Multicenter phase I/II study of docetaxel, cisplatin and fluorouracil combination chemotherapy in patients with advanced or recurrent squamous cell carcinoma of the esophagus

Oncology

Volumn 80, Issue 5-6, 2011, Pages 307-313

  Yamasaki, Makoto ^a   Miyata, Hiroshi ^a   Tanaka, Koji ^c   Shiraishi, Osamu ^b   Motoori, Masaaki ^c   Peng, Y F ^b   Yasuda, Takushi ^b   Yano, Masahiko ^c   Shiozaki, Hitoshi ^b   Mori, Masaki ^a   Doki, Yuichiro ^a  

^a OSAKA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b KINKI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^c OSAKA MEDICAL CENTER FOR CANCER AND CARDIOVASCULAR DISEASES   (Japan)

Author keywords

Chemotherapy; Cisplatin; Docetaxel; Fluorouracil; Squamous cell carcinoma of esophagus

Indexed keywords

CISPLATIN; DOCETAXEL; FLUOROURACIL;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CLINICAL ARTICLE; CONTINUOUS INFUSION; DEMENTIA; DIARRHEA; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG TOLERABILITY; ESOPHAGEAL SQUAMOUS CELL CARCINOMA; FEBRILE NEUTROPENIA; FEMALE; HUMAN; LEUKOPENIA; LYMPH NODE METASTASIS; MALE; MAXIMUM TOLERATED DOSE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RECOMMENDED DRUG DOSE; RECURRENT CANCER; STOMATITIS; THROMBOCYTOPENIA; VEIN THROMBOSIS;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, SQUAMOUS CELL; CISPLATIN; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; ESOPHAGEAL NEOPLASMS; FEMALE; FLUOROURACIL; HUMANS; LIVER NEOPLASMS; LUNG NEOPLASMS; LYMPHATIC METASTASIS; MALE; MIDDLE AGED; RECURRENCE; TAXOIDS; TREATMENT OUTCOME;

EID: 79960549412     PISSN: 00302414     EISSN: 14230232     Source Type: Journal    
DOI: 10.1159/000329806     Document Type: Article

References (25)

1. Iizuka T, Kakegawa T, Ide H, Ando N, Watanabe H, Tanaka O, Takagi I, Isono K, Ishida K, Arimori M, et al: Phase II evaluation of cisplatin and 5-fluorouracil in advanced squamous cell carcinoma of the esophagus: A Japanese Esophageal Oncology Group Trial. Jpn J Clin Oncol 1992; 22: 172-176.
2. Polee MB, Kok TC, Siersema PD, Tilanus HW, Splinter TA, Stoter G, Van der Gaast A: Phase II study of the combination cisplatin, etoposide, 5-fluorouracil and folinic acid in patients with advanced squamous cell carcinoma of the esophagus. Anticancer Drugs 2001; 12: 513-517. (Pubitemid 32692595)
3. Hayashi K, Ando N, Watanabe H, Ide H, Nagai K, Aoyama N, Takiyama W, Ishida K, Isono K, Makuuchi H, Imamura M, Shinoda M, Ikeuchi S, Kabuto T, Yamana H, Fukuda H: Phase II evaluation of protracted infusion of cisplatin and 5-fluorouracil in advanced squamous cell carcinoma of the esophagus: A Japan Esophageal Oncology Group (JEOG) Trial (JCOG9407). Jpn J Clin Oncol 2001; 31: 419-423. (Pubitemid 33039748)
4. Bleiberg H, Conroy T, Paillot B, Lacave AJ, Blijham G, Jacob JH, Bedenne L, Namer M, De Besi P, Gay F, Collette L, Sahmoud T: Randomised phase II study of cisplatin and 5-fluorouracil (5-FU) versus cisplatin alone in advanced squamous cell oesophageal cancer. Eur J Cancer 1997; 33: 1216-1220. (Pubitemid 27359638)
5. Honda M, Miura A, Izumi Y, Kato T, Ryotokuji T, Monma K, Fujiwara J, Egashira H, Nemoto T: Doxorubicin, cisplatin, and fluorouracil combination therapy for metastatic esophageal squamous cell carcinoma. Dis Esophagus 2010; 23: 641-645.
6. Muro K, Hamaguchi T, Ohtsu A, Boku N, Chin K, Hyodo I, Fujita H, Takiyama W, Ohtsu T: A phase II study of single-agent docetaxel in patients with metastatic esophageal cancer. Ann Oncol 2004; 15: 955-959. (Pubitemid 39004353)
7. Ilson DH, Ajani J, Bhalla K, Forastiere A, Huang Y, Patel P, Martin L, Donegan J, Pazdur R, Reed C, Kelsen DP: Phase II trial of paclitaxel, fluorouracil, and cisplatin in patients with advanced carcinoma of the esophagus. J Clin Oncol 1998; 16: 1826-1834.
8. Higuchi K, Koizumi W, Tanabe S, Sasaki T, Katada C, Ishiyama H, Hayakawa K: A phase I trial of definitive chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil (DCF-R) for advanced esophageal carcinoma: Kitasato Digestive Disease & Oncology Group Trial (KDOG 0501). Radiother Oncol 2008; 87: 398-404.
9. Tanaka T, Fujita H, Sueyoshi S, Tanaka Y, Sasahara H, Mori N, Nagano T, Yamana H, Shirouzu K: Second-line combination chemotherapy with docetaxel for cisplatin-pretreated refractory metastatic esophageal cancer: A preliminary report of initial experience. Chemotherapy 2007; 53: 449-453. (Pubitemid 350085262)
10. Pasini F, de Manzoni G, Pedrazzani C, Grandinetti A, Durante E, Gabbani M, Tomezzoli A, Griso C, Guglielmi A, Pelosi G, Maluta S, Cetto GL, Cordiano C: High pathological response rate in locally advanced esophageal cancer after neoadjuvant combined modality therapy: Dose finding of a weekly chemotherapy schedule with protracted venous infusion of 5-fluorouracil and dose escalation of cisplatin, docetaxel and concurrent radiotherapy. Ann Oncol 2005; 16: 1133-1139. (Pubitemid 41418316)
11. Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL: Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med 2007; 357: 1695-1704. (Pubitemid 350005151)
12. Posner MR, Hershock DM, Blajman CR, Mickiewicz E, Winquist E, Gorbounova V, Tjulandin S, Shin DM, Cullen K, Ervin TJ, Murphy BA, Raez LE, Cohen RB, Spaulding M, Tishler RB, Roth B, Viroglio Rdel C, Venkatesan V, Romanov I, Agarwala S, Harter KW, Dugan M, Cmelak A, Markoe AM, Read PW, Steinbrenner L, Colevas AD, Norris CM Jr, Haddad RI: Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med 2007; 357: 1705-1715. (Pubitemid 350005152)
13. Roth AD, Fazio N, Stupp R, Falk S, Bernhard J, Saletti P, Koberle D, Borner MM, Rufibach K, Maibach R, Wernli M, Leslie M, Glynne- Jones R, Widmer L, Seymour M, de Braud F: Docetaxel, cisplatin, and fluorouracil; docetaxel and cisplatin; and epirubicin, cisplatin, and fluorouracil as systemic treatment for advanced gastric carcinoma: A randomized phase II trial of the Swiss Group for Clinical Cancer Research. J Clin Oncol 2007; 25: 3217-3223. (Pubitemid 47325604)
14. Ajani JA, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, Rodrigues A, Fodor M, Chao Y, Voznyi E, Marabotti C, Van Cutsem E: Clinical benefit with docetaxel plus fluorouracil and cisplatin compared with cisplatin and fluorouracil in a phase III trial of advanced gastric or gastroesophageal cancer adenocarcinoma: The V-325 Study Group. J Clin Oncol 2007; 25: 3205-3209. (Pubitemid 47333732)
15. Yoon YC, Lee KS, Shim YM, Kim BT, Kim K, Kim TS: Metastasis to regional lymph nodes in patients with esophageal squamous cell carcinoma: CT versus FDG PET for presurgical detection prospective study. Radiology 2003; 227: 764-770. (Pubitemid 36583034)
16. Japanese Society for Esophageal Disease: Guideline for the Clinical and Pathologic Studies on Carcinoma of the Esophagus, ed 10. Tokyo, Kanehara, 2001.
17. Levard H, Pouliquen X, Hay JM, Fingerhut A, Langlois-Zantain O, Huguier M, Lozach P, Testart J: 5-Fluorouracil and cisplatin as palliative treatment of advanced oesophageal squamous cell carcinoma. A multicentre randomised controlled trial. The French Associations for Surgical Research. Eur J Surg 1998; 164: 849-857. (Pubitemid 28527290)
18. Yamasaki M, Miyata H, Fujiwara Y, Takiguchi S, Nakajima K, Nishida T, Yasuda T, Matsuyama J, Mori M, Doki Y: P53 genotype predicts response to chemotherapy in patients with squamous cell carcinoma of the esophagus. Ann Surg Oncol 2010; 17: 634-642.
19. Ikeda K, Ishida K, Sato N, Koeda K, Aoki K, Kimura Y, Iwaya T, Ogasawara S, Iijima S, Nakamura R, Uesugi N, Maesawa C, Saito K: Chemoradiotherapy followed by surgery for thoracic esophageal cancer potentially or actually involving adjacent organs. Dis Esophagus 2001; 14: 197-201. (Pubitemid 34170808)
20. Fujita H, Sueyoshi S, Tanaka T, Tanaka Y, Sasahara H, Shirouzu K, Suzuki G, Hayabuchi N, Inutsuka H: Prospective non-randomized trial comparing esophagectomy-followedby- chemoradiotherapy versus chemoradiotherapy- followed-by-esophagectomy for T4 esophageal cancers. J Surg Oncol 2005; 90: 209-219. (Pubitemid 40770935)
21. Ishida K, Ando N, Yamamoto S, Ide H, Shinoda M: Phase II study of cisplatin and 5-fluorouracil with concurrent radiotherapy in advanced squamous cell carcinoma of the esophagus: A Japan Esophageal Oncology Group (JEOG)/Japan Clinical Oncology Group trial (JCOG9516). Jpn J Clin Oncol 2004; 34: 615-619. (Pubitemid 40662717)
22. Takahashi H, Arimura Y, Yamashita K, Okahara S, Tanuma T, Kodaira J, Hokari K, Tsukagoshi H, Shinomura Y, Hosokawa M: Phase I/II study of docetaxel/cisplatin/fluorouracil combination chemotherapy against metastatic esophageal squamous cell carcinoma. J Thorac Oncol 2010; 5: 122-128.
23. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J: New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer 2009; 2: 228-247.
24. Bogaerts J, Ford R, Sargent D, Schwartz LH, Rubinstein L, Lacombe D, Eisenhauer E, Verweij J, Therasse P, RECIST Working Party: Individual patient data analysis to assess modifications to the RECIST criteria. Eur J Cancer 2009; 2: 248-260.
25. Miyata H, Yamasaki M, Takiguchi S, Nakajima K, Fujiwara Y, Nishida T, Mori M, Doki Y: Salvage esophagectomy after definitive chemoradiotherapy for thoracic esophageal cancer. J Surg Oncol 2009; 100: 442-446.