Entecavir vs lamivudine for prevention of hepatitis B virus reactivation among patients with untreated diffuse large B-cell lymphoma receiving R-CHOP chemotherapy: A randomized clinical trial

JAMA - Journal of the American Medical Association

Volumn 312, Issue 23, 2014, Pages 2521-2530

  Huang, He ^a   Li, Xueying ^a   Zhu, Jun ^b   Ye, Sheng ^c   Zhang, Hongyu ^c   Wang, Wei ^d   Wu, Xiangyuan ^c   Peng, Jiewen ^e   Xu, Bing ^f   Lin, Yingcheng ^g   Cao, Yabing ^h   Li, Haoran ^a   Lin, Suxia ^a   Liu, Qing ^a   Lin, Tongyu ^a  

^a SUN YAT SEN UNIVERSITY CANCER CENTER   (China)

^b PEKING UNIVERSITY CANCER HOSPITAL AND INSTITUTE   (China)

^c SUN YAT SEN UNIVERSITY   (China)

^d Second People's Hospital of Foshan   (China)

^e Zhongshan People's Hospital   (China)

^f SOUTHERN MEDICAL UNIVERSITY   (China)

^g SHANTOU UNIVERSITY MEDICAL COLLEGE   (China)

^h KiangWu Hospital   (Macao)

Author keywords

[No Author keywords available]

Indexed keywords

ADEFOVIR DIPIVOXIL; CYCLOPHOSPHAMIDE; DOXORUBICIN; ENTECAVIR; HEPATITIS B SURFACE ANTIGEN; LAMIVUDINE; PREDNISONE; RITUXIMAB; VINCRISTINE; ANTINEOPLASTIC AGENT; ANTIVIRUS AGENT; GUANINE; MONOCLONAL ANTIBODY; R-CHOP PROTOCOL;

ADULT; ANTIVIRAL THERAPY; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CONTROLLED STUDY; DIZZINESS; DRUG EFFICACY; DRUG RESPONSE; DRUG TOLERABILITY; FATIGUE; FEMALE; HEADACHE; HEPATITIS B; HEPATITIS B VIRUS; HUMAN; LARGE CELL LYMPHOMA; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; SURVIVAL RATE; TREATMENT DURATION; VIRUS REACTIVATION; AGED; ANALOGS AND DERIVATIVES; BLOOD; CLINICAL TRIAL; COMPARATIVE STUDY; IMMUNOLOGY; LYMPHOMA, LARGE B-CELL, DIFFUSE; MIDDLE AGED; MULTICENTER STUDY; VIROLOGY; YOUNG ADULT;

ADULT; AGED; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; ANTIVIRAL AGENTS; CYCLOPHOSPHAMIDE; DOXORUBICIN; FEMALE; GUANINE; HEPATITIS B; HEPATITIS B SURFACE ANTIGENS; HEPATITIS B VIRUS; HUMANS; LAMIVUDINE; LYMPHOMA, LARGE B-CELL, DIFFUSE; MALE; MIDDLE AGED; PREDNISONE; VINCRISTINE; YOUNG ADULT;

EID: 84919332882     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2014.15704     Document Type: Article

References (38)

1. YeoW, Zee B, Zhong S, et al. Comprehensive analysis of risk factors associating with hepatitis B virus (HBV) reactivation in cancer patients undergoing cytotoxic chemotherapy. Br J Cancer. 2004;90(7):1306-1311.
2. YeoW, Chan PK, Hui P, et al. Hepatitis B virus reactivation in breast cancer patients receiving cytotoxic chemotherapy: a prospective study. J Med Virol. 2003;70(4):553-561.
3. Lau GK, Yiu HH, Fong DY, et al. Early is superior to deferred preemptive lamivudine therapy for hepatitis B patients undergoing chemotherapy. Gastroenterology. 2003;125(6):1742-1749.
4. Marcucci F, Mele A, Spada E, et al. High prevalence of hepatitis B virus infection in B-cell non-Hodgkin's lymphoma. Haematologica. 2006; 91(4):554-557.
5. Wang F, Xu RH, Han B, et al. High incidence of hepatitis B virus infection in B-cell subtype non-Hodgkin lymphoma compared with other cancers. Cancer. 2007;109(7):1360-1364.
6. Park SC, Jeong SH, Kim J, et al. High prevalence of hepatitis B virus infection in patients with B-cell non-Hodgkin's lymphoma in Korea. J Med Virol. 2008;80(6):960-966.
7. Coiffier B, Lepage E, Briere J, et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002;346(4):235-242.
8. Coiffier B, Thieblemont C, Van Den Neste E, et al. Long-term outcome of patients in the LNH-98.5 trial, the first randomized study comparing rituximab-CHOP to standard CHOP chemotherapy in DLBCL patients: a study by the Groupe d'Etudes des Lymphomes de l'Adulte. Blood. 2010;116(12):2040-2045.
9. YeoW, Chan PK, Ho WM, et al. Lamivudine for the prevention of hepatitis B virus reactivation in hepatitis B s-antigen seropositive cancer patients undergoing cytotoxic chemotherapy. J Clin Oncol. 2004;22(5):927-934.
10. Hsu C, Hsiung CA, Su IJ, et al. A revisit of prophylactic lamivudine for chemotherapyassociated hepatitis B reactivation in non-Hodgkin's lymphoma: a randomized trial. Hepatology. 2008; 47(3):844-853.
11. LongM, JiaW, Li S, et al. A single-center, prospective and randomized controlled study: can the prophylactic use of lamivudine prevent hepatitis B virus reactivation in hepatitis B s-antigen seropositive breast cancer patients during chemotherapy? Breast Cancer Res Treat. 2011;127 (3):705-712.
12. Li HR, Huang JJ, Guo HQ, et al. Comparison of entecavir and lamivudine in preventing hepatitis B reactivation in lymphoma patients during chemotherapy. J Viral Hepat. 2011;18(12):877-883.
13. Huang YH, Hsiao LT, Hong YC, et al. Randomized controlled trial of entecavir prophylaxis for rituximab-associated hepatitis B virus reactivation in patients with lymphoma and resolved hepatitis B. J Clin Oncol. 2013;31(22):2765-2772.
14. Cancer Therapy Evaluation Program; National Cancer Institute. Common terminology criteria for adverse events. August 9, 2006. http://ctep .cancer.gov/protocolDevelopment/electronic-applications/docs/ctcaev3.pdf#search=%22Common%20Terminology%20Criteria%20for%20Adverse%20Events%20Version%203 .0%22. Accessibility verified November 17, 2014.
15. EspyMJ, Uhl JR, Sloan LM, et al. Real-time PCR in clinical microbiology: applications for routine laboratory testing. Clin Microbiol Rev. 2006;19(1): 165-256.
16. Lok AS, Liang RH, Chiu EK,Wong KL, Chan TK, Todd D. Reactivation of hepatitis B virus replication in patients receiving cytotoxic therapy: report of a prospective study. Gastroenterology. 1991;100(1): 182-188.
17. YeoW, Chan PK, Zhong S, et al. Frequency of hepatitis B virus reactivation in cancer patients undergoing cytotoxic chemotherapy: a prospective study of 626 patients with identification of risk factors. J Med Virol. 2000;62(3):299-307.
18. Coiffier B. State-of-the-art therapeutics: diffuse large B-cell lymphoma. J Clin Oncol. 2005;23(26): 6387-6393.
19. Pfreundschuh M, Schubert J, ZiepertM, et al; German High-Grade Non-Hodgkin Lymphoma Study Group (DSHNHL). Six versus eight cycles of bi-weekly CHOP-14 with or without rituximab in elderly patients with aggressive CD20+ B-cell lymphomas: a randomised controlled trial (RICOVER-60). Lancet Oncol. 2008;9(2):105-116.
20. Feugier P, Van Hoof A, Sebban C, et al. Long-term results of the R-CHOP study in the treatment of elderly patients with diffuse large B-cell lymphoma: a study by the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol. 2005;23 (18):4117-4126.
21. Pfreundschuh M, Trumper L, Osterborg A, et al; MabThera International Trial Group. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group. Lancet Oncol. 2006;7(5):379-391.
22. Chen MH, Hsiao LT, Chiou TJ, et al. High prevalence of occult hepatitis B virus infection in patients with B cell non-Hodgkin's lymphoma. Ann Hematol. 2008;87(6):475-480.
23. Takai S, Tsurumi H, Ando K, et al. Prevalence of hepatitis B and C virus infection in haematological malignancies and liver injury following chemotherapy. Eur J Haematol. 2005;74(2):158-165.
24. Kang J, Cho JH, Suh CW, et al. High prevalence of hepatitis B and hepatitis C virus infections in Korean patients with hematopoietic malignancies. Ann Hematol. 2011;90(2):159-164.
25. Hsu CH, Hsu HC, Chen HL, et al. Doxorubicin activates hepatitis B virus (HBV) replication in HBV-harboring hepatoblastoma cells: a possible novel mechanism of HBV reactivation in HBV carriers receiving systemic chemotherapy. Anticancer Res. 2004;24(5A):3035-3040.
26. YeoW, Chan TC, Leung NW, et al. Hepatitis B virus reactivation in lymphoma patients with prior resolved hepatitis B undergoing anticancer therapy with or without rituximab. J Clin Oncol. 2009;27(4): 605-611.
27. Evens AM, Jovanovic BD, Su YC, et al. Rituximab-associated hepatitis B virus (HBV) reactivation in lymphoproliferative diseases: meta-analysis and examination of FDA safety reports. Ann Oncol. 2011;22(5):1170-1180.
28. Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology. 2009;50(3):661-662.
29. European Association for the Study of the Liver. EASL clinical practice guidelines: management of chronic hepatitis B. J Hepatol. 2009;50(2):227-242.
30. Chang TT, Gish RG, de Man R, et al; BEHoLD AI463022 Study Group. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med. 2006;354(10):1001-1010.
31. Lai CL, Shouval D, Lok AS, et al; BEHoLD AI463027 Study Group. Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. N Engl J Med. 2006;354(10): 1011-1020.
32. Idilman R, Arat M, Soydan E, et al. Lamivudine prophylaxis for prevention of chemotherapyinduced hepatitis B virus reactivation in hepatitis B virus carriers with malignancies. J Viral Hepat. 2004;11(2):141-147.
33. Lim LL,Wai CT, Lee YM, et al. Prophylactic lamivudine prevents hepatitis B reactivation in chemotherapy patients. Aliment Pharmacol Ther. 2002;16(11):1939-1944.
34. Lee GW, Ryu MH, Lee JL, et al. The prophylactic use of lamivudine can maintain dose-intensity of adriamycin in hepatitis-B surface antigen (HBs Ag)-positive patients with non-Hodgkin's lymphoma who receive cytotoxic chemotherapy. J Korean Med Sci. 2003;18(6):849-854.
35. Cil T, Altintas A, Pasa S, Bayan K, Ozekinci T, Isikdogan A. Lamivudine for the prevention of hepatitis B virus reactivation in hepatitis-B surface antigen (HBSAG) seropositive cancer patients undergoing cytotoxic chemotherapy. Leuk Lymphoma. 2008;49(5):939-947.
36. Pei SN, Chen CH, Lee CM, et al. Reactivation of hepatitis B virus following rituximab-based regimens: a serious complication in both HBsAg-positive and HBsAg-negative patients. Ann Hematol. 2010;89(3):255-262.
37. Dai MS, Chao TY, KaoWY, Shyu RY, Liu TM. Delayed hepatitis B virus reactivation after cessation of preemptive lamivudine in lymphoma patients treated with rituximab plus CHOP. Ann Hematol. 2004;83(12):769-774.
38. National Comprehensive Cancer Network. Prevention and treatment of cancer-related infections. Version 1. 2013. http://oralcancerfoundation.org/treatment/pdf/infections.pdf. Accessibility verified November 17, 2014.