A randomized phase II trial of irinotecan in combination with infusional or two different bolus 5-fluorouracil and folinic and regimens as first-line therapy for advanced colorectal cancer

Kamel Bouzid; S. Khalfallah; J. Tujakowski; B. Piko; G. Purkalne; S. Plate; P. Padrik; M. Serafy; E. M. Pshevloutsky; B. Boussard; P. P. Bapsy; S. Ben Ahmed; T. Salek; S. Doneo; D. A. Gerges; D. C. Doval; E. Buyukunal; I. N. Chernozemsky; V. I. Tzekova; H. A. El-Azim; H. Errihani; R. Samlali; J. S. Godz; N. Ghilezan; B. A. Berdov; G. N. Tchaikovsky; M. Wagnerova; N. F. Aykan; J. Zidan; G. Chachine

doi:10.1093/annonc/mdg288

A randomized phase II trial of irinotecan in combination with infusional or two different bolus 5-fluorouracil and folinic and regimens as first-line therapy for advanced colorectal cancer

Kamel Bouzid, S. Khalfallah, J. Tujakowski, B. Piko, G. Purkalne, S. Plate, P. Padrik, M. Serafy, E. M. Pshevloutsky, B. Boussard, P. P. Bapsy, S. Ben Ahmed, T. Salek, S. Doneo, D. A. Gerges, D. C. Doval, E. Buyukunal, I. N. Chernozemsky, V. I. Tzekova, H. A. El-AzimH. Errihani, R. Samlali, J. S. Godz, N. Ghilezan, B. A. Berdov, G. N. Tchaikovsky, M. Wagnerova, N. F. Aykan, J. Zidan, G. Chachine

Bar-Ilan University - Azrieli Faculty of Medicine

Research output: Contribution to journal › Article › peer-review

22 Scopus citations

Abstract

Background: Three different therapeutic regimens of irinotecan (CPT-11) in combination with 5-fluorouracil (5-FU) and folinic acid (FA) were evaluated for efficacy and safety in the first-line therapy of advanced colorectal cancer. Patients and methods: Patients were randomly assigned to receive intravenously either: CPT-11 125 mg/m², FA 20 mg/m² followed by 5-FU 500 mg/m² bolus, weekly for 4 weeks (arm A, Saltz regimen); or CPT-11 180 mg/m² day 1 then FA 200 mg/m² over 2 h and 5-FU 400 mg/m² bolus and 5-FU 600 mg/m² 22-h infusion on days 1 and 2, every 2 weeks (arm B, Douillard regimen); or CPT-11 350 mg/m² (days 1 and 43) alternating with FA 20 mg/m²/day followed by 5-FU bolus 425 mg/m²/day during 5 days (days 22-26) (arm C, Mayo Clinic regimen). Results: A total of 154 patients were included in the study (arm A, 51 patients; arm B, 53; arm C, 50). Overall response rates for the intention-to-treat populations were 33% [95% confidence interval (CI) 21% to 48%], 42% (95% CI 28% to 56%) and 30% (95% CI 18% to 45%) for arms A, B and C, respectively. Median times to progression were 6, 8 and 7 months for arms A, B and C, respectively. Median survival times were 15, 12 and 17 months for arms A, B and C, respectively. Overall response rates for the evaluable patient populations were 40% (95% CI 24% to 58%) in arm A, 44% (95% CI 29% to 60%) in arm B and 31% (95% CI 17% to 47%) in arm C. Neutropenia was the main serious adverse event in arms A (30% of patients) and C (22% of patients) but occurred in only 8% of patients in arm B. Delayed diarrhea was the main severe adverse event for the three regimens, from 15% to 22%. Conclusion: All three regimens were highly active. The biweekly combination of CPT-11 and 5-FU/FA (arm B) was notable for its low incidence of grade 3/4 neutropenia. The incidence of grade 3/4 delayed diarrhea was equivalent for the three treatment arms.

Original language	English
Pages (from-to)	1106-1114
Number of pages	9
Journal	Annals of Oncology
Volume	14
Issue number	7
DOIs	https://doi.org/10.1093/annonc/mdg288
State	Published - 1 Jul 2003

Keywords

5-fluorouracil/folinic acid
Colorectal cancer
First-line
Irinotecan

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1093/annonc/mdg288

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Bouzid, K., Khalfallah, S., Tujakowski, J., Piko, B., Purkalne, G., Plate, S., Padrik, P., Serafy, M., Pshevloutsky, E. M., Boussard, B., Bapsy, P. P., Ahmed, S. B., Salek, T., Doneo, S., Gerges, D. A., Doval, D. C., Buyukunal, E., Chernozemsky, I. N., Tzekova, V. I., ... Chachine, G. (2003). A randomized phase II trial of irinotecan in combination with infusional or two different bolus 5-fluorouracil and folinic and regimens as first-line therapy for advanced colorectal cancer. Annals of Oncology, 14(7), 1106-1114. https://doi.org/10.1093/annonc/mdg288

@article{ed5c26a22222447292767eca51aa8803,

title = "A randomized phase II trial of irinotecan in combination with infusional or two different bolus 5-fluorouracil and folinic and regimens as first-line therapy for advanced colorectal cancer",

abstract = "Background: Three different therapeutic regimens of irinotecan (CPT-11) in combination with 5-fluorouracil (5-FU) and folinic acid (FA) were evaluated for efficacy and safety in the first-line therapy of advanced colorectal cancer. Patients and methods: Patients were randomly assigned to receive intravenously either: CPT-11 125 mg/m2, FA 20 mg/m2 followed by 5-FU 500 mg/m2 bolus, weekly for 4 weeks (arm A, Saltz regimen); or CPT-11 180 mg/m2 day 1 then FA 200 mg/m2 over 2 h and 5-FU 400 mg/m2 bolus and 5-FU 600 mg/m2 22-h infusion on days 1 and 2, every 2 weeks (arm B, Douillard regimen); or CPT-11 350 mg/m2 (days 1 and 43) alternating with FA 20 mg/m2/day followed by 5-FU bolus 425 mg/m2/day during 5 days (days 22-26) (arm C, Mayo Clinic regimen). Results: A total of 154 patients were included in the study (arm A, 51 patients; arm B, 53; arm C, 50). Overall response rates for the intention-to-treat populations were 33% [95% confidence interval (CI) 21% to 48%], 42% (95% CI 28% to 56%) and 30% (95% CI 18% to 45%) for arms A, B and C, respectively. Median times to progression were 6, 8 and 7 months for arms A, B and C, respectively. Median survival times were 15, 12 and 17 months for arms A, B and C, respectively. Overall response rates for the evaluable patient populations were 40% (95% CI 24% to 58%) in arm A, 44% (95% CI 29% to 60%) in arm B and 31% (95% CI 17% to 47%) in arm C. Neutropenia was the main serious adverse event in arms A (30% of patients) and C (22% of patients) but occurred in only 8% of patients in arm B. Delayed diarrhea was the main severe adverse event for the three regimens, from 15% to 22%. Conclusion: All three regimens were highly active. The biweekly combination of CPT-11 and 5-FU/FA (arm B) was notable for its low incidence of grade 3/4 neutropenia. The incidence of grade 3/4 delayed diarrhea was equivalent for the three treatment arms.",

keywords = "5-fluorouracil/folinic acid, Colorectal cancer, First-line, Irinotecan",

author = "Kamel Bouzid and S. Khalfallah and J. Tujakowski and B. Piko and G. Purkalne and S. Plate and P. Padrik and M. Serafy and Pshevloutsky, {E. M.} and B. Boussard and Bapsy, {P. P.} and Ahmed, {S. Ben} and T. Salek and S. Doneo and Gerges, {D. A.} and Doval, {D. C.} and E. Buyukunal and Chernozemsky, {I. N.} and Tzekova, {V. I.} and El-Azim, {H. A.} and H. Errihani and R. Samlali and Godz, {J. S.} and N. Ghilezan and Berdov, {B. A.} and Tchaikovsky, {G. N.} and M. Wagnerova and Aykan, {N. F.} and J. Zidan and G. Chachine",

year = "2003",

month = jul,

day = "1",

doi = "10.1093/annonc/mdg288",

language = "אנגלית",

volume = "14",

pages = "1106--1114",

journal = "Annals of Oncology",

issn = "0923-7534",

publisher = "Elsevier Ltd.",

number = "7",

}

Bouzid, K, Khalfallah, S, Tujakowski, J, Piko, B, Purkalne, G, Plate, S, Padrik, P, Serafy, M, Pshevloutsky, EM, Boussard, B, Bapsy, PP, Ahmed, SB, Salek, T, Doneo, S, Gerges, DA, Doval, DC, Buyukunal, E, Chernozemsky, IN, Tzekova, VI, El-Azim, HA, Errihani, H, Samlali, R, Godz, JS, Ghilezan, N, Berdov, BA, Tchaikovsky, GN, Wagnerova, M, Aykan, NF, Zidan, J & Chachine, G 2003, 'A randomized phase II trial of irinotecan in combination with infusional or two different bolus 5-fluorouracil and folinic and regimens as first-line therapy for advanced colorectal cancer', Annals of Oncology, vol. 14, no. 7, pp. 1106-1114. https://doi.org/10.1093/annonc/mdg288

A randomized phase II trial of irinotecan in combination with infusional or two different bolus 5-fluorouracil and folinic and regimens as first-line therapy for advanced colorectal cancer. / Bouzid, Kamel; Khalfallah, S.; Tujakowski, J. et al.
In: Annals of Oncology, Vol. 14, No. 7, 01.07.2003, p. 1106-1114.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - A randomized phase II trial of irinotecan in combination with infusional or two different bolus 5-fluorouracil and folinic and regimens as first-line therapy for advanced colorectal cancer

AU - Bouzid, Kamel

AU - Khalfallah, S.

AU - Tujakowski, J.

AU - Piko, B.

AU - Purkalne, G.

AU - Plate, S.

AU - Padrik, P.

AU - Serafy, M.

AU - Pshevloutsky, E. M.

AU - Boussard, B.

AU - Bapsy, P. P.

AU - Ahmed, S. Ben

AU - Salek, T.

AU - Doneo, S.

AU - Gerges, D. A.

AU - Doval, D. C.

AU - Buyukunal, E.

AU - Chernozemsky, I. N.

AU - Tzekova, V. I.

AU - El-Azim, H. A.

AU - Errihani, H.

AU - Samlali, R.

AU - Godz, J. S.

AU - Ghilezan, N.

AU - Berdov, B. A.

AU - Tchaikovsky, G. N.

AU - Wagnerova, M.

AU - Aykan, N. F.

AU - Zidan, J.

AU - Chachine, G.

PY - 2003/7/1

Y1 - 2003/7/1

N2 - Background: Three different therapeutic regimens of irinotecan (CPT-11) in combination with 5-fluorouracil (5-FU) and folinic acid (FA) were evaluated for efficacy and safety in the first-line therapy of advanced colorectal cancer. Patients and methods: Patients were randomly assigned to receive intravenously either: CPT-11 125 mg/m2, FA 20 mg/m2 followed by 5-FU 500 mg/m2 bolus, weekly for 4 weeks (arm A, Saltz regimen); or CPT-11 180 mg/m2 day 1 then FA 200 mg/m2 over 2 h and 5-FU 400 mg/m2 bolus and 5-FU 600 mg/m2 22-h infusion on days 1 and 2, every 2 weeks (arm B, Douillard regimen); or CPT-11 350 mg/m2 (days 1 and 43) alternating with FA 20 mg/m2/day followed by 5-FU bolus 425 mg/m2/day during 5 days (days 22-26) (arm C, Mayo Clinic regimen). Results: A total of 154 patients were included in the study (arm A, 51 patients; arm B, 53; arm C, 50). Overall response rates for the intention-to-treat populations were 33% [95% confidence interval (CI) 21% to 48%], 42% (95% CI 28% to 56%) and 30% (95% CI 18% to 45%) for arms A, B and C, respectively. Median times to progression were 6, 8 and 7 months for arms A, B and C, respectively. Median survival times were 15, 12 and 17 months for arms A, B and C, respectively. Overall response rates for the evaluable patient populations were 40% (95% CI 24% to 58%) in arm A, 44% (95% CI 29% to 60%) in arm B and 31% (95% CI 17% to 47%) in arm C. Neutropenia was the main serious adverse event in arms A (30% of patients) and C (22% of patients) but occurred in only 8% of patients in arm B. Delayed diarrhea was the main severe adverse event for the three regimens, from 15% to 22%. Conclusion: All three regimens were highly active. The biweekly combination of CPT-11 and 5-FU/FA (arm B) was notable for its low incidence of grade 3/4 neutropenia. The incidence of grade 3/4 delayed diarrhea was equivalent for the three treatment arms.

AB - Background: Three different therapeutic regimens of irinotecan (CPT-11) in combination with 5-fluorouracil (5-FU) and folinic acid (FA) were evaluated for efficacy and safety in the first-line therapy of advanced colorectal cancer. Patients and methods: Patients were randomly assigned to receive intravenously either: CPT-11 125 mg/m2, FA 20 mg/m2 followed by 5-FU 500 mg/m2 bolus, weekly for 4 weeks (arm A, Saltz regimen); or CPT-11 180 mg/m2 day 1 then FA 200 mg/m2 over 2 h and 5-FU 400 mg/m2 bolus and 5-FU 600 mg/m2 22-h infusion on days 1 and 2, every 2 weeks (arm B, Douillard regimen); or CPT-11 350 mg/m2 (days 1 and 43) alternating with FA 20 mg/m2/day followed by 5-FU bolus 425 mg/m2/day during 5 days (days 22-26) (arm C, Mayo Clinic regimen). Results: A total of 154 patients were included in the study (arm A, 51 patients; arm B, 53; arm C, 50). Overall response rates for the intention-to-treat populations were 33% [95% confidence interval (CI) 21% to 48%], 42% (95% CI 28% to 56%) and 30% (95% CI 18% to 45%) for arms A, B and C, respectively. Median times to progression were 6, 8 and 7 months for arms A, B and C, respectively. Median survival times were 15, 12 and 17 months for arms A, B and C, respectively. Overall response rates for the evaluable patient populations were 40% (95% CI 24% to 58%) in arm A, 44% (95% CI 29% to 60%) in arm B and 31% (95% CI 17% to 47%) in arm C. Neutropenia was the main serious adverse event in arms A (30% of patients) and C (22% of patients) but occurred in only 8% of patients in arm B. Delayed diarrhea was the main severe adverse event for the three regimens, from 15% to 22%. Conclusion: All three regimens were highly active. The biweekly combination of CPT-11 and 5-FU/FA (arm B) was notable for its low incidence of grade 3/4 neutropenia. The incidence of grade 3/4 delayed diarrhea was equivalent for the three treatment arms.

KW - 5-fluorouracil/folinic acid

KW - Colorectal cancer

KW - First-line

KW - Irinotecan

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DO - 10.1093/annonc/mdg288

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AN - SCOPUS:0043202994

SN - 0923-7534

VL - 14

SP - 1106

EP - 1114

JO - Annals of Oncology

JF - Annals of Oncology

IS - 7

ER -

A randomized phase II trial of irinotecan in combination with infusional or two different bolus 5-fluorouracil and folinic and regimens as first-line therapy for advanced colorectal cancer

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Keywords

UN SDGs

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