Background
The addition of B to platinum-doublet chemotherapy in first-line treatment for non-squamous NSCLC showed improvement of progression free survival (PFS) and overall survival (OS) (ECOG 4599). However, in a subset analysis of this trial, grade 3 to 5 toxicities occurred more frequently in elderly patients treated with CPB compared with patients treated with CP and in elderly patients compared with younger patients. Grade 3/4 neutropenia was 34% in elderly patients. GIDO1201 is the first trial addressed specifically to assess the safety of B in elderly patients. We hypothesized that an adjusted dose-regimen administered to elderly patients selected by an adapted geriatric assessment could decrease the rate of neutropenia to 20%.
Methods
Elderly (≥70 years old) chemotherapy-naive stage IIIB/IV or recurrent non-squamous NSCLC patients, ECOG-PS 0-1, measurable target lesion, and adequate organ functions were eligible for this study. After an Adapted Geriatric Assessment, elderly patients with NSCLC received a modified regimen consisting on triweekly C AUC 4 + P 175 mg/m2 + B 7.5 mg/kg.
Results
Twenty-six eligible patients (20 male, 6 female; median age, 76 years) were enrolled between August 2013 and June 2015. Six and 20 patients had ECOG-PS of 0 and 1, respectively. The median number of CPB treatment cycles received was 4 (2-6). 17 patients (66%) received B maintenance (median number of cycles 7). At the time of analysis, 3 patients are still on treatment. Grade 3/4 neutropenia was observed only in one patient (3.8%). Grade 3/4 non-hematological and hematological toxicities were observed in 10 (38.5%) and 4 (15.4%). pts, respectively. The most common grade 3/4 AEs included anemia (11.5%) and hypertension (15.4%). One fatal AE was observed. At the time of this preliminary analysis, median PFS was 8.22 months (6.0-10.3) and median OS was 11.6 (8.0-15.1)
Conclusion
CPB triweekly followed by BEV showed an acceptable toxicity profile with a favorable grade 3-4 neutropenia of 3.8% compared with previously reported. Efficacy of this first-line regimen for selected elderly non-squamous NSCLC patients was similar to younger patients. However, this study has the limitation of the small number of patients, although a simple size of 51 patients was needed to test this hypothesis, the study was halted after the inclusion of 26 patients due to the slow recruitment.
Keywords
elderly, bevacizumab, NSCLC, Geriatric assessment
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