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Cancer Chemotherapy and Pharmacology

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01-04-2011 | Original Article

Phase I clinical trial of the anti-EGFR monoclonal antibody nimotuzumab with concurrent external thoracic radiotherapy in Canadian patients diagnosed with stage IIb, III or IV non-small cell lung cancer unsuitable for radical therapy

Authors: Gwyn Bebb, Colum Smith, Stewart Rorke, William Boland, Leonardo Nicacio, Ryan Sukhoo, Anthony Brade

Published in: Cancer Chemotherapy and Pharmacology | Issue 4/2011

Abstract

Purpose

Many patients with non-small cell lung cancer (NSCLC) are eligible only for palliative radiation (RT) at presentation. This study was designed to assess the feasibility of adding the anti-EGFR monoclonal antibody nimotuzumab to palliative thoracic RT.

Methods

Patients with stage IIB, III or IV NSCLC considered unsuitable for radical radiation or chemo-radiation received nimotuzumab weekly 8× (100, 200 or 400 mg) with radiation (30 or 36 Gy in 3 Gy fractions). If response or disease stability was observed, nimotuzumab was continued every other week starting from week 10 until progression or toxicity.

Results

Eighteen patients were enrolled: 6 at 100 mg, 7 at 200 mg, 5 at 400 mg nimotuzumab. Patient characteristics included median age 69 years, 11 males, 17 smokers, 17 Caucasians, stage IIIA/IIIB/IV 2/7/9, 5 Eastern Cooperative Oncology Group performance status (PS) 2; 9 adenocarcinoma. The most commonly reported adverse events were fatigue, anorexia, chills, pain and hypophosphatemia (grades 1 to 2 in most patients). No severe skin or allergic toxicity was noted. No dose-limiting toxicity was encountered. Objective response rate and disease control rate inside the radiation field were 66 and 94.0%, respectively.

Conclusion

Nimotuzumab administered concurrently with palliative thoracic radiation is well tolerated at each of the three doses investigated in NSCLC patients unsuitable for radical treatment. The low toxicity and absence of rash make this combination therapeutically attractive for frail patients with other co-morbidities and poor performance status. These results support further testing of this regimen in the phase II setting.

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Title: Phase I clinical trial of the anti-EGFR monoclonal antibody nimotuzumab with concurrent external thoracic radiotherapy in Canadian patients diagnosed with stage IIb, III or IV non-small cell lung cancer unsuitable for radical therapy
Authors: Gwyn Bebb
Colum Smith
Stewart Rorke
William Boland
Leonardo Nicacio
Ryan Sukhoo
Anthony Brade
Publication date: 01-04-2011
Publisher: Springer-Verlag
Published in: Cancer Chemotherapy and Pharmacology / Issue 4/2011
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-010-1379-9

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Purpose

Methods

Results

Conclusion

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