Phase i study evaluating the treatment of patients with hepatocellular carcinoma (HCC) with carbon ion radiotherapy: The PROMETHEUS-01 trial

BMC Cancer

Volumn 11, Issue , 2011, Pages

  Combs, Stephanie E ^a   Habermehl, Daniel ^a   Ganten, Tom ^a   Schmidt, Jan ^a   Edler, Lutz ^b   Burkholder, Iris ^c   Jäkel, Oliver ^a   Haberer, Thomas ^a   Debus, Jürgen ^a  

^a UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

^b GERMAN CANCER RESEARCH CENTER DKFZ   (Germany)

^c Pistorstr 7 ^*  (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CANCER CONTROL; CANCER RADIOTHERAPY; DOSIMETRY; ION THERAPY; LIVER CELL CARCINOMA; PHASE 1 CLINICAL TRIAL (TOPIC); PROGRESSION FREE SURVIVAL; RADIATION INJURY; TREATMENT RESPONSE; ADOLESCENT; ADULT; AGED; ALGORITHM; CANCER STAGING; CLINICAL TRIAL; FEMALE; HUMAN; LIVER TUMOR; MALE; MIDDLE AGED; PATHOLOGY; PHASE 1 CLINICAL TRIAL; RADIATION DOSE;

CARBON; ION;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ALGORITHMS; CARBON; CARCINOMA, HEPATOCELLULAR; FEMALE; HUMANS; IONS; LIVER NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; RADIOTHERAPY DOSAGE; YOUNG ADULT;

EID: 79751525739     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-11-67     Document Type: Article

References (42)

1. Okuda K, Nakanuma Y, Miyazaki M. Cholangiocarcinoma: recent progress. Part 1: epidemiology and etiology. J Gastroenterol Hepatol 2002, 17:1049-55. 10.1046/j.1440-1746.2002.02781.x, 12201863.
2. Parkin DM, Bray F, Ferlay J, Pisani P. Estimating the world cancer burden: Globocan 2000. Int J Cancer 2001, 94:153-6. 10.1002/ijc.1440, 11668491.
3. Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005, 55:74-108. 10.3322/canjclin.55.2.74, 15761078.
4. El Serag HB, Mason AC. Rising incidence of hepatocellular carcinoma in the United States. N Engl J Med 1999, 340:745-50. 10.1056/NEJM199903113401001, 10072408.
5. Tanaka Y, Hanada K, Mizokami M, Yeo AE, Shih JW, Gojobori T, et al. Inaugural Article: A comparison of the molecular clock of hepatitis C virus in the United States and Japan predicts that hepatocellular carcinoma incidence in the United States will increase over the next two decades. Proc Natl Acad Sci USA 2002, 99:15584-9. 10.1073/pnas.242608099, 137760, 12438687.
6. Bruno S, Silini E, Crosignani A, Borzio F, Leandro G, Bono F, et al. Hepatitis C virus genotypes and risk of hepatocellular carcinoma in cirrhosis: a prospective study. Hepatology 1997, 25:754-8. 10.1002/hep.510250344, 9049231.
7. Bruix J, Barrera JM, Calvet X, Ercilla G, Costa J, Sanchez-Tapias JM, et al. Prevalence of antibodies to hepatitis C virus in Spanish patients with hepatocellular carcinoma and hepatic cirrhosis. Lancet 1989, 2:1004-6. 10.1016/S0140-6736(89)91015-5, 2572739.
8. Colombo M, Kuo G, Choo QL, Donato MF, Del Ninno E, Tommasini MA, et al. Prevalence of antibodies to hepatitis C virus in Italian patients with hepatocellular carcinoma. Lancet 1989, 2:1006-8. 10.1016/S0140-6736(89)91016-7, 2572740.
9. Colombo M, De Franchis R, Del Ninno E, Sangiovanni A, De Fazio C, Tommasini M, et al. Hepatocellular carcinoma in Italian patients with cirrhosis. N Engl J Med 1991, 325:675-80. 10.1056/NEJM199109053251002, 1651452.
10. Tsukuma H, Hiyama T, Tanaka S, Nakao M, Yabuuchi T, Kitamura T, et al. Risk factors for hepatocellular carcinoma among patients with chronic liver disease. N Engl J Med 1993, 328:1797-801. 10.1056/NEJM199306243282501, 7684822.
11. Niederau C, Fischer R, Sonnenberg A, Stremmel W, Trampisch HJ, Strohmeyer G. Survival and causes of death in cirrhotic and in noncirrhotic patients with primary hemochromatosis. N Engl J Med 1985, 313:1256-62. 10.1056/NEJM198511143132004, 4058506.
12. Umemura T, Ichijo T, Yoshizawa K, Tanaka E, Kiyosawa K. Epidemiology of hepatocellular carcinoma in Japan. J Gastroenterol 2009, 44(Suppl 19):102-7. 10.1007/s00535-008-2251-0, 19148802.
13. Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet 2003, 362:1907-17. 10.1016/S0140-6736(03)14964-1, 14667750.
14. Llovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival. Hepatology 2003, 37:429-42. 10.1053/jhep.2003.50047, 12540794.
15. Lopez PM, Villanueva A, Llovet JM. Systematic review: evidence-based management of hepatocellular carcinoma--an updated analysis of randomized controlled trials. Aliment Pharmacol Ther 2006, 23:1535-47. 10.1111/j.1365-2036.2006.02932.x, 16696801.
16. Asnacios A, Fartoux L, Romano O, Tesmoingt C, Louafi SS, Mansoubakht T, et al. Gemcitabine plus oxaliplatin (GEMOX) combined with cetuximab in patients with progressive advanced stage hepatocellular carcinoma: results of a multicenter phase 2 study. Cancer 2008, 112:2733-9. 10.1002/cncr.23489, 18412149.
17. Zhu AX, Stuart K, Blaszkowsky LS, Muzikansky A, Reitberg DP, Clark JW, et al. Phase 2 study of cetuximab in patients with advanced hepatocellular carcinoma. Cancer 2007, 110:581-9. 10.1002/cncr.22829, 17583545.
18. Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 2008, 359:378-90. 10.1056/NEJMoa0708857, 18650514.
19. Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, et al. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol 2009, 10:25-34. 10.1016/S1470-2045(08)70285-7, 19095497.
20. Lawrence TS, Ten Haken RK, Kessler ML, Robertson JM, Lyman JT, Lavigne ML, et al. The use of 3-D dose volume analysis to predict radiation hepatitis. Int J Radiat Oncol Biol Phys 1992, 23:781-8. 10.1016/0360-3016(92)90651-W, 1618671.
21. Robertson JM, Lawrence TS, Dworzanin LM, Andrews JC, Walker S, Kessler ML, et al. Treatment of primary hepatobiliary cancers with conformal radiation therapy and regional chemotherapy. J Clin Oncol 1993, 11:1286-93.
22. Robertson JM, Lawrence TS, Andrews JC, Walker S, Kessler ML, Ensminger WD. Long-term results of hepatic artery fluorodeoxyuridine and conformal radiation therapy for primary hepatobiliary cancers. Int J Radiat Oncol Biol Phys 1997, 37:325-30. 10.1016/S0360-3016(96)00528-7, 9069303.
23. Park HC, Seong J, Han KH, Chon CY, Moon YM, Suh CO. Dose-response relationship in local radiotherapy for hepatocellular carcinoma. Int J Radiat Oncol Biol Phys 2002, 54:150-5. 10.1016/S0360-3016(02)03283-2, 12182985.
24. Dawson LA, McGinn CJ, Normolle D, Ten Haken RK, Walker S, Ensminger W, et al. Escalated focal liver radiation and concurrent hepatic artery fluorodeoxyuridine for unresectable intrahepatic malignancies. J Clin Oncol 2000, 18:2210-8.
25. Blomgren H, Lax I, Naslund I, Svanstrom R. Stereotactic high dose fraction radiation therapy of extracranial tumors using an accelerator. Clinical experience of the first thirty-one patients. Acta Oncol 1995, 34:861-70. 10.3109/02841869509127197, 7576756.
26. Herfarth KK, Debus J, Lohr F, Bahner ML, Fritz P, Hoss A, et al. Extracranial stereotactic radiation therapy: set-up accuracy of patients treated for liver metastases. Int J Radiat Oncol Biol Phys 2000, 46:329-35. 10.1016/S0360-3016(99)00413-7, 10661339.
27. Wulf J, Hadinger U, Oppitz U, Olshausen B, Flentje M. Stereotactic radiotherapy of extracranial targets: CT-simulation and accuracy of treatment in the stereotactic body frame. Radiother Oncol 2000, 57:225-36. 10.1016/S0167-8140(00)00226-7, 11054527.
28. Timmerman R, Papiez L, Suntharalingam M. Extracranial stereotactic radiation delivery: expansion of technology beyond the brain. Res Treat 2003, 2:153-60.
29. Jianshe Y, Xigang J, Wenjian L, Zhuanzi W, Guangming Z, Jufang W, et al. Correlation between initial chromatid damage and survival of various cell lines exposed to heavy charged particles. Radiat Environ Biophys 2006, 45:261-6. 10.1007/s00411-006-0063-2, 16964490.
30. Jianshe Y, Wenjian L, Xiaodong J, Xigang J, Chuanling G, Wei W, et al. Survival and initial chromatid breakage in normal and tumour cells exposed in vitro to gamma rays and carbon ions at the HIRFL. Br J Radiol 2006, 79:518-21. 10.1259/bjr/99734289, 16714755.
31. Hata M, Tokuuye K, Sugahara S, Kagei K, Igaki H, Hashimoto T, et al. Proton beam therapy for hepatocellular carcinoma with portal vein tumor thrombus. Cancer 2005, 104:794-801. 10.1002/cncr.21237, 15981284.
32. Chiba T, Tokuuye K, Matsuzaki Y, Sugahara S, Chuganji Y, Kagei K, et al. Proton beam therapy for hepatocellular carcinoma: a retrospective review of 162 patients. Clin Cancer Res 2005, 11:3799-805. 10.1158/1078-0432.CCR-04-1350, 15897579.
33. Kawashima M, Furuse J, Nishio T, Konishi M, Ishii H, Kinoshita T, et al. Phase II study of radiotherapy employing proton beam for hepatocellular carcinoma. J Clin Oncol 2005, 23:1839-46. 10.1200/JCO.2005.00.620, 15774777.
34. Hata M, Tokuuye K, Sugahara S, Fukumitsu N, Hashimoto T, Ohnishi K, et al. Proton beam therapy for hepatocellular carcinoma patients with severe cirrhosis. Strahlenther Onkol 2006, 182:713-20. 10.1007/s00066-006-1564-2, 17149578.
35. Hata M, Tokuuye K, Sugahara S, Fukumitsu N, Hashimoto T, Ohnishi K, et al. Proton beam therapy for hepatocellular carcinoma with limited treatment options. Cancer 2006, 107:591-8. 10.1002/cncr.22039, 16804931.
36. Hashimoto T, Tokuuye K, Fukumitsu N, Igaki H, Hata M, Kagei K, et al. Repeated proton beam therapy for hepatocellular carcinoma. Int J Radiat Oncol Biol Phys 2006, 65:196-202. 10.1016/j.ijrobp.2005.11.043, 16563656.
37. Hata M, Tokuuye K, Sugahara S, Tohno E, Nakayama H, Fukumitsu N, et al. Proton beam therapy for aged patients with hepatocellular carcinoma. Int J Radiat Oncol Biol Phys 2007, 69:805-12. 10.1016/j.ijrobp.2007.04.016, 17524568.
38. Schulz-Ertner D, Tsujii H. Particle radiation therapy using proton and heavier ion beams. J Clin Oncol 2007, 25:953-64. 10.1200/JCO.2006.09.7816, 17350944.
39. Tsujii H, Mizoe JE, Kamada T, Baba M, Kato S, Kato H, et al. Overview of clinical experiences on carbon ion radiotherapy at NIRS. Radiother Oncol 2004, 73(Suppl 2):S41-S49. 10.1016/S0167-8140(04)80012-4, 15971308.
40. Kato H, Tsujii H, Miyamoto T, Mizoe JE, Kamada T, Tsuji H, et al. Results of the first prospective study of carbon ion radiotherapy for hepatocellular carcinoma with liver cirrhosis. Int J Radiat Oncol Biol Phys 2004, 59:1468-76. 10.1016/j.ijrobp.2004.01.032, 15275734.
41. Emami B, Lyman J, Brown A, Coia L, Goitein M, Munzenrider JE, et al. Tolerance of normal tissue to therapeutic irradiation. Int J Radiat Oncol Biol Phys 1991, 21:109-22.
42. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009, 45:228-47. 10.1016/j.ejca.2008.10.026, 19097774.