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Items: 34

1.

Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials.

Bottomley A, Pe M, Sloan J, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Moinpour CM, Musoro JZ, O'Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Smith AW, Soltys KM, Sridhara R, Taphoorn MJB, Velikova G, Coens C; Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) Consortium.

Clin Trials. 2018 Aug 24:1740774518795637. doi: 10.1177/1740774518795637. [Epub ahead of print]

PMID:
30141714
2.

Metastasis-free Survival - A New End Point in Prostate Cancer Trials.

Beaver JA, Kluetz PG, Pazdur R.

N Engl J Med. 2018 Jun 28;378(26):2458-2460. doi: 10.1056/NEJMp1805966. No abstract available.

3.

Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop.

Kluetz PG, Kanapuru B, Lemery S, Johnson LL, Fiero MH, Arscott K, Barbachano Y, Basch E, Campbell M, Cappelleri JC, Cella D, Cleeland C, Coens C, Daniels S, Denlinger CS, Fairclough DL, Hillard JR, Minasian L, Mitchell SA, O'Connor D, Patel S, Rubin EH, Ryden A, Soltys K, Sridhara R, Thanarajasingam G, Velikova G, Coons SJ.

Value Health. 2018 Jun;21(6):742-747. doi: 10.1016/j.jval.2017.09.009. Epub 2017 Nov 7.

PMID:
29909880
4.

Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies.

Thanarajasingam G, Minasian LM, Baron F, Cavalli F, De Claro RA, Dueck AC, El-Galaly TC, Everest N, Geissler J, Gisselbrecht C, Gribben J, Horowitz M, Ivy SP, Jacobson CA, Keating A, Kluetz PG, Krauss A, Kwong YL, Little RF, Mahon FX, Matasar MJ, Mateos MV, McCullough K, Miller RS, Mohty M, Moreau P, Morton LM, Nagai S, Rule S, Sloan J, Sonneveld P, Thompson CA, Tzogani K, van Leeuwen FE, Velikova G, Villa D, Wingard JR, Wintrich S, Seymour JF, Habermann TM.

Lancet Haematol. 2018 Jun 12. pii: S2352-3026(18)30051-6. doi: 10.1016/S2352-3026(18)30051-6. [Epub ahead of print] Review.

PMID:
29907552
5.

Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada.

Kluetz PG, O'Connor DJ, Soltys K.

Lancet Oncol. 2018 May;19(5):e267-e274. doi: 10.1016/S1470-2045(18)30097-4. Review.

PMID:
29726391
6.

FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy.

Ison G, Howie LJ, Amiri-Kordestani L, Zhang L, Tang S, Sridhara R, Pierre V, Charlab R, Ramamoorthy A, Song P, Li F, Yu J, Manheng W, Palmby TR, Ghosh S, Horne HN, Lee EY, Philip R, Dave K, Chen XH, Kelly SL, Janoria KG, Banerjee A, Eradiri O, Dinin J, Goldberg KB, Pierce WF, Ibrahim A, Kluetz PG, Blumenthal GM, Beaver JA, Pazdur R.

Clin Cancer Res. 2018 Sep 1;24(17):4066-4071. doi: 10.1158/1078-0432.CCR-18-0042. Epub 2018 Apr 12.

PMID:
29650751
7.

U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer.

Singh H, Walker AJ, Amiri-Kordestani L, Cheng J, Tang S, Balcazar P, Barnett-Ringgold K, Palmby TR, Cao X, Zheng N, Liu Q, Yu J, Pierce WF, Daniels SR, Sridhara R, Ibrahim A, Kluetz PG, Blumenthal GM, Beaver JA, Pazdur R.

Clin Cancer Res. 2018 Aug 1;24(15):3486-3491. doi: 10.1158/1078-0432.CCR-17-3628. Epub 2018 Mar 9.

PMID:
29523624
8.

A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.

Beaver JA, Howie LJ, Pelosof L, Kim T, Liu J, Goldberg KB, Sridhara R, Blumenthal GM, Farrell AT, Keegan P, Pazdur R, Kluetz PG.

JAMA Oncol. 2018 Jun 1;4(6):849-856. doi: 10.1001/jamaoncol.2017.5618.

PMID:
29494733
9.

Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections.

Kim J, Singh H, Ayalew K, Borror K, Campbell M, Johnson LL, Karesh A, Khin NA, Less JR, Menikoff J, Minasian L, Mitchell SA, Papadopoulos EJ, Piekarz RL, Prohaska KA, Thompson S, Sridhara R, Pazdur R, Kluetz PG.

Clin Cancer Res. 2018 Apr 15;24(8):1780-1784. doi: 10.1158/1078-0432.CCR-17-2555. Epub 2017 Dec 13.

PMID:
29237718
10.

Clinical Development of Cancer Drugs in Combination With External Beam Radiation Therapy: US Food and Drug Administration Perspective.

Walker AJ, Kim H, Saber H, Kluetz PG, Kim G, Pazdur R.

Int J Radiat Oncol Biol Phys. 2017 May 1;98(1):5-7. doi: 10.1016/j.ijrobp.2016.12.037. No abstract available.

PMID:
28587052
11.

Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies.

Blumenthal GM, Kluetz PG, Schneider J, Goldberg KB, McKee AE, Pazdur R.

Oncologist. 2017 Jul;22(7):762-767. doi: 10.1634/theoncologist.2017-0152. Epub 2017 Jun 2. No abstract available.

12.

Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials-Response.

Kluetz PG, Papadopoulos EJ, Johnson LL, Donoghue M, Kwitkowski VE, Chen WH, Sridhara R, Farrell AT, Keegan P, Kim G, Pazdur R.

Clin Cancer Res. 2016 Nov 15;22(22):5618. doi: 10.1158/1078-0432.CCR-16-2140. No abstract available.

13.

U.S. Food and Drug Administration Approval: Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma.

Singh H, Brave M, Beaver JA, Cheng J, Tang S, Zahalka E, Palmby TR, Venugopal R, Song P, Liu Q, Liu C, Yu J, Chen XH, Wang X, Wang Y, Kluetz PG, Daniels SR, Papadopoulos EJ, Sridhara R, McKee AE, Ibrahim A, Kim G, Pazdur R.

Clin Cancer Res. 2017 Jan 15;23(2):330-335. doi: 10.1158/1078-0432.CCR-16-1073. Epub 2016 Oct 28.

14.

Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards.

Bottomley A, Pe M, Sloan J, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Moinpour CM, Musoro J, O'Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Smith AW, Soltys KM, Taphoorn MJ, Velikova G, Coens C; Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) consortium.

Lancet Oncol. 2016 Nov;17(11):e510-e514. doi: 10.1016/S1470-2045(16)30510-1. Epub 2016 Oct 18. Review.

15.

FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer.

Walker AJ, Wedam S, Amiri-Kordestani L, Bloomquist E, Tang S, Sridhara R, Chen W, Palmby TR, Fourie Zirkelbach J, Fu W, Liu Q, Tilley A, Kim G, Kluetz PG, McKee AE, Pazdur R.

Clin Cancer Res. 2016 Oct 15;22(20):4968-4972. Epub 2016 Jul 12.

17.

Neoadjuvant breast cancer therapy and drug development.

Cortazar P, Kluetz PG.

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

PMID:
27058702
18.

Looking to the future in an unprecedented time for cancer drug development.

Kluetz PG, Pazdur R.

Semin Oncol. 2016 Feb;43(1):2-3. doi: 10.1053/j.seminoncol.2016.01.001. Epub 2016 Jan 15.

PMID:
26970117
19.

Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms.

Kluetz PG, Slagle A, Papadopoulos EJ, Johnson LL, Donoghue M, Kwitkowski VE, Chen WH, Sridhara R, Farrell AT, Keegan P, Kim G, Pazdur R.

Clin Cancer Res. 2016 Apr 1;22(7):1553-8. doi: 10.1158/1078-0432.CCR-15-2035. Epub 2016 Jan 12.

20.

Expansion Cohorts in First-in-Human Solid Tumor Oncology Trials.

Theoret MR, Pai-Scherf LH, Chuk MK, Prowell TM, Balasubramaniam S, Kim T, Kim G, Kluetz PG, Keegan P, Pazdur R.

Clin Cancer Res. 2015 Oct 15;21(20):4545-51. doi: 10.1158/1078-0432.CCR-14-3244.

21.

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.

22.

Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.

Basch E, Geoghegan C, Coons SJ, Gnanasakthy A, Slagle AF, Papadopoulos EJ, Kluetz PG.

JAMA Oncol. 2015 Jun;1(3):375-9. doi: 10.1001/jamaoncol.2015.0530. Review.

PMID:
26181187
23.

Reply by the authors.

Jarow J, Kluetz PG, Lerner SP, Liu K, Sridhara R, Bajorin D, Chang S, Dinney CP, Groshen S, Morton RA, O'Donnell M, Quale DZ, Schoenberg M, Seigne J, Vikram B.

Urology. 2014 Aug;84(2):495-6. doi: 10.1016/j.urology.2014.04.004. No abstract available.

PMID:
25065996
24.

Under-representation of racial minorities in prostate cancer studies submitted to the US Food and Drug Administration to support potential marketing approval, 1993-2013.

Wissing MD, Kluetz PG, Ning YM, Bull J, Merenda C, Murgo AJ, Pazdur R.

Cancer. 2014 Oct 1;120(19):3025-32. doi: 10.1002/cncr.28809. Epub 2014 Jun 25.

25.

Drug and device development for localized prostate cancer: report of a Food and Drug Administration/American Urological Association public workshop.

Jarow JP, Thompson IM, Kluetz PG, Baxley J, Sridhara R, Scardino P, Carroll P, Albertsen P, Carter HB, Brawley O, Sartor O, Sandler H, Kiefert JJ, Morton RA Jr.

Urology. 2014 May;83(5):975-8. doi: 10.1016/j.urology.2013.10.087. Epub 2014 Mar 22.

PMID:
24661332
26.

Pain palliation measurement in cancer clinical trials: the US Food and Drug Administration perspective.

Basch E, Trentacosti AM, Burke LB, Kwitkowski V, Kane RC, Autio KA, Papadopoulos E, Stansbury JP, Kluetz PG, Smith H, Justice R, Pazdur R.

Cancer. 2014 Mar 1;120(5):761-7. doi: 10.1002/cncr.28470. Epub 2013 Dec 5.

27.

Clinical trial design for the development of new therapies for nonmuscle-invasive bladder cancer: report of a Food and Drug Administration and American Urological Association public workshop.

Jarow JP, Lerner SP, Kluetz PG, Liu K, Sridhara R, Bajorin D, Chang S, Dinney CP, Groshen S, Morton RA, O'Donnell M, Quale DZ, Schoenberg M, Seigne J, Vikram B.

Urology. 2014 Feb;83(2):262-4. doi: 10.1016/j.urology.2013.10.030. Epub 2013 Dec 12.

PMID:
24332121
28.

Radium Ra 223 dichloride injection: U.S. Food and Drug Administration drug approval summary.

Kluetz PG, Pierce W, Maher VE, Zhang H, Tang S, Song P, Liu Q, Haber MT, Leutzinger EE, Al-Hakim A, Chen W, Palmby T, Alebachew E, Sridhara R, Ibrahim A, Justice R, Pazdur R.

Clin Cancer Res. 2014 Jan 1;20(1):9-14. doi: 10.1158/1078-0432.CCR-13-2665. Epub 2013 Nov 4.

29.

Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer: U.S. Food and Drug Administration drug approval summary.

Kluetz PG, Ning YM, Maher VE, Zhang L, Tang S, Ghosh D, Aziz R, Palmby T, Pfuma E, Zirkelbach JF, Mehrotra N, Tilley A, Sridhara R, Ibrahim A, Justice R, Pazdur R.

Clin Cancer Res. 2013 Dec 15;19(24):6650-6. doi: 10.1158/1078-0432.CCR-13-2134. Epub 2013 Oct 22.

30.

A SNP in CYP2C8 is not associated with the development of bisphosphonate-related osteonecrosis of the jaw in men with castrate-resistant prostate cancer.

English BC, Baum CE, Adelberg DE, Sissung TM, Kluetz PG, Dahut WL, Price DK, Figg WD.

Ther Clin Risk Manag. 2010 Nov 19;6:579-83. doi: 10.2147/TCRM.S14303.

31.

Angiogenesis inhibitors in the treatment of prostate cancer.

Kluetz PG, Figg WD, Dahut WL.

Expert Opin Pharmacother. 2010 Feb;11(2):233-47. doi: 10.1517/14656560903451716. Review.

32.

Successful treatment of small cell lung cancer during pregnancy.

Kluetz PG, Edelman MJ.

Lung Cancer. 2008 Jul;61(1):129-30. doi: 10.1016/j.lungcan.2007.10.007. Epub 2008 Feb 1.

PMID:
18242765
33.

Acute pulmonary embolism: imaging in the emergency department.

Kluetz PG, White CS.

Radiol Clin North Am. 2006 Mar;44(2):259-71, ix. Review.

PMID:
16500208
34.

Combined PET/CT Imaging in Oncology. Impact on Patient Management.

Kluetz PG, Meltzer CC, Villemagne VL, Kinahan PE, Chander S, Martinelli MA, Townsend DW.

Clin Positron Imaging. 2000 Nov;3(6):223-230.

PMID:
11378434

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