Addition of either irinotecan or methotrexate to bolus 5-fluorouracil and high-dose folinic acid every 2 weeks in advanced colorectal carcinoma: A randomised study by the Southern Italy Cooperative Oncology Group

P. Comella; E. Crucitta; F. De Vita; L. De Lucia; A. Farris; F. Del Gaizo; S. Palmeri; A. Iannelli; S. Mancarella; S. Tafuto; L. Maiorino; F. Buzzi; G. De Cataldis; R. Casaretti; A. Avallone; M. Montella; G. Comella; M. Orditura; G. Catalano; V. Lorusso; M. De Lena; M. Biglietto; G. Sanna; M. G. Sarobba; C. Belli; A. Russo; V. Pizzardi; V. Accurso; A. Musca; A. Gravina; G. Leopaldi; C. Brunetti; D. Muci; S. Leo; F. Avino; L. De Luca; E. Greco; C. Aiello

doi:10.1093/annonc/mdf133

Addition of either irinotecan or methotrexate to bolus 5-fluorouracil and high-dose folinic acid every 2 weeks in advanced colorectal carcinoma: A randomised study by the Southern Italy Cooperative Oncology Group

P. Comella, E. Crucitta, F. De Vita, L. De Lucia, A. Farris, F. Del Gaizo, S. Palmeri, A. Iannelli, S. Mancarella, S. Tafuto, L. Maiorino, F. Buzzi, G. De Cataldis, R. Casaretti, A. Avallone, M. Montella, G. Comella, M. Orditura, G. Catalano, V. LorussoM. De Lena, M. Biglietto, G. Sanna, M. G. Sarobba, C. Belli, A. Russo, V. Pizzardi, V. Accurso, A. Musca, A. Gravina, G. Leopaldi, C. Brunetti, D. Muci, S. Leo, F. Avino, L. De Luca, E. Greco, C. Aiello

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

Abstract

Purpose: The purpose of this study was to compare the activity and toxicity of the combination of irinotecan (IRI) plus folinic acid (FA)-modulated 5-fluorouracil (5-FU) i.v. bolus with a regimen of double modulation of 5-FU with methotrexate (MTX) and FA in patients with advanced colorectal carcinoma. Patients and methods: Two-hundred and thirty-four patients were enrolled: 118 patients received IRI 200 mg/m² (90-min i.v. infusion) on day 1, followed by levo-FA 250 mg/m² (2-hi.v. infusion) and 5-FU 850 mg/m² (i.v. bolus) on day 2 (IRIFAFU), and 116 patients received MTX 750 mg/m² (2-h i.v. infusion) on day 1, followed by levo-FA 250 mg/m² (2-h i.v. infusion) and FU 800 mg/m² (i.v. bolus) on day 2 (MTXFAFU). Both cycles were repeated every 2 weeks until progression or to a maximum of 16 cycles. Response rate (RR) was the main end point of the study; responses were assessed every four cycles and confirmed after 2 additional months of treatment. Results: RR was significantly greater with IRIFAFU (36%) than with MTXFAFU (20%) (P

Original language	English
Pages (from-to)	866-873
Number of pages	8
Journal	Annals of Oncology
Volume	13
Issue number	6
DOIs	https://doi.org/10.1093/annonc/mdf133
Publication status	Published - 2002

Keywords

Advanced colorectal carcinoma
Combination regimen
Irinotecan plus modulated 5-fluorouracil
Randomised trial

ASJC Scopus subject areas

Oncology
Cancer Research

Access to Document

10.1093/annonc/mdf133

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Comella, P., Crucitta, E., De Vita, F., De Lucia, L., Farris, A., Del Gaizo, F., Palmeri, S., Iannelli, A., Mancarella, S., Tafuto, S., Maiorino, L., Buzzi, F., De Cataldis, G., Casaretti, R., Avallone, A., Montella, M., Comella, G., Orditura, M., Catalano, G., ... Aiello, C. (2002). Addition of either irinotecan or methotrexate to bolus 5-fluorouracil and high-dose folinic acid every 2 weeks in advanced colorectal carcinoma: A randomised study by the Southern Italy Cooperative Oncology Group. Annals of Oncology, 13(6), 866-873. https://doi.org/10.1093/annonc/mdf133

Addition of either irinotecan or methotrexate to bolus 5-fluorouracil and high-dose folinic acid every 2 weeks in advanced colorectal carcinoma : A randomised study by the Southern Italy Cooperative Oncology Group. / Comella, P.; Crucitta, E.; De Vita, F.; De Lucia, L.; Farris, A.; Del Gaizo, F.; Palmeri, S.; Iannelli, A.; Mancarella, S.; Tafuto, S.; Maiorino, L.; Buzzi, F.; De Cataldis, G.; Casaretti, R.; Avallone, A.; Montella, M.; Comella, G.; Orditura, M.; Catalano, G.; Lorusso, V.; De Lena, M.; Biglietto, M.; Sanna, G.; Sarobba, M. G.; Belli, C.; Russo, A.; Pizzardi, V.; Accurso, V.; Musca, A.; Gravina, A.; Leopaldi, G.; Brunetti, C.; Muci, D.; Leo, S.; Avino, F.; De Luca, L.; Greco, E.; Aiello, C.

In: Annals of Oncology, Vol. 13, No. 6, 2002, p. 866-873.

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

Comella, P, Crucitta, E, De Vita, F, De Lucia, L, Farris, A, Del Gaizo, F, Palmeri, S, Iannelli, A, Mancarella, S, Tafuto, S, Maiorino, L, Buzzi, F, De Cataldis, G, Casaretti, R , Avallone, A , Montella, M, Comella, G, Orditura, M, Catalano, G, Lorusso, V, De Lena, M, Biglietto, M, Sanna, G, Sarobba, MG, Belli, C, Russo, A, Pizzardi, V, Accurso, V, Musca, A, Gravina, A, Leopaldi, G, Brunetti, C, Muci, D, Leo, S, Avino, F, De Luca, L, Greco, E & Aiello, C 2002, 'Addition of either irinotecan or methotrexate to bolus 5-fluorouracil and high-dose folinic acid every 2 weeks in advanced colorectal carcinoma: A randomised study by the Southern Italy Cooperative Oncology Group', Annals of Oncology, vol. 13, no. 6, pp. 866-873. https://doi.org/10.1093/annonc/mdf133

Comella, P. ; Crucitta, E. ; De Vita, F. ; De Lucia, L. ; Farris, A. ; Del Gaizo, F. ; Palmeri, S. ; Iannelli, A. ; Mancarella, S. ; Tafuto, S. ; Maiorino, L. ; Buzzi, F. ; De Cataldis, G. ; Casaretti, R. ; Avallone, A. ; Montella, M. ; Comella, G. ; Orditura, M. ; Catalano, G. ; Lorusso, V. ; De Lena, M. ; Biglietto, M. ; Sanna, G. ; Sarobba, M. G. ; Belli, C. ; Russo, A. ; Pizzardi, V. ; Accurso, V. ; Musca, A. ; Gravina, A. ; Leopaldi, G. ; Brunetti, C. ; Muci, D. ; Leo, S. ; Avino, F. ; De Luca, L. ; Greco, E. ; Aiello, C. / Addition of either irinotecan or methotrexate to bolus 5-fluorouracil and high-dose folinic acid every 2 weeks in advanced colorectal carcinoma : A randomised study by the Southern Italy Cooperative Oncology Group. In: Annals of Oncology. 2002 ; Vol. 13, No. 6. pp. 866-873.

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abstract = "Purpose: The purpose of this study was to compare the activity and toxicity of the combination of irinotecan (IRI) plus folinic acid (FA)-modulated 5-fluorouracil (5-FU) i.v. bolus with a regimen of double modulation of 5-FU with methotrexate (MTX) and FA in patients with advanced colorectal carcinoma. Patients and methods: Two-hundred and thirty-four patients were enrolled: 118 patients received IRI 200 mg/m2 (90-min i.v. infusion) on day 1, followed by levo-FA 250 mg/m2 (2-hi.v. infusion) and 5-FU 850 mg/m2 (i.v. bolus) on day 2 (IRIFAFU), and 116 patients received MTX 750 mg/m2 (2-h i.v. infusion) on day 1, followed by levo-FA 250 mg/m2 (2-h i.v. infusion) and FU 800 mg/m2 (i.v. bolus) on day 2 (MTXFAFU). Both cycles were repeated every 2 weeks until progression or to a maximum of 16 cycles. Response rate (RR) was the main end point of the study; responses were assessed every four cycles and confirmed after 2 additional months of treatment. Results: RR was significantly greater with IRIFAFU (36%) than with MTXFAFU (20%) (P ",

keywords = "Advanced colorectal carcinoma, Combination regimen, Irinotecan plus modulated 5-fluorouracil, Randomised trial",

author = "P. Comella and E. Crucitta and {De Vita}, F. and {De Lucia}, L. and A. Farris and {Del Gaizo}, F. and S. Palmeri and A. Iannelli and S. Mancarella and S. Tafuto and L. Maiorino and F. Buzzi and {De Cataldis}, G. and R. Casaretti and A. Avallone and M. Montella and G. Comella and M. Orditura and G. Catalano and V. Lorusso and {De Lena}, M. and M. Biglietto and G. Sanna and Sarobba, {M. G.} and C. Belli and A. Russo and V. Pizzardi and V. Accurso and A. Musca and A. Gravina and G. Leopaldi and C. Brunetti and D. Muci and S. Leo and F. Avino and {De Luca}, L. and E. Greco and C. Aiello",

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T1 - Addition of either irinotecan or methotrexate to bolus 5-fluorouracil and high-dose folinic acid every 2 weeks in advanced colorectal carcinoma

T2 - A randomised study by the Southern Italy Cooperative Oncology Group

AU - Comella, P.

AU - Crucitta, E.

AU - De Vita, F.

AU - De Lucia, L.

AU - Farris, A.

AU - Del Gaizo, F.

AU - Palmeri, S.

AU - Iannelli, A.

AU - Mancarella, S.

AU - Tafuto, S.

AU - Maiorino, L.

AU - Buzzi, F.

AU - De Cataldis, G.

AU - Casaretti, R.

AU - Avallone, A.

AU - Montella, M.

AU - Comella, G.

AU - Orditura, M.

AU - Catalano, G.

AU - Lorusso, V.

AU - De Lena, M.

AU - Biglietto, M.

AU - Sanna, G.

AU - Sarobba, M. G.

AU - Belli, C.

AU - Russo, A.

AU - Pizzardi, V.

AU - Accurso, V.

AU - Musca, A.

AU - Gravina, A.

AU - Leopaldi, G.

AU - Brunetti, C.

AU - Muci, D.

AU - Leo, S.

AU - Avino, F.

AU - De Luca, L.

AU - Greco, E.

AU - Aiello, C.

PY - 2002

Y1 - 2002

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KW - Advanced colorectal carcinoma

KW - Combination regimen

KW - Irinotecan plus modulated 5-fluorouracil

KW - Randomised trial

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