Background: Aim of this study was to evaluate efficacy and safety of cetuximab plus FOLFIRI as first-line treatment for advanced gastric or GEJ cancer. Methods: Eligibility criteria: histological diagnosis of stomach or GEJ adenocarcinoma, unresectable/metastatic/recurrent disease, EGFR+ (Dako), measurable disease, no prior chemotherapy for advanced cancer. Pts received cetuximab weekly at 400 mg/m2 iv loading dose, then at 250 mg/m2 iv, CPT11 180 mg/m2 iv d1, LFA 100 mg/m2 iv followed by 5FU 400 mg/m2 iv bolus and 600 mg/m2 iv continuous infusion 22h d1-2 (FOLFIRI) every 2 weeks, for a maximum of 24 weeks, then cetuximab alone was allowed in pts with CR/PR/SD. Objective response (OR) activity was assessed by CT and PET at baseline and after 6 weeks, and further by CT+/- PET every 6 weeks. Results: From november 2004 to december 2005, 49/54 (90.7%) screened subjects were EGFR+, and 38 pts were enrolled. Pt characteristics: 26 (68.4%) males, 12 (31.6%) females; median age 63.5 years (39-82); median KPS 90 (70-100); 34 (89.4%) stomach, 4 (10.5%) GEJ; 18 (47.3%) gastrectomy; 13 (34.2%) adjuvant chemotherapy; 4 (10.5%) locally advanced disease, 34 (89.4%) metastatic disease; main metastatic sites: 19 (50%) lymphnodes, 12 (31.5%) liver, 4 (10.5%) lung, 8 (21.0%) peritoneal. Median number of treatment weeks was: 10 (1-46). Median dose intensity was: 5FU 100% (25-100), CPT11 100% (25-100) and cetuximab 100% (80-100). At the present time, 25 pts are assessable for response and 28 for toxicity. The OR (RECIST) were: 3 (12%) CR, 11 (44%) PR, e.g. 56% CR+PR (95% CI: 37-75), 11 (44%) SD. The PFS at 3 months is 80% (95% CI: 64-96). Survival data are pramature (73.6% of the pts are alive; madian follow-up 3 months, range 1-12). Grade 3-4 toxicity (CTC v3.0) was: 15 (53.6%) neutropenia (1 pt died of febrile neutropenia), 1 (3.4%) hyperbilirubinemia. Cutaneous toxicity was: 7 (25%) gr1, 11 (39.2%) gr2, 5 (17.8%) gr3. Conclusions: combination of 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; the major toxicity is neutropenia.
Pinto C, Di Fabio F, Siena S, Cascinu S, Rojas Llimpe FL, Ceccarelli C, 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 (FOLFOX study): preliminary results.
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 (FOLFOX study): preliminary results
CECCARELLI, CLAUDIO;
2006
Abstract
Background: Aim of this study was to evaluate efficacy and safety of cetuximab plus FOLFIRI as first-line treatment for advanced gastric or GEJ cancer. Methods: Eligibility criteria: histological diagnosis of stomach or GEJ adenocarcinoma, unresectable/metastatic/recurrent disease, EGFR+ (Dako), measurable disease, no prior chemotherapy for advanced cancer. Pts received cetuximab weekly at 400 mg/m2 iv loading dose, then at 250 mg/m2 iv, CPT11 180 mg/m2 iv d1, LFA 100 mg/m2 iv followed by 5FU 400 mg/m2 iv bolus and 600 mg/m2 iv continuous infusion 22h d1-2 (FOLFIRI) every 2 weeks, for a maximum of 24 weeks, then cetuximab alone was allowed in pts with CR/PR/SD. Objective response (OR) activity was assessed by CT and PET at baseline and after 6 weeks, and further by CT+/- PET every 6 weeks. Results: From november 2004 to december 2005, 49/54 (90.7%) screened subjects were EGFR+, and 38 pts were enrolled. Pt characteristics: 26 (68.4%) males, 12 (31.6%) females; median age 63.5 years (39-82); median KPS 90 (70-100); 34 (89.4%) stomach, 4 (10.5%) GEJ; 18 (47.3%) gastrectomy; 13 (34.2%) adjuvant chemotherapy; 4 (10.5%) locally advanced disease, 34 (89.4%) metastatic disease; main metastatic sites: 19 (50%) lymphnodes, 12 (31.5%) liver, 4 (10.5%) lung, 8 (21.0%) peritoneal. Median number of treatment weeks was: 10 (1-46). Median dose intensity was: 5FU 100% (25-100), CPT11 100% (25-100) and cetuximab 100% (80-100). At the present time, 25 pts are assessable for response and 28 for toxicity. The OR (RECIST) were: 3 (12%) CR, 11 (44%) PR, e.g. 56% CR+PR (95% CI: 37-75), 11 (44%) SD. The PFS at 3 months is 80% (95% CI: 64-96). Survival data are pramature (73.6% of the pts are alive; madian follow-up 3 months, range 1-12). Grade 3-4 toxicity (CTC v3.0) was: 15 (53.6%) neutropenia (1 pt died of febrile neutropenia), 1 (3.4%) hyperbilirubinemia. Cutaneous toxicity was: 7 (25%) gr1, 11 (39.2%) gr2, 5 (17.8%) gr3. Conclusions: combination of 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; the major toxicity is neutropenia.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
