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A phase I study of nimotuzumab in combination with radiotherapy in stages IIB-IV non-small cell lung cancer unsuitable for radical therapy: Korean results.

 Hye Jin Choi  ;  Joo Hyuk Sohn  ;  Chang Geol Lee  ;  Hyo Sub Shim  ;  Ik-Jae Lee  ;  Woo Ick Yang  ;  Ji Eun Kwon  ;  Se Kyu Kim  ;  Moo-Suk Park  ;  Ju Hee Lee  ;  Joo Hang Kim 
 LUNG CANCER, Vol.71(1) : 55-59, 2011 
Journal Title
Issue Date
Aged ; Aged, 80 and over ; Antibodies, Monoclonal/administration & dosage* ; Antibodies, Monoclonal/adverse effects* ; Antibodies, Monoclonal, Humanized ; Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/adverse effects ; Carcinoma, Non-Small-Cell Lung/drug therapy* ; Carcinoma, Non-Small-Cell Lung/radiotherapy* ; Combined Modality Therapy ; Dose-Response Relationship, Drug ; Female ; Humans ; Lung Neoplasms/drug therapy* ; Lung Neoplasms/radiotherapy* ; Male ; Middle Aged ; Phosphorylation/drug effects ; Receptor, Epidermal Growth Factor/antagonists & inhibitors ; Receptor, Epidermal Growth Factor/metabolism ; Republic of Korea
Nimotuzumab ; Phase I ; Epidermal growth factor receptor (EGFR) inhibitor ; Non-small cell lung cancer ; Palliative radiotherapy
PURPOSE: This study was undertaken to determine safety and tolerability of nimotuzumab, a humanized anti-epidermal growth factor receptor monoclonal antibody, in combination with radiotherapy in stages IIB-IV non-small cell lung cancer (NSCLC) patients who are unsuitable for radical therapy or chemotherapy. METHODS: Nimotuzumab (100mg, 200mg and 400mg) was administered weekly from week 1 to week 8 with palliative radiotherapy (30-36 Gy, 3 Gy/day). If tumor control was achieved, nimotuzumab was continued every 2 weeks until unacceptable toxicity or disease progression. Serial skin biopsies were collected for pharmacodynamic assessment. RESULTS: Fifteen patients were enrolled in the study, with cohorts of five patients assigned in each dose level of nimotuzumab. Patients and disease characteristics included median age 73 years; Eastern Cooperative Oncology Group performance status (PS) 0-1/2 (n=3/12); female sex (n=2); adenocarcinoma (n=5); never-smoker status (n=2); and stages IIB/IIIB/IV (n=1/8/6). All patients were unable to tolerate radical therapy because of old age or multiple comorbidities. The most commonly reported adverse events were lymphopenia and asthenia (grades 1-2 in most patients). No skin rash or allergic toxicities appeared. Dose-limiting toxicity occurred with pneumonia with grade 4 neutropenia at the 200mg dose of nimotuzumab. Objective response rate and disease control rate inside the radiation field were 46.7% and 100.0%, respectively. CONCLUSIONS: Nimotuzumab in combination with radiotherapy is well-tolerated and feasible. Further clinical investigation of nimotuzumab in NSCLC patients is warranted.
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Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Radiation Oncology (방사선종양학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Dermatology (피부과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pathology (병리학교실) > 1. Journal Papers
Yonsei Authors
Kwon, Ji Eun(권지은)
Kim, Se Kyu(김세규)
Kim, Joo Hang(김주항)
Park, Moo Suk(박무석) ORCID logo https://orcid.org/0000-0003-0820-7615
Sohn, Joo Hyuk(손주혁) ORCID logo https://orcid.org/0000-0002-2303-2764
Shim, Hyo Sup(심효섭) ORCID logo https://orcid.org/0000-0002-5718-3624
Yang, Woo Ick(양우익) ORCID logo https://orcid.org/0000-0002-6084-5019
Lee, Ik Jae(이익재) ORCID logo https://orcid.org/0000-0001-7165-3373
Lee, Ju Hee(이주희) ORCID logo https://orcid.org/0000-0002-1739-5956
Lee, Chang Geol(이창걸) ORCID logo https://orcid.org/0000-0002-8702-881X
Choi, Hye Jin(최혜진) ORCID logo https://orcid.org/0000-0001-5917-1400
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