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 language | English |
|---|---|
| Pages (from-to) | 510-517 |
| Number of pages | 8 |
| Journal | Annals of Oncology |
| Volume | 18 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Mar 2007 |
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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 journal › Article
}
TY - JOUR
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
UR - http://www.scopus.com/inward/record.url?scp=33847663871&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33847663871&partnerID=8YFLogxK
U2 - 10.1093/annonc/mdl459
DO - 10.1093/annonc/mdl459
M3 - Article
C2 - 17164226
AN - SCOPUS:33847663871
VL - 18
SP - 510
EP - 517
JO - Annals of Oncology
JF - Annals of Oncology
SN - 0923-7534
IS - 3
ER -