Nason, Katie S.

The following, from the 12th OESO World Conference: Cancers of the Esophagus, includes commentaries on the role of the nurse in preparation of esophageal resection (ER); the management of patients who develop high‐grade dysplasia after having undergone Nissen fundoplication; the trajectory of care for the patient with esophageal cancer; the influence of the site of tumor in the choice of treatment; the best location for esophagogastrostomy; management of chylous leak after esophagectomy; the optimal approach to manage thoracic esophageal leak after esophagectomy; the choice for operational approach in surgery of cardioesophageal crossing; the advantages of robot esophagectomy; the place of open esophagectomy; the advantages of esophagectomy compared to definitive chemoradiotherapy; the pathologist report in the resected specimen; the best way to manage patients with unsuspected positive microscopic margin after ER; enhanced recovery after surgery for ER: expedited care protocols; and long‐term quality of life in patients following esophagectomy.

Abstract Background: Esophageal adenocarcinoma (EAC) is a lethal cancer, and the incidence is increasing. Our group demonstrated that over-expression of the epidermal growth factor receptor (EGFR) correlated with reduced survival in EAC. Panitumumab (P) is a fully human IgG2 monoclonal antibody against human EGFR. Cetuximab combined with irinotecan (I) has shown activity for second-line treatment of advanced colorectal cancer (CRC). P alone is active in EGFR expressing CRC as well. Our group has empiric evidence for the activity of cetuximab + I as third-line treatment for advanced EAC. As such, a phase II study was designed to evaluate P + I as second-line therapy for advanced EAC. Trial Design: The primary endpoint is overall response (OR) as measured by RECIST (cross-sectional imaging every 2 cycles). Secondary endpoints include overall survival, safety/toxicity and correlative studies. Patients with confirmed EAC with history of one prior treatment are treated with P 9 mg/m2 on day 1 and I 125 mg/m2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles. Inclusion criteria include confirmed EAC, measurable disease, no prior I or P, PS <2 and normal organ function. A Simon two-stage design is used with power of 80% and a type I error of 0.05. 18 patients will be tested in the first stage and will terminate the trial if 2 or fewer respond. A total of 43 patients will be studied. Blood and tissue are obtained to analyse the role of FCα-R receptors as well EGFR pathway components and kras mutations. Enrollment: The 1st patient was enrolled in May 2009. Through August 2011, 7 patients received treatment. Preliminary results: Of the 7 patients treated, all are white males, median age 62. 2 patients completed 6 cycles. 1 patient received 3 cycles, 3 received 2 cycles and 1 patient completed 1 cycle. 3 patients are still alive. However, only 1 patient is still in the trial. 4 patients received dose reductions due to grade 3 or 4 side effects, including GI disturbances (5), fatigue(1), skin rash(1), electrolyte imbalances(2) and hematologic abnormalities (5). Reasons for discontinuation included progressive disease (PD, 5 patients) and patient refusal (2). The longest survival was 338 days–1 of the 2 patients who completed 6 cycles. The second patient who completed 6 cycles is alive at 307 days. 1 patient completed 3 cycles and survived 213 days after PD. 1 patient survived 174 days followed PD after 2 cycles. 2 patients completed 2 cycles and are still alive, surviving 151 (pt refusal) and 103 days respectively. The shortest survival was 85 days who completed only 1 cycle. Conclusion: Preliminary data from this Phase II trial suggests that patients with advanced EAC might benefit from P+I regimen as 2nd line therapy. 3 additional centers will open the trial. Accrual is ongoing, and correlative studies will follow. This project used the University of Pittsburgh Cancer Institute and was supported in part by award P30CA047904 Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 103rd Annual Meeting of the American Association for Cancer Research; 2012 Mar 31-Apr 4; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2012;72(8 Suppl):Abstract nr 3708. doi:1538-7445.AM2012-3708