-term survival differences for bronchiolo-alveolar carcinoma patients with ipsilateral intrapulmonary metastasis at diagnosis. Ann Oncol 2006; 17: 1255-1262. PMID:16766595

9. Lam, P., Berman, S., Thurer, R., Ashiku, A., DeCamp, M., Goldstein, M., Schumer, S., Halmos, B., Karp, D., Coute, D., Bergman, M., Boyd-Sirard, C., Ou, S.-H., Muzikansky, A., Woodard, C., Huberman, M. Phase II trial of sequential chemotherapy followed by chemoradiation, surgery, and postoperative chemotherapy for the treatment of stage IIIA/IIIB non-small-cell lung cancer. Clin Lung Cancer 2006; 8: 122-129. PMID:17026813

10. Raz, D. J., Zell, J. A., Karnezis A.N., Odisho A., Ou, S-H. I., Anton-Culver, H, Jablons D. M. Misclassification of bronchioloalveolar carcinoma with cytologic diagnosis of lung cancer. J Thorac Oncol 2006; 1: 943-948. PMID:17409976


11. Ou, S.-H. I.,* Zell, J.A., Ziogas, A., and Anton-Culver, H. Epidemiology of nasopharyngeal carcinoma in the United States: improved survival of Chinese patients within the keratinizing squamous cell carcinoma histology. Ann Oncol 2007; 18: 29-35. *corresponding author. PMID:17060483

12. Zell, J. A., Ou, S.-H. I., Ziogas, A., Anton-Culver, H. Validation of the proposed IASLC non-small-cell lung cancer staging system revisions for advanced bronchioloalveolar carcinoma using data from the California Cancer Registry. J Thorac Oncol 2007; 2: 1078-1085. PMID:18090578

13. Raz, D. J., Zell, J. A., Ou, S-H. I., Gandara, D. R., Anton-Culver H., Jablons, D. M. Natural history of stage I non-small cell lung cancer: implications for early detection. Chest 2007; 132: 193-199.
PMID:17505036

14. Ou, S.-H. I.,* Zell, J.A., Ziogas, A., and Anton-Culver, H. Prognostic factors for survival of stage I non-small cell lung cancer (NSCLC) patients: a population-based analysis of 19,702 stage I patients in the California Cancer Registry (CCR) from 1989 to 2003. The significance of histologic grade, tumor size > 4 cm, and non-upper lobar tumor location. Cancer 2007; 110: 1532-1541. *corresponding author. PMID:17702091

15. Ou, S.-H. I.,* Zell, J.A., Ziogas, A., and Anton-Culver, H. Prognostic significance of the non-size based AJCC T2 descriptors: visceral pleura invasion (VPI), hilar atelectasis or obstructive pneumonitis in stage IB non-small-cell lung cancer (NSCLC) is dependent on tumor size. A population-based analysis of 10,545 stage IB NSCLC patients in the California Cancer Registry from 1989 to 2003. Chest 2008; 133: 662-669. *corresponding author. PMID:17925418

16. Zell, J. A., Ou, S-H. I., Ziogas, A., Anton-Culver, H. Survival improvements for advanced stage nonbronchioloalveolar carcinoma-type nonsmall cell lung cancer cases with ipsilateral intrapulmonary nodules. Cancer 2008; 112: 136-143. PMID:17960795

17. Ou, S.-H. I.,* Zell, J. A. Validation study of the proposed IASLC staging revisions of the T4 and M non-small cell lung cancer descriptors using data from 23,583 patients in the California Cancer Registry. J Thorac Oncol 2008; 3: 216-227. *corresponding author. PMID:18317063

18. Ou, S.-H. I.,* Zell, J. A., Ziogas, A., Anton-Culver, H. Low socio- economic status independently portends poor survival in stage I non-small-cell lung cancer. Cancer 2008; 112: 2011-2020. *corresponding author. PMID:18361399

19. Ou, S.-H. I.,* Zell, J.A. Prognostic significance of number of lymph nodes removed at lobectomy in stage IA non-small cell lung cancer (NSCLC). J Thorac Oncol 2008; 3: 880-886. *corresponding author. PMID:18670306

20. Ou, S.-H. I.,* Ziogas, A., Zell, J. A. Prognostic factors for survival in extensive stage small cell lung cancer (ED-SCLC): The importance of smoking history, socioeconomic and marital statuses, and ethnicity. J Thorac Oncol 2009; 4: 37-43. *corresponding author. PMID:19096304

21. Ou, S.-H. I.,* Zell, J. A. The applicability of the IASLC proposed staging system to small cell lung cancer (SCLC) with comparison to the current UICC 6th TNM staging system. J Thorac Oncol 2009; 4: 300-310. *corresponding author. PMID:19156001

22. Schiller, J., Larson, T., Ou, S-H. I., Limentani, S., Sandler, A., Vokes, E., Kim, S., Liau K., Bycott, P., Olszanski, A. Efficacy and safety of axitinib in patients with advanced non-small-cell lung cancer: Results from a phase II trial. J Clin Oncol 2009; 27: 3836-3841. PMID:19597027

23. Ou, S.-H. I.,* Ziogas, A., Zell, J. A. Asian ethnicity is a favorable prognostic factor for overall survival in NSCLC and is independent of smoking status. J Thorac Oncol 2009; 4: 1083-1093. *corresponding author. PMID:19652625

24. Ou, S.-H. I.,* Zell, J. A. Carcinoma NOS (not otherwise specified) is a common histologic diagnosis and is increasing in proportion among non-small-cell lung cancer (NSCLC). J Thorac Oncol 2009; 4: 1202-1211. *corresponding author. PMID:19701111

25. Ou, S.-H. I.,* Ziogas, A., Zell, J. A. A comparison study of clinicopathologic characteristics of Southern California Asian-American non-small cell lung cancer (NSCLC) patients by smoking status. J Thorac Oncol 2010; 5: 158-168. *corresponding author. PMID:20040896

26. Ou, S.-H. I.,* Ziogas, A., Zell, J. A. Primary signet-ring carcinoma (SRC) of the lung. A population-based epidemiologic study of 262 cases with comparison to adenocarcinoma of the lung. J Thorac Oncol 2010; 5: 420-427. *corresponding author. PMID:20130484

27. Kawaguchi, T., Takada, M., Kubo, A., Matsumura, A., Fukai, S., Tamura, A., Saito, R., Maruyama, Y., Kawahara, M., Ou, S.-H. I. Performance status and smoking status are independent favorable prognostic factors for survival in non-small-cell lung cancer (NSCLC). A comprehensive analysis of 26,957 NSCLC patients. J Thorac Oncol 2010; 5: 620-630. PMID:20354456

28. Kawaguchi, T., Matsumura, A., Fukai, S., Tamura, A., Saito, R., Zell, J. A., Maruyama, Y., Ziogas, A., Kawahara, M., Ou, S.-H. I.* Japanese ethnicity as compared to Caucasian ethnicity and never-smoking status are independent favorable prognostic factors for overall survival in non-small-cell lung cancer. A collaborative epidemiologic study of the National Hospital Organization Study Group for Lung Cancer (NHSGLC) in Japan and a Southern California regional Cancer Registry databases. J Thorac Oncol 2010; 5: 1001-1010. *corresponding author. PMID:20526205

29. Ahn, M-J., Lee, J., Park, Y-H., Ahn, J-S., Ziogas, A., Zell, J.A., Park, K., Ou, S.-H. I.* Korean ethnicity as compared to Caucasian ethnicity is an independent favorable prognostic factor for overall survival in NSCLC before and after the oral EGFR TKI era. J Thorac Oncol 2010; 5: 1185-1196. *corresponding author. PMID:20592628

30. Kwak, E.L., Bang, Y-J., Camidge, D.R., Shaw, A.T., Solomon, B., Maki, R.G., Ou, S.-H. I., Dezube, B.R., Jainne, P.A., Costa, D.B., Varella-Garcia, M., Kim, W-H., Lynch, T.L., Fidias, P., Stubbs, H., Engelman, J.A., Sequist, L.V., Tan, W., Gandhi, L., Mino-Kenudson, M., Wei, G.C., Shreeve, S.G., Ratain, M. J., Christensen, J. G., Haber, D. A., Wilner, K. Salgia, R., Shapiro, G. L., Clark, J.W., Iafrate, A.J. Anasplatic lymphoma kinase (ALK) inhibition in non-small-cell lung cancer. N Engl J Med 2010; 363: 1693-1703. PMID:20979469

31. Kawaguchi, T., Ando, M., Kubo, A., Takada, M., Atagi, S., Okishio, K., Asami, K., Matsumura, A., Tsujino, K., Ou, S.-H. I., Sakasi, H. Long exposure of environmental tobacco smoke associated with activating epidermal growth factor receptor mutations in never-smokers with non-small cell lung cancer. Clin Cancer Res 2011; 17: 39-45. PMID: 21059816

32. Arnold, S. M., Moon, J., Williamson, S. K., Atkins, J. N., Ou, S.-H. I., LeBlanc, M., Urba, S. G. Phase II evaluation of eribulin mesylate (E7389, NSC 707389) in patients with metastatic or recurrent squamous cell carcinoma of the head and neck: Southwest Oncology Group trial S0618. Invest New Drugs 2011; 29: 352-359. PMID: 19937365

33. Ou, S.-H. I.,* Kwak, E.L., Siwak-Tapp, C., Dy, J., Bergethon, K., Clark, J.W., Camidge, D.R., Solomon, B.J., Maki, R.G.,Bang, Y.-J., Kim, D.-W., Christensen, J., Tan, W., Wilner,K.D., Salgia, R., Iafrate, A.J. Activity of crizotinib (PF02341066), a dual mesenchymal-epithelial transition (MET) and anaplastic lymphoma kinase (ALK) inhibitor, in a non-small cell lung cancer patient with de novo MET amplification. J Thorac Oncol 2011; 6: 942-946. *corresponding author. PMID:21623265

34. Soo, R. A., Loh, M., Mok, T. S., Ou, S.-H. I., Cho, B.-C., Yeo, Tenen, D.G., Soong, R. Ethnic difference in outcome in patients with advanced stage non-small cell lung cancer. Results from a meta-analysis of randomized controlled trials. J Thorac Oncol 2011; 6: 1030-1038. PMID:21532500

35. Shaw, A. T., Yeap, B. Y., Solomon, B. J., Riely, G. J., Gainor, J., Engelman, J. A., Shapiro, G. I., Costa, D. B., Ou, S.-H. I., Butaney, M., Salgia, R., Maki, R.G., Varella-Garcia, M., Doebele, R.C., Bang, Y.-J., Kulig, K., Selaru, P., Tang, Y., Wilner, K.D., Kwak, E.L., Clark, J.W., Iafrate, A.J., Camidge, D. R. Effect of crizotinib on overall survival in patients with advanced non-small cell lung cancer harbouring ALK gene rearrangement: A retrospective analysis. Lancet Oncol 2011; 12: 1004-1012. PMID:21933749

36. Hasegawa, Y., Kawaguchi, T., Kubo, A., Ando, M., Shiraishi, J., Isa, S., Tsuji, T., Tsujino, K., Ou, S-H. I., Nakagawa, K., Takada, M. Ethnic difference in hematological toxicity in patients with non-small cell lung cancer treated with chemotherapy: a pool analysis on Asian versus non-Asian in phase II and III clinical trials. J Thorac Oncol 2011; 6: 1881-1888. PMID:21841503

37. Ou, S.-H. I.,* Azada, M., Dy, J., Stiber, J. A. Asymptomatic profound sinus bradycardia (heart-rate =< 45) in non-small cell lung cancer patients treated with crizotinib. J Thorac Oncol 2011; 6: 2135-2137. *corresponding author. PMID:22088989

38. Kurahara, Y., Kawaguchi, T., Tachibana, K., Atagi, S., Hayashi, S., Kitaichi, M., Ou, S.-H. I., Takada, M. Small-cell lung cancer in never-smokers: a case series with information on family history of cancer and environmental tobacco smoke. Clin Lung Cancer 2012; 1: 75-79. PMID:21729654

39. Bergethon, K*., Shaw, A.T*., Ou, S.-H. I.,* Katayama, R., Lovly, C. M., McDonald, N.T., Massion, P. P., Siwak-Tapp, C., Gonzalez, A., Fang, R., Mark, E., Batten, J. M., Chen, H., Wilner, K.D., Carbone, D. P., Ji, H., Engelman, J., Mino-Kenudson, M., Pao, W., Iafrate, A. J. ROS1 rearrangements define a unique class of lung cancers. J Clin Oncol 2012; 30: 863-870. *co-first authors. PMID:22215748

40. Kim, Y., Ko, J., Cui, Z., Abolhoda, A., Ahn, J.S., Ou, S-H., Ahn, M-J., Park, K. The EGFR T790M mutation in acquired resistance to an irreversible second-generation EGFR inhibitor. Mol Cancer Ther 2012; 11: 784-791. PMID:22228822

41. Yang, JC-H., Shih, J.-Y., Su, W.-C., Hsia, T.-C., Tsai, C.-M., Ou, S.-H.I., Yu, C.J., Chang, C.-C., Ho, C.-L., Sequist, L.V., Dudek, A., Shahidi, M., Cong, X.J., Lorence, R.M., Yang, P.-C., Miller, V.A. Afatinib for patients with lung adenocarcinoma and epidermal growth factor receptor mutations (LUX-Lung 2): a phase 2 trial. Lancet Oncol 2012; 13: 539-548. PMID:22452895

42. Kawaguchi, T., Tamiya, A., Tamura, A., Arao, M., Saito, R., Matsumura, A., Ou, S.-H. I., Taro Tamura, T. Chemotherapy is beneficial for elderly patients with advanced non-small-cell lung cancer: Analysis of patients aged 70-74, 75-79, and over 80 in Japan. Clin Lung Cancer 2012; 13: 442-447. PMID:22609051

43. Camidge, D.R., Bang, Y., Kwak, E. L., Iafrate, A.J., Varella-Garcia, M., Fox, S., Riely, G., B Solomon, B., Ou, S.-H. I., Kim, D.W., Salgia, R., Fidias, P., Gandhi, L., Janne, P.A., Costa, D.B., Shapiro, G.I., LoRusso, P., Ruffner, K., Stephenson, P., Tang, Y., Wilner, K., J Clark, J., Shaw, A.T. Efficacy and safety of crizotinib (PF-02341066) in patients with ALK-positive non-small cell lung cancer: updated results from the molecularly defined cohort of the first-in-man study. Lancet Oncol 2012; 10: 1011-1019. PMID:22954507

44. Lee, J., Lee, S. E., Kang, S.Y., Do, I-G., Lee, S., Ha, S. Y., Cho, J., Kang, W.K., Jang, J., Ou, S.-H. I.,* Kim, K-M. Identification of ROS1 rearrangement in gastric adenocarcinoma. Cancer 2013; 199: 1627-1635. *corresponding author. PMID:23400546

45. Ou, S.-H. I.,* Tong, W. P., Azada, M., Siwak-Tapp, C., Dy, J., Stiber, J. A. Heart rate changes during crizotinib treatment and potential correlation to clinical response. Cancer 2013; 119: 1969-1975. *corresponding author. PMID:23505007

46. Weickhardt, A. J., Doebele, R. C., Purcell, T., Bunn, P. A., Oton, A. B., Rothman, M. S., Wierman, M. E., Mok, T., Popat, S., Rabinowitz, I., Nieva, J., Novello, S., Ou, S.-H. I., Camidge, D. R. Symptomatic reduction in free testosterone levels secondary to crizotinib use in male cancer patients. Cancer 2013; 119: 2383-2390. PMID:23585220

47. Gainor, J.F., Varghese, A. M., Ou, S.-H. I, Kabraji, S., Awad, M. M., Katayama, R., Pawlak, A., Mino-Kenudson, M., Yeap, B. Y., Riely, G. J., Iafrate, A. J., Arcila, M. E., Ladanyi, M., Engelman, J. A, Dias-Santagata, D., Shaw, A. T. ALK rearrangements are mutually exclusive with mutations in EGFR or KRAS: an analysis of 1683 patients with non-small cell lung cancer. Clin Cancer Res 2013; 19: 4273-4281. PMID:23729361

48. Kim, H.R., Lim, S.M., Kim, H.J., Hwang, S.K., Park, J.K., Shin, E., Bae, M.K., Ou, S.H., Wang, J., Jewell, S.S., Kang, D.R., Soo, R.A., Haack, H., Kim, J.H., Shim, H.S., Cho, B.C. The frequency and impact of ROS1 rearrangement on clinical outcomes in never smokers with lung adenocarcinoma. Ann Oncol 2013; 24: 2364-2370. PMID:23788756

49. Ha, S.Y., Lee, J., Kang, S.Y., Do, I.-G., Ahn, S., Park, J.O., Kang, W.K., Choi, M.G., Sohn, T.S., Bae, J.M., Kim, S., Kim, M., Kim, S., Park, C.K., Ou, S.-H. I., Kim, K.-M. MET overexpression assessed by new interpretation method predicts gene amplification and poor survival in advanced gastric carcinomas. Mod Pathol 2013; 26: 1632-1641. PMID:23807774

50. Tsujino, K., Kurata, T., Yamamoto, S., Kawaguchi, T., Kubo, A., Isa, S., Hasegawa, Y., Ou, S. H. I., Takada, M., Ando, M. Is consolidation chemotherapy after concurrent chemo-radiotherapy beneficial for patients with locally advanced non-small-cell lung cancer? A pooled analysis of the literature. J Thorac Oncol 2013; 8: 1181-1189. PMID:23883782

51. Gainor, J. F., Ou, S.-H. I., Logan, J., Borges, L. F., Shaw, A. T. The central nervous system as a sanctuary site in ALK-positive non–small-cell lung cancer. J Thorac Oncol 2013; 8: 1570-1573. PMID:24389440

52. Hasegawa, Y., Ando, M., Kubo, A., Isa, S.I., Yamamoto, S., Tsujino, K., Kurata, T., Ou, S.-H. I., Takada, M., Kawaguchi, T. Human papilloma virus in non-small cell lung cancer in never smokers: A systematic review of the literature. Lung Cancer 2014; 83: 8-13. PMID: 24252423

53. Ou, S.-H. I.,* Janne, P. A., Bartlett, C. H., Tang, Y., Kim, D. W., Otterson, G. A., Crino, L., Selaru, P., Cohen, D. P., Clark, J. W., Riely, G. C. Clinical benefit of continuing ALK inhibition with crizotinib beyond initial disease progression in patients with advanced ALK-positive NSCLC. Ann Oncol 2014; 25: 415-422. *corresponding author. PMID:24478318

54. Ou, S-H. I.,* Azada, M., Hsiang, D. J., Herman, J. M., Kain, T. S., Siwak-Tapp, C., Casey, C., He, J., Ali, S. M., Klempner, S. J., Miller, V. A. Next generation sequencing reveals a novel NSCLC ALK F1174V mutation and confirms ALK G1202R mutation confers high-level resistance to alectinib (CH5424802/RO5424802) in ALK-rearranged NSCLC patients who progressed on crizotinib. J Thorac Oncol 2014; 9: 549-553. *corresponding author. PMID:24736079

55. Locati, L. D., Licitra, L., Agate, L., Ou, S.-H. I., Boucher, A., Jarzab, B., Qin, S., Kane, M. A., Wirth, L. J., Chen, C., Kim, S., Ingrosso, A., Pithavala, Y., Bycott, P., Cohen, E. E. W. Treatment of advanced thyroid cancer With axitinib: Phase 2 study with pharmacokinetic/ pharmacodynamic and quality-of-life assessments. Cancer 2014; 120: 2694-2703. PMID:24844950

56. Gadgeel, S. M., Gandhi, L.,Riely, G. J., Chiappori, A. A., West, H. L., Azada, M. A., Morcos, P. N., Lee, R.-M., Garcia, L., Yu, L., Boisserie, F., Di Laurenzio, L., Golding, S., Sato, J., Yokoyama, S., Tanaka, T., Ou, S.-H. I.* Alectinib activity against systemic disease and brain metastases in crizotinib-resistant ALK–rearranged non-small-cell lung cancer (NSCLC) patients: Results from the dose-finding portion of a phase 1/2 study (AF-002JG). Lancet Oncol 2014; 15: 1119-1128. *corresponding author. PMID: 25153538

57. Ou, S.-H. I.,* Klempner, S. J. , Greenbowe, J. R., Azada, M., Schrock, A. B., Ali, S. M., Ross, J. S., Stephens, P. J., Miller, V. A. Identification of a novel HIP1-ALK fusion variant in non-small-cell lung cancer (NSCLC) and discovery of ALK I1171 (I1171N/S) mutations in two ALK-rearranged NSCLC patients with resistance to alectinib. J Thorac Oncol 2014; 9: 1821-1825.*corresponding author. PMID: 25393796

58. Shaw, A. T., Ou, S.-H. I.,* Bang, Y.-J., Camidge, D. R., Solomon, B. J., Salgia, R., Riely, G. J., Varella-Garcia, M., Shapiro, G. I., Costa, D. B., Doebele, R. C., Le, L. P., Zheng, Z., Weiwei Tan, W., Stephenson, P., Shreeve, S. M., Tye, L. M., Christensen, J. G., Wilner, K. D., Clark, J. W., Iafrate, A. J.. Crizotinib in ROS1-rearranged non-small cell lung cancer. N Engl J Med 2014; 371: 1963-1971. *co-first author. PMID: 25264305

59. Jänne, P. A. Ou, S.-H. I., Kim, D.-W., Oxnard, G. R., Martins, R., Kris, M. G., Dunphy, F., Nishio, M., O’Connell, J., Paweletz, C., Taylor, I., Zhang, H., Goldberg, Z., Mok, T. Phase 2 trial of dacomitinib as initial treatment in patients with clinically and/or molecularly selected advanced non-small cell lung cancer. Lancet Oncol 2014; 15: 1433-1441. PMID: 25456362

60. Ou, S.-H. I.,* Moon, J., Garland, L. L., Mack, P. C., Testa, J. R., Tsao, A. S., Wozniak, A. J., Gandara, D. R. SWOG S0722: Phase II study of mTOR inhibitor everolimus (RAD001) in advanced malignant pleural mesothelioma (MPM). J Thorac Oncol 2015; 10: 387-391. *corresponding author. PMID: 25611229

61. Hasegawa, Y., Ando, M., Maemondo, M., Yamamoto, S., Isa, S.I., Saka, H., Kubo, A., Kawaguchi, T., Takada, M., Rosell, R., Kurata, T., Ou, S.-H. I.* The role of smoking status on the progression-free survival of non-small-cell lung cancer patients harboring activating epidermal growth factor receptor (EGFR) mutations receiving first-line EGFR tyrosine kinase inhibitor versus platinum double chemotherapy: A meta-analysis of prospective randomized trials. Oncologist 2015; 20: 307-315. *corresponding author. PMID: 25657199

62. Costa, D. B., Shaw, A. T., Ou, S.-H. I., Solomon, B. J., Riely, G. J., Ahn, M. J., Zhou, C., Shreeve, S. M., Selaru, P., Polli, A., Schnell, P., Wilner, K. D., Wiltshire, R., Camidge, D. R., Crinò, L. Clinical Experience With Crizotinib in Patients With Advanced ALK-Rearranged Non-Small-Cell Lung Cancer and Brain Metastases. J Clin Oncol 2015 Jan 26. pii: JCO.2014.59.0539. [Epub ahead of print]. PMID: 25624436

63. Ali, S. M., Sanford, E. M., Klempner, S. J., Rubinson, D. A., Wang, K., Palma, N. A., Chmielecki, J., Yelensky, R., Palmer, G. A., Morosini, D., Lipson, D., Catenacci, D. V., Braiteh, F., Erlich, R., Stephens, P. J., Ross, J. S., Ou, S.-H. I., Miller, V. A. Prospective comprehensive genomic profiling of advanced gastric carcinoma cases reveals frequent clinically relevant genomic alterations and new routes for targeted therapies. Oncologist 2015 Apr 16. pii: theoncologist.2014-0378. [Epub ahead of print]. PMID: 25882375

64. Frampton GM, Ali SM2Rosenzweig M, Chmielecki J, Lu X, Bauer TM, Akimov M, Bufill J, Lee C, Jentz D, Hoover R, Ou SHI, Salgia R, Brennan T, Chalmers Z, Elvin JA, Erlich R, Fichtenholtz A, Gowen KA, Greenbowe J, Johnson A, Khaira D, McMahon C, Sanford EM, Roels S, White J, Lipson D, Yelensky R2Morosini D, Ross JS, Collisson E, Peters M, Stephens PJ, Miller VA. Activation of MET via diverse exon 14 splicing alterations occurs in multiple tumor types and confers clinical sensitivity to MET inhibitors. Cancer Discov. 2015 May 13. pii: CD-15-0285. [Epub ahead of print]. PMID: 25971938
Letter to editors

1. Ou, S.-H. I. Re: A prospective, molecular epidemiology studyof EGFR mutations in Asian patients with advanced non-small-cell lung cancer of adenocarcinoma histology (PIONEER). J Thorac Oncol 2014; 9: e57-8. PMID:24926558

Response to Letter to editors

1. Zell, J. A., Ou, S-H. I., Ziogas, A., Anton-Culver, H. In reply: Overestimating the influence of the 1999 WHO classification of lung tumors on survival in bronchioloalveloar carcinoma. J Clin Oncol 2006; 24: 1963-1964

2. Ou, S.-H. I.,* Zell, J. A. Response: Non-sized-based descriptors in staging of stage I non-small cell lung cancer. Chest 2008; 134: 673-674. *corresponding author

3. Ou, S.-H. I.,* Zell, J. A. Response: Non-sized-based descriptors in staging of stage I non-small cell lung cancer. Chest 2009; 135: 1695-1696. *corresponding author

4. Ou, S.-H. I.,* Zell, J. A. Response: Prognostic factors for survival in extensive stage small cell lung cancer (ED-SCLC): The importance of smoking history, socioeconomic and marital statuses, and ethnicity. J Thorac Oncol 2009; 4: 1041-0142. *corresponding author

5. Ou, S.-H. I.,* Janne, P. Reply to "Letter to the editor on "Clinical benefit of continuing ALK inhibition with crizotinib beyond initial disease progression in patients with advanced ALK-positive NSCLC". Ann Oncol 2014; 25: 2093. *corresponding author. PMID:2503527
Case report

1. Petti, C. A., Ou, S.-H. I., Sexton, D. J. Acute terminal ileitis associated with pneumococcal bacteremia: case report and review of pneumococcal gastrointestinal diseases. Clin Infectious Diseases 2002; 34: e50-e53. PMID:11981747

2. Zell, J. A., Yoon E. J., Ou, S.-H. I., Hoefs, J. C., and Chang, J.C. Precore mutant hepatitis B reactivation after treatment with CHOP-rituximab. Anti-cancer Drugs 2005; 16: 83-85. PMID:15613909

3. Feinberg, S. M., Ou, S.-H. I., Gu, M., Shibuya, T. Y. Burkitt’s lymphoma of the base of tongue: a case report and review of the literature. Ear, Nose and Throat Journal 2007; 6: 356-360. PMID:17703817

4. Ou, S.-H. I.,* Bazhenova, L., Camidge, D.R., Solomon, B.J., Herman, J., Kain, T., Bang, Y.-J., Kwak, E.L., Shaw, A. T., Salgia, R., Maki, R.G., Clark, J.W., Wilner, K.D., Iafrate, A.J. Rapid and dramatic radiographic and clinical response to an ALK inhibitor (crizotinib, PF02341066) in an ALK translocation-positive patient with non-small cell lung cancer. J Thorac Oncol 2010; 5: 2044-2046. *corresponding author. PMID:21102269

5. Klempner, S. J., Aubin, G., Dash, A., Ou, S.-H. I.* Spontaneous regression of crizotinib-associated complex renal cysts during continuous crizotinib treatment. Oncologist 2014; 19: 1008-1010. *corresponding author. PMID:25096999

6. Lu, S., Azada, M., Ou, S.-H. I.* Choroidal metastasis response to crizotinib in a ROS1-rearranged NSCLC patient. Lung Cancer 2015; 87: 207-209. *corresponding author. PMID: 25558789

7. Ou, S.-H. I.,* Sommers, K. R., Azada, M. C., Garon, E. B. Alectinib Induces a durable (>15 months) complete response in an ALK-positive non-small cell lung cancer patient who progressed on crizotinib with diffuse leptomeningeal carcinomatosis. Oncologist 2015; 20: 224-226. *corresponding author. PMID: 25568147

8. Ou, S.-H. I.,* Greenbowe, J., Khan, Z. U., Azada, M. C., Ross, J. C., Stephens, P. J., Ali, S. M., Miller, V. A., Gitlitz, B. J. I1171 missense mutation (particularly I1171N) is a common resistance mutation in ALK-positive NSCLC patients who have progressive disease while on alectinib and is sensitive to ceritinib. Lung Cancer 2015; 88: 231-234. *corresponding author. PMID: 25736571

9. Ou, S.-H.I.,* Chalmers, Z. R., Azada, M. C., Ross, J. S., Stephens, P. J., Ali, S. M. , Miller, V. A. Identification of a novel TMEM106B-ROS1 fusion variant in lung adenocarcinoma by comprehensive genomic profiling. Lung Cancer 2015 Mar 21. *corresponding author. PMID: 25851827

10. Ou, S.-H. I.,* Klempner, S. J., Azada, M. C., Rausei-Mills, V., Duma, C. Radiation necrosis presenting as pseudoprogression (PsP) during alectinib treatment of previously radiated brain metastases in ALK-positive NSCLC: Implications for disease assessment and management. Lung Cancer. 2015 Mar 30. pii: S0169-5002(15)00174-9. doi: 10.1016/j.lungcan.2015.03.022. [Epub ahead of print]. *corresponding author. PMID: 25882777
Editorial

1. Zell, J. A. Ou, S.-H. I. Implications of prognostication in non-small cell lung cancer. J Thorac Oncol 2009; 4: 785-786. PMID:19550241

Research Highlights

1. Rosell, R., Karachaliou, N., Wolf, J., Ou, S.-H. I. ALK and ROS1 non-small-cell lung cancer: two molecular subgroups sensitive to targeted therapy. Lancet Respir Med 2014; 2: 966-968. PMID: 25466349

Invited Commentary

1. Ou, S.-H. I., Holcombe, R. F. Capecitabine in advanced gastric and oesophagogastric cancer. Drugs 2007; 67: 611-612. PMID:17352521

Perspective

1. Ou, S.-H. I. Keeping our fingers crossed on 2nd generation EGFR TKIs: is better good enough? Transl Lung Cancer Res 2013;2(1):55-57. DOI: 10.3978/j.issn.2218-6751.2012.09.10
Review article (peer review)

1. Ou, S.-H. I., Ho, C. Treatment of advanced lung cancer. Clinical Pulmonary Medicine 2009; 16: 157-171. DOI: 10.1097/CPM.0b013e3181a3dbba

2. Ou, S.-H. I.,* Kawaguchi, T., Soo, R.A., Kitaichi, M. Rare subtype of adenocarcinoma of the lung. Expert Rev Anticancer Ther 2011; 11: 1535-1542. *corresponding author. PMID:21999127

3. Ou, S.-H. I. Crizotinib: a novel and first-in-class multi-targeted tyrosine kinase inhibitor for the treatment of anaplastic lymphoma kinase (ALK) rearranged non-small cell lung cancer (NSCLC) and beyond. Drug Des Devel Ther 2011; 5: 471-485. PMID:22162641

4. Ou, S.-H. I. Second-generation irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs): A better mousetrap? A review of the clinical evidence. Crit Rev Oncol Hematol 2012; 83: 407-421. PMID:22257651

5. Soo, R.A., Kawaguchi, T., Loh, M., Ou, S.-H. I., Shieh, M. P., Cho, B.-C., Mok, T.S., Soong, R. Differences in outcome and toxicity between Asian and Caucasian patients with lung cancer treated with systemic therapy. Future Oncol 2012; 4: 451-462. PMID:22515448

6. Ou, S.-H. I. Crizotinib (PF02341066) for the treatment of ALK-rearranged NSCLC-a drug that crystallizes a unique molecular subset of NSCLC and highlights its signaling pathways. Expert Rev Anticancer Ther 2012; 12: 151-162. PMID:22316363

7. Ou, S.-H, I.,* Tan, J., Yen, Y., Soo, R. A. ROS1 as a “druggable” receptor tyrosine kinase: lessons learned from inhibiting the ALK pathway. Expert Rev Anticancer Ther 2012; 12: 447-456. *corresponding author. PMID:22500682

8. Ou, S.-H. I., Huang-Bartlett C., Mino-Kenudson, M., Cui, J., Iafrate, A.J. Crizotinib for the treatment of ALK-rearranged non-small cell lung cancer: A success story to usher in the second decade of molecular targeted therapy in oncology. Oncologist 2012; 7: 1351-1375. *corresponding author. PMID:22989574

9. Chin, L.P., Soo, R.A., Soong, R., Ou, S.-H. I. Targeting ROS1 with Anaplastic Lymphoma Kinase Inhibitors: A Promising Therapeutic Strategy for a Newly Defined Molecular Subset of Non-Small-Cell Lung Cancer. J Thorac Oncol 2012; 7: 1625-1630. PMID:23070242

10. Ou, S.-H. I. Lung cancer in never-smokers. Does smoking history matter in the era of molecular diagnostics and targeted therapy? J Clin Pathol 2013; 66: 839-846. PMID:23661716

11. Lee, J., Ou, S.-H. I.* Towards the goal of personalized medicine in gastric cancer -- time to move beyond HER2 inhibition. Part I: Targeting receptor tyrosine kinase gene amplification. Discov Med 2013; 15: 333-341. *corresponding author. PMID:23819947

12. Lee, J., Ou, S.-H. I.* Towards the goal of personalized medicine in gastric cancer -- time to move beyond HER2 inhibition. Part II: Targeting gene mutations and gene amplifications and the angiogenesis pathway. Discov Med 2013; 16: 7-14. *corresponding author. PMID:23911227

13. Ou, S.-H. I.* Republished: Lung cancer in never-smokers. Does smoking history matter in the era of molecular diagnostics and targeted therapy? Postgrad Med J 2014; 90: 228-235. *corresponding author. PMID:24643262

14. Ou, S.-H. I.,* Soo, R. A., Kubo, A., Kawaguchi, T., Ahn, M.-J. Will the requirement by the US FDA to simultaneously co-develop companion diagnostics (CDx) delay the approval of receptor tyrosine kinase inhibitors for RTK-rearranged (ROS1-, RET-, AXL-, PDGFR-a-, NTRK1-) non-small cell lung cancer globally? Front Oncol 2014 Apr 1;4:58| doi: 10.3389/fonc.2014.00058. *corresponding author. PMID:24744988

15. Lee, J., Kim, K. M., Kang, W. K., Ou, S.-H. I.* Innovative Personalized Medicine in Gastric Cancer: Time to move forward. Clin Genet 2014; 86: 37-43. *corresponding author. PMID:2474994

16. Klempner SJ, Ou SHI, Costa DB, VanderLaan PA, Sanford EM, Schrock A, Gay L, Ali SM, Miller VA. The clinical use of genomic profiling to distinguish intrapulmonary metastases from synchronous primaries in non-small-cell lung cancer: A mini-review. Clin Lung Cancer 2015 Mar 26. pii: S1525-7304(15)00077-7. doi: 10.1016/j.cllc.2015.03.004. [Epub ahead of print].
Book Chapters
1. Ou, S.-H. I., Wu, F., Gaynor, R. B. 1995. Analysis of HIV-1 LTR DNA binding proteins. Pages 211-230. HIV: A practical Approach. Volume 2. Biochemistry, molecular biology and drug discovery. Edited by J. Karn. IRL Press at Oxford University Press.

2. Ou, S.-H. Ignatius., Gaynor, Richard B. 1995. Intracellular factors involved in gene expression of human retroviruses. Pages 97-184. The Retroviridae, Volume 4, edited by Jay A. Levy, Plenum Press, New York.
Professional Societies
American Society of Clinical Oncology (ASCO)
National Surgical Adjuvant Breast and Bowel Project
Southwest Oncology Group (SWOG)
American College of Surgeons Oncology Group
European Society of Medical Oncology (ESMO)
International Association for the Study of Lung Cancer
Medical Oncology Association of Southern California (MOASC)
Other Experience
Intern, Internal Medicine
Duke University Medical Center, Durham, NC 1997—1998
Resident, Internal Medicine
Duke University Medical Center, Durham, NC 1998—2000
Fellow, Hematolgy/Oncology
Beth Israel Deaconess Medical Center, Harvard Medical School 2000—2003
Research Centers
Chao Family Comprehensive Cancer Center
Last updated
10/15/2021