Phase I/II study of S-1 combined with weekly docetaxel in patients with metastatic gastric carcinoma

British Journal of Cancer

Volumn 98, Issue 8, 2008, Pages 1305-1311

  Park, S R ^a   Kim, H K ^a   Kim, C G ^a   Choi, I J ^a   Lee, J S ^a   Lee, J H ^a   Ryu, K W ^a   Kim, Y W ^a   Bae, J M ^a   Kim, N K ^a  

^a National Cancer Center   (South Korea)

Author keywords

Docetaxel; Metastatic gastric carcinoma; Phase I II study; S 1

Indexed keywords

DOCETAXEL;

ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; CANCER SURVIVAL; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED STUDY; DIARRHEA; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG TOLERABILITY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPERBILIRUBINEMIA; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MAXIMUM TOLERATED DOSE; NAUSEA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RASH; SIDE EFFECT; STOMACH CARCINOMA; STOMACH PERFORATION; STOMATITIS; THROMBOCYTOPENIA; TREATMENT OUTCOME; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DRUG COMBINATIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; OXONIC ACID; STOMACH NEOPLASMS; TAXOIDS; TEGAFUR;

EID: 42149136707     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6604312     Document Type: Article

References (36)

1. Al-Batran SE, Atmaca A, Hegewisch-Becker S, Jaeger D, Hahnfeld S, Rummel MJ, Seipelt G, Rost A, Orth J, Knuth A, Jaeger E (2004) Phase II trial of biweekly infusional fluorouracil, folinic acid, and oxaliplatin in patients with advanced gastric cancer. J Clin Oncol 22: 658-663
2. Bang YJ, Kang WK, Kang YK, Kim HC, Jacques C, Zuber E, Daglish B, Boudraa Y, Kim WS, Heo DS, Kim NK (2002) Docetaxel 75 mg/m(2) is active and well tolerated in patients with metastatic or recurrent gastric cancer: a phase II trial. Jpn J Clin Oncol 32: 248-254
3. Boku N, Yamamoto S, Shirao K, Doi T, Sawaki A, Koizumi W, Saito H, Yamaguchi K, Kimura A, Ohtsu A, Group GOSGJCO (2007) Randomized phase III study of 5-fluorouracil (5-FU) alone vs combination of irinotecan and cisplatin (CP) vs S-1 alone in advanced gastric cancer (JCOG9912). Proc Am Soc Clin Oncol 25: 200s (abstract LBA4513)
4. Bouche O, Raoul JL, Bonnetain F, Giovannini M, Etienne PL, Lledo G, Arsene D, Paitel JF, Guerin-Meyer V, Mitry E, Buecher B, Kaminsky MC, Seitz JF, Rougier P, Bedenne L, Milan C (2004) Randomized multicenter phase II trial of a biweekly regimen of fluorouracil and leucovorin (LV5FU2), LV5FU2 plus cisplatin, or LV5FU2 plus irinotecan in patients with previously untreated metastatic gastric cancer: a Federation Francophone de Cancerologie Digestive Group Study - FFCD 9803. J Clin Oncol 22: 4319-4328
5. Bria E, Cuppone F, Ciccarese M, Nistico C, Facciolo F, Milella M, Izzo F, Terzoli E, Cognetti F, Giannarelli D (2006) Weekly docetaxel as second line chemotherapy for advanced non-small-cell lung cancer: meta-analysis of randomized trials. Cancer Treat Rev 32: 583-587
6. Camps C, Massuti B, Jimenez A, Maestu I, Gomez RG, Isla D, Gonzalez JL, Almenar D, Blasco A, Rosell R, Carrato A, Vinolas N, Batista N, Giron CG, Galan A, Lopez M, Blanco R, Provencio M, Diz P, Felip E (2006) Randomized phase III study of 3-weekly vs weekly docetaxel in pretreated advanced non-small-cell lung cancer: a Spanish Lung Cancer Group trial. Ann Oncol 17: 467-472
7. Chollet P, Schoffski P, Weigang-Kohler K, Schellens JH, Cure H, Pavlidis N, Grunwald V, De Boer R, Wanders J, Fumoleau P (2003) Phase II trial with S-1 in chemotherapy-naive patients with gastric cancer. A trial performed by the EORTC Early Clinical Studies Group (ECSG). Eur J Cancer 39: 1264-1270
8. Chun JH, Kim HK, Lee JS, Choi JY, Hwangbo B, Lee HG, Park SR, Choi IJ, Kim CG, Ryu KW, Kim YW, Bae JM (2005) Weekly docetaxel in combination with capecitabine in patients with metastatic gastric cancer. Am J Clin Oncol 28: 188-194
9. Giordano KF, Jatoi A, Stella PJ, Foster N, Tschetter LK, Alberts SR, Dakhil SR, Mailliard JA, Flynn PJ, Nikcevich DA (2006) Docetaxel and capecitabine in patients with metastatic adenocarcinoma of the stomach and gastroesophageal junction: a phase II study from the North Central Cancer Treatment Group. Ann Oncol 17: 652-656
10. Glimelius B, Ekstrom K, Hoffman K, Graf W, Sjoden PO, Haglund U, Svensson C, Enander LK, Linne T, Sellstrom H, Heuman R (1997) Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. Ann Oncol 8: 163-168
11. Kang Y, Kang WK, Shin DB, Chen J, Xiong J, Wang J, Lichinitser M, Salas MP, Suarez T, Santamaria J (2006) Randomized phase III trial of capecitabine/cisplatin (XP) vs continuous infusion of 5-FU/cisplatin (FP) as first-line therapy in patients (pts) with advanced gastric cancer (AGC): efficacy and safety results. Proc Am Soc Clin Oncol 24: 183s (abstract LBA4018)
12. Kim JG, Sohn SK, Kim DH, Baek JH, Sung WJ, Park JY, Kim TB, Jung HY, Yu W, Lee KB (2005) Phase II study of docetaxel and capecitabine in patients with metastatic or recurrent gastric cancer. Oncology 68: 190-195
13. Koizumi W, Kurihara M, Nakano S, Hasegawa K (2000) Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. For the S-1 Cooperative Gastric Cancer Study Group. Oncology 58: 191-197
14. Moehler M, Eimermacher A, Siebler J, Hohler T, Wein A, Menges M, Flieger D, Junginger T, Geer T, Gracien E, Galle PR, Heike M (2005) Randomised phase II evaluation of irinotecan plus high-dose 5-fluorouracil and leucovorin (ILF) vs 5-fluorouracil, leucovorin, and etoposide (ELF) in untreated metastatic gastric cancer. Br J Cancer 92: 2122-2128
15. Narahara H, Koizumi W, Hara T, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O, TS-1 Advanced Gastric Cancer (AGC) Clinical Trial Group (2007) Randomized phase III study of S-1 alone vs S-1+cisplatin in the treatment for advanced gastric cancer (The SPIRITS trial) SPIRITS: S-1 plus cisplatin vs S-1 in RCT in the treatment for stomach cancer. Proc Am Soc Clin Oncol 25: 201s (abstract 4514)
16. Ohtsu A, Shimada Y, Shirao K, Boku N, Hyodo I, Saito H, Yamamichi N, Miyata Y, Ikeda N, Yamamoto S, Fukuda H, Yoshida S (2003) Randomized phase III trial of fluorouracil alone vs fluorouracil plus cisplatin vs uracil and tegafur plus mitomycin in patients with unresectable, advanced gastric cancer: The Japan Clinical Oncology Group Study (JCOG9205). J Clin Oncol 21: 54-59
17. Orditura M, Martinelli E, Galizia G, Carlomagno C, Aurilio G, Vecchione L, Lieto E, De Placido S, Catalano G, Ciardiello F, De Vita F (2006) Weekly docetaxel and capecitabine is not effective in the treatment of advanced gastric cancer: a phase II study. Ann Oncol 17: 1529-1532
18. Park YH, Ryoo BY, Choi SJ, Kim HT (2004) A phase II study of capecitabine and docetaxel combination chemotherapy in patients with advanced gastric cancer. Br J Cancer 90: 1329-1333
19. Parkin DM, Bray F, Ferlay J, Pisani P (2005) Global cancer statistics, 2002. CA Cancer J Clin 55: 74-108
20. Pyrhonen S, Kuitunen T, Nyandoto P, Kouri M (1995) Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with non-resectable gastric cancer. Br J Cancer 71: 587-591
21. Ridwelski K, Gebauer T, Fahlke J, Kroning H, Kettner E, Meyer F, Eichelmann K, Lippert H (2001) Combination chemotherapy with docetaxel and cisplatin for locally advanced and metastatic gastric cancer. Ann Oncol 12: 47-51
22. Roth AD, Maibach R, Martinelli G, Fazio N, Aapro MS, Pagani O, Morant R, Borner MM, Herrmann R, Honegger H, Cavalli F, Alberto P, Castiglione M, Goldhirsch A (2000) Docetaxel (Taxotere)-cisplatin (TC): an effective drug combination in gastric carcinoma. Swiss Group for Clinical Cancer Research (SAKK), and the European Institute of Oncology (EIO). Ann Oncol 11: 301-306
23. Sakata Y, Ohtsu A, Horikoshi N, Sugimachi K, Mitachi Y, Taguchi T (1998) Late phase II study of novel oral fluoropyrimidine anticancer drug S-1 (1 Mtegafur-0.4 M gimestat-1 M otastat potassium) in advanced gastric cancer patients. Eur J Cancer 34: 1715-1720
24. Schuette W, Nagel S, Blankenburg T, Lautenschlaeger C, Hans K, Schmidt EW, Dittrich I, Schweisfurth H, von Weikersthal LF, Raghavachar A, Reissig A, Serke M (2005) Phase III study of second-line chemotherapy for advanced non-small-cell lung cancer with weekly compared with 3-weekly docetaxel. J Clin Oncol 23: 8389-8395
25. Shirasaka T, Nakano K, Takechi T, Satake H, Uchida J, Fujioka A, Saito H, Okabe H, Oyama K, Takeda S, Unemi N, Fukushima M (1996) 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: 2602-2606
26. Simon R (1989) Optimal two-stage designs for phase II clinical trials. Control Clin Trials 10: 1-10
27. Sulkes A, Smyth J, Sessa C, Dirix LY, Vermorken JB, Kaye S, Wanders J, Franklin H, LeBail N, Verweij J (1994) Docetaxel (Taxotere) in advanced gastric cancer: results of a phase II clinical trial. EORTC Early Clinical Trials Group. Br J Cancer 70: 380-383
28. Takahashi I, Emi Y, Kakeji Y, Uchida J, Fukushima M, Maehara Y (2005) Increased antitumor activity in combined treatment TS-1 and docetaxel. A preclinical study using gastric cancer xenografts. Oncology 68: 130-137
29. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92: 205-216
30. Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, Rodrigues A, Fodor M, Chao Y, Voznyi E, Risse ML, Ajani JA (2006) Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol 24: 4991-4997
31. Vanhoefer U, Rougier P, Wilke H, Ducreux MP, Lacave AJ, Van Cutsem E, Planker M, Santos JG, Piedbois P, Paillot B, Bodenstein H, Schmoll HJ, Bleiberg H, Nordlinger B, Couvreur ML, Baron B, Wils JA (2000) Final results of a randomized phase III trial of sequential high-dose methotrexate, fluorouracil, and doxorubicin vs etoposide, leucovorin, and fluorouracil vs infusional fluorouracil and cisplatin in advanced gastric cancer: a trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group. J Clin Oncol 18: 2648-2657
32. Wada Y, Yoshida K, Suzuki T, Mizuiri H, Konishi K, Ukon K, Tanabe K, Sakata Y, Fukushima M (2006) Synergistic effects of docetaxel and S-1 by modulating the expression of metabolic enzymes of 5-fluorouracil in human gastric cancer cell lines. Int J Cancer 119: 783-791
33. Webb A, Cunningham D, Scarffe JH, Harper P, Norman A, Joffe JK, Hughes M, Mansi J, Findlay M, Hill A, Oates J, Nicolson M, Hickish T, O'Brien M, Iveson T, Watson M, Underhill C, Wardley A, Meehan M (1997) Randomized trial comparing epirubicin, cisplatin, and fluorouracil vs fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer. J Clin Oncol 15: 261-267
34. Yamaguchi K, Shimamura T, Hyodo I, Koizumi W, Doi T, Narahara H, Komatsu Y, Kato T, Saitoh S, Akiya T, Munakata M, Miyata Y, Maeda Y, Takiuchi H, Nakano S, Esaki T, Kinjo F, Sakata Y (2006) Phase I/II study of docetaxel and S-1 in patients with advanced gastric cancer. Br J Cancer 94: 1803-1808
35. Yoshida K, Hirabayashi N, Takiyama W, Ninomiya M, Takakura N, Sakamoto J, Nishiyama M, Toge T (2004) Phase I study of combination therapy with S-1 and docetaxel (TXT) for advanced or recurrent gastric cancer. Anticancer Res 24: 1843-1851
36. Yoshida K, Ninomiya M, Takakura N, Hirabayashi N, Takiyama W, Sato Y, Todo S, Terashima M, Gotoh M, Sakamoto J, Nishiyama M (2006) Phase II study of docetaxel and S-1 combination therapy for advanced or recurrent gastric cancer. Clin Cancer Res 12: 3402-3407