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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
 Lung Cancer 
Issue Date
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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1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실)
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Radiation Oncology (방사선종양학교실)
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Dermatology (피부과학교실)
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Pathology (병리학교실)
Yonsei Authors
권지은(Kwon, Ji Eun)
김세규(Kim, Se Kyu)
김주항(Kim, Joo Hang)
박무석(Park, Moo Suk) ORCID logo https://orcid.org/0000-0003-0820-7615
손주혁(Sohn, Joo Hyuk) ORCID logo https://orcid.org/0000-0002-2303-2764
심효섭(Shim, Hyo Sup) ORCID logo https://orcid.org/0000-0002-5718-3624
양우익(Yang, Woo Ick) ORCID logo https://orcid.org/0000-0002-6084-5019
이익재(Lee, Ik Jae) ORCID logo https://orcid.org/0000-0001-7165-3373
이주희(Lee, Ju Hee) ORCID logo https://orcid.org/0000-0002-1739-5956
이창걸(Lee, Chang Geol) ORCID logo https://orcid.org/0000-0002-8702-881X
최혜진(Choi, Hye Jin)
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