Observational Aranesp Survey to Investigate the Q3W Schedule (OASIS): a prospective observational study of treatment of chemotherapy-induced anaemia with every 3 weeks darbepoetin alfa.

INTRODUCTION: This prospective observational study examined the adherence to published European guidelines on erythropoiesis-stimulating agents (ESAs) and the pattern of use and effect of darbepoetin alfa (DA) 500 microg once every 3 weeks (Q3W) for the treatment of chemotherapy-induced anaemia (CIA). MATERIALS AND METHODS: A total of 293 patients were included (263 solid tumour, 30 haematologic malignancy). Their mean age was 63 years, 51% were male, 57% had platinum-based chemotherapy. DA was started at a haemoglobin (Hb) level between 9 and 11 g/dL in 82% of patients. RESULTS AND DISCUSSION: In an analysis correcting for transfusions, 55% of patients achieved > or =2 g/dL increase in Hb, and a Hb level of >11 g/dL was reached in 81%. Transfusion rate was 27%. Most patients (70%) were treated in a Q3W chemotherapy, and planned synchronisation of chemotherapy and Q3W DA could be maintained in 76%. CONCLUSION: Adherence to European guidelines for DA treatment was good, and Q3W DA treatment was in synchronisation with Q3W chemotherapy in the majority of the patients, thereby reproducing the findings of a recent phase III study.

Long-term survival of surgically staged IIIA-N2 non-small-cell lung cancer treated with surgical combined modality approach: analysis of a 7-year prospective experience.

BACKGROUND: The aim of this study was to analyse the outcome of surgically staged IIIA-N2 non-small-cell lung cancer (NSCLC) treated with induction chemotherapy followed by surgical exploration. METHODS: Univariate and multivariate analyses were carried out on a prospective cohort of 131 mediastinoscopy-proven IIIA-N2 NSCLC patients. Three preoperative cycles of vindesine-ifosfamide-cisplatin (VIP) were given. Patients with at least stable disease (SD) were considered for surgery, or radical radiotherapy in selected cases. RESULTS: The response rate after VIP was 54% (95% confidence interval 45% to 63%) and was important for the final outcome. The median and 5-year survival for the total group were 24 months and 21% (38 months and 30% in responders), respectively. Involvement of subcarinal nodes at diagnosis was the most important prognostic factor (P=0.022). Seventy-five patients were considered for surgery. Downstaging occurred in 34 of 70 resection specimens, with a pathological complete response in six. Median and 5-year survival in the surgical cohort were 45 months and 35%, respectively. Surgery was rewarding both in patients with a response and in those with SD, although the complete resection rate was significantly lower in the latter. On multivariate analysis, favourable prognostic factors were low pathological T-stage (P=0.001) and downstaging of mediastinal nodes in the resection specimen (P=0.008). CONCLUSIONS: VIP induction chemotherapy followed by surgical exploration was rewarding in mediastinoscopy-proven stage IIIA-N2 NSCLC, both in cases of response and SD, despite a lower complete resection rate in the latter. Patients with subcarinal nodes at diagnosis (5-year survival 8.5%) or without nodal downstaging at post-induction surgery (13.7%) might preferably be treated with a non-surgical approach.