Cornelius F Waller1, Ihor Vynnychenko2, Igor Bondarenko3, Yaroslav Shparyk4, Jeffrey P Hodge5, Anne Freeman5, Brian Huber5, Ronald Lieberman5, Mark J Shelton5, Harish Dave5. 1. Universitätsklinikum Freiburg, Department of Internal Medicine, Oncology, Hematology, and Stem Cell Transplantation, Freiburg, Germany. Electronic address: Cornelius.waller@uniklinik-freiburg.de. 2. Sumy State University, Sumy Regional Clinical Oncological Dispensary Thoracic Department, Sumy, Ukraine. 3. Municipal Multifield Clinical Hospital #4, Department of Chemotherapy, Donetsk State Medical University, Donetsk, Ukraine. 4. Department of Chemotherapy, Lviv State Oncology Regional Treatment and Diagnostic Center, Lviv, Ukraine. 5. Quintiles, Durham, NC.
Abstract
INTRODUCTION: New treatment options are needed for second-line therapy in patients with NSCLC. PATIENTS AND METHODS: This was a phase Ib/II study in patients with nonsquamous NSCLC in whom 1 previous platinum-based chemotherapy regimen had failed. Fifteen patients were enrolled in a dose escalation oferibulin mesylate in combination with pemetrexed (E+P). In phase II (n = 80), E+P at the maximum tolerated dose was compared with P. RESULTS: In phase Ib, the maximum tolerated dose of E+P was defined as eribulin 0.9 mg/m(2) with pemetrexed (500 mg/m(2)) each on day 1 of a 21-day cycle. In phase II, adverse events were comparable between groups. PFS and OS were similar between treatment groups. Median PFS was 21.4 weeks for E+P (n = 26; 95% confidence interval [CI], 12.7-39.6) and 23.4 weeks for P (n = 29; 95% CI, 17.1-29.9), with a hazard ratio of 1.0 (95% CI, 0.6-1.7). CONCLUSION: During phase Ib, E+P was tolerated only at a markedly lower dosing intensity relative to the eribulin monotherapy regimen approved for breast cancer and used in phase II studies of NSCLC. At the selected phase II dosing regimen, E+P was generally safe and well tolerated but provided no therapeutic advantage for the second-line treatment of locally advanced or metastatic nonsquamous NSCLC.
RCT Entities:
INTRODUCTION: New treatment options are needed for second-line therapy in patients with NSCLC. PATIENTS AND METHODS: This was a phase Ib/II study in patients with nonsquamous NSCLC in whom 1 previous platinum-based chemotherapy regimen had failed. Fifteen patients were enrolled in a dose escalation of eribulin mesylate in combination with pemetrexed (E+P). In phase II (n = 80), E+P at the maximum tolerated dose was compared with P. RESULTS: In phase Ib, the maximum tolerated dose of E+P was defined as eribulin 0.9 mg/m(2) with pemetrexed (500 mg/m(2)) each on day 1 of a 21-day cycle. In phase II, adverse events were comparable between groups. PFS and OS were similar between treatment groups. Median PFS was 21.4 weeks for E+P (n = 26; 95% confidence interval [CI], 12.7-39.6) and 23.4 weeks for P (n = 29; 95% CI, 17.1-29.9), with a hazard ratio of 1.0 (95% CI, 0.6-1.7). CONCLUSION: During phase Ib, E+P was tolerated only at a markedly lower dosing intensity relative to the eribulin monotherapy regimen approved for breast cancer and used in phase II studies of NSCLC. At the selected phase II dosing regimen, E+P was generally safe and well tolerated but provided no therapeutic advantage for the second-line treatment of locally advanced or metastatic nonsquamous NSCLC.
Authors: N Katakami; E Felip; D R Spigel; J-H Kim; M Olivo; M Guo; H Nokihara; J C-H Yang; N Iannotti; M Satouchi; F Barlesi Journal: Ann Oncol Date: 2017-09-01 Impact factor: 32.976