Clinical Research

Over the last decade, our team has provided critical appraisals for clinical trials of numerous cancer therapeutics spanning multiple cancer types, ensuring that clinicians follow evidence-based protocols when prescribing therapeutics to patients. Our team advocates for the use of clinical endpoints such as overall survival and quality of life, and the use of validated control arms in clinical trials to demonstrate the magnitude of clinical benefit a novel therapeutic can offer. Lastly, our team focuses on the applicability of clinical trials to LMICs to ensure access to newly approved therapeutics in a timely and cost-effective manner.

Relevant Publications:

  1. Gyawali B*. Problematic crossovers in cancer drug trials. Nat Rev Clin Oncol. 2023. PMID: 37460633.
  2. Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures. Lancet Oncol. 2023 Jun. PMID: 37269858.
  3. Rubagumya F, Fundytus A, Keith-Brown S, Hopman WM, Gyawali B, Mukherji D, Hammad N, Pramesh CS, Aggarwal A, Eniu A, Sengar M, Riechelmann RSR, Sullivan R, Booth CM. Allocation of authorship and patient enrollment among global clinical trials in oncology. Cancer. 2023 PMID: 37382190.
  4. Farid-Kapadia M, Barton M, Bider-Canfield Z, Cheema PK, Gyawali B, Nightingale NM, Latifovic L, Conter HJ. Comparison of tumor-agnostic and tumor-specific clinical oncology trial designs: a systematic review and meta-analysis. Future Oncol. 2023. PMID: 37283038.
  5. Sengar M, Hopman WM, Mohyuddin GR, Goodman AM, Gyawali B, Mukherji D, Hammad N, Pramesh CS, Aggarwal A, Sullivan R, Booth CM. Randomised controlled trials evaluating anticancer therapies in haematological cancers: an overview of global research activity. Ecancermedicalscience. 2023 Jun 8. PMID: 37396096
  6. Wright K, Digby GC, Gyawali B, Jad R, Menard A, Moraes FY, Wijeratne DT. Malignant Superior Vena Cava Syndrome: A Scoping Review. J Thorac Oncol. 2023 May. PMID: 37146753.
  7. Tannock IF, Goldstein DA, Ofer J, Gyawali B, Meirson T. Evaluating Trials of Adjuvant Therapy: Is There Benefit for People With Resected Renal Cancer? J Clin Oncol. 2023 PMID: 36961983.
  8. Gyawali B, Bowman M, Sharpe I, Jalink M, Srivastava S, Wijeratne DT. A systematic review of eHealth technologies for breast cancer supportive care. Cancer Treat Rev. 2023 Jan. PMID: 36736125.
  9. Gyawali B, Griffiths R, Robinson AG, McInnes MDF, Bedard PL, Booth CM. Utilization of imaging for active surveillance in testicular cancer: Is real-world practice concordant with guidelines?Can Urol Assoc J. 2022. PMID: 34582333
  10. Van Wambeke S, Vera-Badillo FE, Gyawali B. Controlling the Control Arm in Metastatic Castration-Resistant Prostate Cancer Trials: Best Standard of Care or the Minimum Standard of Care? J Clin Oncol. 2022 Feb 21. PMID: 35188830. Altmetric Score: 71
  11. Van Wambeke S and Gyawali B. Atezolizumab in Metastatic Triple-Negative Breast Cancer-No Contradiction in the Eyes of a Dispassionate Observer. JAMA Oncol. 2021 Jun 24. PMID: 34165499.
  12. Wijeratne DT, Wright K, Gyawali B*. Risk-Stratifying Treatment Strategies for Febrile Neutropenia-Tools, Tools Everywhere, and Not a Single One That Works? JCO Oncol Pract. 2021 Apr 29. PMID: 33914611.
  13. Merchant SJ, Kong W, Gyawali B, Hanna TP, Chung W, Nanji S, Patel SV, and Booth CM. First-Line Palliative Chemotherapy for Esophageal and Gastric Cancer: Practice Patterns and Outcomes in the General Population. JCO Oncology Practice. 2021 PMID:  33449833
  14. Gyawali B* and West J. Lessons From ADAURA on Adjuvant Cancer Drug Trials: Evidence, Ethics, and Economics. Journal of Clinical Oncology. December 04, 2020. PMID: 33275490. Altmetric score: 90
  15. Desai A#, Gyawali B*. Assessing the benefits and harms of direct oral anticoagulants in patients with cancer for the prophylaxis and treatment of venous thromboembolism: a systematic review and meta-analysis. ecancer 14 1091 (2020). PMID: 33014133.
  16. Effing S# and Gyawali B*. Assessing the risk-benefit profile of ramucirumab in patients with advanced solid tumors: A meta-analysis of randomized controlled trials. Eclinicalmedicine, Published by the Lancet. July 15, 2020 PMID: 32954236
  17. Robinson AG, Gyawali B, Evans G. COVID-19 and cancer: do we really know what we think we know? Nat Rev Clin Oncol. 2020;1‐3. doi:10.1038/s41571-020-0394-y PMID: 32424196. Altmetric score: 52. This work has been cited in the WHO policy document, available here.
  18. Ginsburg O, Yip CH, Brooks A, Cabanes A, Caleffi M, Yataco JAD, Gyawali B et al. Breast cancer early detection: A phased approach to implementation. Cancer. 2020;126 Suppl 10:2379‐2393. doi:10.1002/cncr.32887. PMID: 32348566
  19. Merchant SJ, Kong W, Gyawali B, Hanna T, Chung W, Nanji S, Patel SV, Booth CM. Effectiveness of Trastuzumab in Routine Clinical Practice: A Population-based Study of Patients with HER-2-positive Oesophageal, Gastroesophageal and Gastric Cancer. Clin Oncol (R Coll Radiol).  PMID: 32747152
  20. Gupta A, Wang P, Ali SA, Rajkumar SV, Gyawali B, Overton HN, Makary MA. Use of Bone-Modifying Agents Among Medicare Beneficiaries With Multiple Myeloma. JAMA Oncology. 2019 Dec. PMID: 31830210. Altmetric score:81
  21. Parikh RB, Galsky MD, Gyawali B, Riaz F, Kauffman T, Cohen AB, Adamson BJS, Gross CP, Meropol NJ and Mamtani R. Trends in Checkpoint Inhibitor Therapy for Advanced Urothelial Cell Carcinoma at the End of Life: Insights from Real‐World Practice. The Oncologist. 2019. PMID: 30944183.
  22. Mamtani, R. , Wang, X. V., Gyawali, B. , DiPaola, R. S., Epperson, C. N., Haas, N. B. and Dutcher, J. P.  Association between age and sex and mortality after adjuvant therapy for renal cancer. Cancer. 2019. PMID: 30620389
  23. Passaro A, Spitaleri G,  Gyawali B and de Marinis F. Immunotherapy in Non–Small-Cell Lung Cancer Patients With Performance Status 2: Clinical Decision Making With Scant Evidence. Journal of Clinical Oncology. 2019. PMID: 30995172
  24. Gyawali B* and Kesselheim AS. The Promise of ESCAT: A New System for Evaluating Cancer Drug-Target Combination. Nature Reviews Clinical Oncology 2018. PMID: 30317250
  25. Niraula S and Gyawali B. Optimal duration of adjuvant trastuzumab in treatment of early breast cancer: a meta-analysis of randomized controlled trials. Breast Cancer Res Treat 2018. PMID: 30238273
  26. Gyawali B*, Kesselheim AS and d’Andrea Elvira. Does Helicobacter pylori eradication therapy to prevent gastric cancer increase all-cause mortality? International Journal of Cancer 2018. PMID: 30152520
  27. Gyawali B* and Niraula S. Cancer treatment in the last 6 months of life: when inaction can outperform action. Ecancermedicalscience. 2018 April. PMID: 29743946. Altmetric score: 259
  28. Dhakal B, Szabo A, Chhabra S,Hamadani M, D’Souza A, Usmani S, Sieracki R, Gyawali B, Jackson JL, Asimakopoulos F and Hari PN. Autologous Transplantation for Newly Diagnosed Multiple Myeloma in the Era of Novel Agent Induction: A Systematic Review and Meta-analysis. JAMA Oncology 2018. PMID: 29302684 
  29. Gyawali B* and Goldstein D. The US Food and Drug Administration’s Approval of Adjuvant Sunitinib for Renal Cell Cancer: A Case of Regulatory Capture? JAMA Oncology. May 2018. PMID: 29522146. Altmetric score: 105
  30. Gyawali B and Prasad V. Health policy: Me-too drugs with limited benefits – the tale of regorafenib for HCC. Nature Reviews Clinical Oncology. (PMID: 28719584) . Altmetric score:83.
  31. Gyawali B and Prasad V. Pemetrexed in Nonsquamous Non–Small-Cell Lung Cancer: The Billion Dollar Subgroup Analysis JAMA Oncology. (PMID: 28750129) . Altmetric score:105.
  32. Tsukuura H, Miyazaki M, Morita T, Sugishita M, Kato H, Murasaki Y, Gyawali B, Kubo Y, Ando M, Kondo M, Yamada K, Hasegawa Y and Ando Y. Efficacy of Prophylactic Treatment for Oxycodone-Induced Nausea and Vomiting Among Patients with Cancer Pain (POINT): A Randomized, Placebo-Controlled, Double-Blind Trial. The Oncologist 2017.  PMID: 29038236
  33. Gyawali B and Niraula S. Duration of adjuvant trastuzumab in HER2 positive breast cancer: Overall and disease free survival results from meta-analyses of randomized controlled trials. Cancer Treatment Reviews 2017.  PMID: 28863313
  34. Fernandes R, Mazzarello S, Stober C, Ibrahim MFK, Dudani S, Perdrizet K, Majeed H, Vandermeer L, Shorr R, Hutton B, Fergusson D, Gyawali B, and Clemons M. Primary Febrile Neutropenia Prophylaxis for Patients Who Receive FEC-D Chemotherapy for Breast Cancer: A Systematic Review. Journal of Global Oncology. PMID: 30241156
  35. Khoja L and Gyawali B*. Adoptive Cell Therapy and modulation of the tumour microenvironment: New Insights from ASCO 2016. Ecancermedicalscience (PMID: 27610200).
  36. Gyawali B* and Ando Y. Adjuvant Sunitinib for high-risk resected renal cell carcinoma: a meta-analysis of ASSURE and S-TRAC trials. Annals of Oncology. (2017) 28 (4): 898-899. (PMID: 27993814).
  37. Gyawali B*. The OlympiAD trial: Who Won the Gold? ecancer 2017, 11:ed75. Published December 6, 2017. PMID : 29290761
  38. Gyawali B* and Iddawela M. Bevacizumab in advanced cervical cancer: issues and challenges for low- and middle- income countries. Journal of Global Oncology. 3, no. 2 (April 2017) 93-97. (PMID: 28717748)
  39. Gyawali B*, Shimokata T, Ando M, Honda K and Ando Y. Risk of Serious Adverse Events and Fatal Adverse Events with Sorafenib use in Patients with Solid Cancer: A meta-analysis of phase 3 Randomized Controlled Trials. Annals of Oncology. (2017) 28 (2): 246-253. (PMID: 27771613).
  40. Gyawali B* and Prasad V. Negative trials in ovarian cancer: is there such a thing as too-much optimism?Ecancermedicalscience. (PMID: 27594913)
  41. Gyawali B*, Shimokata T, Honda K, Kondoh C, Hayashi N, Yoshino Y, Sassa N, Nakano Y, Gotoh M and Ando Y. Muscle wasting associated with the long term use of mTOR inhibitors. Molecular and clinical Oncology, 5, 641-646. (PMID: 27900103).
  42. Sharma-Poudyal B, Tuladhar S and Gyawali B*. TKI-induced Pure Red Cell Aplasia: First Case Report of pure red cell aplasia with both imatinib and nilotinib. ESMO-Open May 2016, 1 (3) e000058; (PMID: 27843612)
  43. Gyawali B*, Shimokata T, Honda K and Ando Y. Chemotherapy in locally advanced head and neck squamous cell carcinoma. Cancer Treatment Reviews. 44:10-6. (PMID: 26924194)
  44. Hayashi N, Ando Y, Gyawali B, Shimokata T, Maeda O, Fukaya M, Goto H, Nagino M and Kodera Y. Low skeletal muscle density is associated with poor survival in patients who receive chemotherapy for metastatic gastric cancer. Oncology reports 35, 1727-1731. (PMID: 26648321).
  45. Tsukuura H, Ando Y, Gyawali B, Matsumoto M, Sugishita M, Honda K, Urakawa H, Maeda O and Hasegawa Y. Prophylactic Use of Antiemetics for Prevention of Opioid-Induced Nausea and Vomiting: A Questionnaire Survey among Japanese Physicians. Journal of palliative medicine 2015;18:977-80.(PMID: 26509390)
  46. Morita S, Hiramatsu M, Sugishita M, Gyawali B, Shibata T, Shimokata T, Urakawa H, Mitsuma A, Moritani S, Kubota T, Ichihara S and Ando Y. Pazopanib monotherapy in a patient with a malignant granular cell tumor originating from the right orbit: A case report. Oncology Letters 10.2 (2015): 972-974. (PMID: 26622607)
  47. Gyawali B*, Hayashi N, Tsukuura H, Honda K, Shimokata T, Ando Y. Opioid-induced constipation. Scandinavian journal of gastroenterology 2015;50:1331-8. (PMID:26061717)