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A Pilot Study (SWOG S0429) of Weekly Cetuximab and Chest Radiotherapy for Poor-Risk Stage III Non-Small Cell Lung Cancer.

Chen Y, Moon J, Pandya KJ, Lau DH, Kelly K, Hirsch FR, Gaspar LE, Redman M, Gandara DR - Front Oncol (2013)

Bottom Line: 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.Further studies with larger sample sizes will be useful to establish the optimal therapeutic ratio of this regimen.

View Article: PubMed Central - PubMed

Affiliation: Department of Radiation Oncology, University of Rochester , Rochester, NY , USA.

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/m(2)) was delivered week 1, followed by weekly cetuximab (250 mg/m(2))/RT to 64.8 Gy in 1.8 Gy daily fractions, and maintenance weekly cetuximab (250 mg/m(2)) 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.

No MeSH data available.


Related in: MedlinePlus

A plot of Kaplan–Meier estimates of progression-free survival (PFS) of patients treated with concurrent cetuximab and chest radiation. PFS was defined as the time from the date of enrollment until the date of first documentation of disease progression (per RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact and are marked on the curve with a tic representing the last follow-up time.
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Figure 2: A plot of Kaplan–Meier estimates of progression-free survival (PFS) of patients treated with concurrent cetuximab and chest radiation. PFS was defined as the time from the date of enrollment until the date of first documentation of disease progression (per RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact and are marked on the curve with a tic representing the last follow-up time.

Mentions: As of April 11, 2012, four patients remained alive with a median follow-up of 25 months (range: 17–32 months). Kaplan–Meier OS estimate at 1-year survival was 55% (95% confidence interval: 32–72%) and the median OS estimate was 14 months (95% confidence interval: 8–24 months) (Figure 1). The estimated 1-year PFS was 18% (95% confidence interval: 6–36%) and the estimated median PFS was 8 months (95% confidence interval: 5–9 months) (Figure 2).


A Pilot Study (SWOG S0429) of Weekly Cetuximab and Chest Radiotherapy for Poor-Risk Stage III Non-Small Cell Lung Cancer.

Chen Y, Moon J, Pandya KJ, Lau DH, Kelly K, Hirsch FR, Gaspar LE, Redman M, Gandara DR - Front Oncol (2013)

A plot of Kaplan–Meier estimates of progression-free survival (PFS) of patients treated with concurrent cetuximab and chest radiation. PFS was defined as the time from the date of enrollment until the date of first documentation of disease progression (per RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact and are marked on the curve with a tic representing the last follow-up time.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3755267&req=5

Figure 2: A plot of Kaplan–Meier estimates of progression-free survival (PFS) of patients treated with concurrent cetuximab and chest radiation. PFS was defined as the time from the date of enrollment until the date of first documentation of disease progression (per RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact and are marked on the curve with a tic representing the last follow-up time.
Mentions: As of April 11, 2012, four patients remained alive with a median follow-up of 25 months (range: 17–32 months). Kaplan–Meier OS estimate at 1-year survival was 55% (95% confidence interval: 32–72%) and the median OS estimate was 14 months (95% confidence interval: 8–24 months) (Figure 1). The estimated 1-year PFS was 18% (95% confidence interval: 6–36%) and the estimated median PFS was 8 months (95% confidence interval: 5–9 months) (Figure 2).

Bottom Line: 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.Further studies with larger sample sizes will be useful to establish the optimal therapeutic ratio of this regimen.

View Article: PubMed Central - PubMed

Affiliation: Department of Radiation Oncology, University of Rochester , Rochester, NY , USA.

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/m(2)) was delivered week 1, followed by weekly cetuximab (250 mg/m(2))/RT to 64.8 Gy in 1.8 Gy daily fractions, and maintenance weekly cetuximab (250 mg/m(2)) 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.

No MeSH data available.


Related in: MedlinePlus