Irinotecan plus folinic acid/continuous 5-fluorouracil as simplified bimonthly FOLFIRI regimen for first-line therapy of metastatic colorectal cancer

<p>Abstract</p> <p>Background</p> <p>Combination therapy of irinotecan, folinic acid (FA) and 5-fluorouracil (5-FU) has been proven to be highly effective for the treatment of metastatic colorectal cancer. However, in light of safety and efficacy concerns, the best comb...

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Main Authors: Höhler Thomas, Klein O, Adami Bernd, Schroeder M, Hohl Herbert, Zanke Christiane, Siebler Jürgen, Steinmann Silke, Teufel Andreas, Galle Peter R, Heike Michael, Moehler Markus
Format: Article
Language:English
Published: BMC 2004-07-01
Series:BMC Cancer
Subjects:
Online Access:http://www.biomedcentral.com/1471-2407/4/38
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author Höhler Thomas
Klein O
Adami Bernd
Schroeder M
Hohl Herbert
Zanke Christiane
Siebler Jürgen
Steinmann Silke
Teufel Andreas
Galle Peter R
Heike Michael
Moehler Markus
author_facet Höhler Thomas
Klein O
Adami Bernd
Schroeder M
Hohl Herbert
Zanke Christiane
Siebler Jürgen
Steinmann Silke
Teufel Andreas
Galle Peter R
Heike Michael
Moehler Markus
author_sort Höhler Thomas
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>Combination therapy of irinotecan, folinic acid (FA) and 5-fluorouracil (5-FU) has been proven to be highly effective for the treatment of metastatic colorectal cancer. However, in light of safety and efficacy concerns, the best combination regimen for first-line therapy still needs to be defined. The current study reports on the bimonthly FOLFIRI protocol consisting of irinotecan with continuous FA/5-FU in five German outpatient clinics, with emphasis on the safety and efficiency, quality of life, management of delayed diarrhea, and secondary resection of regressive liver metastases.</p> <p>Methods</p> <p>A total of 35 patients were treated for metastatic colorectal cancer. All patients received first-line treatment according to the FOLFIRI regimen, consisting of irinotecan (180 mg/m<sup>2</sup>), L-FA (200 mg/m<sup>2</sup>) and 5-FU bolus (400 mg/m<sup>2</sup>) on day 1, followed by a 46-h continuous infusion 5-FU (2400 mg/m<sup>2</sup>). One cycle contained three fortnightly administrations. Staging was performed after 2 cycles. Dosage was reduced at any time if toxicity NCI CTC grade III/IV was observed. Chemotherapy was administered only to diarrhea-free patients.</p> <p>Results</p> <p>The FOLFIRI regimen was generally well tolerated. It was postponed for one-week in 51 of 415 applications (12.3%). Dose reduction was necessary in ten patients. Grade III/IV toxicity was rare, with diarrhea (14%), nausea/vomiting (12%), leucopenia (3%), neutropenia (9%) and mucositis (3%). The overall response rate was 31% (4 CR and 7 PR), with disease control in 74%. After primary chemotherapy, resection of liver metastases was achieved in three patients. In one patient, the CR was confirmed pathologically. Median progression-free and overall survival were seven and 17 months, respectively.</p> <p>Conclusions</p> <p>The FOLFIRI regimen proved to be safe and efficient. Outpatient treatment was well tolerated. Since downstaging was possible, combinations of irinotecan and continuous FA/5-FU should further be investigated in neoadjuvant protocols.</p>
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spelling doaj.art-65abf2ffd14b4169b63e00211e1dea042022-12-22T02:59:28ZengBMCBMC Cancer1471-24072004-07-01413810.1186/1471-2407-4-38Irinotecan plus folinic acid/continuous 5-fluorouracil as simplified bimonthly FOLFIRI regimen for first-line therapy of metastatic colorectal cancerHöhler ThomasKlein OAdami BerndSchroeder MHohl HerbertZanke ChristianeSiebler JürgenSteinmann SilkeTeufel AndreasGalle Peter RHeike MichaelMoehler Markus<p>Abstract</p> <p>Background</p> <p>Combination therapy of irinotecan, folinic acid (FA) and 5-fluorouracil (5-FU) has been proven to be highly effective for the treatment of metastatic colorectal cancer. However, in light of safety and efficacy concerns, the best combination regimen for first-line therapy still needs to be defined. The current study reports on the bimonthly FOLFIRI protocol consisting of irinotecan with continuous FA/5-FU in five German outpatient clinics, with emphasis on the safety and efficiency, quality of life, management of delayed diarrhea, and secondary resection of regressive liver metastases.</p> <p>Methods</p> <p>A total of 35 patients were treated for metastatic colorectal cancer. All patients received first-line treatment according to the FOLFIRI regimen, consisting of irinotecan (180 mg/m<sup>2</sup>), L-FA (200 mg/m<sup>2</sup>) and 5-FU bolus (400 mg/m<sup>2</sup>) on day 1, followed by a 46-h continuous infusion 5-FU (2400 mg/m<sup>2</sup>). One cycle contained three fortnightly administrations. Staging was performed after 2 cycles. Dosage was reduced at any time if toxicity NCI CTC grade III/IV was observed. Chemotherapy was administered only to diarrhea-free patients.</p> <p>Results</p> <p>The FOLFIRI regimen was generally well tolerated. It was postponed for one-week in 51 of 415 applications (12.3%). Dose reduction was necessary in ten patients. Grade III/IV toxicity was rare, with diarrhea (14%), nausea/vomiting (12%), leucopenia (3%), neutropenia (9%) and mucositis (3%). The overall response rate was 31% (4 CR and 7 PR), with disease control in 74%. After primary chemotherapy, resection of liver metastases was achieved in three patients. In one patient, the CR was confirmed pathologically. Median progression-free and overall survival were seven and 17 months, respectively.</p> <p>Conclusions</p> <p>The FOLFIRI regimen proved to be safe and efficient. Outpatient treatment was well tolerated. Since downstaging was possible, combinations of irinotecan and continuous FA/5-FU should further be investigated in neoadjuvant protocols.</p>http://www.biomedcentral.com/1471-2407/4/38irinotecan5-fluorouracilsafetymetastatic colorectal cancerneoadjuvant
spellingShingle Höhler Thomas
Klein O
Adami Bernd
Schroeder M
Hohl Herbert
Zanke Christiane
Siebler Jürgen
Steinmann Silke
Teufel Andreas
Galle Peter R
Heike Michael
Moehler Markus
Irinotecan plus folinic acid/continuous 5-fluorouracil as simplified bimonthly FOLFIRI regimen for first-line therapy of metastatic colorectal cancer
BMC Cancer
irinotecan
5-fluorouracil
safety
metastatic colorectal cancer
neoadjuvant
title Irinotecan plus folinic acid/continuous 5-fluorouracil as simplified bimonthly FOLFIRI regimen for first-line therapy of metastatic colorectal cancer
title_full Irinotecan plus folinic acid/continuous 5-fluorouracil as simplified bimonthly FOLFIRI regimen for first-line therapy of metastatic colorectal cancer
title_fullStr Irinotecan plus folinic acid/continuous 5-fluorouracil as simplified bimonthly FOLFIRI regimen for first-line therapy of metastatic colorectal cancer
title_full_unstemmed Irinotecan plus folinic acid/continuous 5-fluorouracil as simplified bimonthly FOLFIRI regimen for first-line therapy of metastatic colorectal cancer
title_short Irinotecan plus folinic acid/continuous 5-fluorouracil as simplified bimonthly FOLFIRI regimen for first-line therapy of metastatic colorectal cancer
title_sort irinotecan plus folinic acid continuous 5 fluorouracil as simplified bimonthly folfiri regimen for first line therapy of metastatic colorectal cancer
topic irinotecan
5-fluorouracil
safety
metastatic colorectal cancer
neoadjuvant
url http://www.biomedcentral.com/1471-2407/4/38
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