Manuel Constenla

Phase III Study of Docetaxel and Cisplatin Plus Fluorouracil Compared With Cisplatin and Fluorouracil As First-Line Therapy for Advanced Gastric Cancer: A Report of the V325 Study Group

PURPOSE In the randomized, multinational phase II/III trial (V325) of untreated advanced gastric cancer patients, the phase II part selected docetaxel, cisplatin, and fluorouracil (DCF) over docetaxel and cisplatin for comparison against cisplatin and fluorouracil (CF; reference regimen) in the phase III part. PATIENTS AND METHODS Advanced gastric cancer patients were randomly assigned to docetaxel 75 mg/m2 and cisplatin 75 mg/m2 (day 1) plus fluorouracil 750 mg/m2/d (days 1 to 5) every 3 weeks or cisplatin 100 mg/m2 (day 1) plus fluorouracil 1,000 mg/m2/d (days 1 to 5) every 4 weeks. The primary end point was time-to-progression (TTP). RESULTS In 445 randomly assigned and treated patients (DCF = 221; CF = 224), TTP was longer with DCF versus CF (32% risk reduction; log-rank P < .001). Overall survival was longer with DCF versus CF (23% risk reduction; log-rank P = .02). Two-year survival rate was 18% with DCF and 9% with CF. Overall response rate was higher with DCF (chi2 P = .01). Grade 3 to 4 treatment-related adverse events occurred in 69% (DCF) v 59% (CF) of patients. Frequent grade 3 to 4 toxicities for DCF v CF were: neutropenia (82% v 57%), stomatitis (21% v 27%), diarrhea (19% v 8%), lethargy (19% v 14%). Complicated neutropenia was more frequent with DCF than CF (29% v 12%). CONCLUSION Adding docetaxel to CF significantly improved TTP, survival, and response rate in gastric cancer patients, but resulted in some increase in toxicity. Incorporation of docetaxel, as in DCF or with other active drug(s), is a new therapy option for patients with untreated advanced gastric cancer.

147P: Level of concordance between EGFR mutation status obtained from tissue/cytology and blood (plasma) for advanced non-small-cell lung cancer in Spain: ASSESS study

147P Level of concordance between EGFR mutation status obtained from tissue/cytology and blood (plasma) for advanced non-small-cell lung cancer in Spain: ASSESS study E. Arriola1, A. Paredes2, R. Garcı́a Gomez3, P. Diz4, M. Constenla5, C. Garcı́a Girón6, M. Amador7, M. Reck8, G. López Vivanco9. 1 Cancer Sciences Unit, Southampton General Hospital Southampton University Hospitals NHS Trust, Southampton, UK , 2 Servicio de Oncologı́a Médica, Hospital Donostia, San Sebastian, Spain, 3 Servicio de Oncologı́a Médica, Hospital General Universitario Gregorio Marañon, Madrid, Spain, 4 Servicio de Oncologı́a Médica, Complejo Asistencial Universitario de León, Leon, Spain, 5 Servicio de Oncologı́a Médica, Complejo Hospitalario de Pontevedra, Pontevedra, Spain, 6 Servicio de Oncologı́a Médica, Hospital Universitario de Burgos, Burgos, Spain, 7Medical Department, AstraZeneca, Madrid, Spain, 8 Department of Thoracic Oncology, LungenClinic Grosshansdorf, Grosshansdorf, Germany, 9 Servicio de Oncologı́a Médica, Hospital Universitario Cruces, Barakaldo, Spain

Dynamic perspective of neutrophil-lymphocyte ratio in metastatic gastric cancer.

e16095Background: This study explores the prognostic value of a baseline and dynamic measure of neutrophil-lymphocyte ratio (NLR and dNLR) in metastatic gastric cancer (mGC), as well as chemotherap...

Role of nutritional and inflammatory status in the prognosis of advanced gastric cancer.

35Background: This study explores the prognosis impact of nutritional and immune status in metastatic gastric cancer (GC). Recently research has been focused on a proinflammatory status and the relevance of inmune system of the patient in GC. Neutrophil-lymphocyte ratio (NLR) and prognostic nutritional index (PNI) has showed prognostic value in local disease. Our study was assesed in metastatic disease. Methods: One hundred and twenty patients with metastatic gastric adenocarcinoma were retrospectively evaluated between 2011 and 2015. 67.2% were metastatic at diagnosis and 32.8% had a recurrence of disease. Clinical, laboratory and histopathological characteristics were selected as risk factors. The optimal cut-off levels were defined as NLR = 3, PNI (10 x albumin concentration +0.005 x total lymphocyte count) = 43.8, albumin = 3.5 g/dL, body mass index (BMI) = 25. Patients with high NLR and hypoalbuminemia were defined as 2, patients who presented only one abnormally were defined as 1 and those with neit...

First-line panitumumab plus docetaxel and cisplatin in advanced gastric or gastroesophageal junction adenocarcinoma: Results of a phase II trial (SPIGA).

e15507Background: Panitumumab (Pmab) is the first fully human IgG2 monoclonal antibody that is directed against the human EGFR which is over-expressed in around 35-80% of gastric cancers. We tested...