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ORIGINAL ARTICLES: CLINICAL ONCOLOGY

A phase II study on the neo-adjuvant combination of pazopanib and radiotherapy in patients with high-risk, localized soft tissue sarcoma

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Pages 1557-1564 | Received 02 Jul 2021, Accepted 13 Aug 2021, Published online: 23 Sep 2021

References

  • WHO Classification of Tumours Editorial Board. WHO classification of tumours of soft tissue and bone. 5th ed. Lyon: IARC Press; 2020.
  • PDQ Adult Treatment Editorial Board. Adult soft tissue sarcoma treatment (PDQ®): health professional version. In: PDQ cancer information summaries. Bethesda (MD): National Cancer Institute (US); 2002.
  • O'Sullivan B, Davis AM, Turcotte R, et al. Preoperative versus postoperative radiotherapy in soft-tissue sarcoma of the limbs: a randomised trial. Lancet. 2002;359(9325):2235–2241.
  • O'Sullivan B, Davis A, Turcotte R, et al. Five-year results of a randomized phase III trial of pre-operative vs post-operative radiotherapy in extremity soft tissue sarcoma. J Clin Oncol. 2004;22(14_suppl):9007–819s.
  • Davis A, Osullivan B, Turcotte R, et al. Late radiation morbidity following randomization to preoperative versus postoperative radiotherapy in extremity soft tissue sarcoma. Radiother Oncol. 2005;75(1):48–53.
  • Haas RL, Delaney TF, O'Sullivan B, et al. Radiotherapy for management of extremity soft tissue sarcomas: why, when, and where? Int J Radiat Oncol Biol Phys. 2012;84(3):572–580.
  • Hanahan D, Folkman J. Patterns and emerging mechanisms of the angiogenic switch during tumorigenesis. Cell. 1996;86(3):353–364.
  • Rocchi L, Caraffi S, Perris R, et al. The angiogenic asset of soft tissue sarcomas: a new tool to discover new therapeutic targets. Biosci Rep. 2014;34(6):e00147.
  • van der Graaf WT, Blay JY, Chawla SP, et al. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2012;379(9829):1879–1886.
  • Bitterman D, Du K. Safety and efficacy of combination targeted therapy and radiotherapy. Am J Hematol Oncol. 2016;12:23–31.
  • Goedegebuure RSA, de Klerk LK, Bass AJ, et al. Combining radiotherapy with anti-angiogenic therapy and immunotherapy; a therapeutic triad for cancer? Front Immunol. 2018;9:3107.
  • Haas RL, Gelderblom H, Sleijfer S, et al. A phase I study on the combination of neoadjuvant radiotherapy plus pazopanib in patients with locally advanced soft tissue sarcoma of the extremities. Acta Oncol. 2015;54(8):1195–1201.
  • Haas RL, Miah AB, LePechoux C, et al. Preoperative radiotherapy for extremity soft tissue sarcoma; past, present and future perspectives on dose fractionation regimens and combined modality strategies. Radiother Oncol. 2016;119(1):14–21.
  • Wardelmann E, Haas RL, Bovée JV, et al. Evaluation of response after neoadjuvant treatment in soft tissue sarcomas; the European organization for research and treatment of Cancer-Soft tissue and bone sarcoma group (EORTC-STBSG) recommendations for pathological examination and reporting. Eur J Cancer. 2016;53:84–95.
  • Eilber FC, Rosen G, Eckardt J, et al. Treatment-induced pathologic necrosis: a predictor of local recurrence and survival in patients receiving neoadjuvant therapy for high-grade extremity soft tissue sarcomas. J Clin Oncol. 2001;19(13):3203–3209.
  • Canter RJ, Martinez SR, Tamurian RM, et al. Radiographic and histologic response to neoadjuvant radiotherapy in patients with soft tissue sarcoma. Ann Surg Oncol. 2010;17(10):2578–2584.
  • Shah D, Borys D, Martinez SR, et al. Complete pathologic response to neoadjuvant radiotherapy is predictive of oncological outcome in patients with soft tissue sarcoma. Anticancer Res. 2012;32(9):3911–3915.
  • Fletcher CD, Hogendoorn P, Mertens F, et al. WHO classification of tumours of soft tissue and bone. 4th ed. Lyon: IARC Press; 2013.
  • Schaefer IM, Hornick JL, Barysauskas CM, et al. Histologic appearance after preoperative radiation therapy for soft tissue sarcoma: assessment of the European organization for research and treatment of Cancer-Soft tissue and bone sarcoma group response score. Int J Radiat Oncol Biol Phys. 2017;98(2):375–383.
  • Bonvalot S, Rutkowski PL, Thariat J, et al. NBTXR3, a first-in-class radioenhancer hafnium oxide nanoparticle, plus radiotherapy versus radiotherapy alone in patients with locally advanced soft-tissue sarcoma (act.In.Sarc): a multicentre, phase 2-3, randomised, controlled trial [published correction appears in lancet oncol. 2019 sep;20(9):e468]. Lancet Oncol. 2019;20(8):1148–1159.
  • Powles T, Bracarda S, Chen M, et al. Characterisation of liver chemistry abnormalities associated with pazopanib monotherapy: a systematic review and meta-analysis of clinical trials in advanced cancer patients. Eur J Cancer. 2015;51(10):1293–1302.
  • Goyal S, Shah S, Khan AJ, et al. Evaluation of acute locoregional toxicity in patients with breast cancer treated with adjuvant radiotherapy in combination with pazopanib. ISRN Oncol. 2012;2012:896202.
  • De Wolf K, Rottey S, Vermaelen K, et al. Combined high dose radiation and pazopanib in metastatic renal cell carcinoma: a phase I dose escalation trial. Radiat Oncol. 2017;12(1):157.
  • Weiss AR, Chen YL, Scharschmidt TJ, et al. Pathological response in children and adults with large unresected intermediate-grade or high-grade soft tissue sarcoma receiving preoperative chemoradiotherapy with or without pazopanib (ARST1321): a multicentre, randomised, open-label, phase 2 trial. Lancet Oncol. 2020;21(8):1110–1122.
  • Giannini EG, Testa R, Savarino V. Liver enzyme alteration: a guide for clinicians. CMAJ. 2005;172(3):367–379.
  • Hu PF, Xie WF. Corticosteroid therapy in drug-induced liver injury: pros and cons. J Dig Dis. 2019;20(3):122–126.
  • Weber S, Benesic A, Rotter I, et al. Early ALT response to corticosteroid treatment distinguishes idiosyncratic drug-induced liver injury from autoimmune hepatitis. Liver Int. 2019;39(10):1906–1917.
  • Jain RK. Normalizing tumor microenvironment to treat cancer: bench to bedside to biomarkers. J Clin Oncol. 2013;31(17):2205–2218.
  • Viallard C, Larrivée B. Tumor angiogenesis and vascular normalization: alternative therapeutic targets. Angiogenesis. 2017;20(4):409–426.
  • Dings RPM, Loren M, Heun H, et al. Scheduling of radiation with angiogenesis inhibitors anginex and avastin improves therapeutic outcome via vessel normalization. Clin Cancer Res. 2007;13(11):3395–3402.
  • Matsumoto S, Batra S, Saito K, et al. Antiangiogenic agent sunitinib transiently increases tumor oxygenation and suppresses cycling hypoxia. Cancer Res. 2011;71(20):6350–6359.
  • Yoon SS, Duda DG, Karl DL, et al. Phase II study of neoadjuvant bevacizumab and radiotherapy for resectable soft tissue sarcomas. Int J Radiat Oncol Biol Phys. 2011;81(4):1081–1090.
  • Meyer JM, Perlewitz KS, Hayden JB, et al. Phase I trial of preoperative chemoradiation plus sorafenib for high-risk extremity soft tissue sarcomas with dynamic contrast-enhanced MRI correlates. Clin Cancer Res. 2013;19(24):6902–6911.
  • Canter RJ, Borys D, Olusanya A, et al. Phase I trial of neoadjuvant conformal radiotherapy plus sorafenib for patients with locally advanced soft tissue sarcoma of the extremity. Ann Surg Oncol. 2014;21(5):1616–1623.
  • Jakob J, Simeonova A, Kasper B, et al. Combined sunitinib and radiation therapy for preoperative treatment of soft tissue sarcoma: results of a phase I trial of the German interdisciplinary sarcoma group (GISG-03). Radiat Oncol. 2016;11:77.
  • Stacchiotti S, Verderio P, Messina A, et al. Tumor response assessment by modified Choi criteria in localized high-risk soft tissue sarcoma treated with chemotherapy. Cancer. 2012;118(23):5857–5866.
  • Vujanić GM, Sandstedt B, Kelsey A, et al. Central pathology review in multicenter trials and studies: lessons from the nephroblastoma trials. Cancer. 2009;115(9):1977–1983.