Panitumumab in combination with modified docetaxel/ cisplatin/5-fluorouracil as first-line treatment in gastric and gastroesophageal junction adenocarcinomas: a multicenter phase II study by the Hellenic Oncology Research Group

摘要: Background A phase I/II study to define the maximum tolerated dose (MTD) of biweekly docetaxel/cisplatin/5-fluorouracil (DCF) plus panitumumab (P), its efficacy, and tolerability as first-line treatment in advanced gastroesophageal cancer. Methods In I part, patients with unresectable locally or metastatic adenocarcinomas stomach junction received cisplatin (40 mg/m2 on day 1), leucovorin (400 5-fluorouracil bolus (1000 mg/m2/daycontinuous infusion days 1-2), escalated doses docetaxel (on 1) P (6 mg/kg every 2 weeks. II were treated DCF/P at MTD primary endpoint was response rate. The expected rate set >40%. Results for mDCF/P defined 40 a total evaluable enrolled study. One (2.5%) complete 13 (32.5%) partial responses (overall rate: 35%), well 16 (40%) disease stabilizations documented. median progression-free survival 6.9 months (95% confidence interval [CI] 3.5-10.3) overall 11.3 (95%CI 7.7-14.8). Grade 3-4 neutropenia occurred 10 (25%) febrile (5%). Allergic reactions (grade 1-4) 9 (22.5%). There 1 treatment-related death. Conclusions combination feasible, though associated poor toxicity profile. However, failed meet terminated prematurely due futility.