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

作者：Choi Hye Jin; Sohn Joo Hyuk; Lee Chang Geol; Shim Hyo Sub; Lee Ik Jae; Yang Woo Ick; Kwon Ji Eun; Kim Se Kyu; Park Moo Suk; Lee Ju Hee; Kim Joo Hang^*

来源：Lung Cancer, 2011, 71(1): 55-59.

DOI：10.1016/j.lungcan.2010.04.010

• 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 (100 mg, 200 mg and 400 mg) 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 200 mg 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.

• 出版日期2011-1