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Predicting Renal Cancer Recurrence: Defining Limitations of Existing Prognostic Models With Prospective Trial-Based Validation.

Correa AF, Jegede O, Haas NB, Flaherty KT, Pins MR, Messing EM, Manola J, Wood CG, Kane CJ, Jewett MAS, Dutcher JP, DiPaola RS, Carducci MA, Uzzo RG.

J Clin Oncol. 2019 Jun 19:JCO1900107. doi: 10.1200/JCO.19.00107. [Epub ahead of print]


Lenalidomide and dexamethasone in patients with relapsed multiple myeloma and impaired renal function: PrE1003, a PrECOG study.

Mikhael J, Manola J, Dueck AC, Hayman S, Oettel K, Kanate AS, Lonial S, Rajkumar SV.

Blood Cancer J. 2018 Aug 29;8(9):86. doi: 10.1038/s41408-018-0110-7.


Randomized Phase II Trial of Fulvestrant Plus Everolimus or Placebo in Postmenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy: Results of PrE0102.

Kornblum N, Zhao F, Manola J, Klein P, Ramaswamy B, Brufsky A, Stella PJ, Burnette B, Telli M, Makower DF, Cheema P, Truica CI, Wolff AC, Soori GS, Haley B, Wassenaar TR, Goldstein LJ, Miller KD, Sparano JA.

J Clin Oncol. 2018 Jun 1;36(16):1556-1563. doi: 10.1200/JCO.2017.76.9331. Epub 2018 Apr 17.


Validation of a new prognostic model to easily predict outcome in renal cell carcinoma: the GRANT score applied to the ASSURE trial population.

Buti S, Puligandla M, Bersanelli M, DiPaola RS, Manola J, Taguchi S, Haas NB.

Ann Oncol. 2018 Jul 1;29(7):1604. doi: 10.1093/annonc/mdx799. No abstract available.


Longitudinal and dynamic measurement invariance of the FACIT-Fatigue scale: an application of the measurement model of derivatives to ECOG-ACRIN study E2805.

Estabrook R, Cella D, Zhao F, Manola J, DiPaola RS, Wagner LI, Haas NB.

Qual Life Res. 2018 Jun;27(6):1589-1597. doi: 10.1007/s11136-018-1817-4. Epub 2018 Mar 5.


Fatigue among patients with renal cell carcinoma receiving adjuvant sunitinib or sorafenib: patient-reported outcomes of ECOG-ACRIN E2805 trial.

Zhao F, Cella D, Manola J, DiPaola RS, Wagner LI, Haas NSB.

Support Care Cancer. 2018 Jun;26(6):1889-1895. doi: 10.1007/s00520-017-4027-7. Epub 2017 Dec 23.


Phase 2 Study of Weekly Paclitaxel Plus Estramustine in Metastatic Hormone-Refractory Prostate Carcinoma: ECOG-ACRIN Cancer Research Group (E1898) Trial.

Wong YN, Manola J, Hudes GR, Roth BJ, Moul JW, Barsevick AM, Scher RM, Volk MJ, Vaughn DJ, Williams SD, Fisch MJ, Cella D, Carducci MA, Wilding G.

Clin Genitourin Cancer. 2018 Apr;16(2):e315-e322. doi: 10.1016/j.clgc.2017.10.001. Epub 2017 Oct 16.


Tumor Microvessel Density as a Prognostic Marker in High-Risk Renal Cell Carcinoma Patients Treated on ECOG-ACRIN E2805.

Jilaveanu LB, Puligandla M, Weiss SA, Wang XV, Zito C, Flaherty KT, Boeke M, Neumeister V, Camp RL, Adeniran A, Pins M, Manola J, DiPaola RS, Haas NB, Kluger HM.

Clin Cancer Res. 2018 Jan 1;24(1):217-223. doi: 10.1158/1078-0432.CCR-17-1555. Epub 2017 Oct 24.


Validation of a new prognostic model to easily predict outcome in renal cell carcinoma: the GRANT score applied to the ASSURE trial population.

Buti S, Puligandla M, Bersanelli M, DiPaola RS, Manola J, Taguchi S, Haas NB.

Ann Oncol. 2017 Nov 1;28(11):2747-2753. doi: 10.1093/annonc/mdx492.


Transforming the Perioperative Treatment Paradigm in Non-Metastatic RCC-A Possible Path Forward.

Harshman LC, Drake CG, Haas NB, Manola J, Puligandla M, Signoretti S, Cella D, Gupta RT, Bhatt R, Van Allen E, Lara P, Choueiri TK, Kapoor A, Heng DYC, Shuch B, Jewett M, George D, Michaelson D, Carducci MA, McDermott D, Allaf M.

Kidney Cancer. 2017 Jul 26;1(1):31-40. doi: 10.3233/KCA-170010. Review.


Retroperitoneal Lymphadenectomy for High Risk, Nonmetastatic Renal Cell Carcinoma: An Analysis of the ASSURE (ECOG-ACRIN 2805) Adjuvant Trial.

Ristau BT, Manola J, Haas NB, Heng DYC, Messing EM, Wood CG, Kane CJ, DiPaola RS, Uzzo RG.

J Urol. 2018 Jan;199(1):53-59. doi: 10.1016/j.juro.2017.07.042. Epub 2017 Jul 18.


Association between patients' perception of the comorbidity burden and symptoms in outpatients with common solid tumors.

Ritchie CS, Zhao F, Patel K, Manola J, Kvale EA, Snyder CF, Fisch MJ.

Cancer. 2017 Oct 1;123(19):3835-3842. doi: 10.1002/cncr.30801. Epub 2017 Jun 13.


A Randomized Phase II Study to Determine the Effect of 2 Different Doses of Aflibercept in Patients With Metastatic Renal Cell Carcinoma (ECOG-ACRIN [E4805]).

Pili R, Jegede O, Carducci MA, Manola J, Groteluschen DL, Appleman LL, Liu G, Shanks JC, Dakhil SR, Dutcher J, DiPaola RS.

Clin Genitourin Cancer. 2017 Dec;15(6):642-651.e1. doi: 10.1016/j.clgc.2017.04.023. Epub 2017 Apr 26.


Adjuvant Treatment for High-Risk Clear Cell Renal Cancer: Updated Results of a High-Risk Subset of the ASSURE Randomized Trial.

Haas NB, Manola J, Dutcher JP, Flaherty KT, Uzzo RG, Atkins MB, DiPaola RS, Choueiri TK.

JAMA Oncol. 2017 Sep 1;3(9):1249-1252. doi: 10.1001/jamaoncol.2017.0076.


Association of fatigue and depression with circulating levels of proinflammatory cytokines and epidermal growth factor receptor ligands: a correlative study of a placebo-controlled fatigue trial.

Rich T, Zhao F, Cruciani RA, Cella D, Manola J, Fisch MJ.

Cancer Manag Res. 2017 Jan 31;9:1-10. doi: 10.2147/CMAR.S115835. eCollection 2017.


Lack of Patient-Clinician Concordance in Cancer Patients: Its Relation With Patient Variables.

Chandwani KD, Zhao F, Morrow GR, Deshields TL, Minasian LM, Manola J, Fisch MJ.

J Pain Symptom Manage. 2017 Jun;53(6):988-998. doi: 10.1016/j.jpainsymman.2016.12.347. Epub 2017 Feb 6.


Enrollment Trends and Disparity Among Patients With Lung Cancer in National Clinical Trials, 1990 to 2012.

Pang HH, Wang X, Stinchcombe TE, Wong ML, Cheng P, Ganti AK, Sargent DJ, Zhang Y, Hu C, Mandrekar SJ, Redman MW, Manola JB, Schilsky RL, Cohen HJ, Bradley JD, Adjei AA, Gandara D, Ramalingam SS, Vokes EE.

J Clin Oncol. 2016 Nov 20;34(33):3992-3999. doi: 10.1200/JCO.2016.67.7088. Epub 2016 Sep 30.


Extramedullary Disease in Adult Acute Myeloid Leukemia Is Common but Lacks Independent Significance: Analysis of Patients in ECOG-ACRIN Cancer Research Group Trials, 1980-2008.

Ganzel C, Manola J, Douer D, Rowe JM, Fernandez HF, Paietta EM, Litzow MR, Lee JW, Luger SM, Lazarus HM, Cripe LD, Wiernik PH, Tallman MS.

J Clin Oncol. 2016 Oct 10;34(29):3544-3553.


Adjuvant sunitinib or sorafenib for high-risk, non-metastatic renal-cell carcinoma (ECOG-ACRIN E2805): a double-blind, placebo-controlled, randomised, phase 3 trial.

Haas NB, Manola J, Uzzo RG, Flaherty KT, Wood CG, Kane C, Jewett M, Dutcher JP, Atkins MB, Pins M, Wilding G, Cella D, Wagner L, Matin S, Kuzel TM, Sexton WJ, Wong YN, Choueiri TK, Pili R, Puzanov I, Kohli M, Stadler W, Carducci M, Coomes R, DiPaola RS.

Lancet. 2016 May 14;387(10032):2008-16. doi: 10.1016/S0140-6736(16)00559-6. Epub 2016 Mar 9. Erratum in: Lancet. 2016 May 14;387(10032):1998.


Atrasentan in Patients With Advanced Renal Cell Carcinoma: A Phase 2 Trial of the ECOG-ACRIN Cancer Research Group (E6800).

Carducci MA, Manola J, Nair SG, Liu G, Rousey S, Dutcher JP, Wilding G.

Clin Genitourin Cancer. 2015 Dec;13(6):531-539.e1. doi: 10.1016/j.clgc.2015.07.002. Epub 2015 Jul 17.


Effects of Adjuvant Sorafenib and Sunitinib on Cardiac Function in Renal Cell Carcinoma Patients without Overt Metastases: Results from ASSURE, ECOG 2805.

Haas NB, Manola J, Ky B, Flaherty KT, Uzzo RG, Kane CJ, Jewett M, Wood L, Wood CG, Atkins MB, Dutcher JJ, Wilding G, DiPaola RS.

Clin Cancer Res. 2015 Sep 15;21(18):4048-54. doi: 10.1158/1078-0432.CCR-15-0215. Epub 2015 May 12.


NF-κB and stat3 transcription factor signatures differentiate HPV-positive and HPV-negative head and neck squamous cell carcinoma.

Gaykalova DA, Manola JB, Ozawa H, Zizkova V, Morton K, Bishop JA, Sharma R, Zhang C, Michailidi C, Considine M, Tan M, Fertig EJ, Hennessey PT, Ahn J, Koch WM, Westra WH, Khan Z, Chung CH, Ochs MF, Califano JA.

Int J Cancer. 2015 Oct 15;137(8):1879-89. doi: 10.1002/ijc.29558. Epub 2015 Jun 23.


Phase II Study of Gemcitabine, Carboplatin, and Iniparib As Neoadjuvant Therapy for Triple-Negative and BRCA1/2 Mutation-Associated Breast Cancer With Assessment of a Tumor-Based Measure of Genomic Instability: PrECOG 0105.

Telli ML, Jensen KC, Vinayak S, Kurian AW, Lipson JA, Flaherty PJ, Timms K, Abkevich V, Schackmann EA, Wapnir IL, Carlson RW, Chang PJ, Sparano JA, Head B, Goldstein LJ, Haley B, Dakhil SR, Reid JE, Hartman AR, Manola J, Ford JM.

J Clin Oncol. 2015 Jun 10;33(17):1895-901. doi: 10.1200/JCO.2014.57.0085. Epub 2015 Apr 6.


A phase I study of everolimus and docetaxel in patients with castration-resistant prostate cancer.

Courtney KD, Manola JB, Elfiky AA, Ross R, Oh WK, Yap JT, Van den Abbeele AD, Ryan CW, Beer TM, Loda M, Priolo C, Kantoff P, Taplin ME.

Clin Genitourin Cancer. 2015 Apr;13(2):113-23. doi: 10.1016/j.clgc.2014.08.007. Epub 2014 Oct 22.


Predicting survival in head and neck squamous cell carcinoma from TP53 mutation.

Masica DL, Li S, Douville C, Manola J, Ferris RL, Burtness B, Forastiere AA, Koch WM, Chung CH, Karchin R.

Hum Genet. 2015 May;134(5):497-507. doi: 10.1007/s00439-014-1470-0. Epub 2014 Aug 10.


Patterns and predictors of antidepressant use in ambulatory cancer patients with common solid tumors.

Fisch MJ, Zhao F, Manola J, Miller AH, Pirl WF, Wagner LI.

Psychooncology. 2015 May;24(5):523-32. doi: 10.1002/pon.3606. Epub 2014 Jun 14.


Comparison of performance of various tumour response criteria in assessment of regorafenib activity in advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib.

Shinagare AB, Jagannathan JP, Kurra V, Urban T, Manola J, Choy E, Demetri GD, George S, Ramaiya NH.

Eur J Cancer. 2014 Mar;50(5):981-6. doi: 10.1016/j.ejca.2013.11.037. Epub 2014 Jan 2.


Phase 2 trial of aromatase inhibition with letrozole in patients with uterine leiomyosarcomas expressing estrogen and/or progesterone receptors.

George S, Feng Y, Manola J, Nucci MR, Butrynski JE, Morgan JA, Ramaiya N, Quek R, Penson RT, Wagner AJ, Harmon D, Demetri GD, Krasner C.

Cancer. 2014 Mar 1;120(5):738-43. doi: 10.1002/cncr.28476. Epub 2013 Nov 12.


Using patient-reported outcomes to assess and improve prostate cancer brachytherapy.

Talcott JA, Manola J, Chen RC, Clark JA, Kaplan I, D'Amico AV, Zietman AL.

BJU Int. 2014 Oct;114(4):511-6. doi: 10.1111/bju.12464. Epub 2014 May 22.


Induction chemotherapy meta-analysis in head and neck cancer: right answer, wrong question.

Forastiere AA, Adelstein DJ, Manola J.

J Clin Oncol. 2013 Aug 10;31(23):2844-6. doi: 10.1200/JCO.2013.50.3136. Epub 2013 Jul 8. No abstract available.


Vandetanib plus chemotherapy for induction followed by vandetanib or placebo as maintenance for patients with advanced non-small-cell lung cancer: a randomized phase 2 PrECOG study (PrE0501).

Aisner J, Manola JB, Dakhil SR, Stella PJ, Sovak MA, Schiller JH.

J Thorac Oncol. 2013 Aug;8(8):1075-83. doi: 10.1097/JTO.0b013e3182937317.


Clinical correlates of promoter hypermethylation of four target genes in head and neck cancer: a cooperative group correlative study.

Roh JL, Wang XV, Manola J, Sidransky D, Forastiere AA, Koch WM.

Clin Cancer Res. 2013 May 1;19(9):2528-40. doi: 10.1158/1078-0432.CCR-12-3047. Epub 2013 Feb 26.


Employment outcomes among survivors of common cancers: the Symptom Outcomes and Practice Patterns (SOAPP) study.

Tevaarwerk AJ, Lee JW, Sesto ME, Buhr KA, Cleeland CS, Manola J, Wagner LI, Chang VT, Fisch MJ.

J Cancer Surviv. 2013 Jun;7(2):191-202. doi: 10.1007/s11764-012-0258-2. Epub 2013 Feb 2.


Predictors for major wound complications following preoperative radiotherapy and surgery for soft-tissue sarcoma of the extremities and trunk: importance of tumor proximity to skin surface.

Baldini EH, Lapidus MR, Wang Q, Manola J, Orgill DP, Pomahac B, Marcus KJ, Bertagnolli MM, Devlin PM, George S, Abraham J, Ferrone ML, Ready JE, Raut CP.

Ann Surg Oncol. 2013 May;20(5):1494-9. doi: 10.1245/s10434-012-2797-1. Epub 2012 Dec 15.


Improvement in overall survival of patients with advanced renal cell carcinoma: prognostic factor trend analysis from an international data set of clinical trials.

Patil S, Manola J, Elson P, Negrier S, Escudier B, Eisen T, Atkins M, Bukowski R, Motzer RJ.

J Urol. 2012 Dec;188(6):2095-100. doi: 10.1016/j.juro.2012.08.026. Epub 2012 Oct 18.


Transoral resection of pharyngeal cancer: summary of a National Cancer Institute Head and Neck Cancer Steering Committee Clinical Trials Planning Meeting, November 6-7, 2011, Arlington, Virginia.

Adelstein DJ, Ridge JA, Brizel DM, Holsinger FC, Haughey BH, O'Sullivan B, Genden EM, Beitler JJ, Weinstein GS, Quon H, Chepeha DB, Ferris RL, Weber RS, Movsas B, Waldron J, Lowe V, Ramsey S, Manola J, Yueh B, Carey TE, Bekelman JE, Konski AA, Moore E, Forastiere A, Schuller DE, Lynn J, Ullmann CD.

Head Neck. 2012 Dec;34(12):1681-703. doi: 10.1002/hed.23136. Epub 2012 Sep 26.


L-carnitine supplementation for the management of fatigue in patients with cancer: an eastern cooperative oncology group phase III, randomized, double-blind, placebo-controlled trial.

Cruciani RA, Zhang JJ, Manola J, Cella D, Ansari B, Fisch MJ.

J Clin Oncol. 2012 Nov 1;30(31):3864-9. doi: 10.1200/JCO.2011.40.2180. Epub 2012 Sep 17.


Efficacy and safety of regorafenib in patients with metastatic and/or unresectable GI stromal tumor after failure of imatinib and sunitinib: a multicenter phase II trial.

George S, Wang Q, Heinrich MC, Corless CL, Zhu M, Butrynski JE, Morgan JA, Wagner AJ, Choy E, Tap WD, Yap JT, Van den Abbeele AD, Manola JB, Solomon SM, Fletcher JA, von Mehren M, Demetri GD.

J Clin Oncol. 2012 Jul 1;30(19):2401-7. doi: 10.1200/JCO.2011.39.9394. Epub 2012 May 21.


Prospective, observational study of pain and analgesic prescribing in medical oncology outpatients with breast, colorectal, lung, or prostate cancer.

Fisch MJ, Lee JW, Weiss M, Wagner LI, Chang VT, Cella D, Manola JB, Minasian LM, McCaskill-Stevens W, Mendoza TR, Cleeland CS.

J Clin Oncol. 2012 Jun 1;30(16):1980-8. doi: 10.1200/JCO.2011.39.2381. Epub 2012 Apr 16.


Cardiac toxicity associated with bevacizumab (Avastin) in combination with CHOP chemotherapy for peripheral T cell lymphoma in ECOG 2404 trial.

Advani RH, Hong F, Horning SJ, Kahl BS, Manola J, Swinnen LJ, Habermann TM, Ganjoo K.

Leuk Lymphoma. 2012 Apr;53(4):718-20. doi: 10.3109/10428194.2011.623256. Epub 2011 Dec 5. No abstract available.


Multicenter phase 2 trial of sirolimus for tuberous sclerosis: kidney angiomyolipomas and other tumors regress and VEGF- D levels decrease.

Dabora SL, Franz DN, Ashwal S, Sagalowsky A, DiMario FJ Jr, Miles D, Cutler D, Krueger D, Uppot RN, Rabenou R, Camposano S, Paolini J, Fennessy F, Lee N, Woodrum C, Manola J, Garber J, Thiele EA.

PLoS One. 2011;6(9):e23379. doi: 10.1371/journal.pone.0023379. Epub 2011 Sep 6.


When bad things happen to good studies.

Manola JB, Gray RJ.

J Clin Oncol. 2011 Sep 10;29(26):3497-9. doi: 10.1200/JCO.2011.37.1393. Epub 2011 Aug 15. No abstract available.


Prognostic model for survival in patients with metastatic renal cell carcinoma: results from the international kidney cancer working group.

Manola J, Royston P, Elson P, McCormack JB, Mazumdar M, Négrier S, Escudier B, Eisen T, Dutcher J, Atkins M, Heng DY, Choueiri TK, Motzer R, Bukowski R; International Kidney Cancer Working Group.

Clin Cancer Res. 2011 Aug 15;17(16):5443-50. doi: 10.1158/1078-0432.CCR-11-0553. Epub 2011 Aug 9.


A phase II trial of doxorubicin and gemcitabine in renal cell carcinoma with sarcomatoid features: ECOG 8802.

Haas NB, Lin X, Manola J, Pins M, Liu G, McDermott D, Nanus D, Heath E, Wilding G, Dutcher J.

Med Oncol. 2012 Jun;29(2):761-7. doi: 10.1007/s12032-011-9829-8. Epub 2011 Feb 6.


Combination mTOR and IGF-1R inhibition: phase I trial of everolimus and figitumumab in patients with advanced sarcomas and other solid tumors.

Quek R, Wang Q, Morgan JA, Shapiro GI, Butrynski JE, Ramaiya N, Huftalen T, Jederlinic N, Manola J, Wagner AJ, Demetri GD, George S.

Clin Cancer Res. 2011 Feb 15;17(4):871-9. doi: 10.1158/1078-0432.CCR-10-2621. Epub 2010 Dec 22.


Hyperthermia combined with radiation for the treatment of locally advanced prostate cancer: long-term results from Dana-Farber Cancer Institute study 94-153.

Hurwitz MD, Hansen JL, Prokopios-Davos S, Manola J, Wang Q, Bornstein BA, Hynynen K, Kaplan ID.

Cancer. 2011 Feb 1;117(3):510-6. doi: 10.1002/cncr.25619. Epub 2010 Sep 30.


Effects of complementary therapies on clinical outcomes in patients being treated with radiation therapy for prostate cancer.

Beard C, Stason WB, Wang Q, Manola J, Dean-Clower E, Dusek JA, Decristofaro S, Webster A, Doherty-Gilman AM, Rosenthal DS, Benson H.

Cancer. 2011 Jan 1;117(1):96-102. doi: 10.1002/cncr.25291. Epub 2010 Aug 27.


Acupuncture as palliative therapy for physical symptoms and quality of life for advanced cancer patients.

Dean-Clower E, Doherty-Gilman AM, Keshaviah A, Baker F, Kaw C, Lu W, Manola J, Penson RT, Matulonis UA, Rosenthal DS.

Integr Cancer Ther. 2010 Jun;9(2):158-67. doi: 10.1177/1534735409360666.


Radiation therapy induces circulating serum Hsp72 in patients with prostate cancer.

Hurwitz MD, Kaur P, Nagaraja GM, Bausero MA, Manola J, Asea A.

Radiother Oncol. 2010 Jun;95(3):350-8. doi: 10.1016/j.radonc.2010.03.024. Epub 2010 Apr 27.

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