Multicenter Phase I/II Study of Docetaxel, Cisplatin and Fluorouracil Combination Chemotherapy in Patients with Advanced or Recurrent Squamous Cell Carcinoma of the Esophagus
Objective: Esophageal squamous cell carcinoma (ESCC) is refractory to current therapeutic regimens and more effective therapies are imperative. To this end, we conducted a multicenter phase I/II trial of docetaxel, cisplatin, and fluorouracil (DCF) combination chemotherapy for ESCC. Methods: The stu...
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| Published in | Oncology Vol. 80; no. 5-6; pp. 307 - 313 |
|---|---|
| Main Authors | , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Basel, Switzerland
Karger
01.01.2011
S. Karger AG |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0030-2414 1423-0232 1423-0232 |
| DOI | 10.1159/000329806 |
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| Abstract | Objective: Esophageal squamous cell carcinoma (ESCC) is refractory to current therapeutic regimens and more effective therapies are imperative. To this end, we conducted a multicenter phase I/II trial of docetaxel, cisplatin, and fluorouracil (DCF) combination chemotherapy for ESCC. Methods: The study subjects were 46 patients with advanced or recurrent ESCC. Treatment included docetaxel at 60, 70, and 75 mg/m 2 , cisplatin at 70 mg/m 2 on day 1, and daily fluorouracil at 700 mg/m 2 on days 1 through 5. The recommended dose of docetaxel was determined in phase I, while the response rate (RR) and progression-free survival rates were analyzed in phase II. Results: The recommended dose was determined to be 70 mg/m 2 in phase I. In phase II, the RR was 72.5%. Interim analysis showed median and 1-year progression-free survival of 14 months and 55.6%, respectively. Grade 3/4 toxicities of leukopenia and neutropenia occurred in 72.5 and 90% of patients, respectively. No treatment-related death was recorded. Surgical resection was subsequently performed in 20 patients after chemotherapy, and curative resection was achieved in 19. Conclusion: DCF was tolerable and effective for advanced and recurrent ESCC. Such findings might encourage a change in the treatment strategy for ESCC. |
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| AbstractList | Objective: Esophageal squamous cell carcinoma (ESCC) is refractory to current therapeutic regimens and more effective therapies are imperative. To this end, we conducted a multicenter phase I/II trial of docetaxel, cisplatin, and fluorouracil (DCF) combination chemotherapy for ESCC. Methods: The study subjects were 46 patients with advanced or recurrent ESCC. Treatment included docetaxel at 60, 70, and 75 mg/m 2 , cisplatin at 70 mg/m 2 on day 1, and daily fluorouracil at 700 mg/m 2 on days 1 through 5. The recommended dose of docetaxel was determined in phase I, while the response rate (RR) and progression-free survival rates were analyzed in phase II. Results: The recommended dose was determined to be 70 mg/m 2 in phase I. In phase II, the RR was 72.5%. Interim analysis showed median and 1-year progression-free survival of 14 months and 55.6%, respectively. Grade 3/4 toxicities of leukopenia and neutropenia occurred in 72.5 and 90% of patients, respectively. No treatment-related death was recorded. Surgical resection was subsequently performed in 20 patients after chemotherapy, and curative resection was achieved in 19. Conclusion: DCF was tolerable and effective for advanced and recurrent ESCC. Such findings might encourage a change in the treatment strategy for ESCC. Esophageal squamous cell carcinoma (ESCC) is refractory to current therapeutic regimens and more effective therapies are imperative. To this end, we conducted a multicenter phase I/II trial of docetaxel, cisplatin, and fluorouracil (DCF) combination chemotherapy for ESCC. The study subjects were 46 patients with advanced or recurrent ESCC. Treatment included docetaxel at 60, 70, and 75 mg/m(2), cisplatin at 70 mg/m(2) on day 1, and daily fluorouracil at 700 mg/m(2) on days 1 through 5. The recommended dose of docetaxel was determined in phase I, while the response rate (RR) and progression-free survival rates were analyzed in phase II. The recommended dose was determined to be 70 mg/m(2) in phase I. In phase II, the RR was 72.5%. Interim analysis showed median and 1-year progression-free survival of 14 months and 55.6%, respectively. Grade 3/4 toxicities of leukopenia and neutropenia occurred in 72.5 and 90% of patients, respectively. No treatment-related death was recorded. Surgical resection was subsequently performed in 20 patients after chemotherapy, and curative resection was achieved in 19. DCF was tolerable and effective for advanced and recurrent ESCC. Such findings might encourage a change in the treatment strategy for ESCC. Objective: Esophageal squamous cell carcinoma (ESCC) is refractory to current therapeutic regimens and more effective therapies are imperative. To this end, we conducted a multicenter phase I/II trial of docetaxel, cisplatin, and fluorouracil (DCF) combination chemotherapy for ESCC. Methods: The study subjects were 46 patients with advanced or recurrent ESCC. Treatment included docetaxel at 60, 70, and 75 mg/m2, cisplatin at 70 mg/m2 on day 1, and daily fluorouracil at 700 mg/m2 on days 1 through 5. The recommended dose of docetaxel was determined in phase I, while the response rate (RR) and progression-free survival rates were analyzed in phase II. Results: The recommended dose was determined to be 70 mg/m2 in phase I. In phase II, the RR was 72.5%. Interim analysis showed median and 1-year progression-free survival of 14 months and 55.6%, respectively. Grade 3/4 toxicities of leukopenia and neutropenia occurred in 72.5 and 90% of patients, respectively. No treatment-related death was recorded. Surgical resection was subsequently performed in 20 patients after chemotherapy, and curative resection was achieved in 19. Conclusion: DCF was tolerable and effective for advanced and recurrent ESCC. Such findings might encourage a change in the treatment strategy for ESCC. Esophageal squamous cell carcinoma (ESCC) is refractory to current therapeutic regimens and more effective therapies are imperative. To this end, we conducted a multicenter phase I/II trial of docetaxel, cisplatin, and fluorouracil (DCF) combination chemotherapy for ESCC.OBJECTIVEEsophageal squamous cell carcinoma (ESCC) is refractory to current therapeutic regimens and more effective therapies are imperative. To this end, we conducted a multicenter phase I/II trial of docetaxel, cisplatin, and fluorouracil (DCF) combination chemotherapy for ESCC.The study subjects were 46 patients with advanced or recurrent ESCC. Treatment included docetaxel at 60, 70, and 75 mg/m(2), cisplatin at 70 mg/m(2) on day 1, and daily fluorouracil at 700 mg/m(2) on days 1 through 5. The recommended dose of docetaxel was determined in phase I, while the response rate (RR) and progression-free survival rates were analyzed in phase II.METHODSThe study subjects were 46 patients with advanced or recurrent ESCC. Treatment included docetaxel at 60, 70, and 75 mg/m(2), cisplatin at 70 mg/m(2) on day 1, and daily fluorouracil at 700 mg/m(2) on days 1 through 5. The recommended dose of docetaxel was determined in phase I, while the response rate (RR) and progression-free survival rates were analyzed in phase II.The recommended dose was determined to be 70 mg/m(2) in phase I. In phase II, the RR was 72.5%. Interim analysis showed median and 1-year progression-free survival of 14 months and 55.6%, respectively. Grade 3/4 toxicities of leukopenia and neutropenia occurred in 72.5 and 90% of patients, respectively. No treatment-related death was recorded. Surgical resection was subsequently performed in 20 patients after chemotherapy, and curative resection was achieved in 19.RESULTSThe recommended dose was determined to be 70 mg/m(2) in phase I. In phase II, the RR was 72.5%. Interim analysis showed median and 1-year progression-free survival of 14 months and 55.6%, respectively. Grade 3/4 toxicities of leukopenia and neutropenia occurred in 72.5 and 90% of patients, respectively. No treatment-related death was recorded. Surgical resection was subsequently performed in 20 patients after chemotherapy, and curative resection was achieved in 19.DCF was tolerable and effective for advanced and recurrent ESCC. Such findings might encourage a change in the treatment strategy for ESCC.CONCLUSIONDCF was tolerable and effective for advanced and recurrent ESCC. Such findings might encourage a change in the treatment strategy for ESCC. Objective: Esophageal squamous cell carcinoma (ESCC) is refractory to current therapeutic regimens and more effective therapies are imperative. To this end, we conducted a multicenter phase I/II trial of docetaxel, cisplatin, and fluorouracil (DCF) combination chemotherapy for ESCC. Methods: The study subjects were 46 patients with advanced or recurrent ESCC. Treatment included docetaxel at 60, 70, and 75 mg/m2, cisplatin at 70 mg/m2 on day 1, and daily fluorouracil at 700 mg/m2 on days 1 through 5. The recommended dose of docetaxel was determined in phase I, while the response rate (RR) and progression-free survival rates were analyzed in phase II. Results: The recommended dose was determined to be 70 mg/m2 in phase I. In phase II, the RR was 72.5%. Interim analysis showed median and 1-year progression-free survival of 14 months and 55.6%, respectively. Grade 3/4 toxicities of leukopenia and neutropenia occurred in 72.5 and 90% of patients, respectively. No treatment-related death was recorded. Surgical resection was subsequently performed in 20 patients after chemotherapy, and curative resection was achieved in 19. Conclusion: DCF was tolerable and effective for advanced and recurrent ESCC. Such findings might encourage a change in the treatment strategy for ESCC. [PUBLICATION ABSTRACT] |
| Author | Motoori, Masaaki Shiozaki, Hitoshi Mori, Masaki Doki, Yuichiro Peng, Y.F. Tanaka, Koji Miyata, Hiroshi Yano, Masahiko Shiraishi, Osamu Yasuda, Takushi Yamasaki, Makoto |
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| Copyright | 2011 S. Karger AG, Basel 2015 INIST-CNRS Copyright © 2011 S. Karger AG, Basel. Copyright (c) 2011 S. Karger AG, Basel |
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| Keywords | Chemotherapy Squamous cell carcinoma of esophagus Cisplatin Docetaxel Fluorouracil Antineoplastic agent Relapse Multicenter study Esophageal disease Esophagus squamous cell carcinoma Cancerology Taxane derivatives Phase II trial Advanced stage Antimitotic Platinum II Complexes Human Drug combination Enzyme Fluoropyrimidine derivatives Transferases Enzyme inhibitor Malignant tumor Thymidylate synthase Alkylating agent Treatment Antimetabolic Methyltransferases Phase I trial Pyrimidine derivatives Digestive diseases Combined treatment Cancer |
| Language | English |
| License | Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. https://www.karger.com/Services/SiteLicenses CC BY 4.0 Copyright © 2011 S. Karger AG, Basel. |
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Jpn J Clin Oncol 1992;22:172–176.1518165 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;14:197–201.10.1046%2Fj.1442-2050.2001.00184.x 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. 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| References_xml | – reference: Fujita H, Sueyoshi S, Tanaka T, Tanaka Y, Sasahara H, Shirouzu K, Suzuki G, Hayabuchi N, Inutsuka H: Prospective non-randomized trial comparing esophagectomy-followed-by-chemoradiotherapy versus chemoradiotherapy-followed-by-esophagectomy for T4 esophageal cancers. J Surg Oncol 2005;90:209–219.10.1002%2Fjso.20259 – reference: 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;23:641–645.10.1111%2Fj.1442-2050.2010.01070.x – reference: 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;100:442–446.10.1002%2Fjso.21353 – reference: 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;357:1705–1715.1796001310.1056%2FNEJMoa070956 – reference: 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;25:3205–3209.1766446710.1200%2FJCO.2006.10.4968 – reference: 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. – reference: 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;5:122–128.10.1097%2FJTO.0b013e3181c1ffd5 – reference: 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;357:1695–1704.1796001210.1056%2FNEJMoa071028 – reference: 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;31:419–423.1168959410.1093%2Fjjco%2Fhye090 – reference: 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;17:634–642.10.1245%2Fs10434-009-0851-4 – reference: 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;2:248–260.10.1016%2Fj.ejca.2008.10.027 – reference: 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;14:197–201.10.1046%2Fj.1442-2050.2001.00184.x – reference: 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;33:1216–1220.930144510.1016%2FS0959-8049%2897%2900088-9 – reference: 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;87:398–404.10.1016%2Fj.radonc.2008.03.006 – reference: 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;12:513–517.1145999710.1097%2F00001813-200107000-00004 – reference: 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;227:764–770.1277368010.1148%2Fradiol.2281020423 – reference: Japanese Society for Esophageal Disease: Guideline for the Clinical and Pathologic Studies on Carcinoma of the Esophagus, ed 10. Tokyo, Kanehara, 2001. – reference: 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;2:228–247.10.1016%2Fj.ejca.2008.10.026 – reference: 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;22:172–176.1518165 – reference: 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;25:3217–3223.1766446910.1200%2FJCO.2006.08.0135 – reference: 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;16:1826–1834.9586897 – reference: 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;53:449–453.1795200610.1159%2F000110018 – reference: 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;16:1133–1139.10.1093%2Fannonc%2Fmdi207 – reference: 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;34:615–619.10.1093%2Fjjco%2Fhyh107 – reference: 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. 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| Snippet | Objective: Esophageal squamous cell carcinoma (ESCC) is refractory to current therapeutic regimens and more effective therapies are imperative. To this end, we... Esophageal squamous cell carcinoma (ESCC) is refractory to current therapeutic regimens and more effective therapies are imperative. To this end, we conducted... |
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| SubjectTerms | Adult Aged Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Cancer Carcinoma, Squamous Cell - drug therapy Carcinoma, Squamous Cell - secondary Chemotherapy Cisplatin - administration & dosage Clinical Study Disease-Free Survival Drug Administration Schedule Esophageal Neoplasms - drug therapy Esophageal Neoplasms - pathology Esophagus Female Fluorouracil - administration & dosage Gastroenterology. Liver. Pancreas. Abdomen Humans Liver Neoplasms - drug therapy Liver Neoplasms - secondary Lung Neoplasms - drug therapy Lung Neoplasms - secondary Lymphatic Metastasis Male Medical sciences Middle Aged Recurrence Side effects Taxoids - administration & dosage Treatment Outcome Tumors |
| Title | Multicenter Phase I/II Study of Docetaxel, Cisplatin and Fluorouracil Combination Chemotherapy in Patients with Advanced or Recurrent Squamous Cell Carcinoma of the Esophagus |
| URI | https://karger.com/doi/10.1159/000329806 https://www.ncbi.nlm.nih.gov/pubmed/21778771 https://www.proquest.com/docview/898312097 https://www.proquest.com/docview/887937975 |
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