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

Yuhchyau Chen, James Moon, Kishan J. Pandya, Derick H Lau, Karen Kelly, Fred R. Hirsch, Laurie E. Gaspar, Mary Redman, David R Gandara

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Abstract

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.

Original languageEnglish (US)
Article number00219
JournalFrontiers in Oncology
Volume3 AUG
DOIs
StatePublished - 2013

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Non-Small Cell Lung Carcinoma
Radiotherapy
Thorax
Radiation
docetaxel
Chemoradiotherapy
Epidermal Growth Factor Receptor
Maintenance
Morbidity
Lung
Skin
Troponin
Esophagitis
Cetuximab
Acne Vulgaris
Embolism
Sample Size
Disease-Free Survival
Disease Progression
Cohort Studies

Keywords

  • Cetuximab
  • EGFR
  • Performance status
  • Radiosensitization
  • Stage III non-small cell lung cancer

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

A pilot study (SWOG S0429) of weekly cetuximab and chest radiotherapy for poor-risk stage III non-small cell lung cancer. / Chen, Yuhchyau; Moon, James; Pandya, Kishan J.; Lau, Derick H; Kelly, Karen; Hirsch, Fred R.; Gaspar, Laurie E.; Redman, Mary; Gandara, David R.

In: Frontiers in Oncology, Vol. 3 AUG, 00219, 2013.

Research output: Contribution to journalArticle

Chen, Yuhchyau ; Moon, James ; Pandya, Kishan J. ; Lau, Derick H ; Kelly, Karen ; Hirsch, Fred R. ; Gaspar, Laurie E. ; Redman, Mary ; Gandara, David R. / A pilot study (SWOG S0429) of weekly cetuximab and chest radiotherapy for poor-risk stage III non-small cell lung cancer. In: Frontiers in Oncology. 2013 ; Vol. 3 AUG.
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abstract = "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, EGFR, Performance status, Radiosensitization, Stage III non-small cell lung cancer",
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T1 - A pilot study (SWOG S0429) of weekly cetuximab and chest radiotherapy for poor-risk stage III non-small cell lung cancer

AU - Chen, Yuhchyau

AU - Moon, James

AU - Pandya, Kishan J.

AU - Lau, Derick H

AU - Kelly, Karen

AU - Hirsch, Fred R.

AU - Gaspar, Laurie E.

AU - Redman, Mary

AU - Gandara, David R

PY - 2013

Y1 - 2013

N2 - 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.

AB - 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.

KW - Cetuximab

KW - EGFR

KW - Performance status

KW - Radiosensitization

KW - Stage III non-small cell lung cancer

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