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Irinotecan and capecitabine as second-line treatment after failure for first-line infusional 24-h 5-fluorouracil/folinic acid in advanced colorectal cancer: a phase II study

Irinotecan and capecitabine as second-line treatment after failure for first-line infusional 24-h 5-fluorouracil/folinic acid in advanced colorectal cancer: a phase II study
Irinotecan and capecitabine as second-line treatment after failure for first-line infusional 24-h 5-fluorouracil/folinic acid in advanced colorectal cancer: a phase II study
The efficacy of combination therapy with irinotecan and capecitabine has been demonstrated for the first-line treatment of metastatic colorectal cancer (MCRC). The aim of this trial was to evaluate the efficacy and safety of this combination in MCRC as second-line treatment after failure of 24-h infusional 5-fluorouracil (5-FU24h) and folinic acid (FA). Patients pre-treated with 5-FU24h/FA were recruited at two institutions to receive 6xweekly irinotecan 70 mg/m2 and capecitabine (1000 mg/m2 b.i.d. days 1-14 and 22-35). Courses were repeated on day 50. In elderly patients (>65 years) a 20% dose reduction of both drugs was scheduled. Twenty-eight patients [M/F 20/8; median age 65 years (range 44-79); median ECOG score 1] were enrolled. The most frequent sites of metastases were liver, n=20, lymph nodes and lungs, n=10, respectively. Half of the patients had two or more metastatic sites. A total of 71 treatment courses (median 2, range 1-8) were administered. Main toxicities [worst per patient (%); CTC grade 1/2/3/4] were: anaemias 18/14/-/-; leukocytopenia 11/21/-/-; thrombocytopenia 11/-/-/-; diarrhea 18/36/21/-; nausea/vomiting 43/29/4/-; mucositis 4/11/-/-; alopecia 7/25/-/-; hand-foot syndrome 7/21/-/-; fatigue 14/14/-/-; renal insufficiency (caused by diarrhea and exsiccosis) -/-/-/7. Dose intensity in the first course was [median/mean (%)]: irinotecan 92/83; capecitabine 88/82. Twenty-three patients are evaluable for response analysis (five did not complete the first course): three patients showed partial remissions (13%) and 11 patients had stable disease (48%). Median time to progression was 3.0 months for the total population (range 1.4-17.3) and 6.5 months for responders (partial response plus no change). Seventy-four percent of the patients received a third-line therapy. Overall survival was 15.7 months calculated from the start of study treatment. Second-line therapy with irinotecan and capecitabine yielded a tumor control in 61% of patients with MCRC. Efficacy and toxicity data are comparable to 5-FU/irinotecan combinations, although the likelihood of severe diarrhea appears to be higher with capecitabine/irinotecan.
0959-4973
39-45
Hofheinz, Ralf-Dieter
020c70d2-b88e-4776-9422-fe6d0cfe174f
Gnad-Vogt, Ulrike
4a3d74d0-fe3d-485c-8d6c-54d6811c0cc0
Wein, Axel
8a6d4484-7c1a-4846-8a7a-ce1be7cb4ccf
Saussele, Susanne
148d36ac-b14b-42ff-b4cc-17dbe7f720f7
Kreil, Sebastian
bdd3cef1-cffa-4ec7-a783-e183cde237f4
Pilz, Lothar
b84ea4c7-b601-426e-be8c-27a8c3fa714a
Hehlmann, Rudiger
3e2a5d6e-9b68-4675-93ce-44e3f7892493
Hochhaus, Andreas
b37b9b7d-85ff-455e-994d-fcc2adf94088
Hofheinz, Ralf-Dieter
020c70d2-b88e-4776-9422-fe6d0cfe174f
Gnad-Vogt, Ulrike
4a3d74d0-fe3d-485c-8d6c-54d6811c0cc0
Wein, Axel
8a6d4484-7c1a-4846-8a7a-ce1be7cb4ccf
Saussele, Susanne
148d36ac-b14b-42ff-b4cc-17dbe7f720f7
Kreil, Sebastian
bdd3cef1-cffa-4ec7-a783-e183cde237f4
Pilz, Lothar
b84ea4c7-b601-426e-be8c-27a8c3fa714a
Hehlmann, Rudiger
3e2a5d6e-9b68-4675-93ce-44e3f7892493
Hochhaus, Andreas
b37b9b7d-85ff-455e-994d-fcc2adf94088

Hofheinz, Ralf-Dieter, Gnad-Vogt, Ulrike, Wein, Axel, Saussele, Susanne, Kreil, Sebastian, Pilz, Lothar, Hehlmann, Rudiger and Hochhaus, Andreas (2005) Irinotecan and capecitabine as second-line treatment after failure for first-line infusional 24-h 5-fluorouracil/folinic acid in advanced colorectal cancer: a phase II study. Anti-Cancer Drugs, 16 (1), 39-45.

Record type: Article

Abstract

The efficacy of combination therapy with irinotecan and capecitabine has been demonstrated for the first-line treatment of metastatic colorectal cancer (MCRC). The aim of this trial was to evaluate the efficacy and safety of this combination in MCRC as second-line treatment after failure of 24-h infusional 5-fluorouracil (5-FU24h) and folinic acid (FA). Patients pre-treated with 5-FU24h/FA were recruited at two institutions to receive 6xweekly irinotecan 70 mg/m2 and capecitabine (1000 mg/m2 b.i.d. days 1-14 and 22-35). Courses were repeated on day 50. In elderly patients (>65 years) a 20% dose reduction of both drugs was scheduled. Twenty-eight patients [M/F 20/8; median age 65 years (range 44-79); median ECOG score 1] were enrolled. The most frequent sites of metastases were liver, n=20, lymph nodes and lungs, n=10, respectively. Half of the patients had two or more metastatic sites. A total of 71 treatment courses (median 2, range 1-8) were administered. Main toxicities [worst per patient (%); CTC grade 1/2/3/4] were: anaemias 18/14/-/-; leukocytopenia 11/21/-/-; thrombocytopenia 11/-/-/-; diarrhea 18/36/21/-; nausea/vomiting 43/29/4/-; mucositis 4/11/-/-; alopecia 7/25/-/-; hand-foot syndrome 7/21/-/-; fatigue 14/14/-/-; renal insufficiency (caused by diarrhea and exsiccosis) -/-/-/7. Dose intensity in the first course was [median/mean (%)]: irinotecan 92/83; capecitabine 88/82. Twenty-three patients are evaluable for response analysis (five did not complete the first course): three patients showed partial remissions (13%) and 11 patients had stable disease (48%). Median time to progression was 3.0 months for the total population (range 1.4-17.3) and 6.5 months for responders (partial response plus no change). Seventy-four percent of the patients received a third-line therapy. Overall survival was 15.7 months calculated from the start of study treatment. Second-line therapy with irinotecan and capecitabine yielded a tumor control in 61% of patients with MCRC. Efficacy and toxicity data are comparable to 5-FU/irinotecan combinations, although the likelihood of severe diarrhea appears to be higher with capecitabine/irinotecan.

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Published date: 2005

Identifiers

Local EPrints ID: 24756
URI: http://eprints.soton.ac.uk/id/eprint/24756
ISSN: 0959-4973
PURE UUID: 107248e7-2818-4045-bd59-6cae863e4a17

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Date deposited: 03 Apr 2006
Last modified: 22 Jul 2022 20:29

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Contributors

Author: Ralf-Dieter Hofheinz
Author: Ulrike Gnad-Vogt
Author: Axel Wein
Author: Susanne Saussele
Author: Sebastian Kreil
Author: Lothar Pilz
Author: Rudiger Hehlmann
Author: Andreas Hochhaus

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