Randomised phase II trial of S-1 plus oxaliplatin vs S-1 in patients with gemcitabine-refractory pancreatic cancer

British Journal of Cancer

Volumn 112, Issue 9, 2015, Pages 1428-1434

  Ohkawa, S ^a   Okusaka, T ^b   Isayama, H ^c   Fukutomi, A ^d   Yamaguchi, K ^e   Ikeda, M ^f   Funakoshi, A ^g   Nagase, M ^h   Hamamoto, Y ⁱ   Nakamori, S ^j   Tsuchiya, Y ^k   Baba, H ^l   Ishii, H ^m   Omuro, Y ⁿ   Sho, M ^o   Matsumoto, S ^p   Yamada, N ^q   Yanagimoto, H ^r   Unno, M ^s   Ichikawa, Y ^t   Takahashi, S ^s   Watanabe, G ^u   Wakabayashi, G ^v   Egawa, N ^w   Tsuda, M ^x   Hosotani, R ^y   Hamada, C ^z   Hyodo, I ^aa   more..

^a KANAGAWA CANCER CENTER   (Japan)

^b NATIONAL CANCER CENTER HOSPITAL   (Japan)

^c UNIVERSITY OF TOKYO HOSPITAL   (Japan)

^d SHIZUOKA CANCER CENTER   (Japan)

^e SAITAMA CANCER CENTER   (Japan)

^f NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^g NATIONAL KYUSHU CANCER CENTER   (Japan)

^h JAPANESE RED CROSS NAGOYA FIRST HOSPITAL   (Japan)

ⁱ KEIO UNIVERSITY HOSPITAL   (Japan)

^j OSAKA NATIONAL HOSPITAL   (Japan)

^k Department of Surgery   (Japan)

^l KUMAMOTO UNIVERSITY HOSPITAL   (Japan)

^m CANCER INSTITUTE HOSPITAL   (Japan)

ⁿ TOKYO METROPOLITAN KOMAGOME HOSPITAL   (Japan)

^o NARA MEDICAL UNIVERSITY HOSPITAL   (Japan)

^p KYOTO UNIVERSITY HOSPITAL   (Japan)

^q OSAKA CITY UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^r KANSAI MEDICAL UNIVERSITY HOSPITAL   (Japan)

^s TOHOKU UNIVERSITY HOSPITAL   (Japan)

^t YOKOHAMA CITY UNIVERSITY HOSPITAL   (Japan)

^u TORANOMON HOSPITAL   (Japan)

^v IWATE MEDICAL UNIVERSITY   (Japan)

^w TOKYO METROPOLITAN MATSUZAWA HOSPITAL   (Japan)

^x HYOGO CANCER CENTER   (Japan)

^y KOBE CITY MEDICAL CENTER GENERAL HOSPITAL   (Japan)

^z TOKYO UNIVERSITY OF SCIENCE   (Japan)

^aa UNIVERSITY OF TSUKUBA   (Japan)

more..

Author keywords

chemotherapy; oxaliplatin; pancreatic cancer; S 1; SOX

Indexed keywords

GEMCITABINE; GIMERACIL PLUS OTERACIL POTASSIUM PLUS TEGAFUR; OXALIPLATIN; SODIUM; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; DRUG COMBINATION; OTERACIL; PLATINUM COMPLEX; S 1 (COMBINATION); TEGAFUR;

ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; BACTERIAL PERITONITIS; BODY SURFACE; CANCER COMBINATION CHEMOTHERAPY; CANCER STAGING; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG ERUPTION; DRUG FATALITY; DRUG FEVER; DRUG SAFETY; FEBRILE NEUTROPENIA; FEMALE; HUMAN; INFECTION; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUTROPENIA; NEUTROPHIL COUNT; OPEN STUDY; OVERALL SURVIVAL; PANCREAS CANCER; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SENSORY NEUROPATHY; SODIUM BLOOD LEVEL; STOMATITIS; THROMBOCYTE COUNT; THROMBOCYTOPENIA; TIME TO TREATMENT; TREATMENT DURATION; TREATMENT RESPONSE; VERY ELDERLY; ADENOCARCINOMA; ANALOGS AND DERIVATIVES; CANCER GRADING; CARCINOMA, ADENOSQUAMOUS; CLINICAL TRIAL; DRUG COMBINATION; DRUG EFFECTS; DRUG RESISTANCE; FOLLOW UP; METASTASIS; MIDDLE AGED; MORTALITY; PANCREATIC NEOPLASMS; PATHOLOGY; PROGNOSIS; SECONDARY; SURVIVAL RATE;

ADENOCARCINOMA; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, ADENOSQUAMOUS; DEOXYCYTIDINE; DRUG COMBINATIONS; DRUG RESISTANCE, NEOPLASM; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; NEOPLASM GRADING; NEOPLASM METASTASIS; NEOPLASM STAGING; ORGANOPLATINUM COMPOUNDS; OXONIC ACID; PANCREATIC NEOPLASMS; PROGNOSIS; SURVIVAL RATE; TEGAFUR;

EID: 84928769997     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/bjc.2015.103     Document Type: Article

References (20)

1. Argyriou AA, Polychronopoulos P, Iconomou G, Koutras A, Makatsoris T, Gerolymos MK, Gourzis P, Assimakopoulos K, Kalofonos HP, Chroni E. (2007). Incidence and characteristics of peripheral neuropathy during oxaliplatin-based chemotherapy for metastatic colon cancer. Acta Oncol 46: 1131-1137
2. Boeck S, Wilkowski R, Bruns CJ, Issels RD, Schulz C, Moosmann N, Laessig D, Haas M, Golf A, Heinemann V. (2007). Oral capecitabine in gemcitabine-pretreated patients with advanced pancreatic cancer. Oncology 73: 221-227
3. Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul J-L, Gourgou-Bourgade S, Fouchardiere C, Bennouna J, Bachet J-B, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Chem M, Ducreux M. (2011). FOLFIRINOX versus gemcitabine for metastatic pancreas cancer. N Engl J Med 364: 1817-1825
4. Gebbia V, Maiello E, Giuliani F, Borsellino N, Caruso M, Di Maggio G, Ferraú F, Bordonaro R, Verderame F, Tralongo P, Di Cristina L, Agueli R, Russo P, Colucci G. (2007). Second-line chemotherapy in advanced pancreatic carcinoma: a multicenter survey of the Gruppo Oncologico Italia Meridionale on the activity and safety of the FOLFOX4 regimen in clinical practice. Ann Oncol 6: vi124-vi127
5. Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. (2011). Global cancer statistics. CA Cancer J Clin 61: 69-90
6. Kalofonos HP, Aravantinos G, Kosmidis P, Papakostas P, Economopoulos T, Dimopoulos M, Skarlos D, Bamias A, Pectasides D, Chalkidou S, Karina M, Koutras A, Samantas E, Bacoyiannis C, Samelis GF, Basdanis G, Kalfarentzos F, Fountzilas G. (2005). Irinotecan or oxaliplatin combined with leucovorin and 5-fluorouracil as first-line treatment in advanced colorectal cancer: a multicenter, randomized, phase II study. Ann Oncol 16: 869-877
7. Koizumi W, Takiuchi H, Yamada Y, Boku N, Fuse N, Muro K, Komatsu Y, Tsuburaya A. (2010). Phase II study of oxaliplatin plus S-1 as first-line treatment for advanced gastric cancer (G-SOX study). Ann Oncol 21: 1001-1005
8. Kulke MH, Blaszkowsky LS, Ryan DP, Clark JW, Meyerhardt JA, Zhu AX, Enzinger PC, Kwak EL, Muzikansky A, Lawrence C, Fuchs CS. (2007). Capecitabine plus erlotinib in gemcitabine-refractory advanced pancreatic cancer. J Clin Oncol 25: 4787-4792
9. Land SR, Kopec JA, Cecchini RS, Ganz PA, Wieand HS, Colangelo LH, Murphy K, Kuebler JP, Seay TE, Needles BM, Bearden III JD, Colman LK, Lanier KS, Pajon Jr. ER, Cella D, Smith RE, OConnell MJ, Costantino JP, Wolmark N. (2007). Neurotoxicity from oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: NSABP C-07. J Clin Oncol 25: 2205-2211
10. Morizane C, Okusaka T, Furuse J, Ishii H, Ueno H, Ikeda M, Nakachi K, Najima M, Ogura T, Suzuki E. (2009). A phase II study of S-1 in gemcitabine-refractory metastatic pancreatic cancer. Cancer Chemother Pharmacol 63: 313-319
11. Novarino A, Satolli MA, Chiappino I, Giacobino A, Bellone G, Rahimi F, Milanesi E, Bertetto O, Ciuffreda L. (2009). Oxaliplatin, 5-fluorouracil, and leucovorin as second-line treatment for advanced pancreatic cancer. Am J Clin Oncol 32: 44-48
12. Oettle H, Riess H, Stieler JM, Heil G, Schwaner I, Seraphin J, Görner M, Mölle M, Greten TF, Lakner V, Bischoff S, Sinn M, Dörken B, Pelzer U. (2014). Second-line oxaliplatin, folnic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from CONKO-003 trial. J Clin Oncol 32: 2423-2429
13. Otsu S, Hirashima Y, Nishikawa K, Sakashita H, Morinaga R, Watanabe K, Shirao K. (2014). Neurological toxicity in metastatic colorectal cancer patients treated with modified FOLFOX6 plus bevacizumab. Jpn Clin Med 5: 19-23
14. Petrelli F, Borgonovo K, Ghilardi M, Cabiddu M, Barni S. (2010). What else in gemcitabine-pretreated advanced pancreatic cancer? An update of second line therapies. Rev Recent Clin Trials 5: 43-56
15. Pocock SJ, Simon R. (1975). Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 31: 103-115
16. Rahma OE, Duffy A, Liewehr DJ, Steinberg SM, Greten TF. (2013). Second-line treatment in advanced pancreatic cancer: a comprehensive analysis of published clinical trials. Ann Oncol 24: 1972-1979
17. Van Cutsem E, Nordlinger B, Adam R, Köhne CH, Pozzo C, Poston G, Ychou M, Rougier P. (2006). Towards a pan-European consensus on the treatment of patients with colorectal liver metastases. Eur J Cancer 42: 2212-2221
18. Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Cutsem EV, Wei X, Iglesias J, Renschler MF. (2013). Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med 369: 1691-1703
19. Xiong HQ, Varadhachary GR, Blais JC, Hess KR, Abbruzzese JL, Wolff RA. (2008). Phase 2 trial of oxaliplatin plus capecitabine (XELOX) as second-line therapy for patients with advanced pancreatic cancer. Cancer 113: 2046-2052
20. Yamada Y, Tahara M, Miya T, Satoh T, Shirao K, Shimada Y, Ohtsu A, Sasaki Y, Tanigawara Y. (2008). Phase I/II study of oxaliplatin with oral S-1 as first-line therapy for patients with metastatic colorectal cancer. Br J Cancer 98: 1034-1038