Original Research ARTICLE

Front. Oncol., 28 August 2013 | http://dx.doi.org/10.3389/fonc.2013.00219

A pilot study (SWOG S0429) of weekly cetuximab and chest radiotherapy for poor-risk stage III non-small cell lung cancer

Yuhchyau Chen1*, James Moon2, Kishan J. Pandya3, Derick H. M. Lau4, Karen Kelly4, Fred R. Hirsch5, Laurie E. Gaspar6, Mary Redman2 and David R. Gandara4
  • 1Department of Radiation Oncology, University of Rochester, Rochester, NY, USA
  • 2SWOG Statistical Center, Seattle, WA, USA
  • 3Hematology Oncology, University of Rochester, Rochester, NY, USA
  • 4Hematology Oncology, University of California at Davis, Sacramento, CA, USA
  • 5Department of Medicine and Pathology, University of Colorado, Denver, CO, USA
  • 6Department of Radiation Oncology, University of Colorado, Denver, CO, USA

Purpose: Stage III non-small cell lung cancer (NSCLC) patients with poor performance status (PS) or co-morbidities are often not candidates for standard chemoradiotherapy (chemoRT) due to poor tolerance to treatments. A pilot study for poor-risk stage III NSCLC patients was conducted combining cetuximab, a chimeric monoclonal antibody targeting epidermal growth factor receptor (EGFR), with chest radiation (RT).

Methods: Stage III NSCLC patients with Zubrod PS 2, or Zubrod PS 0–1 with poor pulmonary function and co-morbidities prohibiting chemoRT were eligible. A loading dose of cetuximab (400 mg/m2) was delivered week 1, followed by weekly cetuximab (250 mg/m2)/RT to 64.8 Gy in 1.8 Gy daily fractions, and maintenance weekly cetuximab (250 mg/m2) for 2 years or until disease progression. H-score for EGFR protein expression was conducted in available tumors.

Results: Twenty-four patients were enrolled. Twenty-two were assessed for outcome and toxicity. Median survival was 14 months and median progression-free survival was 8 months. The response rate was 47% and disease control rate was 74%. Toxicity assessment revealed 22.7% overall ≥Grade 3 non-hematologic toxicities. Grade 3 esophagitis was observed in one patient (5%). The skin reactions were mostly Grade 1 or 2 except two of 22 (9%) had Grade 3 acne and one of 22 (5%) had Grade 3 radiation skin burn. Grade 3–4 hypomagnesemia was seen in four (18%) patients. One patient (5%) had elevated cardiac troponin and pulmonary emboli. H-score did not reveal prognostic significance. An initially planned second cohort of the study did not commence due to slow accrual, which would have added weekly docetaxel to cetuximab/RT after completion of the first cohort of patients.

Conclusion: Concurrent weekly cetuximab/chest RT followed by maintenance cetuximab for poor-risk stage III NSCLC was well tolerated. Further studies with larger sample sizes will be useful to establish the optimal therapeutic ratio of this regimen.

Keywords: cetuximab, stage III non-small cell lung cancer, EGFR, performance status, radiosensitization

Citation: Chen Y, Moon J, Pandya KJ, Lau DHM, Kelly K, Hirsch FR, Gaspar LE, Redman M and Gandara DR (2013) A pilot study (SWOG S0429) of weekly cetuximab and chest radiotherapy for poor-risk stage III non-small cell lung cancer. Front. Oncol. 3:219. doi: 10.3389/fonc.2013.00219

Received: 14 May 2013; Accepted: 09 August 2013;
Published online: 28 August 2013.

Edited by:

William Thomas Sause, Intermountain Health Care, USA

Reviewed by:

Heloisa De Andrade Carvalho, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brazil
David Ball, Peter MacCallum Cancer Centre, Australia
Ajeet Gajra, SUNY Upstate Medical University, USA

Copyright: © 2013 Chen, Moon, Pandya, Lau, Kelly, Hirsch, Gaspar, Redman and Gandara. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: Yuhchyau Chen, Department of Radiation Oncology, University of Rochester Medical Center, 601 Elmwood Avenue, Box 647, Rochester, NY 14642, USA e-mail: yuhchyau_chen@urmc.rochester.edu