Literature DB >> 20368840

Phase II study of irinotecan, 5-fluorouracil, and leucovorin in relapsed or metastatic colorectal cancer as first-line therapy.

Young-Woong Won1, Young-Hyo Lim, Ho-Yong Park, Ho-Suk Oh, Jung-Hye Choi, Young-Yeul Lee, In-Soon Kim, Il-Young Choi, Myung-Ju Ahn.   

Abstract

BACKGROUND: The purpose of this study was to assess the efficacy and toxicity of biweekly irinotecan plus 5-fluorouracil (FU) and leucovorin (LV) in patients with relapsed or metastatic colorectal cancer.
MATERIALS AND METHODS: Between March 2002 and May 2004, 24 patients with histologically confirmed relapsed or metastatic colorectal cancer were enrolled in this study. One chemotherapy cycle consisted of irinotecan 180 mg/m(2) on days 1 and 15; 5-FU 400 mg/m(2) bolus IV with 600 mg/m(2) by a 22 hour intravenous infusion on days 1, 2, 15 and 16; and leucovorin 20 mg/m(2) on days 1, 2, 15 and 16, every 4 weeks.
RESULTS: The median age of the 24 was 57.5 years (range, 38 approximately 69). Their metastatic sites included: the liver (62.5%), lung (20.8%), peritoneum (16.7%), lymph node (12.5%), ovary (8.3%) and pelvis/vagina (8.3%). Twenty-two patients were evaluable for a response. Six and 7 patients achieved partial responses and stable diseases, respectively. The overall response rate was 27.3% (95% Confidence interval; 10.3 approximately 44.5%). The median follow-up duration for surviving patients was 14.7 months (range, 1.7 approximately 26.5). Median overall survival (OS) and 1-year OS rates were 19 months and 86.3%, respectively. Median response duration and median progression free survival were 7.47 and 5.57 months, respectively. A total of 83 cycles (median 4 cycles) were administered. The main non-hematologic toxicities were nausea/vomiting (44.5%/18.1%) and diarrhea (8.4%). The most common hematologic toxicity was NCI grade I/II anemia (31.3%) and grade I/II neutropenia was 10.8%. There was no life-threatening toxicity.
CONCLUSION: The results suggested that irinotecan, 5-FU and leucovorin combination chemotherapy in a biweekly schedule is a practical and tolerable treatment option in patients with advanced colorectal cancer.

Entities:  

Keywords:  5-Fluorouracil; Irinotecan; Leucovorin; Metastatic colorectal cancer

Year:  2004        PMID: 20368840      PMCID: PMC2843893          DOI: 10.4143/crt.2004.36.4.235

Source DB:  PubMed          Journal:  Cancer Res Treat        ISSN: 1598-2998            Impact factor:   4.679


  19 in total

1.  Phase II trial of irinotecan in patients with metastatic colorectal carcinoma.

Authors:  H C Pitot; D B Wender; M J O'Connell; G Schroeder; R M Goldberg; J Rubin; J A Mailliard; J A Knost; C Ghosh; R J Kirschling; R Levitt; H E Windschitl
Journal:  J Clin Oncol       Date:  1997-08       Impact factor: 44.544

Review 2.  A comprehensive review of 5-fluorouracil and leucovorin in patients with metastatic colorectal carcinoma.

Authors:  D Machover
Journal:  Cancer       Date:  1997-10-01       Impact factor: 6.860

3.  Clinical activity and benefit of irinotecan (CPT-11) in patients with colorectal cancer truly resistant to 5-fluorouracil (5-FU).

Authors:  E Van Cutsem; D Cunningham; W W Ten Bokkel Huinink; C J Punt; C G Alexopoulos; L Dirix; M Symann; G H Blijham; P Cholet; G Fillet; C Van Groeningen; J M Vannetzel; F Levi; G Panagos; C Unger; J Wils; C Cote; C Blanc; P Hérait; H Bleiberg
Journal:  Eur J Cancer       Date:  1999-01       Impact factor: 9.162

4.  A multicenter, phase II trial of weekly irinotecan (CPT-11) in patients with previously treated colorectal carcinoma.

Authors:  M L Rothenberg; J V Cox; R F DeVore; J D Hainsworth; R Pazdur; S E Rivkin; J S Macdonald; C E Geyer; J Sandbach; D L Wolf; J S Mohrland; G L Elfring; L L Miller; D D Von Hoff
Journal:  Cancer       Date:  1999-02-15       Impact factor: 6.860

5.  Irinotecan combined with bolus fluorouracil, continuous infusion fluorouracil, and high-dose leucovorin every two weeks (LV5FU2 regimen): a clinical dose-finding and pharmacokinetic study in patients with pretreated metastatic colorectal cancer.

Authors:  M Ducreux; M Ychou; J F Seitz; M Bonnay; A Bexon; J P Armand; M Mahjoubi; D Méry-Mignard; P Rougier
Journal:  J Clin Oncol       Date:  1999-09       Impact factor: 44.544

6.  Phase II study of irinotecan in the treatment of advanced colorectal cancer in chemotherapy-naive patients and patients pretreated with fluorouracil-based chemotherapy.

Authors:  P Rougier; R Bugat; J Y Douillard; S Culine; E Suc; P Brunet; Y Becouarn; M Ychou; M Marty; J M Extra; J Bonneterre; A Adenis; J F Seitz; G Ganem; M Namer; T Conroy; S Negrier; Y Merrouche; F Burki; M Mousseau; P Herait; M Mahjoubi
Journal:  J Clin Oncol       Date:  1997-01       Impact factor: 44.544

7.  Phase I clinical and pharmacokinetic study of irinotecan, fluorouracil, and leucovorin in patients with advanced solid tumors.

Authors:  L B Saltz; J Kanowitz; N E Kemeny; L Schaaf; D Spriggs; B A Staton; R Berkery; C Steger; M Eng; A Dietz; P Locker; D P Kelsen
Journal:  J Clin Oncol       Date:  1996-11       Impact factor: 44.544

8.  Phase II trial of irinotecan in patients with progressive or rapidly recurrent colorectal cancer.

Authors:  M L Rothenberg; J R Eckardt; J G Kuhn; H A Burris; J Nelson; S G Hilsenbeck; G I Rodriguez; A M Thurman; L S Smith; S G Eckhardt; G R Weiss; G L Elfring; D A Rinaldi; L J Schaaf; D D Von Hoff
Journal:  J Clin Oncol       Date:  1996-04       Impact factor: 44.544

9.  Irinotecan is an active agent in untreated patients with metastatic colorectal cancer.

Authors:  J A Conti; N E Kemeny; L B Saltz; Y Huang; W P Tong; T C Chou; M Sun; S Pulliam; C Gonzalez
Journal:  J Clin Oncol       Date:  1996-03       Impact factor: 44.544

10.  Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: evidence in terms of response rate. Advanced Colorectal Cancer Meta-Analysis Project.

Authors: 
Journal:  J Clin Oncol       Date:  1992-06       Impact factor: 44.544

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  3 in total

1.  Irinotecan, continuous 5-fluorouracil, and low dose of leucovorin (modified FOLFIRI) as first line of therapy in recurrent or metastatic colorectal cancer.

Authors:  Myung-Ah Lee; Jae-Ho Byun; Byoung-Young Shim; In-Sook Woo; Jin-Hyung Kang; Young Seon Hong; Kyung Shik Lee; Myung Gyu Choi; Suk Kyun Chang; Seong Taek Oh; Sung Il Choi; Doo Suk Lee
Journal:  Korean J Intern Med       Date:  2005-09       Impact factor: 2.884

2.  Responsiveness of CPT-11 in respect to hMLH1 and hMSH2 protein expression in the primary colorectal cancer.

Authors:  In Ja Park; Hee Cheol Kim; Chang Sik Yu; Heung Moon Chang; Jea Hwan Lee; Jong Hoon Kim; Tae Won Kim; Jung Sun Kim; Jin Cheon Kim
Journal:  Cancer Res Treat       Date:  2004-12-31       Impact factor: 4.679

3.  A phase II study of irinotecan, 5-fluorouracil and leucovorin for treatment in patients with previously untreated advanced colorectal cancer.

Authors:  Sang-Byung Bae; Nam-Su Lee; Han-Jo Kim; Kyoung-Ha Kim; Hyun-Jung Kim; Chan-Kyu Kim; Kyu-Taeg Lee; Sung-Kyu Park; Jong-Ho Won; Dae-Sik Hong; Hee-Sook Park
Journal:  Cancer Res Treat       Date:  2006-04-30       Impact factor: 4.679

  3 in total

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