Multicenter phase II study of weekly paclitaxel plus S-1 combination chemotherapy in patients with advanced gastric cancer

Gastric Cancer

Volumn 13, Issue 3, 2010, Pages 149-154

  Ueda, Yuji ^a,b   Yamagishi, Hisakazu ^a   Ichikawa, Daisuke ^a   Okamoto, Kazuma ^a   Otsuji, Eigo ^a   Morii, Jun ^c   Koizumi, Kinya ^c   Kakihara, Naoki ^d   Shimotsuma, Masataka ^d   Yamashita, Tetsuro ^e   Taniguchi, Fumihiro ^e   Aragane, Hideki ^f   Nishi, Hiroshi ^g   Itokawa, Yoshiki ^b   Morita, Satoshi ^h   Sakamoto, Junichi ⁱ  

^a KYOTO PREFECTURAL UNIVERSITY OF MEDICINE   (Japan)

^b NANTAN GENERAL HOSPITAL   (Japan)

^c NATIONAL HOSPITAL ORGANIZATION KYOTO MEDICAL CENTER   (Japan)

^d KYOTO SECOND RED CROSS HOSPITAL   (Japan)

^e KYOTO FIRST RED CROSS HOSPITAL   (Japan)

^f Aiseikai Yamashina Hospital   (Japan)

^g Saiseikai Kyoto Hospital   (Japan)

^h YOKOHAMA CITY UNIVERSITY MEDICAL CENTER   (Japan)

ⁱ NAGOYA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

Author keywords

Gastric cancer; Phase II study; S 1; Weekly paclitaxel

Indexed keywords

5 CHLORO 2,4 DIHYDROXYPYRIDINE PLUS OXONATE POTASSIUM PLUS TEGAFUR; PACLITAXEL; TS 1; UNCLASSIFIED DRUG;

ADULT; ADVANCED CANCER; AGED; ALLERGIC REACTION; ALOPECIA; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; FOLLOW UP; HEMATOLOGIC DISEASE; HUMAN; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROPATHY; NEUTROPENIA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RECURRENT CANCER; STOMACH CANCER; STOMATITIS; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT DURATION; VOMITING;

ADULT; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC AGENTS, PHYTOGENIC; CONFIDENCE INTERVALS; DISEASE PROGRESSION; DRUG COMBINATIONS; FEMALE; HUMANS; JAPAN; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; NEOPLASM METASTASIS; NEOPLASM RECURRENCE, LOCAL; OXONIC ACID; PACLITAXEL; STOMACH NEOPLASMS; TEGAFUR;

EID: 77957959104     PISSN: 14363291     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10120-010-0548-1     Document Type: Article

References (39)

1. C. Velde K. Peeters 2003 The gastric cancer treatment controversy J Clin Oncol 21 2234 2246 10.1200/JCO.2003.91.138 12805321 (Pubitemid 46621857)
2. A.M. Murad F.F. Santiago A. Petroianu P.R. Rocha M.A. Rodrigues M. Ransch 1993 Modified therapy with 5-fluorouracil, doxorubicin, and methotrexate in advanced gastric cancer Cancer 72 37 41 1:STN:280:DyaK3s3osVGqtQ%3D%3D 10.1002/1097-0142(19930701)72:1<37::AID-CNCR2820720109>3.0.CO;2-P 8508427
3. S. Pyrhonen T. Kuitunen P. Nyandoto M. Kouri 1995 Randomized 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 1:STN:280:DyaK2M7os1ertg%3D%3D 7533517
4. B. Glimelius K. Hoffmann U. Haglund O. Nyron P.O. Sjoden 1994 Initial or delayed chemotherapy with best supportive care in advanced gastric cancer Ann Oncol 5 189 190 1:STN:280:DyaK2c3kt1KrsA%3D%3D 8186165
5. J.A. Ajani V.M. Moiseyenko S. Tjulandin A. Majlis M. Constenla C. Boni, et al. 2007 Clinical benefit with docetaxel plus fluorouracil and cisplatin compared with cisplatin and fluorouracil in a phase III trial of advanced gastric cancer or gastroesophageal adenocarcinoma: the V-325 study group J Clin Oncol 25 3205 3209 1:CAS:528:DC%2BD2sXhtVWqs73E 10.1200/JCO.2006.10.4968 17664467 (Pubitemid 47333732)
6. J.A. Ajani V.M. Moiseyenko S. Tjulandin A. Majlis M. Constenla C. Boni, et al. 2007 Quality of life with docetaxel plus cisplatin and fluorouracil compared with cisplatin and fluorouracil from a phase III trial for advanced gastric or gastroesophageal adenocarcinoma: the V-325 study group J Clin Oncol 25 3210 3216 1:CAS:528:DC%2BD2sXhtVWqs7rN 10.1200/JCO.2006.08.3956 17664468 (Pubitemid 47325603)
7. P.B. Schiff J. Fant S.B. Horwitz 1979 Promotion of microtubule assembly in vitro by Taxol Nature 277 665 667 1:CAS:528:DyaE1MXkvVCitrY%3D 10.1038/277665a0 423966
8. M.A. Jordan K. Wendell S. Gardiner W.B. Derry H. Copp L. Wilson 1996 Mitotic block induced in HeLa cells by low concentrations of paclitaxel (Taxol) results in abnormal mitotic exit and apoptotic cell death Cancer Res 56 816 825 1:CAS:528:DyaK28XhtVClsbo%3D 8631019
9. J.H. Schiller D. Harrington C.P. Belani C. Langer A. Sandler J. Krook, et al. 2002 Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer N Engl J Med 346 92 98 1:CAS:528:DC%2BD38Xkt1OlsQ%3D%3D 10.1056/NEJMoa011954 11784875 (Pubitemid 34438899)
10. J.A. Ajani J. Fairweather P. Dumas Y.Z. Patt R. Pazdur P.F. Mansfield 1998 Phase II study of Taxol in patients with advanced gastric carcinoma Cancer J Sci Am 4 269 274 1:STN:280:DyaK1czlsVCnsg%3D%3D 9689986
11. C. Bokemeyer C.S. Lampe M.R. Clemens J.T. Hartmann D. Quietzsch L. Forkmann, et al. 1997 A phase II trial of paclitaxel and weekly 24 h infusion of 5-fluorouracil/folinic acid in patients with advanced gastric cancer Anticancer Drugs 8 396 399 1:CAS:528:DyaK2sXjsVyrs7g%3D 10.1097/00001813-199704000-00014 9180395 (Pubitemid 27204960)
12. C. Kollmannsberger D. Quietzsch C. Haag T. Lingenfelser M. Schroeder J.T. Hartmann, et al. 2000 A phase II study of paclitaxel, weekly, 24-hour continuous infusion 5-fluorouracil, folinic acid and cisplatin in patients with advanced gastric cancer Br J Cancer 83 458 462 1:CAS:528:DC%2BD3cXmtFOmt70%3D 10.1054/bjoc.2000.1295 10945491
13. M.K. Kim K.H. Lee M.S. Hyun Y.R. Do H.S. Song W.S. Lee, et al. 2005 A multi-center, phase II clinical trial of Padexol (paclitaxel) and cisplatin for patients suffering with advanced gastric cancer Cancer Res Treat 37 349 353 10.4143/crt.2005.37.6.349 19956371
14. M.S. Georgiadis E.K. Russell A.F. Gazdar B.E. Johnson 1997 Paclitaxel cytotoxicity against human lung cancer cell lines increases with prolonged exposure durations Clin Cancer Res 3 449 454 1:CAS:528:DyaK2sXitVKlsb0%3D 9815704
15. J.E. Liebmann J.A. Cook C. Lipschultz D. Teague J. Fisher J.B. Mitchell 1993 Cytotoxic studies of paclitaxel (Taxol) in human tumor cell lines Br J Cancer 68 1104 1109 1:CAS:528:DyaK2cXivV2mtrw%3D 7903152
16. Z. Zhan S. Scala A. Monks C. Hose S. Bates T. Fojo 1997 Resistance to paclitaxel mediated by P-glycoprotein can be modulated by changes in the schedule of administration Cancer Chemother Pharmacol 40 245 250 1:CAS:528:DyaK2sXjvF2kurg%3D 10.1007/s002800050654 9219509 (Pubitemid 27257739)
17. W. Akerley J.E. Herndon M.J. Egorin A.P. Lyss H.L. Kindler D.M. Savarese, et al. 2003 Weekly, high-dose paclitaxel in advanced lung carcinoma: a phase II study with pharmacokinetics by the Cancer and Leukemia Group B Cancer 97 2480 2486 1:CAS:528:DC%2BD3sXktV2rurw%3D 10.1002/cncr.11375 12733147 (Pubitemid 36542487)
18. A.D. Seidman C.A. Hudis J. Albanell W. Tong I. Tepler V. Currie, et al. 1998 Dose-dense therapy with weekly 1-hour paclitaxel infusions in the treatment of metastatic breast cancer J Clin Oncol 16 3353 3361 1:CAS:528: DyaK1cXmvFGrtbY%3D 9779712
19. Q.S. Chu L.A. Hammond G. Schwartz L. Ochoa S.Y. Rha L. Denis, et al. 2004 Phase I and pharmacokinetic study of the oral fluoropyrimidine S-1 on a once-daily-for-28-day schedule in patients with advanced malignancies Clin Cancer Res 10 4913 4921 1:CAS:528:DC%2BD2cXmtlSisbk%3D 10.1158/1078-0432.CCR-04- 0469 15297391 (Pubitemid 39099764)
20. P.M. Hoff E.D. Saad J.A. Ajani Y. Lassere C. Wenske D. Medgyesy, et al. 2003 Phase I study with pharmacokinetics of S-1 on an oral daily schedule for 28 days in patients with solid tumors Clin Cancer Res 9 134 142 1:CAS:528:DC%2BD3sXnt1Omtw%3D%3D 12538461
21. P. Chollet P. Schoffski K. Weigang-Kohler J.H. Schellens H. Cure N. Pavlidis, et al. 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 1:CAS:528:DC%2BD3sXjvFelurs%3D 10.1016/S0959-8049(03)00237-5 12763215 (Pubitemid 36579198)
22. H.C. Jeung S.Y. Rha H.K. Kim H.Y. Lim S. Kim S.Y. Kim, et al. 2007 Multiinstitutional phase II study of S-1 monotherapy in advanced gastric cancer with pharmacokinetic and pharmacogenomic evaluations Oncologist 12 543 554 1:CAS:528:DC%2BD2sXntVyns7k%3D 10.1634/theoncologist.12-5-543 17522242 (Pubitemid 350012117)
23. W. Koizumi M. Kurihara S. Nakano K. Hasegawa 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 1:CAS:528:DC%2BD3cXjvVeitr4%3D 10.1159/000012099 10765119
24. Y. Sakata A. Ohtsu N. Horikoshi K. Sugimachi Y. Mitachi T. Taguchi 1998 Late phase II study of novel oral fluoropyrimidine anticancer drug S-1 (1 M tegafur-0.4 M gimestat-1 M otastat potassium) in advanced gastric cancer patients Eur J Cancer 34 1715 1720 1:CAS:528:DyaK1cXntlShurw%3D 10.1016/S0959-8049(98)00211-1 9893658 (Pubitemid 28474225)
25. K. Sugimachi Y. Maehara N. Horikoshi Y. Shimada Y. Sakata Y. Mitachi, et al. 1999 An early phase II study of oral S-1, a newly developed 5-fluorouracil derivative for advanced and recurrent gastrointestinal cancers. The S-1 Gastrointestinal Cancer Study Group Oncology 57 202 210 1:CAS:528: DyaK1MXmvF2msr0%3D 10.1159/000012032 10545788 (Pubitemid 29481693)
26. Y. Kano M. Akutsu S. Tsunoda J. Ando J. Matsui K. Suzuki, et al. 1996 Schedule-dependent interaction between paclitaxel and 5-fluorouracil in human carcinoma cell lines in vitro Br J Cancer 74 704 710 1:CAS:528: DyaK28XmtF2mur0%3D 8795571 (Pubitemid 26300760)
27. A.M. Murad A. Petroianu R.C. Guimaraes B.C. Aragao L.O. Cabral A.O. Scalabrini-Neto 1999 Phase II trial of the combination of paclitaxel and 5-fluorouracil in the treatment of advanced gastric cancer: a novel, safe, and effective regimen Am J Clin Oncol 22 580 586 1:STN:280:DC%2BD3c%2FmsVKisA%3D%3D 10.1097/00000421-199912000-00008 10597742 (Pubitemid 30266056)
28. K. Fujitani H. Narahara H. Takiuchi T. Tsujinaka E. Satomi M. Gotoh, et al. 2005 Phase I and pharmacokinetic study of S-1 combined with weekly paclitaxel in patients with advanced gastric cancer Oncology 69 414 420 1:CAS:528:DC%2BD2MXhtlWiurnN 10.1159/000089996 16319513 (Pubitemid 41797918)
29. Y. Fujiwara J. Fujita K. Kan Y. Tsukahara S. Takiguchi H. Miyata, et al. 2006 A phase I study of combination chemotherapy using TS-1 and weekly paclitaxel for advanced gastric cancer Gan To Kagaku Ryoho 33 45 48 16410697
30. S. Hokita T. Aikou F. Miyazono S. Ishigami K. Aridome S. Maenohara, et al. 2006 A phase I combination chemotherapy study of biweekly paclitaxel and S-1 administration in patients with advanced gastric cancer Cancer Chemother Pharmacol 57 736 740 1:CAS:528:DC%2BD28XjtlWgu7c%3D 10.1007/s00280-005-0122-4 16163539
31. R. Kawabata Y. Fujiwara Y. Doki J. Fujita Y. Tsukahara M. Yamasaki, et al. 2007 Phase I/II study of a combination of S-1 and weekly paclitaxel in patients with advanced or recurrent gastric cancer Oncology 72 219 225 1:CAS:528:DC%2BD1cXptlKksQ%3D%3D 10.1159/000112945 18176087 (Pubitemid 351161614)
32. E. Mochiki T. Ohno Y. Kamiyama R. Aihara N. Haga H. Ojima, et al. 2006 Phase I/II study of S-1 combined with paclitaxel in patients with unresectable and/or recurrent advanced gastric cancer Br J Cancer 95 1642 1647 1:CAS:528:DC%2BD28Xht12ktbfL 10.1038/sj.bjc.6603497 17133268 (Pubitemid 44950789)
33. A. Nakajo S. Hokita S. Ishigami F. Miyazono T. Etoh M. Hamanoue, et al. 2008 A multicenter phase II study of biweekly paclitaxel and S-1 combination chemotherapy for unresectable or recurrent gastric cancer Cancer Chemother Pharmacol 62 1103 1109 1:CAS:528:DC%2BD1cXhtFaju77F 10.1007/s00280-008-0693-y 18317763
34. Y. Ueda H. Yamagishi D. Ichikawa J. Morii K. Koizumi N. Kakihara, et al. 2005 Phase I study of a combination of S-1 and weekly paclitaxel in patients with advanced or recurrent gastric cancer Oncology 69 261 268 1:CAS:528:DC%2BD2MXhtVymt7rM 10.1159/000088072 16138002 (Pubitemid 41433585)
35. P. Therasse S.G. Arbuck E.A. Eisenhauer J. Wanders J.S. Kaplan L. Rubinstein, et al. 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 1:STN:280:DC%2BD3c7it1Gitg%3D%3D 10.1093/jnci/92.3.205 10655437
36. R. Simon 1989 Optimal two-stage designs for phase II clinical trials Control Clin Trials 10 1 10 1:STN:280:DyaL1M7ps1SjsQ%3D%3D 10.1016/0197-2456(89) 90015-9 2702835 (Pubitemid 19099520)
37. K. Yoshida M. Ninomiya N. Takakura N. Hirabayashi W. Takiyama Y. Sato, et al. 2006 Phase II study of docetaxel and S-1 combination therapy for advanced or recurrent gastric cancer Clin Cancer Res 12 3402 3407 1:CAS:528: DC%2BD28XltFyis7k%3D 10.1158/1078-0432.CCR-05-2425 16740764
38. J.A. Ajani F.C. Lee D.A. Singh D.G. Haller H.J. Lenz A.B. Benson 3rd, et al. 2006 Multicenter phase II trial of S-1 plus cisplatin in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma J Clin Oncol 24 663 667 1:CAS:528:DC%2BD28XhvFKhtLs%3D 10.1200/JCO.2005.04.2994 16446338 (Pubitemid 46630431)
39. W. Koizumi H. Narahara T. Hara A. Takagane T. Akiya M. Takagi, et al. 2008 S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial Lancet Oncol 9 215 221 1:CAS:528:DC%2BD1cXivVaqtb4%3D 10.1016/S1470-2045(08)70035-4 18282805