S-1 versus placebo in patients with sorafenib-refractory advanced hepatocellular carcinoma (S-CUBE): a randomised, double-blind, multicentre, phase 3 trial

The Lancet Gastroenterology and Hepatology

Volumn 2, Issue 6, 2017, Pages 407-417

  Kudo, Masatoshi ^a   Moriguchi, Michihisa ^b,c   Numata, Kazushi ^d   Hidaka, Hisashi ^e   Tanaka, Hironori ^f,g   Ikeda, Masafumi ^h   Kawazoe, Seiji ⁱ   Ohkawa, Shinichi ^j   Sato, Yozo ^k   Kaneko, Shuichi ^l   Furuse, Junji ^m   Takeuchi, Madoka ⁿ   Fang, Xuemin ^o   Date, Yoshito ⁿ   Takeuchi, Masahiro ^o   Okusaka, Takuji ^p  

^a KINKI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b KYOTO PREFECTURAL UNIVERSITY OF MEDICINE   (Japan)

^c SHIZUOKA CANCER CENTER   (Japan)

^d YOKOHAMA CITY UNIVERSITY MEDICAL CENTER   (Japan)

^e KITASATO UNIVERSITY HOSPITAL   (Japan)

^f HYOGO COLLEGE OF MEDICINE   (Japan)

^g Takarazuka Municipal Hospital   (Japan)

^h NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

ⁱ Saga Ken Medical Centre Koseikan   (Japan)

^j KANAGAWA CANCER CENTER   (Japan)

^k AICHI CANCER CENTER HOSPITAL   (Japan)

^l KANAZAWA UNIVERSITY HOSPITAL   (Japan)

^m KYORIN UNIVERSITY SCHOOL OF MEDICINE   (Japan)

ⁿ KEIO UNIVERSITY   (Japan)

^o KITASATO UNIVERSITY   (Japan)

^p NATIONAL CANCER CENTER HOSPITAL   (Japan)

more..

Author keywords

[No Author keywords available]

Indexed keywords

GIMERACIL PLUS OTERACIL POTASSIUM PLUS TEGAFUR; PLACEBO; SORAFENIB; ANTINEOPLASTIC ANTIMETABOLITE; OTERACIL; S 1 (COMBINATION); TEGAFUR;

ADVANCED CANCER; ARTICLE; BILIRUBIN BLOOD LEVEL; CONTROLLED STUDY; DEATH; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; EVENING DOSAGE; FOLLOW UP; HUMAN; HYPERPIGMENTATION; JAPAN; LIVER CELL CARCINOMA; MAJOR CLINICAL STUDY; MORNING DOSAGE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; AGED; CHEMICALLY INDUCED; CLINICAL TRIAL; DRUG COMBINATION; EATING DISORDER; FATIGUE; FEMALE; HYPERBILIRUBINEMIA; LIVER TUMOR; MALE; MIDDLE AGED; SURVIVAL ANALYSIS;

AGED; ANTIMETABOLITES, ANTINEOPLASTIC; CARCINOMA, HEPATOCELLULAR; DIARRHEA; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; FATIGUE; FEEDING AND EATING DISORDERS; FEMALE; HUMANS; HYPERBILIRUBINEMIA; HYPERPIGMENTATION; LIVER NEOPLASMS; MALE; MIDDLE AGED; OXONIC ACID; SURVIVAL ANALYSIS; TEGAFUR;

EID: 85018276215     PISSN: 24681253     EISSN: None     Source Type: Journal    
DOI: 10.1016/S2468-1253(17)30072-9     Document Type: Article

References (30)

1. 1 Ferlay, J, Soerjomataram, I, Dikshit, R, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer 136 (2015), E359–E386.
2. 2 Cheng, AL, Kang, YK, Chen, Z, 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 10 (2009), 25–34.
3. 3 Llovet, JM, Ricci, S, Mazzaferro, V, et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 359 (2008), 378–390.
4. 4 Llovet, JM, Decaens, T, Raoul, JL, et al. Brivanib in patients with advanced hepatocellular carcinoma who were intolerant to sorafenib or for whom sorafenib failed: results from the randomized phase III BRISK-PS study. J Clin Oncol 31 (2013), 3509–3516.
5. 5 Zhu, AX, Kudo, M, Assenat, E, et al. Effect of everolimus on survival in advanced hepatocellular carcinoma after failure of sorafenib: the EVOLVE-1 randomized clinical trial. JAMA 312 (2014), 57–67.
6. 6 Zhu, AX, Park, JO, Ryoo, BY, et al. Ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib (REACH): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol 16 (2015), 859–870.
7. 7 Bruix, J, Qin, S, Merle, P, et al. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 389 (2017), 56–66.
8. 8 Shirasaka, T, Nakano, K, Takechi, T, et al. Antitumor activity of 1 M tegafur-0.4 M 5-chloro-2,4-dihydroxypyridine-1 M potassium oxonate (S-1) against human colon carcinoma orthotopically implanted into nude rats. Cancer Res 56 (1996), 2602–2606.
9. 9 Furuse, J, Okusaka, T, Kaneko, S, et al. Phase I/II study of the pharmacokinetics, safety and efficacy of S-1 in patients with advanced hepatocellular carcinoma. Cancer Sci 101 (2010), 2606–2611.
10. 10 Nakamura, M, Nagano, H, Marubashi, S, et al. Pilot study of combination chemotherapy of S-1, a novel oral DPD inhibitor, and interferon-alpha for advanced hepatocellular carcinoma with extrahepatic metastasis. Cancer 112 (2008), 1765–1771.
11. 11 Ueshima, K, Kudo, M, Nagai, T, et al. Combination therapy with S-1 and pegylated interferon alpha for advanced hepatocellular carcinoma. Oncology 75:suppl 1 (2008), 106–113.
12. 12 Llovet, JM, Hernandez-Gea, V, Hepatocellular carcinoma: reasons for phase III failure and novel perspectives on trial design. Clin Cancer Res 20 (2014), 2072–2079.
13. 13 Collins, FS, Varmus, H, A new initiative on precision medicine. N Engl J Med 372 (2015), 793–795.
14. 14 US Food and Drug Administration. Guidance for industry enrichment strategies for clinical trials to support approval of human drugs and biological products, draft guidance. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm332181.pdf, 2012 (accessed Nov 2, 2016).
15. 15 Li, J, Zhao, L, Tian, L, et al. A predictive enrichment procedure to identify potential responders to a new therapy for randomized, comparative controlled clinical studies. Biometrics 72 (2016), 877–887.
16. 16 Kudo, M, Izumi, N, Kokudo, N, et al. Management of hepatocellular carcinoma in Japan: consensus-based clinical practice guidelines proposed by the Japan Society of Hepatology (JSH) 2010 updated version. Dig Dis 29 (2011), 339–364.
17. 17 Uchino, K, Tateishi, R, Shiina, S, et al. Hepatocellular carcinoma with extrahepatic metastasis: clinical features and prognostic factors. Cancer 117 (2011), 4475–4483.
18. 18 Broglio, KR, Berry, DA, Detecting an overall survival benefit that is derived from progression-free survival. J Natl Cancer Inst 101 (2009), 1642–1649.
19. 19 Terashima, T, Yamashita, T, Takata, N, et al. Post-progression survival and progression-free survival in patients with advanced hepatocellular carcinoma treated by sorafenib. Hepatol Res 46 (2016), 650–656.
20. 20 Kudo, M, Izumi, N, Ichida, T, et al. Report of the 19th follow-up survey of primary liver cancer in Japan. Hepatol Res 46 (2016), 372–390.
21. 21 Llovet, JM, Di Bisceglie, AM, Bruix, J, et al. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst 100 (2008), 698–711.
22. 22 Kamiyama, T, Yokoo, H, Kakisaka, T, et al. Multiplication of alpha-fetoprotein and protein induced by vitamin K absence-II is a powerful predictor of prognosis and recurrence in hepatocellular carcinoma patients after a hepatectomy. Hepatol Res 45 (2015), E21–E31.
23. 23 Lencioni, R, Kudo, M, Ye, SL, et al. GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib): second interim analysis. Int J Clin Pract 68 (2014), 609–617.
24. 24 Llovet, JM, Burroughs, A, Bruix, J, Hepatocellular carcinoma. Lancet 362 (2003), 1907–1917.
25. 25 Ikeda, K, Yoshisue, K, Matsushima, E, et al. Bioactivation of tegafur to 5-fluorouracil is catalyzed by cytochrome P-450 2A6 in human liver microsomes in vitro. Clin Cancer Res 6 (2000), 4409–4415.
26. 26 Ueno, H, Okada, S, Okusaka, T, Ikeda, M, Kuriyama, H, Phase I and pharmacokinetic study of 5-fluorouracil administered by 5-day continuous infusion in patients with hepatocellular carcinoma. Cancer Chemother Pharmacol 49 (2002), 155–160.
27. 27 Koizumi, W, Narahara, H, Hara, T, et al. S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol 9 (2008), 215–221.
28. 28 Nagashima, F, Ohtsu, A, Yoshida, S, Ito, K, Japanese nationwide post-marketing survey of S-1 in patients with advanced gastric cancer. Gastric Cancer 8 (2005), 6–11.
29. 29 Ueno, H, Ioka, T, Ikeda, M, et al. Randomized phase III study of gemcitabine plus S-1, S-1 alone, or gemcitabine alone in patients with locally advanced and metastatic pancreatic cancer in Japan and Taiwan: GEST study. J Clin Oncol 31 (2013), 1640–1648.
30. 30 Takashima, T, Mukai, H, Hara, F, et al. Taxanes versus S-1 as the first-line chemotherapy for metastatic breast cancer (SELECT BC): an open-label, non-inferiority, randomised phase 3 trial. Lancet Oncol 17 (2016), 90–98.