A phase II trial of preoperative chemotherapy with epirubicin, cisplatin and capecitabine for patients with localised gastro-oesophageal junctional adenocarcinoma.

Preoperative cisplatin/fluorouracil is used for the treatment of localised oesophageal carcinoma. This phase II study aimed to assess the efficacy and safety of administering preoperative epirubicin/cisplatin/capecitabine (ECX). Patients with stage II or III oesophageal/gastro-oesophageal junctional adenocarcinoma from one institution received 4 cycles of ECX (epirubicin 50 mg m(-2) day 1, cisplatin 60 mg m(-2) day 1, capecitabine 625 mg m(-2) b.i.d. daily) followed by surgery. The primary end point was the pathological complete response (pCR) rate based on a Simon two-stage design. Secondary end points included overall and progression-free survival (OS/PFS). Thirty-four patients were recruited: median age 60 years (range 41-81), 91% male, 97% PS 0/1, 80% T3, 68% N1. Thirty-one patients completed four ECX cycles. Grade 3/4 toxicities >or=5% included neutropenia (62%), hand-foot syndrome (15%) and nausea/vomiting (9%). Thirteen out of 28 (46%) evaluable patients responded to chemotherapy by EUS (>or=30% reduction in maximal tumour thickness). Twenty-six out of 34 (76%) patients underwent resection (R0=73%, R1=27%). Post-operatively, two patients died within 60 days of surgery. The pCR rate was 5.9% (95% CI 0-14%) in the intent-to-treat population. According to the statistical design, this prompted early study termination. However, with a median follow-up of 34 months the median OS and 1- and 2-year survival rates were 17 months, 67 and 39% respectively. Median PFS was 13 months. Of the 14 relapsed patients, 10 presented with distant metastases. Preoperative ECX is feasible and well tolerated. Although associated with a low 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.

Experience in a UK cancer centre of weekly paclitaxel in the treatment of relapsed ovarian and primary peritoneal cancer.

OBJECTIVES: Weekly paclitaxel (WP) has been reported to have significant activity in patients with ovarian and primary peritoneal cancer patients while retaining a favorable toxicity profile. This study assessed the current usage of WP in routine clinical practice in a tertiary cancer center. METHODS: We conducted a retrospective audit in 53 patients with recurrent ovarian or primary peritoneal cancer treated with WP (80-100 mg/m(2)) over a 2-year period (Nov 2003-Nov 2005). Toxicity was assessed using Common Toxicity Criteria, and response was evaluated using radiological and CA-125 criteria. RESULTS: Patients had a median age of 69 (36-86) and previously received a median of 3 treatments (range 1-7). A median of 13 weekly doses of paclitaxel (range 1-39) were given. The response rate was 48% by radiological criteria and 69% by CA-125 assessment. Grade 3 toxicities were fatigue (13% of patients), peripheral neuropathy (11%) and neutropenia (8%) and there were no grade 4 toxicities. The median progression-free survival was 4. 8 months and median survival was 13. 5 months. There was no significant difference in efficacy between those 24 patients previously treated with taxanes (radiol. response 43%/CA-125 response 63%) and those 29 patients who had not received prior taxanes (radiol. response 52%/CA-125 response 76%). There was also no difference in efficacy for patients with platinum-free or treatment-free intervals of less than 6 months compared to 6 months or longer. CONCLUSIONS: WP is a well tolerated and active regimen in patients with pre-treated ovarian cancer and its use in recurrent disease is likely to increase. Further studies should aim to assess the importance of the "paclitaxel-free interval" in predicting response in relapsed disease, along similar lines as are now established for platinums.