Subscribe to RSS
DOI: 10.1055/s-2006-952825
Feasibility, toxicity and quality of life of 1st line chemotherapy with platinum/paclitaxel under phase III clinical trial conditions in elderly patients aged ≥ 70 years with advanced ovarian cancer – A study by the AGO OVAR Germany
Aims: Today, there is evidence that despite several improvements of general health care and supportive therapies, elderly patients with advanced ovarian cancer are still not treated with the currently recommended standard carboplatin/paclitaxel. This study evaluates first-line platinum/paclitaxel under phase III trial conditions in ovarian cancer (OC) patients aged ≥ 70 years. Methods: Phase III results of 779 patients with OC FIGO stage IIB/IV treated with cisplatin/paclitaxel versus carboplatin/paclitaxel were retrospectively analyzed according to feasibility, toxicity (NCI-CTC) and quality of life (Qol) (EORTC QLQ-C30) in patients aged < or ≥ 70 years. Results: 103 (13%) patients were aged ≥ 70 years. Patient characteristics (<70 vs. ≥ 70 years) showed significant differences with regard to ECOG, residual disease and constitutional factors but not to FIGO stage, histology or grading. Elderly patients received 98%, 100% and 96% of the recommended paclitaxel, carboplatin and cisplatin dose per cycle. Early discontinuation and cycle delays were more often in elderly, although Qol, non-hematological and hematological toxicity were comparable between elderly and younger patients, except for febrile neutropenia (5 vs. <1%, p=0.005). There were no significant differences with regard to the use of G-CSF and antibiotics or dose reductions. Conclusion: Despite an inevitable study-participation related bias in the present study, the results show that platinum/paclitaxel appeared to be tolerable in the majority of elderly patients ≥ 70 years of age without relevant compromises in quality of life, but there seems to be a different investigators estimation of toxicity and little intention to maintain trial treatment in elderly.