Toxicity Toxicity in the 104 patients who commenced treatment is summarised in Table 3. Three patients on wTCF and one on wTX had grade III febrile neutropenia; sellckchem both rates are significantly less than the rates observed with 3-weekly docetaxel-based chemotherapy regimens. The most significant common adverse events in the wTCF arm were grade III or IV diarrhoea, grade III or IV fatigue, grade III stomatitis, grade III anorexia, and grade III nausea. The most significant common adverse events in the wTX arm were grade III nausea, grade III vomiting, grade III diarrhoea, grade III anorexia, and grade III fatigue. Table 3 Haematological and non-haematological adverse events (NCI CTCAE, version 3.0) Mortality from any cause at 60 days was 6% in the wTCF arm (three patients; 95% CI, 0.7�C11.

3%) and 0% in the wTX arm (95% CI, 0�C6%). There were no treatment-related deaths. Disease-associated symptoms and quality of life Improvement in a specific disease-associated symptom or an aspect of quality of life was defined as an increase of 10 points or more for that questionnaire item for more than 3 weeks. For wTCF and wTX, improvement in global health and quality of life was seen in 30% and 35% of patients, in nausea and vomiting in 30% and 31%, in fatigue in 36% and 46%, and in pain in 47% and 50%, respectively. The most striking improvement was in dysphagia in patients with oesophageal disease, among whom 71% and 70% treated with wTCF and wTX improved, respectively, compared with 46% and 41% of patients with gastric disease, respectively.

Discussion This randomised phase II study has shown that it is feasible to develop combination chemotherapy regimens incorporating weekly docetaxel for advanced oesophagogastric cancer. There is clear evidence that docetaxel has non-cross-resistant activity in advanced oesophagogastric cancer. Docetaxel has efficacy as a single agent after failure of platinum and fluoropyrimidines, as well as additive activity when used in combination with cisplatin and 5-FU (Cascinu et al, 2001; Van Cutsem et al, 2006). However, significant myelosuppression with 3-weekly administration poses a major problem for the development of combination chemotherapy regimens, because the myelosuppressive effects add to the toxicities of other chemotherapy agents. The most striking change in the safety profile of the weekly docetaxel-based combination regimens used in this study was a substantially lower rate of myelosuppression and complicated neutropenia compared with that of 3-weekly TCF (Van Cutsem et al, 2006). This occurred despite the somewhat Batimastat older population of patients (the median age in both arms was over 60 years) in this study, whereas older patients have higher rates of toxicity with 3-weekly TCF (Van Cutsem et al, 2006).