ABSTRACT
BACKGROUND: To determine efficacy and toxicity of radiation therapy combined with oxaliplatin, 5-fluorouracil, and folinic acid (FOLFOX) and cetuximab in patients with locally advanced oesophageal cancer. PATIENTS AND METHODS: Patients with stage III oesophageal or gastro-oesophageal junction cancer were enrolled in a Simon's two-stage phase II study. Patients received FOLFOX and weekly cetuximab on week 1-10 with concurrent radiotherapy (50.4 Gy in 30 fractions) on week 5-10. Primary end-point was clinical overall response rate (ORR). An ORR rate of more than 50% was expected. RESULTS: Among the 79 included patients, clinical ORR was 77% with 40% complete responses. Median overall survival and progression-free survival were 21.6 and 11.3 months, respectively. The most common grade III-IV toxicities observed during experimental chemoimmunotherapy followed by chemoradiation included neutropenia (28%), oesophagitis (12%), rash (11%), and allergy (9%). There was one treatment-related death due to oesophagitis with gastrointestinal bleeding. CONCLUSIONS: Cetuximab-FOLFOX regimen combined with radiotherapy demonstrated its efficacy and was well tolerated. Unfortunately, these results were not confirmed in two recent phase III studies.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Cetuximab/administration & dosage , Chemoradiotherapy , Esophageal Neoplasms/therapy , Esophagogastric Junction/drug effects , Esophagogastric Junction/radiation effects , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Cetuximab/adverse effects , Chemoradiotherapy/adverse effects , Disease-Free Survival , Esophageal Neoplasms/mortality , Esophageal Neoplasms/pathology , Esophagogastric Junction/pathology , Fluorouracil/administration & dosage , France , Humans , Kaplan-Meier Estimate , Leucovorin/administration & dosage , Neoplasm Staging , Organoplatinum Compounds/administration & dosage , Proportional Hazards Models , Prospective Studies , Radiotherapy Dosage , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Undernutrition is frequently observed in patients with a locally advanced oesophageal carcinoma. However, variations of nutritional parameters during chemoradiotherapy have not been thoroughly investigated. AIM: To evaluate the characteristics and the impact of nutritional variations during treatment. METHODS: Weight loss, body mass index (BMI), serum albumin level and daily food intake at baseline and during treatment (T1=week 1; T2=week 5 or 8; T3=week 11) were retrospectively analyzed in 101 patients with oesophageal carcinoma. RESULTS: Significant variations occurred during chemoradiotherapy with a decrease in serum albumin level (p<0.001), body mass index (p<0.001) and weight (p<0.001). Response rate to treatment was significantly lower in patients with undernutrition at T1 (p=0.05), from T1 to T2 (p=0.01) and from T1 to T3 (p=0.04). Median overall survival was 25 months in patients with persistent undernutrition from T1 to T2 vs 42 months in wellnourished patients from T1 to T2 and those malnourished only at T1 or T2 (p=0.05). In responders, patients presenting with a lower weight or a lower food intake from T1 to T3 had worse survival (33 vs 59 months, p<0.001 and 29 vs 61 months, p=0.001, respectively). CONCLUSION: Significant variations of nutritional parameters occurred during chemoradiotherapy with a worse impact on response and survival.
Subject(s)
Adenocarcinoma/therapy , Body Weight , Carcinoma, Squamous Cell/therapy , Chemoradiotherapy , Energy Intake , Esophageal Neoplasms/therapy , Malnutrition/blood , Serum Albumin , Adenocarcinoma/complications , Aged , Body Mass Index , Carcinoma, Squamous Cell/complications , Cohort Studies , Disease Progression , Disease-Free Survival , Eating , Esophageal Neoplasms/complications , Female , Humans , Male , Malnutrition/complications , Malnutrition/physiopathology , Middle Aged , Multivariate Analysis , Prognosis , Proportional Hazards Models , Retrospective Studies , Risk Factors , Treatment OutcomeABSTRACT
BACKGROUND: The purpose of the study was to investigate the value of 18F-fluorodeoxyglucose-positron emission tomography performed after definitive chemoradiotherapy in patients with locally advanced oesophageal carcinoma. METHODS: Forty consecutive patients underwent 18F-fluorodeoxyglucose-positron emission tomography at baseline and after chemoradiotherapy completion. Assessment of the clinical complete response to chemoradiotherapy included oesophagoscopy plus biopsies and computed tomography scan. Cox regression analysis was used to develop the univariate and multivariate models describing the association of the independent variables with survival and local control. RESULTS: A clinical complete response and 18F-fluorodeoxyglucose-positron emission tomography response were present in 29 patients (72.5%) and 13 patients (32.5%), respectively. A combined response was observed in 11 patients (27.5%). During follow-up, a local failure was detected in 27.2% of patients with 18F-fluorodeoxyglucose-positron emission tomography response versus 33.3% in non-responders (p=.9). In multivariate analysis, clinical complete response (HR 5.77, p=.009) and 18F-fluorodeoxyglucose-positron emission tomography response (HR 6.27, p=.031) were identified as independent prognostic factors of overall survival. CONCLUSION: In patients treated for an esophageal cancer, the present study suggested that 18F-fluorodeoxyglucose-positron emission tomography after chemoradiotherapy completion was an independent prognostic factor of overall survival without significant impact on local recurrence prediction.
