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Design and conduct of early clinical studies of immunotherapy agent combinations: Recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies.

Smoragiewicz M, Bogaerts J, Calvo E, Marabelle A, Perrone A, Seymour L, Shalabi A, Siu LL, Tabernero J, Giaccone G; task force on Methodology for the Development of Innovative Cancer Therapies.

Ann Oncol. 2018 Sep 10. doi: 10.1093/annonc/mdy398. [Epub ahead of print]


Additional germline findings from a tumor profiling program.

Stjepanovic N, Stockley TL, Bedard PL, McCuaig JM, Aronson M, Holter S, Semotiuk K, Leighl NB, Jang R, Krzyzanowska MK, Oza AM, Gupta A, Elser C, Ahmed L, Wang L, Kamel-Reid S, Siu LL, Kim RH.

BMC Med Genomics. 2018 Aug 9;11(1):65. doi: 10.1186/s12920-018-0383-5.


Precision Medicine in Head and Neck Cancer: Myth or Reality?

Malone E, Siu LL.

Clin Med Insights Oncol. 2018 Jun 4;12:1179554918779581. doi: 10.1177/1179554918779581. eCollection 2018.


Concurrent-Adjuvant Chemoradiation Therapy for Stage III-IVB Nasopharyngeal Carcinoma-Exploration for Achieving Optimal 10-Year Therapeutic Ratio.

Ng WT, Tung SY, Lee V, Ngan RKC, Choi HCW, Chan LLK, Leung TW, Siu LL, Lu TX, Tan T, Tan EH, Sze HCK, Ng AWY, Yiu HHY, O'Sullivan B, Chappell R, Lee AWM.

Int J Radiat Oncol Biol Phys. 2018 Aug 1;101(5):1078-1086. doi: 10.1016/j.ijrobp.2018.04.069. Epub 2018 May 2.


Lung cancer in never smokers from the Princess Margaret Cancer Centre.

Korpanty GJ, Kamel-Reid S, Pintilie M, Hwang DM, Zer A, Liu G, Leighl NB, Feld R, Siu LL, Bedard PL, Tsao MS, Shepherd FA.

Oncotarget. 2018 Apr 27;9(32):22559-22570. doi: 10.18632/oncotarget.25176. eCollection 2018 Apr 27.


Phase Ib Trial With Birabresib, a Small-Molecule Inhibitor of Bromodomain and Extraterminal Proteins, in Patients With Selected Advanced Solid Tumors.

Lewin J, Soria JC, Stathis A, Delord JP, Peters S, Awada A, Aftimos PG, Bekradda M, Rezai K, Zeng Z, Hussain A, Perez S, Siu LL, Massard C.

J Clin Oncol. 2018 May 7:JCO2018782292. doi: 10.1200/JCO.2018.78.2292. [Epub ahead of print]


Pretreatment neurocognitive function and self-reported symptoms in patients with newly diagnosed head and neck cancer compared with noncancer cohort.

Bernstein LJ, Pond GR, Gan HK, Tirona K, Chan KK, Hope A, Kim J, Chen EX, Siu LL, Razak ARA.

Head Neck. 2018 Sep;40(9):2029-2042. doi: 10.1002/hed.25198. Epub 2018 Apr 17.


Rational design and identification of immuno-oncology drug combinations.

Iafolla MAJ, Selby H, Warner K, Ohashi PS, Haibe-Kains B, Siu LL.

Eur J Cancer. 2018 May;95:38-51. doi: 10.1016/j.ejca.2018.02.027. Epub 2018 Apr 7.


A phase I, open-label, two-stage study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the oral AKT inhibitor GSK2141795 in patients with solid tumors.

Aghajanian C, Bell-McGuinn KM, Burris HA 3rd, Siu LL, Stayner LA, Wheler JJ, Hong DS, Kurkjian C, Pant S, Santiago-Walker A, Gauvin JL, Antal JM, Opalinska JB, Morris SR, Infante JR.

Invest New Drugs. 2018 Apr 3. doi: 10.1007/s10637-018-0591-z. [Epub ahead of print]


Head and Neck Cancer Survivorship Care Guideline: American Society of Clinical Oncology Clinical Practice Guideline Endorsement Summary.

Nekhlyudov L, Lacchetti C, Siu LL.

J Oncol Pract. 2018 Mar;14(3):167-171. doi: 10.1200/JOP.2017.029041. Epub 2017 Dec 19. No abstract available.


Impact of multi-gene mutational profiling on clinical trial outcomes in metastatic breast cancer.

Pezo RC, Chen TW, Berman HK, Mulligan AM, Razak AA, Siu LL, Cescon DW, Amir E, Elser C, Warr DG, Sridhar SS, Yu C, Wang L, Stockley TL, Kamel-Reid S, Bedard PL.

Breast Cancer Res Treat. 2018 Feb;168(1):159-168. doi: 10.1007/s10549-017-4580-2. Epub 2017 Nov 24.


Association of Neurocognitive Deficits With Radiotherapy or Chemoradiotherapy for Patients With Head and Neck Cancer.

Zer A, Pond GR, Razak ARA, Tirona K, Gan HK, Chen EX, O'Sullivan B, Waldron J, Goldstein DP, Weinreb I, Hope AJ, Kim JJ, Chan KKW, Chan AK, Siu LL, Bernstein LJ.

JAMA Otolaryngol Head Neck Surg. 2017 Nov 22. doi: 10.1001/jamaoto.2017.2235. [Epub ahead of print]


Novel combinations of PI3K-mTOR inhibitors with dacomitinib or chemotherapy in PTEN-deficient patient-derived tumor xenografts.

Brana I, Pham NA, Kim L, Sakashita S, Li M, Ng C, Wang Y, Loparco P, Sierra R, Wang L, Clarke BA, Neel BG, Siu LL, Tsao MS.

Oncotarget. 2017 Jul 8;8(49):84659-84670. doi: 10.18632/oncotarget.19109. eCollection 2017 Oct 17.


The European Society for Medical Oncology (ESMO) Precision Medicine Glossary.

Yates LR, Seoane J, Le Tourneau C, Siu LL, Marais R, Michiels S, Soria JC, Campbell P, Normanno N, Scarpa A, Reis-Filho JS, Rodon J, Swanton C, Andre F.

Ann Oncol. 2018 Jan 1;29(1):30-35. doi: 10.1093/annonc/mdx707.


Molecular Profiling of Patients With Advanced Colorectal Cancer: Princess Margaret Cancer Centre Experience.

Chiu JW, Krzyzanowska MK, Serra S, Knox JJ, Dhani NC, Mackay H, Hedley D, Moore M, Liu G, Burkes RL, Brezden-Masley C, Roehrl MH, Craddock KJ, Tsao MS, Zhang T, Yu C, Kamel-Reid S, Siu LL, Bedard PL, Chen EX.

Clin Colorectal Cancer. 2018 Mar;17(1):73-79. doi: 10.1016/j.clcc.2017.10.010. Epub 2017 Oct 23.


A Multi-Arm Phase I Study of the PI3K/mTOR Inhibitors PF-04691502 and Gedatolisib (PF-05212384) plus Irinotecan or the MEK Inhibitor PD-0325901 in Advanced Cancer.

Wainberg ZA, Alsina M, Soares HP, Braña I, Britten CD, Del Conte G, Ezeh P, Houk B, Kern KA, Leong S, Pathan N, Pierce KJ, Siu LL, Vermette J, Tabernero J.

Target Oncol. 2017 Dec;12(6):775-785. doi: 10.1007/s11523-017-0530-5.


Systemic therapies for recurrent or metastatic nasopharyngeal carcinoma: a systematic review.

Prawira A, Oosting SF, Chen TW, Delos Santos KA, Saluja R, Wang L, Siu LL, Chan KKW, Hansen AR.

Br J Cancer. 2017 Dec 5;117(12):1743-1752. doi: 10.1038/bjc.2017.357. Epub 2017 Oct 24. Review.


Radiation Therapy for Oropharyngeal Squamous Cell Carcinoma: American Society of Clinical Oncology Endorsement of the American Society for Radiation Oncology Evidence-Based Clinical Practice Guideline.

Quon H, Vapiwala N, Forastiere A, Kennedy EB, Adelstein DJ, Boykin H, Califano JA, Holsinger FC, Nussenbaum B, Rosenthal DI, Siu LL, Waldron JN.

J Clin Oncol. 2017 Dec 20;35(36):4078-4090. doi: 10.1200/JCO.2017.73.8633. Epub 2017 Oct 24.


Tumour- and class-specific patterns of immune-related adverse events of immune checkpoint inhibitors: a systematic review.

Khoja L, Day D, Wei-Wu Chen T, Siu LL, Hansen AR.

Ann Oncol. 2017 Oct 1;28(10):2377-2385. doi: 10.1093/annonc/mdx286. Review.


Identifying actionable variants using next generation sequencing in patients with a historical diagnosis of undifferentiated pleomorphic sarcoma.

Lewin J, Garg S, Lau BY, Dickson BC, Traub F, Gokgoz N, Griffin AM, Ferguson PC, Andrulis IL, Sim HW, Kamel-Reid S, Stockley TL, Siu LL, Wunder JS, Razak ARA.

Int J Cancer. 2018 Jan 1;142(1):57-65. doi: 10.1002/ijc.31039. Epub 2017 Oct 9.


Challenges and Opportunities in Adapting Clinical Trial Design for Immunotherapies.

Siu LL, Ivy SP, Dixon EL, Gravell AE, Reeves SA, Rosner GL.

Clin Cancer Res. 2017 Sep 1;23(17):4950-4958. doi: 10.1158/1078-0432.CCR-16-3079.


Demonstrating Noninferiority of Accelerated Radiotherapy With Panitumumab vs Standard Radiotherapy With Cisplatin in Locoregionally Advanced Squamous Cell Head and Neck Carcinoma-Reply.

Chen BE, Siu LL, Parulekar WR.

JAMA Oncol. 2017 Oct 1;3(10):1431. doi: 10.1001/jamaoncol.2017.2023. No abstract available.


A multicenter, phase 3, randomized trial of concurrent chemoradiotherapy plus adjuvant chemotherapy versus radiotherapy alone in patients with regionally advanced nasopharyngeal carcinoma: 10-year outcomes for efficacy and toxicity.

Lee AWM, Tung SY, Ng WT, Lee V, Ngan RKC, Choi HCW, Chan LLK, Siu LL, Ng AWY, Leung TW, Yiu HHY, O'Sullivan B, Chappell R.

Cancer. 2017 Nov 1;123(21):4147-4157. doi: 10.1002/cncr.30850. Epub 2017 Jun 29.


The Cisplatin Total Dose and Concomitant Radiation in Locoregionally Advanced Head and Neck Cancer: Any Recent Evidence for Dose Efficacy?

Carlsson L, Bratman SV, Siu LL, Spreafico A.

Curr Treat Options Oncol. 2017 Jul;18(7):39. doi: 10.1007/s11864-017-0482-0. Review.


Sharing Clinical and Genomic Data on Cancer - The Need for Global Solutions.

Clinical Cancer Genome Task Team of the Global Alliance for Genomics and Health, Lawler M, Haussler D, Siu LL, Haendel MA, McMurry JA, Knoppers BM, Chanock SJ, Calvo F, The BT, Walia G, Banks I, Yu PP, Staudt LM, Sawyers CL.

N Engl J Med. 2017 May 25;376(21):2006-2009. doi: 10.1056/NEJMp1612254. No abstract available.


Towards a global cancer knowledge network: dissecting the current international cancer genomic sequencing landscape.

Vis DJ, Lewin J, Liao RG, Mao M, Andre F, Ward RL, Calvo F, Teh BT, Camargo AA, Knoppers BM, Sawyers CL, Wessels LFA, Lawler M, Siu LL, Voest E; Clinical Working Group of the Global Alliance for Genomics and Health.

Ann Oncol. 2017 May 1;28(5):1145-1151. doi: 10.1093/annonc/mdx037.


Clinicopathological features and outcome of chronic lymphocytic leukaemia in Chinese patients.

Chan TS, Lee YS, Del Giudice I, Marinelli M, Ilari C, Cafforio L, Guarini A, Tan D, Phipps C, Goh YT, Hwang W, Goh AZ, Siu LL, Wu S, Ha CY, Lin SY, Kwok CH, Lau CK, Wong KF, Foà R, Kwong YL, Tse E.

Oncotarget. 2017 Apr 11;8(15):25455-25468. doi: 10.18632/oncotarget.16037.


A phase 2 study of vorinostat in locally advanced, recurrent, or metastatic adenoid cystic carcinoma.

Goncalves PH, Heilbrun LK, Barrett MT, Kummar S, Hansen AR, Siu LL, Piekarz RL, Sukari AW, Chao J, Pilat MJ, Smith DW, Casetta L, Boerner SA, Chen A, Lenkiewicz E, Malasi S, LoRusso PM.

Oncotarget. 2017 May 16;8(20):32918-32929. doi: 10.18632/oncotarget.16464.


Use of Expansion Cohorts in Phase I Trials and Probability of Success in Phase II for 381 Anticancer Drugs.

Bugano DDG, Hess K, Jardim DLF, Zer A, Meric-Bernstam F, Siu LL, Razak ARA, Hong DS.

Clin Cancer Res. 2017 Aug 1;23(15):4020-4026. doi: 10.1158/1078-0432.CCR-16-2354. Epub 2017 Apr 4.


Data resources for the identification and interpretation of actionable mutations by clinicians.

Prawira A, Pugh TJ, Stockley TL, Siu LL.

Ann Oncol. 2017 May 1;28(5):946-957. doi: 10.1093/annonc/mdx023. Review.


Head and Neck Cancer Survivorship Care Guideline: American Society of Clinical Oncology Clinical Practice Guideline Endorsement of the American Cancer Society Guideline.

Nekhlyudov L, Lacchetti C, Davis NB, Garvey TQ, Goldstein DP, Nunnink JC, Ninfea JIR, Salner AL, Salz T, Siu LL.

J Clin Oncol. 2017 May 10;35(14):1606-1621. doi: 10.1200/JCO.2016.71.8478. Epub 2017 Feb 27. Review.


Giant Prolactinoma Presenting As a Base of Skull Tumor With Nasopharyngeal Extension: A Potential Diagnostic Pitfall in Neuroendocrine Lesions of the Base of Skull.

Prawira A, Lazinski D, Siu LL, Perez-Ordonez B.

Head Neck Pathol. 2017 Dec;11(4):537-540. doi: 10.1007/s12105-017-0782-5. Epub 2017 Feb 14.


Cancer Clinical Trials: The Rear-View Mirror and the Crystal Ball.

Cescon D, Siu LL.

Cell. 2017 Feb 9;168(4):575-578. doi: 10.1016/j.cell.2017.01.027.


Determinants of the recommended phase 2 dose of molecular targeted agents.

Hansen AR, Cook N, Amir E, Siu LL, Abdul Razak AR.

Cancer. 2017 Apr 15;123(8):1409-1415. doi: 10.1002/cncr.30579. Epub 2017 Feb 9.


A final report of a phase I study of veliparib (ABT-888) in combination with low-dose fractionated whole abdominal radiation therapy (LDFWAR) in patients with advanced solid malignancies and peritoneal carcinomatosis with a dose escalation in ovarian and fallopian tube cancers.

Reiss KA, Herman JM, Armstrong D, Zahurak M, Fyles A, Brade A, Milosevic M, Dawson LA, Scardina A, Fischer P, Hacker-Prietz A, Kinders RJ, Wang L, Chen A, Temkin S, Horiba N, Stayner LA, Siu LL, Azad NS.

Gynecol Oncol. 2017 Mar;144(3):486-490. doi: 10.1016/j.ygyno.2017.01.016. Epub 2017 Jan 18.


Genotype-matched treatment for patients with advanced type I epithelial ovarian cancer (EOC).

Spreafico A, Oza AM, Clarke BA, Mackay HJ, Shaw P, Butler M, Dhani NC, Lheureux S, Wilson MK, Welch S, Zhang T, Yu C, Stockley T, Siu LL, Kamel-Reid S, Bedard PL.

Gynecol Oncol. 2017 Feb;144(2):250-255. doi: 10.1016/j.ygyno.2016.12.002. Epub 2017 Jan 3.


Quality of life and swallowing with standard chemoradiotherapy versus accelerated radiotherapy and panitumumab in locoregionally advanced carcinoma of the head and neck: A phase III randomised trial from the Canadian Cancer Trials Group (HN.6).

Ringash J, Waldron JN, Siu LL, Martino R, Winquist E, Wright JR, Nabid A, Hay JH, Hammond A, Sultanem K, Hotte S, Leong C, El-Gayed AA, Naz F, Ramchandar K, Owen TE, Montenegro A, O'Sullivan B, Chen BE, Parulekar WR.

Eur J Cancer. 2017 Feb;72:192-199. doi: 10.1016/j.ejca.2016.11.008. Epub 2016 Dec 29.


Effect of Standard Radiotherapy With Cisplatin vs Accelerated Radiotherapy With Panitumumab in Locoregionally Advanced Squamous Cell Head and Neck Carcinoma: A Randomized Clinical Trial.

Siu LL, Waldron JN, Chen BE, Winquist E, Wright JR, Nabid A, Hay JH, Ringash J, Liu G, Johnson A, Shenouda G, Chasen M, Pearce A, Butler JB, Breen S, Chen EX, FitzGerald TJ, Childs TJ, Montenegro A, O'Sullivan B, Parulekar WR.

JAMA Oncol. 2016 Dec 8. doi: 10.1001/jamaoncol.2016.4510. [Epub ahead of print]


Approaches to modernize the combination drug development paradigm.

Day D, Siu LL.

Genome Med. 2016 Oct 28;8(1):115. Review.


Molecular profiling of advanced solid tumors and patient outcomes with genotype-matched clinical trials: the Princess Margaret IMPACT/COMPACT trial.

Stockley TL, Oza AM, Berman HK, Leighl NB, Knox JJ, Shepherd FA, Chen EX, Krzyzanowska MK, Dhani N, Joshua AM, Tsao MS, Serra S, Clarke B, Roehrl MH, Zhang T, Sukhai MA, Califaretti N, Trinkaus M, Shaw P, van der Kwast T, Wang L, Virtanen C, Kim RH, Razak AR, Hansen AR, Yu C, Pugh TJ, Kamel-Reid S, Siu LL, Bedard PL.

Genome Med. 2016 Oct 25;8(1):109.


Phase 1/2 Study of the Addition of Cisplatin to Adjuvant Chemotherapy With Image Guided High-Precision Radiation Therapy for Completely Resected Gastric Cancer.

Goody RB, MacKay H, Pitcher B, Oza A, Siu LL, Kim J, Wong RK, Chen E, Swallow C, Knox J, Kassam Z, Cummings B, Feld R, Hedley D, Liu G, Krzyzanowska MK, Dinniwell R, Brade AM, Dawson LA, Pintilie M, Ringash J.

Int J Radiat Oncol Biol Phys. 2016 Dec 1;96(5):994-1002. doi: 10.1016/j.ijrobp.2016.08.034. Epub 2016 Aug 31.


Impact of cisplatin dose intensity on human papillomavirus-related and -unrelated locally advanced head and neck squamous cell carcinoma.

Spreafico A, Huang SH, Xu W, Granata R, Liu CS, Waldron JN, Chen E, Ringash J, Bayley A, Chan KK, Hope AJ, Cho J, Razak AA, Hansen A, Jang R, Perez-Ordonez B, Weinreb I, Bossi P, Orlandi E, Licitra LF, Song Y, O'Sullivan B, Siu LL, Kim J.

Eur J Cancer. 2016 Nov;67:174-182. doi: 10.1016/j.ejca.2016.08.013. Epub 2016 Sep 24.


Testing ERBB2 p.L755S kinase domain mutation as a druggable target in a patient with advanced colorectal cancer.

Aung KL, Stockley TL, Serra S, Kamel-Reid S, Bedard PL, Siu LL.

Cold Spring Harb Mol Case Stud. 2016 Sep;2(5):a001016. doi: 10.1101/mcs.a001016.


Hypopharyngeal cancer: looking back, moving forward.

Day D, Hansen AR, Siu LL.

Curr Oncol. 2016 Aug;23(4):221-2. doi: 10.3747/co.23.3242. Epub 2016 Aug 12. No abstract available.


A comparison of weekly versus 3-weekly cisplatin during adjuvant radiotherapy for high-risk head and neck cancer.

Oosting SF, Chen TWW, Huang SH, Wang L, Waldron J, Gilbert R, Goldstein D, Halmos GB, Witjes MJH, Gietema JA, O'Sullivan B, Langendijk JA, Siu LL, Hansen AR.

Oral Oncol. 2016 Aug;59:43-49. doi: 10.1016/j.oraloncology.2016.05.016.


Next-generation sequencing with a myeloid gene panel in core-binding factor AML showed KIT activation loop and TET2 mutations predictive of outcome.

Cher CY, Leung GM, Au CH, Chan TL, Ma ES, Sim JP, Gill H, Lie AK, Liang R, Wong KF, Siu LL, Tsui CS, So CC, Wong HW, Yip SF, Lee HK, Liu HS, Lau JS, Luk TH, Lau CK, Lin SY, Kwong YL, Leung AY.

Blood Cancer J. 2016 Jul 8;6(7):e442. doi: 10.1038/bcj.2016.51.


Phase I trial of dacomitinib, a pan-human epidermal growth factor receptor (HER) inhibitor, with concurrent radiotherapy and cisplatin in patients with locoregionally advanced squamous cell carcinoma of the head and neck (XDC-001).

Prawira A, Brana-Garcia I, Spreafico A, Hope A, Waldron J, Razak AR, Chen EX, Jang R, O'Sullivan B, Giuliani M, Bayley A, Cho J, Wang L, Perez-Ordonez B, Weinreb I, Siu LL, Hansen AR.

Invest New Drugs. 2016 Oct;34(5):575-83. doi: 10.1007/s10637-016-0367-2. Epub 2016 Jun 11.


Facilitating a culture of responsible and effective sharing of cancer genome data.

Siu LL, Lawler M, Haussler D, Knoppers BM, Lewin J, Vis DJ, Liao RG, Andre F, Banks I, Barrett JC, Caldas C, Camargo AA, Fitzgerald RC, Mao M, Mattison JE, Pao W, Sellers WR, Sullivan P, Teh BT, Ward RL, ZenKlusen JC, Sawyers CL, Voest EE.

Nat Med. 2016 May 5;22(5):464-71. doi: 10.1038/nm.4089.


A Phase I study of olaparib and irinotecan in patients with colorectal cancer: Canadian Cancer Trials Group IND 187.

Chen EX, Jonker DJ, Siu LL, McKeever K, Keller D, Wells J, Hagerman L, Seymour L.

Invest New Drugs. 2016 Aug;34(4):450-7. doi: 10.1007/s10637-016-0351-x. Epub 2016 Apr 13.


A phase I trial of ANG1/2-Tie2 inhibitor trebaninib (AMG386) and temsirolimus in advanced solid tumors (PJC008/NCI♯9041).

Chiu JW, Hotte SJ, Kollmannsberger CK, Renouf DJ, Cescon DW, Hedley D, Chow S, Moscow J, Chen Z, Perry M, Diaz-Padilla I, Tan D, Hirte H, McWhirter E, Chen H, Siu LL, Bedard PL.

Invest New Drugs. 2016 Feb;34(1):104-11. doi: 10.1007/s10637-015-0313-8. Epub 2015 Dec 19.

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