Phase I/II study of intraperitoneal docetaxel plus S-1 for the gastric cancer patients with peritoneal carcinomatosis

Cancer Chemotherapy and Pharmacology

Volumn 71, Issue 5, 2013, Pages 1265-1272

  Fushida, S ^a   Kinoshita, J ^a   Kaji, M ^b   Hirono, Y ^c   Goda, F ^d   Yagi, Y ^a   Oyama, K ^a   Sudo, Y ^e   Watanabe, Y ^f   Fujimura, T ^a  

^a KANAZAWA UNIVERSITY HOSPITAL   (Japan)

^b Department of Surgery   (Japan)

^c UNIVERSITY OF FUKUI HOSPITAL   (Japan)

^d KAGAWA UNIVERSITY HOSPITAL   (Japan)

^e Department of Surgery   (Japan)

^f EHIME UNIVERSITY HOSPITAL   (Japan)

Author keywords

Docetaxel; Gastric cancer; Intraperitoneal chemotherapy; Peritoneal carcinomatosis; S 1

Indexed keywords

DOCETAXEL; GIMERACIL PLUS OTERACIL POTASSIUM PLUS TEGAFUR;

ABDOMINAL PAIN; ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; CARCINOMATOUS PERITONITIS; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; DIARRHEA; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; FEBRILE NEUTROPENIA; FEMALE; GASTRECTOMY; HUMAN; LAPAROSCOPY; LAPAROTOMY; LEUKOPENIA; LYMPH NODE DISSECTION; MALAISE; MALE; MAXIMUM TOLERATED DOSE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; STOMACH CANCER; STOMATITIS; THROMBOCYTOPENIA;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG COMBINATIONS; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; OXONIC ACID; PERITONEAL NEOPLASMS; STOMACH NEOPLASMS; SURVIVAL RATE; TAXOIDS; TEGAFUR; TREATMENT OUTCOME;

EID: 84877925891     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-013-2122-0     Document Type: Article

References (33)

1. Kodera Y, Ito S, Mochizuki Y, Kondo K, Koshikawa K, Suzuki N, Kojima H, Kojima T, Matsui T, Takase T, Tsuboi K, Fujiwara M, Nakao A, Chubu Clinical Oncology Group (2009) A phase II study of radical surgery followed by postoperative chemotherapy with S-1 for gastric carcinoma with free cancer cells in the peritoneal cavity (CCOG0301 study). Eur J Surg Oncol 35:1158-1163
2. Bando E, Yonemura Y, Takeshita Y, Taniguchi K, Yasui T, Yoshimitsu Y, Fushida S, Fujimura T, Nishimura G, Miwa K (1999) Intraoperative lavage for cytological examination in 1,297 patients with gastric carcinoma. Am J Surg 178:256-262
3. Sugarbaker PH, Yonemura Y (2000) Clinical pathway for the management of resectable gastric cancer with peritoneal seeding: best palliation with a ray of hope for cure. Oncology 58:96-107
4. Chu DZ, Lang NP, Thompson C, Osteen PK, Westbrook KC (1989) Peritoneal carcinomatosis in nongynecologic malignancies. A prospective study of prognostic factors. Cancer 63:364-367
5. Sadeghi B, Arvieux C, Glehen O, Beaujard AC, Rivoire M, Baulieux J, Fontaumard E, Brachet A, Caillot JL, Faure JL, Porcheron J, Peix JL, Francois Y, Vignal J, Gilly FN (2000) Peritoneal carcinomatosis from non-gynecologic malignancies: results of the EVOCAPE 1 multicentric prospective study. Cancer 88:358-363
6. Sugarbaker PH, Stuart OA, Vidal-Jove J, Vidal-Jove J, Pessagno AM, DeBruijn EA (1996) Pharmacokinetics of the peritoneal-plasma barrier after systemic mitomycin C administration. Cancer Treat Res 82:41-52
7. Yonemura Y, Endou Y, Sasaki T, Hirano M, Mizumoto A, Matsuda T, Takao N, Ichunose M, Miura M, Li Y (2010) Surgical treatment for peritoneal carcinomatosis from gastric cancer. Eur J Surg Oncol 36:1131-1138
8. Yang XJ, Huang CQ, Suo T, Mei LJ, Yang GL, Cheng FL, Zhou YF, Xiong B, Yonemura Y, Li Y (2011) Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy improves survival of patients with peritoneal carcinomatosis from gastric cancer: final results of phase III randomized clinical trial. Ann Surg Oncol 18:1575-1581
9. 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 1M tegaful-0.4M 5-chloro-2,4-dehydroxypyridine-1M potassium oxonate (S-1) against human colon carcinoma orthotopically implanted into nude rats. Cancer Res 56:2602-2606
10. Koizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O, Takiyama W, Toh Y, Nagaie T, Takagi S, Yamamura Y, Yanaoka K, Orita H, Takeuchi M (2008) S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPRITS trial): a phase III trial. Lancet Oncol 9:215-221
11. Boku N, Yamamoto S, Fukuda H, Shirao K, Doi T, Sawaki A, Koizumi W, Saito H, Yamaguchi K, Takiuchi H, Nasu J, Ohtsu A, Gastrointestinal Oncology Study Group of the Japan Clinical Oncology Group (2009) Fluorouracil versus combination of irinotecan plus cisplatin versus S-1 in metastatic gastric cancer: a randomized phase 3 study. Lancet Oncol 10:1063-1069
12. Oshima T, Yamada R, Hatori S, Kunisaki C, Imada T (2006) Pharmacokinetics of S-1 in patients with peritoneal dissemination of gastric cancer. Oncol Rep 16:361-366
13. Ringel I, Horwitz B (1991) Studies with RP56976 (Taxotere): a semisynthetic analogue of taxol. J Natl Cancer Inst 83:288-291
14. 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
15. Bang YJ, Kang WK, 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
16. Mai M, Sakata Y, Kanamaru R, Suminaga M, Ota J, Hirabayashi N, Taguchi T, Frue H (1999) A late phase II clinical study of RP56976 (docetaxel) in patients with advanced or recurrent gasyric cancer: a cooperative study group trial (group B). Jpn J Chemother 26:487-496
17. Naitoh H, Kawaguchi A, Yamamoto H, Mekata E, Tan T, Mori H, Chiba M (2004) Mesurement of docetaxel concentration in blood and ascites after drop infusion into each vessel and intraperitoneal cavity of gastric cancer. Jpn J Chemother 31:2031-2034
18. Fushida S, Kinoshita J, Yagi Y, Funaki H, Kinami S, Ninomiya I, Fujimura T, Nishimura G, Kayahara M, Ohta T (2008) Dual-anti-cancer effects of weekly intraperitoneal docetaxel in treatment of advanced gastric cancer patients with peritoneal carcinomatosis: a feasibility and pharmacokinetic study. Oncol Rep 19:1305-1310
19. Japanese Research Society for Gastric Cancer. (1995) Japanese classification of gastric carcinoma, 1st English edn. Kanehara & Co., Ltd, Tokyo
20. Lawless J (1982) Statistical Models and Methods for Lifetime Data. John Wiley and Sons, Hoboken, NJ, p 108
21. Yoshida K, Ninomiya M, Takakura N, Hirabayashi N, Takiyama W, Sato Y, Todo S, Terashima M, Gotoh M, Sakamato 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
22. Markman M, Rowinsky E, Hakes T, Reichman B, Jones W, Lewis JL Jr, Rubin S, Curtin J, Barakat R, Phillips M (1992) Phase I trial of intraperitoneal taxol: a gynecologic oncology group study. J Clin Oncol 10:1485-1491
23. Imano M, Imamoto H, Itoh T, Satou T, Peng YF, Yasuda A, Kato H, Shiraishi O, Yasuda T, Takeyama Y, Okuno K, Shiozaki H (2012) Safety of intraperitoneal administration of paclitaxel after gastrectomy with enbloc D2 lymph node dissection. J Surg Oncol 105:43-47
24. Morgan RJ Jr, Doroshow JH, Synold T, Lim D, Shibata S, Margolin K, Schwarz R, Leong L, Somlo G, Twardoski P, Yen Y, Chow W, Lin P, Paz B, Chu D, Frankel P, Stalter S (2003) Phase I trial of intraperitoneal docetaxel in the treatment of advanced malignancies primarily confined to the peritoneal cavity. Clin Cancer Res 9:5896-5901
25. Tsujimoto H, Hagiwara A, Shimotsuma M, Sakakura C, Osaki K, Sasaki S, Ohyama T, Ohgaki M, Imanishi T, Yamazaki J, Takahashi T (1996) Role of milky spots as selective implantation sites for malignant cell in peritoneal dissemination in mice. J Cancer Res Clin Oncol 122:590-595
26. Markman M (2003) Intraperitoneal antineoplastic drug delivery: rationale and results. Lancet Oncol 4:277-283
27. Ishigami H, Kitayama J, Kaisaki S, Hidemura A, Kato M, Otani K, Kamei T, Soma D, Miyato H, Yamashita H, Nagawa H (2010) Phase II study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 for advanced gastric cancer with peritoneal metastasis. Ann Oncol 21:67-70
28. 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
29. Fujiwara Y, Takiguchi S, Nakajima K, Miyata H, Yamasaki M, Kurokawa Y, Mori M, Doki Y (2012) Intraperitoneal docetaxel with S-1 for advanced gastric cancer with peritoneal dissemination. J Surg Oncol 105:38-42
30. 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
31. Rose PG, Blessing JA, Ball HG, Hoffman J, Warshal D, DeGeest K, Moore DH (2003) A phase II study of docetaxel in paclitaxel-resistant ovarian and peritoneal carcinoma: a gynecologic oncology group study. Gynecol Oncol 88:130-135
32. Ando T, Hosokawa A, Kajiura S, Itaya Y, Ueda A, Fujinami H, Nishikawa J, Kobayashi T, Horikawa N, Tsukioka Y, Yabushita K, Note M, Ogawa K, Sugiyama T (2012) Efficacy of weekly paclitaxel in patients with advanced gastric cancer refractory to docetaxel-based chemotherapy. Gastric Cancer 15:427-432
33. Shitara K, Mizota A, Matsuo K, Sato Y, Kondo C, Takahari D, Ura T, Tajika M, Muro K (2013) Fluoropyrimidine plus cisplatin for patients with advanced or recurrent gastric cancer with peritoneal metastasis. Gastric Cancer 16:48-55