Hb-level stabilisation with epoetin alfa in patients with advanced NSCLC undergoing concurrent neoadjuvant chemo-radiation therapy (phase III study)

Abstract

17110 Background: Patients suffering from advanced stage IIIA/B NSCLC still have a bad prognosis despite the development of new and more effective treatment methods. Improved therapy options include multi-modal treatment approaches with sequential and/or concurrent chemo-radiation therapy and, alternatively, subsequent surgery. The patients have to accept a higher incidence of side effects and longer therapy cycles, which can last up to six months. This means that most patients spend a considerable part of their survival time undergoing therapy, where, in the short or medium term, they are likely to die of a relapse or haematogenous metastatic spread. Therefore we have decided to offer patients with unfavourable prognostic factors (poor general health, high age, comorbidity) a shortened, three-week neoadjuvant and concomitant chemo-radiation therapy plus possible surgery. This form of treatment is expected to produce more positive outcomes than the purely palliative radiation therapy at 40–50 Gy. Preventive dosing with Epoetin alfa as part of an intensive therapy regimen might lead to higher compliance, increased quality of life and possibly even to a better prognosis as a result of stabilising patients’ Hb levels. Methods: 51 stage IIIA/B NSCLC patients received neoadjuvant concurrent chemo-radiation therapy (daily cisplatin (6 mg/m2), 45 Gy hyperfractionated accelerated radiotherapy). 25 patients received additional treatment with Epoetin alfa 3 times a week (10,000 IU sc). Results: While Hb levels dropped significantly (−0.54 g/dL) during therapy in the control group, the Epoetin-alfa group showed a significant rise after only three weeks (+1,35 g/dL). There were no significant differences in remission rates between the goups. Conclusions: In this patient group, preventive treatment with Epoetin alfa stabilises Hb levels at a target level of around 12 g/dL even under intensive therapy. To what extent treatment with erythropoietin affects prognosis should be examined in further studies. No significant financial relationships to disclose.