A phase I trial of combination therapy using gemcitabine and S-1 concurrent with full-dose radiation for resectable pancreatic cancer

Cancer Chemotherapy and Pharmacology

Volumn 73, Issue 2, 2014, Pages 309-315

  Eguchi, Hidetoshi ^a   Nagano, Hiroaki ^a   Kobayashi, Shogo ^a   Kawamoto, Koichi ^a   Wada, Hiroshi ^a   Hama, Naoki ^a   Tomimaru, Yoshito ^a   Akita, Hirofumi ^a   Sakai, Daisuke ^a   Satoh, Taroh ^a   Kudo, Toshihiro ^a   Isohashi, Fumiaki ^a   Mori, Masaki ^a   Doki, Yuichiro ^a  

^a OSAKA UNIVERSITY   (Japan)

Author keywords

Chemoradiotherapy; Gemcitabine; Neoadjuvant chemotherapy; Pancreatic ductal adenocarcinoma; S 1

Indexed keywords

CA 19-9 ANTIGEN; GEMCITABINE; GIMERACIL PLUS OTERACIL POTASSIUM PLUS TEGAFUR;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CANCER COMBINATION CHEMOTHERAPY; CANCER RADIOTHERAPY; CHEMORADIOTHERAPY; CLINICAL ARTICLE; CONSTIPATION; DIARRHEA; DRUG DOSE ESCALATION; DRUG DOSE REGIMEN; DRUG SAFETY; FEMALE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; HUMAN; HYPERBILIRUBINEMIA; LEUKOPENIA; LIVER TOXICITY; MALE; MAXIMUM TOLERATED DOSE; NEUTROPENIA; PANCREAS ADENOCARCINOMA; PANCREAS RESECTION; PHASE 1 CLINICAL TRIAL; PREOPERATIVE TREATMENT; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; RADIATION DOSE FRACTIONATION; RASH; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT RESPONSE;

ADMINISTRATION, ORAL; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, PANCREATIC DUCTAL; CHEMORADIOTHERAPY; DEOXYCYTIDINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; OXONIC ACID; TEGAFUR; TREATMENT OUTCOME;

EID: 84896042514     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-013-2357-9     Document Type: Article

References (28)

1. Siegel R, Naishadham D, Jemal A (2012) Cancer statistics, 2012. CA Cancer J Clin 62(1):10-29. doi:10.3322/caac.20138
2. Neoptolemos JP, Stocken DD, Friess H, Bassi C, Dunn JA, Hickey H, Beger H, Fernandez-Cruz L, Dervenis C, Lacaine F, Falconi M, Pederzoli P, Pap A, Spooner D, Kerr DJ, Buchler MW (2004) A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med 350(12):1200-1210. doi:10.1056/NEJMoa032295 (Pubitemid 38339364)
3. Oettle H, Post S, Neuhaus P, Gellert K, Langrehr J, Ridwelski K, Schramm H, Fahlke J, Zuelke C, Burkart C, Gutberlet K, Kettner E, Schmalenberg H, Weigang-Koehler K, Bechstein WO, Niedergethmann M, Schmidt-Wolf I, Roll L, Doerken B, Riess H (2007) Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial. JAMA 297(3):267-277. doi:10.1001/jama.297.3.267 (Pubitemid 46143304)
4. Neoptolemos JP, Stocken DD, Bassi C, Ghaneh P, Cunningham D, Goldstein D, Padbury R, Moore MJ, Gallinger S, Mariette C, Wente MN, Izbicki JR, Friess H, Lerch MM, Dervenis C, Olah A, Butturini G, Doi R, Lind PA, Smith D, Valle JW, Palmer DH, Buckels JA, Thompson J, McKay CJ, Rawcliffe CL, Buchler MW (2010) Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial. JAMA 304(10):1073-1081. doi:10.1001/jama.2010.1275
5. Ueno H, Kosuge T, Matsuyama Y, Yamamoto J, Nakao A, Egawa S, Doi R, Monden M, Hatori T, Tanaka M, Shimada M, Kanemitsu K (2009) A randomised phase III trial comparing gemcitabine with surgery-only in patients with resected pancreatic cancer: Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer. Br J Cancer 101(6):908-915. doi:10.1038/sj.bjc.6605256
6. Eguchi H, Nagano H, Tanemura M, Takeda Y, Marubashi S, Kobayashi S, Kawamoto K, Wada H, Hama N, Akita H, Mori M, Doki Y (2013) Preoperative chemoradiotherapy, surgery and adjuvant therapy for resectable pancreatic cancer. Hepato-gastroenterology 60(126). doi:10.5754/hge12974
7. Ohigashi H, Ishikawa O, Eguchi H, Takahashi H, Gotoh K, Yamada T, Yano M, Nakaizumi A, Uehara H, Tomita Y, Nishiyama K (2009) Feasibility and efficacy of combination therapy with preoperative full-dose gemcitabine, concurrent three-dimensional conformal radiation, surgery, and postoperative liver perfusion chemotherapy for T3-pancreatic cancer. Ann Surg 250(1):88-95. doi:10.1097/SLA.0b013e3181ad65cc
8. Evans DB, Varadhachary GR, Crane CH, Sun CC, Lee JE, Pisters PW, Vauthey JN, Wang H, Cleary KR, Staerkel GA, Charnsangavej C, Lano EA, Ho L, Lenzi R, Abbruzzese JL, Wolff RA (2008) Preoperative gemcitabine-based chemoradiation for patients with resectable adenocarcinoma of the pancreatic head. J Clin Oncol 26(21):3496-3502. doi:10.1200/jco.2007.15.8634
9. Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K (2007) Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med 357(18):1810-1820. doi:10.1056/NEJMoa072252 (Pubitemid 350044801)
10. Nakai Y, Isayama H, Sasaki T, Sasahira N, Ito Y, Kogure H, Togawa O, Matsubara S, Arizumi T, Yagioka H, Yashima Y, Kawakubo K, Mizuno S, Yamamoto K, Hirano K, Tsujino T, Ijichi H, Tateishi K, Toda N, Tada M, Omata M, Koike K (2010) Impact of S-1 on the survival of patients with advanced pancreatic cancer. Pancreas 39(7):989-993. doi:10.1097/MPA.0b013e3181d91936
11. Schultheis B, Strumberg D, Bergmann L, Graeven U, Hanauske AR, Lipp R, Schuette J, Saito K, Scigalla P, Scheulen ME (2012) Results of a phase II trial of S-1 as first-line treatment of metastatic pancreatic cancer (CESAR-study group). Invest New Drugs 30(3):1184-1192. doi:10.1007/s10637-011-9665-x
12. Ueno H, Ioka T, Ikeda M, Ohkawa S, Yanagimoto H, Boku N, Fukutomi A, Sugimori K, Baba H, Yamao K, Shimamura T, Sho M, Kitano M, Cheng AL, Mizumoto K, Chen JS, Furuse J, Funakoshi A, Hatori T, Yamaguchi T, Egawa S, Sato A, Ohashi Y, Okusaka T, Tanaka M (2013) 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(13):1640-1648. doi:10.1200/jco.2012.43.3680
13. Nakai Y, Isayama H, Sasaki T, Sasahira N, Tsujino T, Toda N, Kogure H, Matsubara S, Ito Y, Togawa O, Arizumi T, Hirano K, Tada M, Omata M, Koike K (2012) A multicentre randomised phase II trial of gemcitabine alone vs gemcitabine and S-1 combination therapy in advanced pancreatic cancer: GEMSAP study. Br J Cancer 106(12):1934-1939. doi:10.1038/bjc.2012.183
14. Ozaka M, Matsumura Y, Ishii H, Omuro Y, Itoi T, Mouri H, Hanada K, Kimura Y, Maetani I, Okabe Y, Tani M, Ikeda T, Hijioka S, Watanabe R, Ohoka S, Hirose Y, Suyama M, Egawa N, Sofuni A, Ikari T, Nakajima T (2012) Randomized phase II study of gemcitabine and S-1 combination versus gemcitabine alone in the treatment of unresectable advanced pancreatic cancer (Japan Clinical Cancer Research Organization PC-01 study). Cancer Chemother Pharmacol 69(5):1197-1204. doi:10.1007/s00280-012-1822-1
15. Dindo D, Demartines N, Clavien PA (2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240(2):205-213 (Pubitemid 38963009)
16. Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Buchler MW (2007) Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery 142(5):761-768. doi:10.1016/j.surg.2007.05.005 (Pubitemid 350018837)
17. Hoffman JP, Lipsitz S, Pisansky T, Weese JL, Solin L, Benson AB 3rd (1998) Phase II trial of preoperative radiation therapy and chemotherapy for patients with localized, resectable adenocarcinoma of the pancreas: an Eastern Cooperative Oncology Group Study. J Clin Oncol 16(1):317-323 (Pubitemid 28041615)
18. Satoi S, Toyokawa H, Yanagimoto H, Yamamoto T, Kamata M, Ohe C, Sakaida N, Uemura Y, Kitade H, Tanigawa N, Inoue K, Matsui Y, Kwon AH (2012) Neo-adjuvant chemoradiation therapy using S-1 followed by surgical resection in patients with pancreatic cancer. J Gastrointest Surg 16(4):784-792. doi:10.1007/s11605-011-1795-0
19. Takahashi H, Ohigashi H, Ishikawa O, Gotoh K, Yamada T, Nagata S, Tomita Y, Eguchi H, Doki Y, Yano M (2012) Perineural invasion and lymph node involvement as indicators of surgical outcome and pattern of recurrence in the setting of preoperative gemcitabine-based chemoradiation therapy for resectable pancreatic cancer. Ann Surg 255(1):95-102. doi:10.1097/SLA.0b013e31823d813c
20. Evans DB, Rich TA, Byrd DR, Cleary KR, Connelly JH, Levin B, Charnsangavej C, Fenoglio CJ, Ames FC (1992) Preoperative chemoradiation and pancreaticoduodenectomy for adenocarcinoma of the pancreas. Arch Surg 127(11):1335-1339
21. Chatterjee D, Katz MH, Rashid A, Varadhachary GR, Wolff RA, Wang H, Lee JE, Pisters PW, Vauthey JN, Crane C, Gomez HF, Abbruzzese JL, Fleming JB (2012) Histologic grading of the extent of residual carcinoma following neoadjuvant chemoradiation in pancreatic ductal adenocarcinoma: a predictor for patient outcome. Cancer 118(12):3182-3190. doi:10.1002/cncr.26651
22. White RR, Xie HB, Gottfried MR, Czito BG, Hurwitz HI, Morse MA, Blobe GC, Paulson EK, Baillie J, Branch MS, Jowell PS, Clary BM, Pappas TN, Tyler DS (2005) Significance of histological response to preoperative chemoradiotherapy for pancreatic cancer. Ann Surg Oncol 12(3):214-221. doi:10.1245/aso.2005.03.105 (Pubitemid 40568908)
23. Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto- Grillot C, Ducreux M (2011) FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med 364(19):1817-1825. doi:10.1056/NEJMoa1011923
24. 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, Van Cutsem E, Wei X, Iglesias J, Renschler MF (2013) Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. doi:10.1056/NEJMoa1304369
25. Matsumura Y, Suyama M, Sai J, Kubokawa Y, Kamiya T, Watanabe S (2010) A phase 1 study of gemcitabine and S-1 concurrent radiotherapy in patients with locally advanced pancreatic cancer. Suizo 25(2):109-116
26. Sho M, Akahori T, Tanaka T, Kinoshita S, Tamamoto T, Nomi T, Yamato I, Hokuto D, Yasuda S, Kawaguchi C, Nishiofuku H, Marugami N, Enomonoto Y, Kasai T, Hasegawa M, Kichikawa K, Nakajima Y (2013) Pathological and clinical impact of neoadjuvant chemoradiotherapy using full-dose gemcitabine and concurrent radiation for resectable pancreatic cancer. J Hepatobiliary Pancreat Sci 20(2):197-205. doi:10.1007/s00534-012-0532-8
27. Desai SP, Ben-Josef E, Normolle DP, Francis IR, Greenson JK, Simeone DM, Chang AE, Colletti LM, Lawrence TS, Zalupski MM (2007) Phase I study of oxaliplatin, full-dose gemcitabine, and concurrent radiation therapy in pancreatic cancer. J Clin Oncol 25(29):4587-4592. doi:10.1200/jco.2007.12.0592 (Pubitemid 350035317)
28. Harada K, Kawaguchi S, Supriatno, Onoue T, Yoshida H, Sato M (2004) Combined effects of the oral fluoropyrimidine anticancer agent, S-1 and radiation on human oral cancer cells. Oral Oncol 40(7):713-719. doi:10.1016/j.oraloncology.2004.01.013 (Pubitemid 38686908)