Phase II trial of combined modality therapy with myeloid growth factor support in patients with locally advanced non-small cell lung cancer

Rogerio Lilenbaum, Michael A Samuels, Michele Taffaro-Neskey, Mike Cusnir, Joseph Pizzolato, Arnold Blaustein

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)837-840
Number of pages4
JournalJournal of Thoracic Oncology
Volume5
Issue number6
DOIs
StatePublished - Jun 1 2010

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Combined Modality Therapy
Non-Small Cell Lung Carcinoma
Intercellular Signaling Peptides and Proteins
Febrile Neutropenia
docetaxel
Neutropenia
Esophagitis
Forced Expiratory Volume
Etoposide
Thrombocytopenia
Cisplatin
Disease-Free Survival
Pneumonia
Radiotherapy
Thorax
Survival Rate
Safety
Drug Therapy
Survival
Incidence

Keywords

  • Combined modality therapy
  • Myeloid growth factors
  • Stage III NSCLC

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

Phase II trial of combined modality therapy with myeloid growth factor support in patients with locally advanced non-small cell lung cancer. / Lilenbaum, Rogerio; Samuels, Michael A; Taffaro-Neskey, Michele; Cusnir, Mike; Pizzolato, Joseph; Blaustein, Arnold.

In: Journal of Thoracic Oncology, Vol. 5, No. 6, 01.06.2010, p. 837-840.

Research output: Contribution to journalArticle

Lilenbaum, Rogerio ; Samuels, Michael A ; Taffaro-Neskey, Michele ; Cusnir, Mike ; Pizzolato, Joseph ; Blaustein, Arnold. / Phase II trial of combined modality therapy with myeloid growth factor support in patients with locally advanced non-small cell lung cancer. In: Journal of Thoracic Oncology. 2010 ; Vol. 5, No. 6. pp. 837-840.
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AU - Pizzolato, Joseph

AU - Blaustein, Arnold

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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.

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