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Articles

Using Delayed Toxicities to Re-evaluate Tolerability in Phase 2 Trials: A Case Example using Bortezomib

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Pages 484-489 | Received 24 Oct 2016, Accepted 06 Jun 2017, Published online: 10 Jul 2017

References

  • Postel-Vinay S, Gomez-Roca C, Molife LR, Anghan B, Levy A, Judson I, et al. Phase I trials of molecularly targeted agents: should we pay more attention to late toxicities? J Clin Oncol 2011;29(13):1728–1735.
  • Postel-Vinay S, Collette L, Paoletti X, Rizzo E, Massard C, Olmos D, et al. Towards new methods for the determination of dose limiting toxicities and the assessment of the recommended dose for further studies of molecularly targeted agents – Dose-limiting toxicity and toxicity assessment recommendation group for early trials of targeted therapies, and european organizsation for research and treatment of cancer-led study. Eur J Cancer 2014;50(12):2040–2049.
  • Minasian L, Rosen O, Auclair D, Rahman A, Pazdur R, Schilsky RL. Optimizing dosing of oncology drugs. Clin Pharmacol Ther 2014;96(5):572–579.
  • Lee SM, Backenroth D, Cheung YKK, Hershman DL, Vulih D, Anderson B, et al. A case study of dose optimization using bortezomib clinical trials data. J Clin Oncol 2016;34:1395–1401.
  • Thanarajasingam G, Atherton PJ, Novotny PJ, Loprinzi CL, Sloan JA, Grothey A. Longitudinal adverse event assessment in oncology clinical trials: the Toxicity over Time (ToxT) analysis of Alliance trials NCCTG N9741 and 979254. Lancet Oncol 2016;17:663–670.
  • Lara PN, Chansky K, Davies AM, Franklin WA, Gumerlock PH, Guaglianone PP, et al. Bortezomib (PS-341) in relapsed or refractory extensive stage small cell lung cancer: A Southwest oncology group phase II trial (S0327). J Thorac Oncol 2006;1(9):996–1001.
  • Davies AM, Chansky K, Lara PN, Gumerlock PH, Crowley J, Albain KS, et al. Bortezomib plus gemcitabine/carboplatin as first-line treatment of advanced non-small cell lung cancer: A phase II Southwest oncology group study (S0339). J Thorac Oncol. 2009;4(1):87–92.
  • Aghajanian C, Soignet S, Dizon DS, Pien CS, Adams J, Elliott PJ, et al. A phase I trial of the novel proteasome inhibitor PS341 in advanced solid tumor malignancies. Clin Cancer Res. 2002;8(8):2505–2511.
  • Davies AM, Ruel C, Lara PN, Lau DH, Gumerlock PH, Bold R, et al. The proteasome inhibitor bortezomib in combination with gemcitabine and carboplatin in advanced non-small cell lung cancer: a California cancer consortium phase I study. J Thorac Oncol. 2008;3(1):68–74.
  • National Cancer Institute CTEP. Common Terminology Criteria for Adverse Events (CTCAE). Bethesda, MD; 2009.
  • San Miguel JF, Schlag R, Khuageva NK, Dimopoulos MA, Shpilberg O, Kropff M, et al. Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma. N Engl J Med. 2008;359:906–917.
  • Dimopoulos MA, Richardson PG, Schlag R, Khuageva NK, Shpilberg O, Kastritis E, et al. VMP (Bortezomib, Melphalan, and Prednisone) is active and well tolerated in newly diagnosed patients with multiple myeloma with moderately impaired renal function, and results in reversal of renal impairment: cohort analysis of the phase III VISTA study. J Clin Oncol. 2009;27(36):6086–6093.
  • Mateos MV, Richardson PG, Dimopoulos MA, Palumbo A, Anderson KC, Shi H, et al. Effect of cumulative bortezomib dose on survival in multiple myeloma patients receiving bortezomib-melphalan-prednisone in the phase III VISTA study. Am J Hematol. 2015;90(4):314–319.
  • Niraula S, Seruga B, Ocana A, Shao T, Goldstein R, Tannock IF, et al. The price we pay for progress: a meta-analysis of harms of newly approved anticancer drugs. J Clin Oncol. 2012;30:3012–3019.
  • Niraula S, Amir E, Vera-Badillo F, Seruga B, Ocana A, Tannock IF. Risk of incremental toxicities and associated costs of new anticancer drugs: a meta-analysis. J Clin Oncol. 2014;32:3634–3642.

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