TY - JOUR
T1 - Phase II trial of combined modality therapy with myeloid growth factor support in patients with locally advanced non-small cell lung cancer
AU - Lilenbaum, Rogerio
AU - Samuels, Michael
AU - Taffaro-Neskey, Michele
AU - Cusnir, Mike
AU - Pizzolato, Joseph
AU - Blaustein, Arnold
N1 - Funding Information:
Supported in part by Amgen Inc., Thousand Oaks, CA.
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2010/6
Y1 - 2010/6
N2 - INTRODUCTION:: To evaluate the efficacy and safety of myeloid growth factors in patients with locally advanced non-small cell lung cancer treated with combined modality therapy (CMT). METHODS:: Patients with stage IIIA/B non-small cell lung cancer, performance status 0 to 1, and forced expiratory volume in 1 second ä1.5, received cisplatin 75 mg/m on day 1 + etoposide 80 mg/m on days 1 to 3 every 3 weeks for 2 cycles concurrent with thoracic radiotherapy to 61 Gy. filgrastim 5 mcg/kg/d was administered for 10 days beginning on day 4 of each chemotherapy cycle. Patients without progression received docetaxel 75 mg/m every 21 days for 3 cycles with peg-filgrastim 6 mg on day 2. The primary end point was a 50% reduction in the incidence of grade 3/4 neutropenia compared with historical controls. RESULTS:: A total of 26 eligible patients were enrolled. Median age was 67, 76% were men, and 58% had stage IIIA. Gr3/4 neutropenia during CMT was 19.2% and 3.8%, respectively. There were no episodes of febrile neutropenia. Gr4 thrombocytopenia was 15.4% with 2 patients requiring transfusions. Gr3 esophagitis was noted in 7.7% and Gr 3/4 pneumonitis in 21.6% of patients. No patients died of treatment-related toxicities. Dose reductions/delays occurred in 3.8% of patients during CMT. Median progression-free survival and median survival were 10.7 and 27.6 months, respectively. The 1- and 2-year survival rates were 61.5% and 46.2%, respectively. CONCLUSIONS:: Our data suggest that the addition of filgrastim to CMT is safe and effective. The rate of grade 3/4 toxicities, including febrile neutropenia, compares favorably to previous trials using a similar regimen. Dose intensity is maintained. This strategy merits further evaluation.
AB - INTRODUCTION:: To evaluate the efficacy and safety of myeloid growth factors in patients with locally advanced non-small cell lung cancer treated with combined modality therapy (CMT). METHODS:: Patients with stage IIIA/B non-small cell lung cancer, performance status 0 to 1, and forced expiratory volume in 1 second ä1.5, received cisplatin 75 mg/m on day 1 + etoposide 80 mg/m on days 1 to 3 every 3 weeks for 2 cycles concurrent with thoracic radiotherapy to 61 Gy. filgrastim 5 mcg/kg/d was administered for 10 days beginning on day 4 of each chemotherapy cycle. Patients without progression received docetaxel 75 mg/m every 21 days for 3 cycles with peg-filgrastim 6 mg on day 2. The primary end point was a 50% reduction in the incidence of grade 3/4 neutropenia compared with historical controls. RESULTS:: A total of 26 eligible patients were enrolled. Median age was 67, 76% were men, and 58% had stage IIIA. Gr3/4 neutropenia during CMT was 19.2% and 3.8%, respectively. There were no episodes of febrile neutropenia. Gr4 thrombocytopenia was 15.4% with 2 patients requiring transfusions. Gr3 esophagitis was noted in 7.7% and Gr 3/4 pneumonitis in 21.6% of patients. No patients died of treatment-related toxicities. Dose reductions/delays occurred in 3.8% of patients during CMT. Median progression-free survival and median survival were 10.7 and 27.6 months, respectively. The 1- and 2-year survival rates were 61.5% and 46.2%, respectively. CONCLUSIONS:: Our data suggest that the addition of filgrastim to CMT is safe and effective. The rate of grade 3/4 toxicities, including febrile neutropenia, compares favorably to previous trials using a similar regimen. Dose intensity is maintained. This strategy merits further evaluation.
KW - Combined modality therapy
KW - Myeloid growth factors
KW - Stage III NSCLC
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U2 - 10.1097/JTO.0b013e3181d6e141
DO - 10.1097/JTO.0b013e3181d6e141
M3 - Article
C2 - 20421820
AN - SCOPUS:77953126777
VL - 5
SP - 837
EP - 840
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
SN - 1556-0864
IS - 6
ER -