The aim of the study was to evaluate the efficacy and safety of cetuximab combined FOLFIRI as a first-line treatment for advanced gastric or GEJ cancer. Methods: Eligibility criteria were: histological diagnosis of stomach or GEJ adenocarcinoma, unresectable/metastatic disease, EGFR+, measurable disease, no CHT for advanced cancer. Pts received cetuximab weekly at 400 mg/m2 iv loading dose, then at 250 mg/m2 iv maintenance dose, CPT11 180 mg/m2 iv d1, LFA 100 mg/m2 iv followed by 5FU 400 mg/m2 iv bolus and 600 mg/m2 iv CI 22h d1-2 every 2 wks, for maximum of 24 wks; therapy with cetuximab alone was continued after 24 wks in CR/PR/SD. The activity was assessed by CT and PET at baseline and after 6 wks, and further by CT alone every 6 wks. Results: From november 2004 to september 2005 32/36 (88.8%) screened pts were EGFR+, and 25 were enrolled. Pt characteristics were: 17(68.0%) M, 8(32%) F; median age 65 years (39-78); median KPS 90 (70-100); 22(88%) stomach, 3(12%) GEJ; 14(56%) prior gastrectomy (total/subtotal); 10(40%) adjuvant CHT; 3(12%) locally advanced disease, 22(88%) metastatic disease. Median number of tretment wks was: 11(1-41). Median dose intensity was: 5FU 100% (25-100), CPT11 100%(25-100) and cetuximab 100% (90-100). At the presnt time, 19 pts are assessable for response (6 too early), and 22 for toxicity. The responses (RECIST) were: 3(16%) CR, 8(42%) PR, 58% CR+PR (95% CI:36-80%), 6(31.5%) SD, 2(10.5%) not evaluable. PFS at 3 months is 81.8% (95% CI:59-104%). Median TTP has not been reached. Gr 3-4 toxicity (CTC v3.0) was: 11(50%) neutropenia, 1(4.5%) thrombocytopenia, 2 (9%) hypertransaminasemia, 1(4.5%) hyperbilirubinemia. Cutaneous toxicity was: 5(22.7%) gr1, 10(45%) gr2, 1(4.5%) gr3. Two deaths occurred within 30 days (1 cardiac failure not treatment-realted; 1 febrile neutropenia). Conclusions: From the preliminary data, the combination of the cetuximab and FOLFIRI appears to be active in gastric and GEJ adenocarcinoma, with a high response and disease control rate. This treatment has been well-tolerated and the major toxicity appars to be limited neutropenia.
Pinto C, Di Fabio F, Siena S, Rojas Llimpe FL, Ceccarelli C, Mutri V, et al. (2006). Phase II study of cetuximab in combination with FOLFIRI as first-line treatment in patients with unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma (FOLCETUX study): preliminary results. SAN FRANCISCO : s.n.
Phase II study of cetuximab in combination with FOLFIRI as first-line treatment in patients with unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma (FOLCETUX study): preliminary results
CECCARELLI, CLAUDIO;
2006
Abstract
The aim of the study was to evaluate the efficacy and safety of cetuximab combined FOLFIRI as a first-line treatment for advanced gastric or GEJ cancer. Methods: Eligibility criteria were: histological diagnosis of stomach or GEJ adenocarcinoma, unresectable/metastatic disease, EGFR+, measurable disease, no CHT for advanced cancer. Pts received cetuximab weekly at 400 mg/m2 iv loading dose, then at 250 mg/m2 iv maintenance dose, CPT11 180 mg/m2 iv d1, LFA 100 mg/m2 iv followed by 5FU 400 mg/m2 iv bolus and 600 mg/m2 iv CI 22h d1-2 every 2 wks, for maximum of 24 wks; therapy with cetuximab alone was continued after 24 wks in CR/PR/SD. The activity was assessed by CT and PET at baseline and after 6 wks, and further by CT alone every 6 wks. Results: From november 2004 to september 2005 32/36 (88.8%) screened pts were EGFR+, and 25 were enrolled. Pt characteristics were: 17(68.0%) M, 8(32%) F; median age 65 years (39-78); median KPS 90 (70-100); 22(88%) stomach, 3(12%) GEJ; 14(56%) prior gastrectomy (total/subtotal); 10(40%) adjuvant CHT; 3(12%) locally advanced disease, 22(88%) metastatic disease. Median number of tretment wks was: 11(1-41). Median dose intensity was: 5FU 100% (25-100), CPT11 100%(25-100) and cetuximab 100% (90-100). At the presnt time, 19 pts are assessable for response (6 too early), and 22 for toxicity. The responses (RECIST) were: 3(16%) CR, 8(42%) PR, 58% CR+PR (95% CI:36-80%), 6(31.5%) SD, 2(10.5%) not evaluable. PFS at 3 months is 81.8% (95% CI:59-104%). Median TTP has not been reached. Gr 3-4 toxicity (CTC v3.0) was: 11(50%) neutropenia, 1(4.5%) thrombocytopenia, 2 (9%) hypertransaminasemia, 1(4.5%) hyperbilirubinemia. Cutaneous toxicity was: 5(22.7%) gr1, 10(45%) gr2, 1(4.5%) gr3. Two deaths occurred within 30 days (1 cardiac failure not treatment-realted; 1 febrile neutropenia). Conclusions: From the preliminary data, the combination of the cetuximab and FOLFIRI appears to be active in gastric and GEJ adenocarcinoma, with a high response and disease control rate. This treatment has been well-tolerated and the major toxicity appars to be limited neutropenia.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
