ENT Medical News about gastro-esophageal junctional adenocarcinoma;epirubicin,cisplatin,and cisplatin

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A phase II trial of preoperative chemotherapy with epirubicin, cisplatin and capecitabine for patients with localised gastro-oesophageal junctional adenocarcinoma
British Journal of Cancer, 05/14/09

Starling N et al. - In a trial to assess the efficacy and safety of administering preoperative epirubicin/cisplatin/capecitabine (ECX) in pts with localised gastro-oesophageal junctional adenocarcinoma, it was found that preoperative ECX is feasible and well tolerated. Although associated with a low pathological complete response (pCR) rate, survival with ECX was comparable with published studies suggesting that pCR may not correlate with satisfactory outcome from preoperative chemotherapy for localised oesophageal adenocarcinoma.

Methods

Pts with stage II or III oesophageal/gastro-oesophageal junctional adenocarcinoma received 4 cycles of ECX (epirubicin 50 mg m-2 day 1, cisplatin 60 mg m-2 day 1, capecitabine 625 mg m-2 bid daily) followed by surgery.
Primary endpoint was the pCR rate based on a Simon 2-stage design.
Secondary endpoints included overall and progression-free survival (OS/PFS).

Results

34 pts were recruited: median age 60 yrs, 91% male, 97% PS 0/1, 80% T3, 68% N1.
31 pts completed 4 ECX cycles.
Grade 3/4 toxicities 5% included neutropenia (62%), hand–foot syndrome (15%), and nausea/vomiting (9%).
13 of 28 (46%) pts responded to chemotherapy by EUS (30% reduction in maximal tumour thickness).
26 of 34 (76%) pts underwent resection (R0=73%, R1=27%).
Post-operatively, 2 pts died within 60 days of surgery.
pCR rate was 5.9% in the intent-to-treat population.
According to statistical design, this prompted early study termination.
With median follow-up of 34 mos, median OS and 1- and 2-yr survival rates were 17 mos, 67 and 39%, respectively.
Median PFS was 13 mos.
Of the 14 relapsed pts, 10 presented with distant metastases.