Phase II study of cetuximab in combination with FOLFIRI in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma (FOLCETUX study)

C. Pinto, F. Di Fabio, S. Siena, S. Cascinu, F. L. Rojas Llimpe, C. Ceccarelli, V. Mutri, L. Giannetta, S. Giaquinta, C. Funaioli, R. Berardi, C. Longobardi, E. Piana, A. A. Martoni

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Abstract

Background: The purpose of this phase II study was to evaluate the efficacy and safety of cetuximab combined with FOLFIRI as a first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Patients and methods: Untreated patients with confirmed advanced gastric or gastroesophageal adenocarcinoma received cetuximab at an initial dose of 400 mg/m2 intravenously (i.v.) followed by weekly doses of 250 mg/m2, CPT 11 180 mg/m2 i.v. on day 1, LFA 100 mg/m2 i.v. followed by 5-FU 400 mg/m2 i.v. bolus, and 600 mg/m2 i.v. 22-h continuous infusion on days 1 and 2 (FOLFIRI) every 2 weeks, for a maximum of 24 weeks, then cetuximab alone was allowed in patients with a complete response, partial response, or stable disease. Antitumor activity was assessed by computed tomography (CT) and positron emission tomography (PET) at baseline and after 6 weeks, and further by CT alone or CT and PET every 6 weeks. Results: Thirty-eight patients were enrolled (median age 63.5 years, range 39-83; median Karnofsky performance status 90, range 70-100; stomach 89.5% and GEJ 10.5%; locally advanced disease 13.2% and metastatic disease 86.8%). All 38 patients were assessed for safety and survival, and 34 patients were assessed for overall response rates (ORR). The ORR was 44.1% [95% confidence interval (CI) 27.5% to 60.9%]. The median time-to-progression was 8 months (95% CI 7-9). At the median follow-up time of 11 months, 55.3% of patients were alive, with a median expected survival time of 16 months (95% CI 9-23). Grade 3-4 toxicity included neutropenia (42.1%), acne-like rash (21.1%), diarrhea (7.9%), asthenia (5.3%), stomatitis (5.3%), and hypertransaminasemia (5.3%). There was one (2.6%) treatment-related death. Conclusions: The combination of cetuximab and FOLFIRI is active in gastric and GEJ adenocarcinoma. The higher toxicity appears to be limited to neutropenia.

Original languageEnglish
Pages (from-to)510-517
Number of pages8
JournalAnnals of Oncology
Volume18
Issue number3
DOIs
Publication statusPublished - Mar 2007

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Esophagogastric Junction
Stomach
Adenocarcinoma
irinotecan
Confidence Intervals
Neutropenia
Safety
Karnofsky Performance Status
Asthenia
Lymphocyte Function-Associated Antigen-1
Stomatitis
Survival
Acne Vulgaris
Cetuximab
Exanthema
Fluorouracil
Diarrhea
Tomography
Therapeutics

Keywords

  • Advanced gastric cancer
  • Cetuximab
  • FOLFIRI regimen

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Phase II study of cetuximab in combination with FOLFIRI in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma (FOLCETUX study). / Pinto, C.; Di Fabio, F.; Siena, S.; Cascinu, S.; Rojas Llimpe, F. L.; Ceccarelli, C.; Mutri, V.; Giannetta, L.; Giaquinta, S.; Funaioli, C.; Berardi, R.; Longobardi, C.; Piana, E.; Martoni, A. A.

In: Annals of Oncology, Vol. 18, No. 3, 03.2007, p. 510-517.

Research output: Contribution to journalArticle

Pinto, C, Di Fabio, F, Siena, S, Cascinu, S, Rojas Llimpe, FL, Ceccarelli, C, Mutri, V, Giannetta, L, Giaquinta, S, Funaioli, C, Berardi, R, Longobardi, C, Piana, E & Martoni, AA 2007, 'Phase II study of cetuximab in combination with FOLFIRI in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma (FOLCETUX study)', Annals of Oncology, vol. 18, no. 3, pp. 510-517. https://doi.org/10.1093/annonc/mdl459
Pinto, C. ; Di Fabio, F. ; Siena, S. ; Cascinu, S. ; Rojas Llimpe, F. L. ; Ceccarelli, C. ; Mutri, V. ; Giannetta, L. ; Giaquinta, S. ; Funaioli, C. ; Berardi, R. ; Longobardi, C. ; Piana, E. ; Martoni, A. A. / Phase II study of cetuximab in combination with FOLFIRI in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma (FOLCETUX study). In: Annals of Oncology. 2007 ; Vol. 18, No. 3. pp. 510-517.
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abstract = "Background: The purpose of this phase II study was to evaluate the efficacy and safety of cetuximab combined with FOLFIRI as a first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Patients and methods: Untreated patients with confirmed advanced gastric or gastroesophageal adenocarcinoma received cetuximab at an initial dose of 400 mg/m2 intravenously (i.v.) followed by weekly doses of 250 mg/m2, CPT 11 180 mg/m2 i.v. on day 1, LFA 100 mg/m2 i.v. followed by 5-FU 400 mg/m2 i.v. bolus, and 600 mg/m2 i.v. 22-h continuous infusion on days 1 and 2 (FOLFIRI) every 2 weeks, for a maximum of 24 weeks, then cetuximab alone was allowed in patients with a complete response, partial response, or stable disease. Antitumor activity was assessed by computed tomography (CT) and positron emission tomography (PET) at baseline and after 6 weeks, and further by CT alone or CT and PET every 6 weeks. Results: Thirty-eight patients were enrolled (median age 63.5 years, range 39-83; median Karnofsky performance status 90, range 70-100; stomach 89.5{\%} and GEJ 10.5{\%}; locally advanced disease 13.2{\%} and metastatic disease 86.8{\%}). All 38 patients were assessed for safety and survival, and 34 patients were assessed for overall response rates (ORR). The ORR was 44.1{\%} [95{\%} confidence interval (CI) 27.5{\%} to 60.9{\%}]. The median time-to-progression was 8 months (95{\%} CI 7-9). At the median follow-up time of 11 months, 55.3{\%} of patients were alive, with a median expected survival time of 16 months (95{\%} CI 9-23). Grade 3-4 toxicity included neutropenia (42.1{\%}), acne-like rash (21.1{\%}), diarrhea (7.9{\%}), asthenia (5.3{\%}), stomatitis (5.3{\%}), and hypertransaminasemia (5.3{\%}). There was one (2.6{\%}) treatment-related death. Conclusions: The combination of cetuximab and FOLFIRI is active in gastric and GEJ adenocarcinoma. The higher toxicity appears to be limited to neutropenia.",
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T1 - Phase II study of cetuximab in combination with FOLFIRI in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma (FOLCETUX study)

AU - Pinto, C.

AU - Di Fabio, F.

AU - Siena, S.

AU - Cascinu, S.

AU - Rojas Llimpe, F. L.

AU - Ceccarelli, C.

AU - Mutri, V.

AU - Giannetta, L.

AU - Giaquinta, S.

AU - Funaioli, C.

AU - Berardi, R.

AU - Longobardi, C.

AU - Piana, E.

AU - Martoni, A. A.

PY - 2007/3

Y1 - 2007/3

N2 - Background: The purpose of this phase II study was to evaluate the efficacy and safety of cetuximab combined with FOLFIRI as a first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Patients and methods: Untreated patients with confirmed advanced gastric or gastroesophageal adenocarcinoma received cetuximab at an initial dose of 400 mg/m2 intravenously (i.v.) followed by weekly doses of 250 mg/m2, CPT 11 180 mg/m2 i.v. on day 1, LFA 100 mg/m2 i.v. followed by 5-FU 400 mg/m2 i.v. bolus, and 600 mg/m2 i.v. 22-h continuous infusion on days 1 and 2 (FOLFIRI) every 2 weeks, for a maximum of 24 weeks, then cetuximab alone was allowed in patients with a complete response, partial response, or stable disease. Antitumor activity was assessed by computed tomography (CT) and positron emission tomography (PET) at baseline and after 6 weeks, and further by CT alone or CT and PET every 6 weeks. Results: Thirty-eight patients were enrolled (median age 63.5 years, range 39-83; median Karnofsky performance status 90, range 70-100; stomach 89.5% and GEJ 10.5%; locally advanced disease 13.2% and metastatic disease 86.8%). All 38 patients were assessed for safety and survival, and 34 patients were assessed for overall response rates (ORR). The ORR was 44.1% [95% confidence interval (CI) 27.5% to 60.9%]. The median time-to-progression was 8 months (95% CI 7-9). At the median follow-up time of 11 months, 55.3% of patients were alive, with a median expected survival time of 16 months (95% CI 9-23). Grade 3-4 toxicity included neutropenia (42.1%), acne-like rash (21.1%), diarrhea (7.9%), asthenia (5.3%), stomatitis (5.3%), and hypertransaminasemia (5.3%). There was one (2.6%) treatment-related death. Conclusions: The combination of cetuximab and FOLFIRI is active in gastric and GEJ adenocarcinoma. The higher toxicity appears to be limited to neutropenia.

AB - Background: The purpose of this phase II study was to evaluate the efficacy and safety of cetuximab combined with FOLFIRI as a first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Patients and methods: Untreated patients with confirmed advanced gastric or gastroesophageal adenocarcinoma received cetuximab at an initial dose of 400 mg/m2 intravenously (i.v.) followed by weekly doses of 250 mg/m2, CPT 11 180 mg/m2 i.v. on day 1, LFA 100 mg/m2 i.v. followed by 5-FU 400 mg/m2 i.v. bolus, and 600 mg/m2 i.v. 22-h continuous infusion on days 1 and 2 (FOLFIRI) every 2 weeks, for a maximum of 24 weeks, then cetuximab alone was allowed in patients with a complete response, partial response, or stable disease. Antitumor activity was assessed by computed tomography (CT) and positron emission tomography (PET) at baseline and after 6 weeks, and further by CT alone or CT and PET every 6 weeks. Results: Thirty-eight patients were enrolled (median age 63.5 years, range 39-83; median Karnofsky performance status 90, range 70-100; stomach 89.5% and GEJ 10.5%; locally advanced disease 13.2% and metastatic disease 86.8%). All 38 patients were assessed for safety and survival, and 34 patients were assessed for overall response rates (ORR). The ORR was 44.1% [95% confidence interval (CI) 27.5% to 60.9%]. The median time-to-progression was 8 months (95% CI 7-9). At the median follow-up time of 11 months, 55.3% of patients were alive, with a median expected survival time of 16 months (95% CI 9-23). Grade 3-4 toxicity included neutropenia (42.1%), acne-like rash (21.1%), diarrhea (7.9%), asthenia (5.3%), stomatitis (5.3%), and hypertransaminasemia (5.3%). There was one (2.6%) treatment-related death. Conclusions: The combination of cetuximab and FOLFIRI is active in gastric and GEJ adenocarcinoma. The higher toxicity appears to be limited to neutropenia.

KW - Advanced gastric cancer

KW - Cetuximab

KW - FOLFIRI regimen

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DO - 10.1093/annonc/mdl459

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JO - Annals of Oncology

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