Pazopanib in the treatment of soft tissue sarcoma

Expert Review of Anticancer Therapy

Volumn 12, Issue 6, 2012, Pages 711-723

  Schöffski, Patrick ^a  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

Author keywords

oral angiogenesis inhibitor; pazopanib; soft tissue sarcoma; tyrosine kinase inhibitor

Indexed keywords

ANTHRACYCLINE; ANTIHYPERTENSIVE AGENT; ANTINEOPLASTIC AGENT; BROSTALLICIN; CYTOTOXIC AGENT; DOCETAXEL; DOXORUBICIN; ERIBULIN; GEMCITABINE; IFOSFAMIDE; PACLITAXEL; PAZOPANIB; PLACEBO; PROTEIN TYROSINE KINASE INHIBITOR; TEMOZOLOMIDE; TRABECTEDIN;

ADVANCED CANCER; ANOREXIA; ANTIANGIOGENIC ACTIVITY; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; BACKACHE; BLOOD TOXICITY; BONE MARROW SUPPRESSION; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER INHIBITION; CANCER PREVENTION; CANCER PROGNOSIS; CANCER RADIOTHERAPY; CANCER STAGING; CANCER SURGERY; CANCER SURVIVAL; CARDIOTOXICITY; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; CLINICAL EFFECTIVENESS; CONCENTRATION RESPONSE; DEPIGMENTATION; DIARRHEA; DISSEMINATED INTRAVASCULAR CLOTTING; DOSE RESPONSE; DRUG ABSORPTION; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG MECHANISM; DRUG METABOLISM; DRUG POTENCY; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; DYSGEUSIA; FATIGUE; HAIR DISEASE; HEART DISEASE; HEMOPTYSIS; HUMAN; HYPERBILIRUBINEMIA; HYPERTENSION; HYPERTRANSAMINASEMIA; HYPOPIGMENTATION; INFECTION; INTESTINE PERFORATION; KIDNEY CARCINOMA; KIDNEY DISEASE; LEIOMYOSARCOMA; LEUKOPENIA; LIPOSARCOMA; LIVER TOXICITY; LUNG EMBOLISM; LYMPHOCYTOPENIA; MALIGNANT FIBROUS HISTIOCYTOMA; MAXIMUM TOLERATED DOSE; METASTASIS; MULTIPLE MYELOMA; NEPHROTOXICITY; NEUROENDOCRINE TUMOR; NEUROLOGIC DISEASE; NEUROTOXICITY; NEUTROPENIA; NONHUMAN; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PERIPHERAL NERVE TUMOR; PERITONITIS; PNEUMOTHORAX; PROGRESSION FREE SURVIVAL; PROTEINURIA; RECOMMENDED DRUG DOSE; REVIEW; SIDE EFFECT; SIGNAL TRANSDUCTION; SINGLE DRUG DOSE; SOFT TISSUE SARCOMA; SOLID TUMOR; STOMATITIS; SYNOVIAL SARCOMA; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT; VENOUS THROMBOEMBOLISM; VISUAL DISORDER; WEIGHT REDUCTION;

ANGIOGENESIS INHIBITORS; ANIMALS; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; DISEASE-FREE SURVIVAL; HUMANS; PROTEIN KINASE INHIBITORS; PYRIMIDINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SARCOMA; SULFONAMIDES;

EID: 84862897753     PISSN: 14737140     EISSN: 17448328     Source Type: Journal    
DOI: 10.1586/era.12.41     Document Type: Review

References (76)

1. Sinha S. Diagnosis and management of soft tissue sarcoma. BMJ 341, C7170 (2010).
2. Sleijfer S, Ray-Coquard I, Papai Z et al. Pazopanib, a multikinase angiogenesis inhibitor, in patients with relapsed or refractory advanced soft tissue sarcoma: a Phase II study from the European Organisation for Research and Treatment of Cancer - Soft Tissue and Bone Sarcoma Group (EORTC Study 62043). J. Clin. Oncol. 27(19), 3126-3132 (2009). Outcomes of the Phase II pazopanib study, in 142 patients with intermediate- or high-grade advanced soft tissue sarcoma, demonstrating prolonged progression-free and overall survival compared with historical controls.
3. Clark MA, Fischer C, Judson I et al. Soft-tissue sarcomas in adults. N. Engl. J. Med. 353, 701-711 (2005).
4. Brennan MF, Singer S, Maki RG. Sarcomas of the soft tissue and bone. In: Cancer: Principles and Practice of Oncology (Volumes 1 & 2), (8th Edition). DeVita VT Jr, Hellman S, Rosenberg SA (Eds). Lippincott Williams & Wilkins, Philadelphia, PA, USA, 1741-1833 (2008).
5. Coindre JM, Terrier P, Guillou L et al. Predictive value of grade for metastasis development in the main histologic types of adult soft tissue sarcomas: a study of 1240 patients from the French Federation of Cancer Centers Sarcoma Group. Cancer 91(10), 1914-1926 (2001).
6. Teixeira LEM, Vilela JC, De Araujo ID. Prognostic factors in soft tissue sarcoma. In: Soft Tissue Tumors. Derbel F (Ed.). InTech, Rijeka, Croatia, 255-262 (2011).
7. Vraa S, Keller J, Nielsen OS et al. Prognostic factors in soft tissue sarcomas: the Aarhus experience. Eur. J. Cancer 34(12), 1876-1882 (1998).
8. Lietman SA. Soft-tissue sarcomas: overview of management, with a focus on surgical treatment considerations. Cleveland Clin. J. Med. 77(Suppl. 1), S13-S17 (2010).
9. Casali PG, Blay JY. Soft tissue sarcomas: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann. Oncol. 21(Suppl. 5), V198-V203 (2010).
10. Weitz J, Antonescu CR, Brennan MF. Localized extremity soft tissue sarcoma: improved knowledge with unchanged survival over time. J. Clin. Oncol. 21, 2719-2725 (2003).
11. Sleijfer S, Seynaeve C, Verweij J. Using single-agent therapy in adult patients with advanced soft tissue sarcoma can still be considered standard care. Oncologist 10, 833-841 (2005).
12. Tascilar M, Loos WJ, Seynaeve C et al. The pharmacologic basis of ifosfamide use in adult patients with advanced soft tissue sarcomas. Oncologist 12, 1351-1360 (2007).
13. Antman K, Crowley J, Balcerzak SP et al. An intergroup Phase III randomized study of doxorubicin and dacarbazine with or without ifosfamide and mesna in advanced soft tissue and bone sarcomas. J. Clin. Oncol. 11(7), 1276-1285 (1993).
14. Penel N, Van Glabbeke M, Marreaud S, Ouali M, Blay JY, Hohenberger P. Testing new regimens in patients with advanced soft tissue sarcoma: analysis of publications from the last 10 years. Ann. Oncol. 22, 1266-1272 (2011).
15. Van Oosterom AT, Verweij J. New drugs for the treatment of sarcoma. Hematol. Oncol. Clin. N. Am. 9, 909-925 (1995).
16. Blanke CD, Rankin C, Demetri GD et al. Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033. J. Clin. Oncol. 26, 626-632 (2008).
17. Cohen MH, Cortazar P, Justice R, Pazdur R. Approval summary: imatinib mesylate in the adjuvant treatment of malignant gastrointestinal stromal tumors. Oncologist 15, 300-307 (2010).
18. Demetri GD, Chawla SP, Van Mehren M et al. Efficacy and safety of trabectedin in patients with advanced or metastatic liposarcoma or leiomyosarcoma after failure of prior anthracyclines and ifosfamide: results of a randomized Phase II study of two different schedules. J. Clin. Oncol. 27, 4188-4196 (2009).
19. Van Glabbeke M, Verweij J, Judson I et al. Progression-free rate as the primary endpoint for Phase II study in soft tissue sarcoma. Eur. J. Cancer 38, 543-549 (2002).
20. Schöffski P, Dumez H, Wolter P et al. Clinical impact of trabectedin (ecteinascidin-743) in advanced/metastatic soft tissue sarcoma. Expert Opin. Pharmacother. 9(9), 1609-1618 (2008).
21. Van Oosterom AT, Mouridsen HT, Nielsen OS et al. Results of randomized studies of the EORTC Soft Tissue and Bone Sarcoma Group (STBSG) with two different ifosfamide regimens in first- and second-line chemotherapy in advanced soft tissue sarcoma patients. Eur. J. Cancer 38, 2397-2406 (2002).
22. Leahy M, Ray-Coquard I, Verweij J et al. Brostallicin, an agent with potential activity in metastatic soft tissue sarcoma: a Phase II study from the European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Eur. J. Cancer 43, 308-315 (2007).
23. Garcia-Del Muro X, Lopez-Pousa A, Martin J et al. A Phase II trial of temozolomide as a 6-week, continuous, oral schedule in patients with advanced soft tissue sarcoma. A study by the Spanish Group for Research on Sarcomas. Cancer 104, 1706-1712 (2005).
24. Hensley ML, Blessing JA, DeGeest K et al. Fixed-dose rate gemcitabine plus docetaxel as second-line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group Phase II study. Gynecol. Oncol. 109, 23-28 (2008).
25. Maki R, Watjhen JK, Patel SR et al. Randomized Phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas: results of sarcoma alliance for research through collaboration study 002. J. Clin. Oncol. 25, 2755-2763 (2007).
26. Losa R, Fra J, Lopez-Pousa A et al. Phase II study with the combination of gemcitabine and DTIC in patients with advanced soft tissue sarcomas. Cancer Chemother. Pharmacol. 59, 251-259 (2007).
27. Bailey HH, Mahoney MR, Ettinger DS et al. Phase II study of oral perifosine in patients with advanced soft tissue sarcoma. Cancer 107, 2462-2467 (2006).
28. Penel N, Binh NB, Bay JO et al. Phase II trial of weekly paclitaxel for unresectable angiosarcoma: the ANGIOTAX study. J. Clin. Oncol. 26, 5269-5274 (2008).
29. Hensley ML, Maki RG, Venkatraman E et al. Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: results of a Phase II trial. J. Clin. Oncol. 20, 2824-2831 (2002).
30. Gotink KJ, Verheul HMW. Anti-angiogenic tyrosine kinase inhibitors: what is their mechanism of action? Angiogenesis 13(1), 1-14 (2010). Provides detailed description on the mechanism of action of tyrosine kinase receptors and their inhibitors.
31. Hamberg P, Verweij J, Sleijfer S. (Pre-)clinical pharmacology and activity of pazopanib, a novel multikinase angiogenesis inhibitor. Oncologist 15, 539-547 (2010).
32. Folkman J. Tumor angiogenesis: therapeutic implications. N. Engl. J. Med. 285, 1182-1186 (1971).
33. Carmeliet P, Jain RK. Angiogenesis in cancer and other diseases. Nature 407, 249-257 (2000).
34. Dirix LY, Vermeulen P, De Wever I, Van Oosterom AT. Soft tissue sarcoma in adults. Curr. Opin. Oncol. 9, 348-359 (1997).
35. Pakosi E, Goussia AC, Tsekerisi G, Papachristou DJ, Stefanou D, Agnantis NJ. Expression of vascular endothelial growth factor and its receptor, KDR/Flk-1, in soft tissue sarcomas. Anticancer Res. 25, 3591-3596 (2005).
36. DuBois S, Demetri G. Markers of angiogenesis and clinical features in patients with sarcoma. Cancer 109(5), 813-819 (2007).
37. Hayes AJ, Mostyn-Jones A, Koban MU, A'Hern R, Burton P, Thomas JM. Serum vascular endothelial growth factor as a tumour marker in soft tissue sarcoma. Br. J. Surg. 91, 242- 247 (2004).
38. Humar R, Kiefer FN, Berns H, Resink TJ, Battegay EJ. Hypoxia enhances vascular cell proliferation and angiogenesis in vitro via rapamycin (mTOR) dependent signaling. FASEB J. 16(11), 771-780 (2002).
39. Kilvaer TK, Valkov A, Sorbye S et al. Profiling of VEGFs and VEGFRs as prognostic factors in soft tissue sarcoma: VEGFR-3 is an independent predictor of poor prognosis. PLoS ONE 5(12), E15368 (2010).
40. Holmes K, Roberts OL, Thomas AM, Cross MJ. Vascular endothelial growth factor receptor-2: structure, function, intracellular signalling and therapeutic inhibition. Cell Signal. 19(10), 2003-2012 (2007).
41. Zwick E, Bange J, Ullrich A. Receptor tyrosine kinase signalling as a target for cancer intervention strategies. Endocrine-Related Cancer 8, 161-173 (2001).
42. Tammela T, Enholm B, Alitalo K, Paavonen K. The biology of vascular endothelial growth factors. Cardiovasc. Res. 65, 550-563 (2005).
43. Wirzenius M, Tammela T, Uutela M et al. Distinct vascular endothelial growth factor signals for lymphatic vessel enlargement and sprouting. J. Exp. Med. 204, 1431-1440 (2007).
44. Adams RH, Alitalo K. Molecular regulation of angiogenesis and lymphangiogenesis. Nat. Rev. Mol. Cell. Biol. 8, 464-478 (2007).
45. Karamysheva AF. Mechanisms of angiogenesis. Biochemistry (Mosc.) 73, 751-762 (2008).
46. Ferrara N, Davis-Smyth T. The biology of vascular endothelial growth factor. Endocr. Rev. 18, 4-25 (1997).
47. Schlessinger J. Cell signaling by receptor tyrosine kinases. Cell 103, 211-225 (2000).
48. Kerbel RS. Tumor angiogenesis. N. Engl. J. Med. 358, 2039-2049 (2008).
49. Distler JH, Hirth A, Kurowska-Stolarska M et al. Angiogenic and angiostatic factors in the molecular control of angiogenesis. Q. J. Nucl. Med. 47, 149-161 (2003).
50. Bergers G, Benjamin LE. Tumorigenesis and the angiogenic switch. Nat. Rev. Cancer 3, 401-410 (2003).
51. Kilvaer TK, Valkov A, Sorbye SW et al. Platelet-derived growth factors in non-GIST soft-tissue sarcomas identify a subgroup of patients with wide resection margins and poor disease-specific survival. Sarcoma 2010, 751304 (2010).
52. Rini BI. Vascular endothelial growth factor-targeted therapy in renal cell carcinoma: current status and future directions. Clin. Cancer Res. 13, 1098-1106 (2007).
53. Faivre S, Demetri G, Sargent W, Raymond E. Molecular basis for sunitinib efficacy and future clinical development. Nat. Rev. Drug. Disc. 6, 734-745 (2007).
54. Homsi J, Daud AI. Spectrum of activity and mechanism of action of VEGF/PDGF inhibitors. Cancer Control 14(3), 285-294 (2007).
55. Sonpavde G, Hutson TE, Sternberg CN. Pazopanib, a potent orally administered small-molecule multitargeted tyrosine kinase inhibitor for renal cell carcinoma. Expert Opin. Investig. Drugs 17, 253-261 (2008).
56. Kumar R, Knick VB, Rudolph SK et al. Pharmacokinetic-pharmacodynamic correlation from mouse to human with pazopanib, a multikinase angiogenesis inhibitor with potent antitumor and antiangiogenic activity. Mol. Cancer Ther. 6, 2012-2021 (2007). Provides detailed description on preclinical studies with pazopanib and information on the mechanism of action of pazopanib.
57. Shor AC, Agresta SV, D'Amato GZ, Sondak VK. Therapeutic potential of directed tyrosine kinase inhibitor therapy in sarcomas. Cancer Control 15(1), 47-54 (2008).
58. Hosaka S, Horiuchi K, Yoda M et al. A novel multi-kinase inhibitor pazopanib suppresses growth of synovial sarcoma cells through inhibition of the PI3K-AKT pathway. J. Orthop. Res. doi:10.1002/jor.22091 (2012) (Epub ahead of print).
59. Podar K, Tonon G, Sattler M et al. The small-molecule VEGF receptor inhibitor pazopanib (GW786034B) targets both tumor and endothelial cells in multiple myeloma. Proc. Natl Acad. Sci. USA 103(51), 19478-19483 (2006).
60. Hurwitz HI, Dowlati A, Saini S et al. Phase I trial of pazopanib in patients with advanced cancer. Clin. Cancer Res. 15, 4220-4227 (2009). Results of the Phase I trial of pazopanib in solid tumors, which provide rationale for the use of the once-daily 800-mg pazopanib dose.
61. Hutson TE, Davis ID, Machiels JP et al. Efficacy and safety of pazopanib in patients with metastatic renal cell carcinoma. J. Clin. Oncol. 28, 475-480 (2010).
62. Sternberg CN, Davis ID, Mardiak J et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized Phase III trial. J. Clin. Oncol. 28, 1061-1068 (2010).
63. Van Der Graaf WT, Blay J, Chawla SP et al. PALETTE: a randomized, double-blind, Phase III trial of pazopanib versus placebo in patients (pts) with soft-tissue sarcoma (STS) whose disease has progressed during or following prior chemotherapy - an EORTC STBSG Global Network Study (EORTC 62072). J. Clin. Oncol. 29(18 Suppl.) (2011) (Abstract LBA10002). Analysis of the Phase III pazopanib study in 369 patients with pazopanib as a second- or later-line treatment in patients with metastatic soft tissue sarcoma, demonstrating prolonged progression-free survival compared with placebo.
64. Yovine A, Riofrio M, Blay JY et al. Phase II study of ecteinascidin-743 in advanced pretreated soft tissue sarcoma patients. J. Clin. Oncol. 22, 890-899 (2004).
65. Garcia-Carbonero R, Supko JG, Manola J et al. Phase II and pharmacokinetic study of ecteinascidin 743 in patients with progressive sarcomas of soft tissues refractory to chemotherapy. J. Clin. Oncol. 22, 1480-1490 (2004).
66. Le Cesne A, Blay JY, Judson I et al. Phase II study of ET-743 in advanced soft tissue sarcoma: a European Organization for the Research and Treatment of Cancer (EORTC) Soft Tissue and Bone Sarcoma Group trial. J. Clin. Oncol. 23, 576-584 (2005).
67. Schöffski P, Ray-Coquard IL, Cioffi A et al. European Organisation for Research and Treatment of Cancer (EORTC) Soft Tissue and Bone Sarcoma Group (STBSG). Activity of eribulin mesylate in patients with soft-tissue sarcoma: a Phase 2 study in four independent histological subtypes. Lancet Oncol. 12(11), 1045-1052 (2011).
68. American Cancer Society. Cancer Facts and Figures. Atlanta, GA, USA (2011). www.cancer.org/Research/CancerFactsFigures/CancerFactsFigures/cancer- facts-figures-2011
69. NICE. Cancer Service Guidance CSGSARCOMA. Improving outcomes for people with sarcoma (2006). http://guidance.nice.org.uk/CSGSarcoma/Guidance/pdf/English
70. National Cancer Institute. PDQ® Adult Soft Tissue Sarcoma Treatment. National Cancer Institute, MD, USA (2011). www.cancer.gov/cancertopics/pdq/ treatment/adult-soft-tissue-sarcoma/Patient/page2
71. ClinicalTrials.gov. Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma. http://clinicaltrials.gov/ct2/show/NCT00297258
72. ClinicalTrials.gov. A Randomized Double Blind Phase III Trial of Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy (PALETTE). http://clinicaltrials. gov/ct2/show/NCT00753688
73. Drug Information Online. Doxorubicin Hydrochloride Injection, USP For Intravenous Use Only. Doxorubicin Prescribing Information. www.drugs.com/pro/ doxorubicin.html
74. Ifex (Ifosfamide for Injection) Product Monograph. Baxter Corporation. www.baxter.ca/en/healthcare-professionals/products/index.html
75. ClinicalTrials.gov. Gemcitabine and Docetaxel in Combination With Pazopanib (Gem/Doce/Pzb) for the Neoadjuvant Treatment of Soft Tissue Sarcoma (STS). http://clinicaltrials.gov/ct2/show/NCT01418001
76. ClinicalTrials.gov. Pazopanib Hydrochloride Followed By Chemotherapy and Surgery in Treating Patients With Soft Tissue Sarcoma. http://clinicaltrials. gov/ct2/show/NCT01446809