Cetuximab in combination with cisplatin and docetaxel as first-line treatment in patients with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma (Italian phase II DOCETUX study)
Coimbra, Joao Carlos; Pinto, Iraja Damiani; Wurdig, Norma Luiza; Do Carmo, Dermeval Aparecido
Journal of Clinical Oncology 26(15_Suppl): 4575-4575
2016
ISSN/ISBN: 0732-183X PMID: 27948665 Accession: 057375504
NlmCategory="UNASSIGNED">4575 Background: The aim of this study was to evaluate the efficacy and safety of cetuximab in combination with cisplatin and docetaxel as first-line treatment for advanced gastric or GEJ cancer. Eligibility criteria were: histological diagnosis of stomach or GEJ adenocarcinoma, locally advanced/metastatic measurable disease, no prior chemotherapy for advanced/metastatic cancer. Pts received cetuximab weekly at 400 mg/m2 iv loading dose, and then at 250 mg/m2 iv maintenance dose, cisplatin 75 mg/m2 iv and docetaxel 75 mg/m2 iv d1 every 3 weeks, for maximum of 6 cycles; therapy with cetuximab alone was continued in pts with CR/PR/SD. Anti-tumor activity was assessed by CT-scan every 6 weeks. Forty-eight pts were enrolled from December 2006 to December 2007: 34 males (71%), 14 females (29%); median age 64 years (25-74); median KPS 90 (70-100); primary site: stomach 40 (83%), GEJ 8 (17%); prior gastrectomy 21 (44%); stage of disease: locally advanced 1 (2%), metastatic 47 (98%); main metastatic sites: lymphnodes 28 (58%), liver 26 (54%), peritoneal 12 (31%), lung 3 (6.25%). The median number of therapy cycles was 4 (1-6). Median dose intensity was cisplatin 100% (55-100), docetaxel 100% (55-100), cetuximab 100% (65-100). At present, 42 pts are evaluable for response (4 not evaluable and 2 too early), and 48 for toxicity. The objective responses (RECIST) were 1 (2.4%) CR, 16 (38.1%) PR, 40.5% CR + PR (95% CI: 25.7-55.3%), 16 (38.1%) SD, 9 (21.4%) PD. The PFS at 3 months is 80% (95% CI: 64.3-95.7%). Survival data are premature (75% of the pts are still alive). Grade 3-4 toxicity (CTC v3.0) was 45.8% neutropenia (22.9% febrile neutropenia), 6.25% anemia, 2.1% thrombocytopenia, 22.9% asthenia, 8.3% vomiting, 6.3% stomatitis, 4.2% diarrhea, 4.2% hyperbilirubinemia, 20% hyponatremia, 16% hypokalemia, 4% hypomagnesemia. Skin reactions ≥ 2 was 31.3%. Three deaths occurred within 60 days from start of therapy (1 bowel occlusion, 1 gastric bleeding, 1 PD). The combination of cetuximab and cisplatin/docetaxel appears to be active (78.6% of disease control rate), while the greater toxicity appears to be limited to neutropenia. No significant financial relationships to disclose.