Abstract
BackgroundSurvival for patients with advanced gastroesophageal cancer (AGC) using standard treatment regimens is poor. EGFR overexpression is common in AGC and associated with poor prognosis. We hypothesized that increasing the dose intensity of chemotherapy and adding panitumumab could improve efficacy.MethodsHER2 negative, PS 0-1 patients, received up to 4 cycles of panitumumab 6 mg/kg d 1, docetaxel 60 mg/m2 d 1, cisplatin 50 mg/m2 d 1, l-folinic acid 100 mg/m2 d 1-2, followed by 5-FU 400 mg/m2 bolus d 1-2, and then 600 mg/m2 as a 22 h c.i. on d 1-2, q15 d, plus pegfilgrastim 6 mg on d 3. Patients with disease control after 4 cycles received panitumumab until progression.ResultsFrom 05/2010 to 01/2014, 52 patients (75% male; median age 64.5 y; metastatic 90%, locally advanced 10%; 96% adenocarcinoma; 25% GEJ) were recruited. Three CR, 29 PR, 10 SD and 8 PD were observed, for an ORR by ITT (primary endpoint) of 62% (95% CI, 48%-75%) and a DCR of 81%. Median TTP was 4.9 months (95% CI, 4.2-7.0) and mOS 10 months (95% CI, 8.2- 13.5). Most frequent G3-4 toxicities: leucopenia (29%), asthenia (27%), skin rash (25%), neutropenia (19%), anorexia (17%), febrile neutropenia (13%), and diarrhea (15%). EGFR expression tested both with dd-PCR and FISH was not associated with any significant clinical benefit from treatment.ConclusionsDose-dense DCF plus panitumumab is an active regimen. However, the toxicity profile of this limits further development. Further research on predictive biomarkers for treatment efficacy in AGC is required.Clinical trial information: 2009-016962-10.
Highlights
Gastroesophageal cancer is a globally important disease; together, gastric and esophageal cancer are responsible for more than 1.1 million deaths annually [1]
Three complete response (CR), 29 partial response (PR), 10 Stable disease (SD) and 8 progressive disease (PD) were observed, for an overall response rate (ORR) by Intention to Treat Analysis (ITT) of 62% and a DCR of 81%
Epidermal growth factor receptor (EGFR) expression tested both with dd-PCR and FISH was not associated with any significant clinical benefit from treatment
Summary
Gastroesophageal cancer is a globally important disease; together, gastric and esophageal cancer are responsible for more than 1.1 million deaths annually [1]. Patients with advanced gastroesophageal cancer have a median survival in clinical trials of first line chemotherapy of less than one year; improved treatment options are desirable for these patients [6, 7]. Standard chemotherapy for patients with advanced gastroesophageal cancer is a cisplatin and fluoropyrimidine doublet, with the addition of either a taxane or anthracycline for fit patients [6, 7]. One of the more active schedules is the combination of docetaxel, cisplatin and 5-FU (DCF), which in a randomized phase III trial, was associated with a significant progression free and overall survival benefit, achieved at the cost of increased toxicity [7]. Survival for patients with advanced gastroesophageal cancer (AGC) using standard treatment regimens is poor. We hypothesized that increasing the dose intensity of chemotherapy and adding panitumumab could improve efficacy
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