Phase i trial of neoadjuvant conformal radiotherapy plus sorafenib for patients with locally advanced soft tissue sarcoma of the extremity

Annals of Surgical Oncology

Volumn 21, Issue 5, 2014, Pages 1616-1623

  Canter, Robert J ^a   Borys, Dariusz ^b   Olusanya, Abimbola ^a   Li, Chin Shang ^c   Lee, Li Yuan ^d   Boutin, Robert D ^b   Christensen, Scott D ^b   Tamurian, Robert M ^b   Monjazeb, Arta M ^b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF MICHIGAN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; SORAFENIB; CARBANILAMIDE DERIVATIVE; NICOTINAMIDE;

ABSCESS; ADJUVANT CHEMORADIOTHERAPY; ADULT; ADVANCED CANCER; AGED; ANEMIA; ARTICLE; CANCER CHEMOTHERAPY; CANCER LOCALIZATION; CANCER RADIOTHERAPY; CANCER SIZE; CANCER SURGERY; CANCER SURVIVAL; CLEAR CELL SARCOMA; CLINICAL ARTICLE; COMPUTER ASSISTED RADIOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ERUPTION; DRUG TOLERABILITY; EVENING DOSAGE; FEMALE; FIBROSARCOMA; FOLLOW UP; HAND FOOT SYNDROME; HIGH GRADE DIFFERENTIATED PLEOMORPHIC SARCOMA; HUMAN; HUMAN TISSUE; HYPERTENSION; LEG; LIPOSARCOMA; LOCAL RECURRENCE FREE SURVIVAL; LUNG METASTASIS; MALE; MAXIMUM TOLERATED DOSE; MONOTHERAPY; MORNING DOSAGE; MULTIMODALITY CANCER THERAPY; MYXOFIBROSARCOMA; MYXOSARCOMA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PERIRECTAL ABSCESS; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; POSTOPERATIVE COMPLICATION; PREOPERATIVE RADIOTHERAPY; PREOPERATIVE TREATMENT; RADIATION DERMATITIS; RECTUM DISEASE; RECURRENCE FREE SURVIVAL; SOFT TISSUE SARCOMA; STEREOTACTIC PROCEDURE; SUPRAVENTRICULAR TACHYCARDIA; TREATMENT RESPONSE; TUMOR NECROSIS; WHOLE BODY RADIATION; WOUND COMPLICATION; ADJUVANT THERAPY; ANALOGS AND DERIVATIVES; CANCER GRADING; CHEMORADIOTHERAPY; CLINICAL TRIAL; LIMB; MIDDLE AGED; PATHOLOGY; PROGNOSIS; SARCOMA;

ADULT; AGED; ANTINEOPLASTIC AGENTS; CHEMORADIOTHERAPY; EXTREMITIES; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOADJUVANT THERAPY; NEOPLASM GRADING; NIACINAMIDE; PHENYLUREA COMPOUNDS; PROGNOSIS; RADIOTHERAPY, CONFORMAL; SARCOMA;

EID: 84898841401     PISSN: 10689265     EISSN: 15344681     Source Type: Journal    
DOI: 10.1245/s10434-014-3543-7     Document Type: Article

References (39)

1. O'Sullivan B, et al. Preoperative versus postoperative radiotherapy in soft-tissue sarcoma of the limbs: A randomised trial. Lancet. 2002;359(9325):2235-41. (Pubitemid 34717977)
2. Jain RK. Tumor angiogenesis and accessibility: role of vascular endothelial growth factor. Semin Oncol. 2002;29(6 Suppl 16):3-9.
3. Jain RK. Angiogenesis and lymphangiogenesis in tumors: insights from intravital microscopy. Cold Spring Harb Symp Quant Biol. 2002;67:239-48. (Pubitemid 36775517)
4. Yoon SS, et al. Circulating angiogenic factor levels correlate with extent of disease and risk of recurrence in patients with soft tissue sarcoma. Ann Oncol. 2004;15(8):1261-6. (Pubitemid 39199315)
5. Yoon SS, et al. Angiogenic profile of soft tissue sarcomas based on analysis of circulating factors and microarray gene expression. J Surg Res. 2006;135(2):282-90. (Pubitemid 44414877)
6. Yudoh K, et al. Concentration of vascular endothelial growth factor in the tumour tissue as a prognostic factor of soft tissue sarcomas. Br J Cancer. 2001;84(12):1610-5. (Pubitemid 32612491)
7. Senan S, Smit EF. Design of clinical trials of radiation combined with antiangiogenic therapy. Oncologist. 2007;12(4):465-77. (Pubitemid 46698724)
8. Czito BG, et al. Bevacizumab, oxaliplatin, and capecitabine with radiation therapy in rectal cancer: phase I trial results. Int J Radiat Oncol Biol Phys. 2007;68(2):472-8. (Pubitemid 46694189)
9. Awada A, et al. Phase I safety and pharmacokinetics of BAY 43-9006 administered for 21 days on/7 days off in patients with advanced, refractory solid tumours. Br J Cancer. 2005;92(10):1855-61. (Pubitemid 40826133)
10. Strumberg D, et al. Phase I clinical and pharmacokinetic study of the Novel Raf kinase and vascular endothelial growth factor receptor inhibitor BAY 43-9006 in patients with advanced refractory solid tumors. J Clin Oncol. 2005;23(5):965-72. (Pubitemid 46202316)
11. Ratain MJ, et al. Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2006;24(16):2505-12. (Pubitemid 46630627)
12. Escudier B, et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007;356(2):125-34. (Pubitemid 46089673)
13. Parulekar WR, Eisenhauer EA. Phase I trial design for solid tumor studies of targeted, non-cytotoxic agents: Theory and practice. J Natl Cancer Inst. 2004;96(13):990-7. (Pubitemid 39162641)
14. Kurzrock R, Benjamin RS. Risks and benefits of phase 1 oncology trials, revisited. N Engl J Med. 2005;352(9):930-2. (Pubitemid 40300304)
15. Shah D, et al. Complete pathologic response to neoadjuvant radiotherapy is predictive of oncological outcome in patients with soft tissue sarcoma. Anticancer Res. 2012;32(9):3911-5.
16. Canter RJ, et al. Radiographic and histologic response to neoadjuvant radiotherapy in patients with soft tissue sarcoma. Ann Surg Oncol. 2010;17(10):2578-84.
17. Eilber FC, 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):3203-9. (Pubitemid 32591437)
18. Wilhelm SM, et al. BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res. 2004;64(19):7099- 109. (Pubitemid 39331023)
19. Plastaras JP, et al. Cell cycle-dependent and schedule-dependent antitumor effects of sorafenib combined with radiation. Cancer Res. 2007;67(19):9443-54. (Pubitemid 47535934)
20. Chang YS, et al. Sorafenib (BAY 43-9006) inhibits tumor growth and vascularization and induces tumor apoptosis and hypoxia in RCC xenograft models. Cancer Chemother Pharmacol. 2007;59(5):561-74. (Pubitemid 46295136)
21. Lim JH, et al. Ras-dependent induction of HIF-1alpha785 via the Raf/MEK/ERK pathway: A novel mechanism of Ras-mediated tumor promotion. Oncogene. 2004; 23(58):9427-31. (Pubitemid 40069675)
22. Wunder JS, et al. Opportunities for improving the therapeutic ratio for patients with sarcoma. Lancet Oncol. 2007;8(6):513-24. (Pubitemid 46823060)
23. Frustaci S, et al. Adjuvant chemotherapy for adult soft tissue sarcomas of the extremities and girdles: results of the Italian randomized cooperative trial. J Clin Oncol. 2001;19(5):1238-47. (Pubitemid 32202526)
24. Frustaci S, et al. Ifosfamide in the adjuvant therapy of soft tissue sarcomas. Oncology. 2003;65 Suppl 2:80-4. (Pubitemid 37346738)
25. Gortzak E, et al. A randomised phase II study on neo-adjuvant chemotherapy for 'high-risk' adult soft-tissue sarcoma. Eur J Cancer. 2001;37(9):1096-103. (Pubitemid 32520882)
26. Petrioli R, et al. Adjuvant epirubicin with or without Ifosfamide for adult soft-tissue sarcoma. Am J Clin Oncol. 2002;25(5):468-73. (Pubitemid 35154951)
27. Brodowicz T, et al. Intensified adjuvant IFADIC chemotherapy for adult soft tissue sarcoma: A prospective randomized feasibility trial. Sarcoma. 2000;4(4):151-60. (Pubitemid 32055721)
28. Pervaiz N, et al. A systematic meta-analysis of randomized controlled trials of adjuvant chemotherapy for localized resectable soft-tissue sarcoma. Cancer. 2008; 113(3):573-81.
29. Maki RG, et al. Phase II study of sorafenib in patients with metastatic or recurrent sarcomas. J Clin Oncol. 2009;27(19):3133-40.
30. von Mehren M, et al. Phase 2 Southwest Oncology Group-directed intergroup trial (S0505) of sorafenib in advanced soft tissue sarcomas. Cancer. 2012;118(3):770-6.
31. Li J, et al. Angiogenesis and radiation response modulation after vascular endothelial growth factor receptor-2 (VEGFR2) blockade. Int J Radiat Oncol Biol Phys. 2005;62(5):1477-85. (Pubitemid 40982073)
32. Jain RK. Antiangiogenic therapy for cancer: current and emerging concepts. Oncology (Williston Park). 2005;19(4 Suppl 3):7-16.
33. Canter RJ, et al. Radiographic and histologic response to neoadjuvant radiotherapy in patients with soft tissue sarcoma. Ann Surg Oncol. 2010;17(10):2578-84.
34. Wunder JS, et al. The histological response to chemotherapy as a predictor of the oncological outcome of operative treatment of Ewing sarcoma. J Bone Joint Surg Am. 1998;80(7):1020-33. (Pubitemid 28355673)
35. Romero AI, et al. Regulation of CD4+NKG2D+ Th1 cells in patients with metastatic melanoma treated with sorafenib: role of IL-15Rα and NKG2D triggering. Cancer Res. 2014;74(1):68-80.
36. Kattan MW, Leung DH, Brennan MF. Postoperative nomogram for 12-year sarcoma-specific death. J Clin Oncol. 2002;20(3):791-6. (Pubitemid 34111387)
37. Pitson G, et al. Radiation response: An additional unique signature of myxoid liposarcoma. Int J Radiat Oncol Biol Phys. 2004;60(2):522-6. (Pubitemid 39233472)
38. Roberge D, et al. Radiological and pathological response following pre-operative radiotherapy for soft-tissue sarcoma. Radiother Oncol. 2010;97(3):404-7.
39. Chung PW, et al. Radiosensitivity translates into excellent local control in extremity myxoid liposarcoma: A comparison with other soft tissue sarcomas. Cancer. 2009; 115(14):3254-61.