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Items: 21


Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Organ Dysfunction, Prior or Concurrent Malignancy, and Comorbidities Working Group.

Lichtman SM, Harvey RD, Damiette Smit MA, Rahman A, Thompson MA, Roach N, Schenkel C, Bruinooge SS, Cortazar P, Walker D, Fehrenbacher L.

J Clin Oncol. 2017 Nov 20;35(33):3753-3759. doi: 10.1200/JCO.2017.74.4102. Epub 2017 Oct 2.


Neoadjuvant breast cancer therapy and drug development.

Cortazar P, Kluetz PG.

Clin Adv Hematol Oncol. 2015 Nov;13(11):755-61. Review.


Neoadjuvant Therapy As a Platform for Drug Development: Current Controversies and Regulatory Perspectives.

Amiri-Kordestani L, Beaver JA, Cortazar P.

Oncology (Williston Park). 2015 Nov;29(11):843-4, 846. No abstract available.


FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer.

Beaver JA, Amiri-Kordestani L, Charlab R, Chen W, Palmby T, Tilley A, Zirkelbach JF, Yu J, Liu Q, Zhao L, Crich J, Chen XH, Hughes M, Bloomquist E, Tang S, Sridhara R, Kluetz PG, Kim G, Ibrahim A, Pazdur R, Cortazar P.

Clin Cancer Res. 2015 Nov 1;21(21):4760-6. doi: 10.1158/1078-0432.CCR-15-1185. Epub 2015 Aug 31. Review.


Pathological complete response in neoadjuvant treatment of breast cancer.

Cortazar P, Geyer CE Jr.

Ann Surg Oncol. 2015 May;22(5):1441-6. doi: 10.1245/s10434-015-4404-8. Epub 2015 Mar 2.


Pathological complete response in breast cancer--authors' reply.

Cortazar P, Geyer CE Jr, Gianni L, Cameron D, von Minckwitz G.

Lancet. 2015 Jan 10;385(9963):114-5. doi: 10.1016/S0140-6736(15)60018-6. No abstract available.


First FDA approval of neoadjuvant therapy for breast cancer: pertuzumab for the treatment of patients with HER2-positive breast cancer.

Amiri-Kordestani L, Wedam S, Zhang L, Tang S, Tilley A, Ibrahim A, Justice R, Pazdur R, Cortazar P.

Clin Cancer Res. 2014 Nov 1;20(21):5359-64. doi: 10.1158/1078-0432.CCR-14-1268. Epub 2014 Sep 9. Review.


FDA approval: ado-trastuzumab emtansine for the treatment of patients with HER2-positive metastatic breast cancer.

Amiri-Kordestani L, Blumenthal GM, Xu QC, Zhang L, Tang SW, Ha L, Weinberg WC, Chi B, Candau-Chacon R, Hughes P, Russell AM, Miksinski SP, Chen XH, McGuinn WD, Palmby T, Schrieber SJ, Liu Q, Wang J, Song P, Mehrotra N, Skarupa L, Clouse K, Al-Hakim A, Sridhara R, Ibrahim A, Justice R, Pazdur R, Cortazar P.

Clin Cancer Res. 2014 Sep 1;20(17):4436-41. doi: 10.1158/1078-0432.CCR-14-0012. Epub 2014 May 30.


American Society of Clinical Oncology perspective: Raising the bar for clinical trials by defining clinically meaningful outcomes.

Ellis LM, Bernstein DS, Voest EE, Berlin JD, Sargent D, Cortazar P, Garrett-Mayer E, Herbst RS, Lilenbaum RC, Sima C, Venook AP, Gonen M, Schilsky RL, Meropol NJ, Schnipper LE.

J Clin Oncol. 2014 Apr 20;32(12):1277-80. doi: 10.1200/JCO.2013.53.8009. Epub 2014 Mar 17. No abstract available.


Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis.

Cortazar P, Zhang L, Untch M, Mehta K, Costantino JP, Wolmark N, Bonnefoi H, Cameron D, Gianni L, Valagussa P, Swain SM, Prowell T, Loibl S, Wickerham DL, Bogaerts J, Baselga J, Perou C, Blumenthal G, Blohmer J, Mamounas EP, Bergh J, Semiglazov V, Justice R, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching PA, Slaets L, Tang S, Gerber B, Geyer CE Jr, Pazdur R, Ditsch N, Rastogi P, Eiermann W, von Minckwitz G.

Lancet. 2014 Jul 12;384(9938):164-72. doi: 10.1016/S0140-6736(13)62422-8. Epub 2014 Feb 14. Review. Erratum in: Lancet. 2019 Mar 9;393(10175):986.


Exposure-response relationship of T-DM1: insight into dose optimization for patients with HER2-positive metastatic breast cancer.

Wang J, Song P, Schrieber S, Liu Q, Xu Q, Blumenthal G, Amiri Kordestani L, Cortazar P, Ibrahim A, Justice R, Wang Y, Tang S, Booth B, Mehrotra N, Rahman A.

Clin Pharmacol Ther. 2014 May;95(5):558-64. doi: 10.1038/clpt.2014.24. Epub 2014 Jan 31.


First FDA approval of dual anti-HER2 regimen: pertuzumab in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer.

Blumenthal GM, Scher NS, Cortazar P, Chattopadhyay S, Tang S, Song P, Liu Q, Ringgold K, Pilaro AM, Tilley A, King KE, Graham L, Rellahan BL, Weinberg WC, Chi B, Thomas C, Hughes P, Ibrahim A, Justice R, Pazdur R.

Clin Cancer Res. 2013 Sep 15;19(18):4911-6. doi: 10.1158/1078-0432.CCR-13-1212. Epub 2013 Jun 25.


FDA approval summary: sunitinib for the treatment of progressive well-differentiated locally advanced or metastatic pancreatic neuroendocrine tumors.

Blumenthal GM, Cortazar P, Zhang JJ, Tang S, Sridhara R, Murgo A, Justice R, Pazdur R.

Oncologist. 2012;17(8):1108-13. doi: 10.1634/theoncologist.2012-0044. Epub 2012 Jul 26.


Overestimation of the effect size in group sequential trials.

Zhang JJ, Blumenthal GM, He K, Tang S, Cortazar P, Sridhara R.

Clin Cancer Res. 2012 Sep 15;18(18):4872-6. doi: 10.1158/1078-0432.CCR-11-3118. Epub 2012 Jul 2.


US Food and Drug Administration approval overview in metastatic breast cancer.

Cortazar P, Justice R, Johnson J, Sridhara R, Keegan P, Pazdur R.

J Clin Oncol. 2012 May 10;30(14):1705-11. doi: 10.1200/JCO.2011.39.2613. Epub 2012 Mar 19. Review. No abstract available.


Approval summary: pemetrexed maintenance therapy of advanced/metastatic nonsquamous, non-small cell lung cancer (NSCLC).

Cohen MH, Cortazar P, Justice R, Pazdur R.

Oncologist. 2010;15(12):1352-8. doi: 10.1634/theoncologist.2010-0224. Epub 2010 Dec 10.


Approval summary: imatinib mesylate in the adjuvant treatment of malignant gastrointestinal stromal tumors.

Cohen MH, Cortazar P, Justice R, Pazdur R.

Oncologist. 2010;15(3):300-7. doi: 10.1634/theoncologist.2009-0120. Epub 2010 Mar 3.


Developing drugs to decrease the toxicity of chemotherapy.

Williams G, Cortazar P, Pazdur R.

J Clin Oncol. 2001 Jul 15;19(14):3439-41. No abstract available.


Second lung cancers in patients successfully treated for lung cancer.

Johnson BE, Cortazar P, Chute JP.

Semin Oncol. 1997 Aug;24(4):492-9. Review.


Survival of patients with limited-stage small cell lung cancer treated with individualized chemotherapy selected by in vitro drug sensitivity testing.

Cortazar P, Gazdar AF, Woods E, Russell E, Steinberg SM, Williams J, Ihde DC, Johnson BE.

Clin Cancer Res. 1997 May;3(5):741-7.

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