Excessive toxicity when treating central tumors in a phase II study of stereotactic body radiation therapy for medically inoperable early-stage lung cancer

Robert Timmerman, Ronald McGarry, Constantin Yiannoutsos, Lech Papiez, Kathy Tudor, Jill DeLuca, Marvene Ewing, Ramzi Abdulrahman, Colleen DesRosiers, Mark Williams, James Fletcher

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Abstract

Purpose: Surgical resection is standard therapy in stage I non-small-cell lung cancer (NSCLC); however, many patients are inoperable due to comorbid diseases. Building on a previously reported phase I trial, we carried out a prospective phase II trial using stereotactic body radiation therapy (SBRT) in this population. Patients and Methods: Eligible patients included clinically staged T1 orT2 (≤ 7 cm), NO, M0, biopsy-confirmed NSCLC. All patients had comorbid medical problems that precluded lobectomy. SBRT treatment dose was 60 to 66 Gy total in three fractions during 1 to 2 weeks. Results: All 70 patients enrolled completed therapy as planned and median follow-up was 17.5 months. The 3-month major response rate was 60%. Kaplan-Meier local control at 2 years was 95%. Altogether, 28 patients have died as a result of cancer (n = 5), treatment (n = 6), or comorbid illnesses (n = 17). Median overall survival was 32.6 months and 2-year overall survival was 54.7%. Grade 3 to 5 toxicity occurred in a total of 14 patients. Among patients experiencing toxicity, the median time to observation was 10.5 months. Patients treated for tumors in the peripheral lung had 2-year freedom from severe toxicity of 83% compared with only 54% for patients with central tumors. Conclusion: High rates of local control are achieved with this SBRT regimen in medically inoperable patients with stage I NSCLC. Both local recurrence and toxicity occur late after this treatment. This regimen should not be used for patients with tumors near the central airways due to excessive toxicity.

Original languageEnglish (US)
Pages (from-to)4833-4839
Number of pages7
JournalJournal of Clinical Oncology
Volume24
Issue number30
DOIs
StatePublished - Oct 20 2006

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Lung Neoplasms
Radiotherapy
Neoplasms
Non-Small Cell Lung Carcinoma
Therapeutics
Survival
Observation
Biopsy
Recurrence
Lung

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Excessive toxicity when treating central tumors in a phase II study of stereotactic body radiation therapy for medically inoperable early-stage lung cancer. / Timmerman, Robert; McGarry, Ronald; Yiannoutsos, Constantin; Papiez, Lech; Tudor, Kathy; DeLuca, Jill; Ewing, Marvene; Abdulrahman, Ramzi; DesRosiers, Colleen; Williams, Mark; Fletcher, James.

In: Journal of Clinical Oncology, Vol. 24, No. 30, 20.10.2006, p. 4833-4839.

Research output: Contribution to journalArticle

Timmerman, Robert ; McGarry, Ronald ; Yiannoutsos, Constantin ; Papiez, Lech ; Tudor, Kathy ; DeLuca, Jill ; Ewing, Marvene ; Abdulrahman, Ramzi ; DesRosiers, Colleen ; Williams, Mark ; Fletcher, James. / Excessive toxicity when treating central tumors in a phase II study of stereotactic body radiation therapy for medically inoperable early-stage lung cancer. In: Journal of Clinical Oncology. 2006 ; Vol. 24, No. 30. pp. 4833-4839.
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abstract = "Purpose: Surgical resection is standard therapy in stage I non-small-cell lung cancer (NSCLC); however, many patients are inoperable due to comorbid diseases. Building on a previously reported phase I trial, we carried out a prospective phase II trial using stereotactic body radiation therapy (SBRT) in this population. Patients and Methods: Eligible patients included clinically staged T1 orT2 (≤ 7 cm), NO, M0, biopsy-confirmed NSCLC. All patients had comorbid medical problems that precluded lobectomy. SBRT treatment dose was 60 to 66 Gy total in three fractions during 1 to 2 weeks. Results: All 70 patients enrolled completed therapy as planned and median follow-up was 17.5 months. The 3-month major response rate was 60{\%}. Kaplan-Meier local control at 2 years was 95{\%}. Altogether, 28 patients have died as a result of cancer (n = 5), treatment (n = 6), or comorbid illnesses (n = 17). Median overall survival was 32.6 months and 2-year overall survival was 54.7{\%}. Grade 3 to 5 toxicity occurred in a total of 14 patients. Among patients experiencing toxicity, the median time to observation was 10.5 months. Patients treated for tumors in the peripheral lung had 2-year freedom from severe toxicity of 83{\%} compared with only 54{\%} for patients with central tumors. Conclusion: High rates of local control are achieved with this SBRT regimen in medically inoperable patients with stage I NSCLC. Both local recurrence and toxicity occur late after this treatment. This regimen should not be used for patients with tumors near the central airways due to excessive toxicity.",
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AU - Timmerman, Robert

AU - McGarry, Ronald

AU - Yiannoutsos, Constantin

AU - Papiez, Lech

AU - Tudor, Kathy

AU - DeLuca, Jill

AU - Ewing, Marvene

AU - Abdulrahman, Ramzi

AU - DesRosiers, Colleen

AU - Williams, Mark

AU - Fletcher, James

PY - 2006/10/20

Y1 - 2006/10/20

N2 - Purpose: Surgical resection is standard therapy in stage I non-small-cell lung cancer (NSCLC); however, many patients are inoperable due to comorbid diseases. Building on a previously reported phase I trial, we carried out a prospective phase II trial using stereotactic body radiation therapy (SBRT) in this population. Patients and Methods: Eligible patients included clinically staged T1 orT2 (≤ 7 cm), NO, M0, biopsy-confirmed NSCLC. All patients had comorbid medical problems that precluded lobectomy. SBRT treatment dose was 60 to 66 Gy total in three fractions during 1 to 2 weeks. Results: All 70 patients enrolled completed therapy as planned and median follow-up was 17.5 months. The 3-month major response rate was 60%. Kaplan-Meier local control at 2 years was 95%. Altogether, 28 patients have died as a result of cancer (n = 5), treatment (n = 6), or comorbid illnesses (n = 17). Median overall survival was 32.6 months and 2-year overall survival was 54.7%. Grade 3 to 5 toxicity occurred in a total of 14 patients. Among patients experiencing toxicity, the median time to observation was 10.5 months. Patients treated for tumors in the peripheral lung had 2-year freedom from severe toxicity of 83% compared with only 54% for patients with central tumors. Conclusion: High rates of local control are achieved with this SBRT regimen in medically inoperable patients with stage I NSCLC. Both local recurrence and toxicity occur late after this treatment. This regimen should not be used for patients with tumors near the central airways due to excessive toxicity.

AB - Purpose: Surgical resection is standard therapy in stage I non-small-cell lung cancer (NSCLC); however, many patients are inoperable due to comorbid diseases. Building on a previously reported phase I trial, we carried out a prospective phase II trial using stereotactic body radiation therapy (SBRT) in this population. Patients and Methods: Eligible patients included clinically staged T1 orT2 (≤ 7 cm), NO, M0, biopsy-confirmed NSCLC. All patients had comorbid medical problems that precluded lobectomy. SBRT treatment dose was 60 to 66 Gy total in three fractions during 1 to 2 weeks. Results: All 70 patients enrolled completed therapy as planned and median follow-up was 17.5 months. The 3-month major response rate was 60%. Kaplan-Meier local control at 2 years was 95%. Altogether, 28 patients have died as a result of cancer (n = 5), treatment (n = 6), or comorbid illnesses (n = 17). Median overall survival was 32.6 months and 2-year overall survival was 54.7%. Grade 3 to 5 toxicity occurred in a total of 14 patients. Among patients experiencing toxicity, the median time to observation was 10.5 months. Patients treated for tumors in the peripheral lung had 2-year freedom from severe toxicity of 83% compared with only 54% for patients with central tumors. Conclusion: High rates of local control are achieved with this SBRT regimen in medically inoperable patients with stage I NSCLC. Both local recurrence and toxicity occur late after this treatment. This regimen should not be used for patients with tumors near the central airways due to excessive toxicity.

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