All 106 patients randomised to the study were included in the PFS and OS analyses on an Bortezomib side effects intention-to-treat basis. The 104 patients who commenced study treatment were included in the toxicity analyses. The 99 patients who completed the QLQs were included in the disease-related symptoms and quality-of-life analyses. Figure 1 Enrolment and analysis in the ATTAX study. wTCF=weekly docetaxel, plus cisplatin and 5-fluorouracil; wTX=weekly docetaxel plus capecitabine. Baseline characteristics were well balanced between the treatment arms (Table 1). Table 1 Patient and cancer baseline characteristics Treatment The median number of cycles delivered per patient was 6 cycles of wTCF (range, 1�C8) and 5 cycles of wTX (range, 1�C14). Dose intensities compared with the starting dosages in the wTCF arm were docetaxel, 92% cisplatin, 91% and 5-FU, 98%.

In the wTX arm, they were docetaxel, 98% and capecitabine, 93%. Four patients in the wTCF arm had cisplatin-related toxicity and subsequently substituted carboplatin for cisplatin. Treatment delays of more than 1 week occurred for 10 patients (29%) in the wTCF arm and for 4 patients (7%) in the wTX arm. Efficacy Interim response analysis was carried out after 21 patients were recruited to each treatment arm. There were 11 partial responses in the wTCF arm and 5 partial responses in the wTX arm, meeting the criterion of at least 5 responses per treatment arm for the study to continue. A total of 106 patients were recruited, and the final response analysis was performed 12 months after the last patient was randomised.

Of the 47 patients assessable for response in the wTCF arm, 2 had complete response, 20 had partial response, and 18 had stable disease. Of the 53 assessable patients in the wTX arm, none had complete response, 14 had partial response, and 28 had stable disease (Table 2). The confirmed overall response rates were 47% (95% CI, 32�C62%) for wTCF and 26% (95% CI, 15�C40%) for wTX. Table 2 Best overall response rates in 100 evaluable patients At the median follow-up time of 40.7 months, 92 patients had progressed, two could not be assessed for progression (one commenced non-protocol treatment before progression and one withdrew consent for further CT scans), whereas four patients in the wTCF arm and one patient in the wTX arm had not progressed. The median durations for response were 6.45 months for wTCF and 6.

74 months for wTX. At the time of analysis, 98 patients had died. Median PFS times were 5.9 months for wTCF and 4.6 months for wTX (Figure 2). Median OS times were 11.2 months for wTCF and 10.1 months for wTX (Figure 3). Figure 2 Kaplan�CMeier curves of progression-free Batimastat survival for advanced oesophagogastric cancer patients treated with weekly docetaxel, plus cisplatin and 5-fluorouracil (wTCF; n=50), or weekly docetaxel with capecitabine (wTX; n=56).