Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer: A Multicenter Study of the Gruppo Oncologico Dell'Italia Meridionale

Giuseppe Colucci, Vittorio Gebbia, Giancarlo Paoletti, Francesco Giuliani, Michele Caruso, Nicola Gebbia, Giacomo Cartenì, Biagio Agostara, Giuseppe Pezzella, Luigi Manzione, Nicola Borsellino, Andrea Misino, Sante Romito, Ernesto Durini, Stefano Cordio, Marisa Di Seri, Massimo Lopez, Evaristo Maiello

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Abstract

Purpose: We performed this phase III study to compare the irinotecan, leucovorin (LV), and fluorouracil (FU) regimen (FOLFIRI) versus the oxaliplatin, LV, and FU regimen (FOLFOX4) in previously untreated patients with advanced colorectal cancer. Patients and Methods: A total of 360 chemotherapy-naive patients were randomly assigned to receive, every 2 weeks, either arm A (FOLFIRI: irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2 [LV5FU2]) or arm B (FOLFOX4: oxaliplatin 85 mg/m2 on day 1 with LV5FU2 regimen). Results: One hundred sixty-four and 172 patients were assessable in arm A and B, respectively. Overall response rates (ORR) were 31% in arm A (95% CI, 24.6% to 38.3%) and 34% in arm B (95% CI, 27.2% to 41.5%; P = .60). In both arms A and B, median time to progression (TTP; 7 v 7 months, respectively), duration of response (9 v 10 months, respectively), and overall survival (OS; 14 v 15 months, respectively) were similar, without any statistically significant difference. Toxicity was mild in both groups: alopecia and gastrointestinal disturbances were the most common toxicities in arm A; thrombocytopenia and neurosensorial were the most common toxicities in arm B. Grade 3 to 4 toxicities were uncommon in both arms, and no statistical significant difference was observed. Conclusion: There is no difference in ORR, TTP, and OS for patients treated with the FOLFIRI or FOLFOX4 regimen. Both therapies seemed effective as first-line treatment in these patients. The difference between these two combination therapies is mainly in the toxicity profile.

Original languageEnglish
Pages (from-to)4866-4875
Number of pages10
JournalJournal of Clinical Oncology
Volume23
Issue number22
DOIs
Publication statusPublished - 2005

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Multicenter Studies
Colorectal Neoplasms
oxaliplatin
irinotecan
Fluorouracil
Leucovorin
Therapeutics
Alopecia
Intravenous Injections
Thrombocytopenia
Drug Therapy
Injections
Survival
thymidine 5'-triphosphate

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer : A Multicenter Study of the Gruppo Oncologico Dell'Italia Meridionale. / Colucci, Giuseppe; Gebbia, Vittorio; Paoletti, Giancarlo; Giuliani, Francesco; Caruso, Michele; Gebbia, Nicola; Cartenì, Giacomo; Agostara, Biagio; Pezzella, Giuseppe; Manzione, Luigi; Borsellino, Nicola; Misino, Andrea; Romito, Sante; Durini, Ernesto; Cordio, Stefano; Di Seri, Marisa; Lopez, Massimo; Maiello, Evaristo.

In: Journal of Clinical Oncology, Vol. 23, No. 22, 2005, p. 4866-4875.

Research output: Contribution to journalArticle

Colucci, G, Gebbia, V, Paoletti, G, Giuliani, F, Caruso, M, Gebbia, N, Cartenì, G, Agostara, B, Pezzella, G, Manzione, L, Borsellino, N, Misino, A, Romito, S, Durini, E, Cordio, S, Di Seri, M, Lopez, M & Maiello, E 2005, 'Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer: A Multicenter Study of the Gruppo Oncologico Dell'Italia Meridionale', Journal of Clinical Oncology, vol. 23, no. 22, pp. 4866-4875. https://doi.org/10.1200/JCO.2005.07.113
Colucci, Giuseppe ; Gebbia, Vittorio ; Paoletti, Giancarlo ; Giuliani, Francesco ; Caruso, Michele ; Gebbia, Nicola ; Cartenì, Giacomo ; Agostara, Biagio ; Pezzella, Giuseppe ; Manzione, Luigi ; Borsellino, Nicola ; Misino, Andrea ; Romito, Sante ; Durini, Ernesto ; Cordio, Stefano ; Di Seri, Marisa ; Lopez, Massimo ; Maiello, Evaristo. / Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer : A Multicenter Study of the Gruppo Oncologico Dell'Italia Meridionale. In: Journal of Clinical Oncology. 2005 ; Vol. 23, No. 22. pp. 4866-4875.
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abstract = "Purpose: We performed this phase III study to compare the irinotecan, leucovorin (LV), and fluorouracil (FU) regimen (FOLFIRI) versus the oxaliplatin, LV, and FU regimen (FOLFOX4) in previously untreated patients with advanced colorectal cancer. Patients and Methods: A total of 360 chemotherapy-naive patients were randomly assigned to receive, every 2 weeks, either arm A (FOLFIRI: irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2 [LV5FU2]) or arm B (FOLFOX4: oxaliplatin 85 mg/m2 on day 1 with LV5FU2 regimen). Results: One hundred sixty-four and 172 patients were assessable in arm A and B, respectively. Overall response rates (ORR) were 31{\%} in arm A (95{\%} CI, 24.6{\%} to 38.3{\%}) and 34{\%} in arm B (95{\%} CI, 27.2{\%} to 41.5{\%}; P = .60). In both arms A and B, median time to progression (TTP; 7 v 7 months, respectively), duration of response (9 v 10 months, respectively), and overall survival (OS; 14 v 15 months, respectively) were similar, without any statistically significant difference. Toxicity was mild in both groups: alopecia and gastrointestinal disturbances were the most common toxicities in arm A; thrombocytopenia and neurosensorial were the most common toxicities in arm B. Grade 3 to 4 toxicities were uncommon in both arms, and no statistical significant difference was observed. Conclusion: There is no difference in ORR, TTP, and OS for patients treated with the FOLFIRI or FOLFOX4 regimen. Both therapies seemed effective as first-line treatment in these patients. The difference between these two combination therapies is mainly in the toxicity profile.",
author = "Giuseppe Colucci and Vittorio Gebbia and Giancarlo Paoletti and Francesco Giuliani and Michele Caruso and Nicola Gebbia and Giacomo Carten{\`i} and Biagio Agostara and Giuseppe Pezzella and Luigi Manzione and Nicola Borsellino and Andrea Misino and Sante Romito and Ernesto Durini and Stefano Cordio and {Di Seri}, Marisa and Massimo Lopez and Evaristo Maiello",
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T1 - Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer

T2 - A Multicenter Study of the Gruppo Oncologico Dell'Italia Meridionale

AU - Colucci, Giuseppe

AU - Gebbia, Vittorio

AU - Paoletti, Giancarlo

AU - Giuliani, Francesco

AU - Caruso, Michele

AU - Gebbia, Nicola

AU - Cartenì, Giacomo

AU - Agostara, Biagio

AU - Pezzella, Giuseppe

AU - Manzione, Luigi

AU - Borsellino, Nicola

AU - Misino, Andrea

AU - Romito, Sante

AU - Durini, Ernesto

AU - Cordio, Stefano

AU - Di Seri, Marisa

AU - Lopez, Massimo

AU - Maiello, Evaristo

PY - 2005

Y1 - 2005

N2 - Purpose: We performed this phase III study to compare the irinotecan, leucovorin (LV), and fluorouracil (FU) regimen (FOLFIRI) versus the oxaliplatin, LV, and FU regimen (FOLFOX4) in previously untreated patients with advanced colorectal cancer. Patients and Methods: A total of 360 chemotherapy-naive patients were randomly assigned to receive, every 2 weeks, either arm A (FOLFIRI: irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2 [LV5FU2]) or arm B (FOLFOX4: oxaliplatin 85 mg/m2 on day 1 with LV5FU2 regimen). Results: One hundred sixty-four and 172 patients were assessable in arm A and B, respectively. Overall response rates (ORR) were 31% in arm A (95% CI, 24.6% to 38.3%) and 34% in arm B (95% CI, 27.2% to 41.5%; P = .60). In both arms A and B, median time to progression (TTP; 7 v 7 months, respectively), duration of response (9 v 10 months, respectively), and overall survival (OS; 14 v 15 months, respectively) were similar, without any statistically significant difference. Toxicity was mild in both groups: alopecia and gastrointestinal disturbances were the most common toxicities in arm A; thrombocytopenia and neurosensorial were the most common toxicities in arm B. Grade 3 to 4 toxicities were uncommon in both arms, and no statistical significant difference was observed. Conclusion: There is no difference in ORR, TTP, and OS for patients treated with the FOLFIRI or FOLFOX4 regimen. Both therapies seemed effective as first-line treatment in these patients. The difference between these two combination therapies is mainly in the toxicity profile.

AB - Purpose: We performed this phase III study to compare the irinotecan, leucovorin (LV), and fluorouracil (FU) regimen (FOLFIRI) versus the oxaliplatin, LV, and FU regimen (FOLFOX4) in previously untreated patients with advanced colorectal cancer. Patients and Methods: A total of 360 chemotherapy-naive patients were randomly assigned to receive, every 2 weeks, either arm A (FOLFIRI: irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2 [LV5FU2]) or arm B (FOLFOX4: oxaliplatin 85 mg/m2 on day 1 with LV5FU2 regimen). Results: One hundred sixty-four and 172 patients were assessable in arm A and B, respectively. Overall response rates (ORR) were 31% in arm A (95% CI, 24.6% to 38.3%) and 34% in arm B (95% CI, 27.2% to 41.5%; P = .60). In both arms A and B, median time to progression (TTP; 7 v 7 months, respectively), duration of response (9 v 10 months, respectively), and overall survival (OS; 14 v 15 months, respectively) were similar, without any statistically significant difference. Toxicity was mild in both groups: alopecia and gastrointestinal disturbances were the most common toxicities in arm A; thrombocytopenia and neurosensorial were the most common toxicities in arm B. Grade 3 to 4 toxicities were uncommon in both arms, and no statistical significant difference was observed. Conclusion: There is no difference in ORR, TTP, and OS for patients treated with the FOLFIRI or FOLFOX4 regimen. Both therapies seemed effective as first-line treatment in these patients. The difference between these two combination therapies is mainly in the toxicity profile.

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