Phase II study of accelerated high-dose radiotherapy with concurrent chemotherapy for patients with limited small-cell lung cancer: Radiation Therapy Oncology Group protocol 0239

Ritsuko Komaki, Rebecca Paulus, David S. Ettinger, Gregory M M Videtic, Jeffrey D. Bradley, Bonnie S. Glisson, Corey J. Langer, William T. Sause, Walter J. Curran, Hak Choy

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Abstract

Purpose: To investigate whether high-dose thoracic radiation given twice daily during cisplatin-etoposide chemotherapy for limited small-cell lung cancer (LSCLC) improves survival, acute esophagitis, and local control rates relative to findings from Intergroup trial 0096 (47%, 27%, and 64%). Patients and Methods: Patients were accrued over a 3-year period from 22 US and Canadian institutions. Patients with LSCLC and good performance status were given thoracic radiation to 61.2 Gy over 5 weeks (daily 1.8-Gy fractions on days 1-22, then twice-daily 1.8-Gy fractions on days 23-33). Cisplatin (60 mg/m 2 IV) was given on day 1 and etoposide (120 mg/m 2 IV) on days 1-3 and days 22-24, followed by 2 cycles of cisplatin plus etoposide alone. Patients who achieved complete response were offered prophylactic cranial irradiation. Endpoints included overall and progression-free survival; severe esophagitis (Common Toxicity Criteria v 2.0) and treatment-related fatalities; response (Response Evaluation Criteria in Solid Tumors); and local control. Results: Seventy-two patients were accrued from June 2003 through May 2006; 71 were evaluable (median age 63 years; 52% female; 58% Zubrod 0). Median survival time was 19 months; at 2 years, the overall survival rate was 36.6% (95% confidence interval [CI] 25.6%-47.7%), and progression-free survival 19.7% (95% CI 11.4%-29.6%). Thirteen patients (18%) experienced severe acute esophagitis, and 2 (3%) died of treatment-related causes; 41% achieved complete response, 39% partial response, 10% stable disease, and 6% progressive disease. The local control rate was 73%. Forty-three patients (61%) received prophylactic cranial irradiation. Conclusions: The overall survival rate did not reach the projected goal; however, rates of esophagitis were lower, and local control higher, than projected. This treatment strategy is now one of three arms of a prospective trial of chemoradiation for LSCLC (Radiation Therapy Oncology Group 0538/Cancer and Leukemia Group B 30610).

Original languageEnglish (US)
JournalInternational Journal of Radiation Oncology Biology Physics
Volume83
Issue number4
DOIs
StatePublished - Jul 15 2012

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Radiation Oncology
Small Cell Lung Carcinoma
chemotherapy
lungs
radiation therapy
Radiotherapy
cancer
Esophagitis
Drug Therapy
dosage
Etoposide
Cisplatin
Cranial Irradiation
progressions
Disease-Free Survival
confidence
Thorax
Survival Rate
Confidence Intervals
Radiation

Keywords

  • Cisplatin
  • Concomitant boost thoracic radiation
  • Etoposide
  • Limited-stage small-cell lung cancer

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Radiation
  • Cancer Research

Cite this

Phase II study of accelerated high-dose radiotherapy with concurrent chemotherapy for patients with limited small-cell lung cancer : Radiation Therapy Oncology Group protocol 0239. / Komaki, Ritsuko; Paulus, Rebecca; Ettinger, David S.; Videtic, Gregory M M; Bradley, Jeffrey D.; Glisson, Bonnie S.; Langer, Corey J.; Sause, William T.; Curran, Walter J.; Choy, Hak.

In: International Journal of Radiation Oncology Biology Physics, Vol. 83, No. 4, 15.07.2012.

Research output: Contribution to journalArticle

Komaki, Ritsuko ; Paulus, Rebecca ; Ettinger, David S. ; Videtic, Gregory M M ; Bradley, Jeffrey D. ; Glisson, Bonnie S. ; Langer, Corey J. ; Sause, William T. ; Curran, Walter J. ; Choy, Hak. / Phase II study of accelerated high-dose radiotherapy with concurrent chemotherapy for patients with limited small-cell lung cancer : Radiation Therapy Oncology Group protocol 0239. In: International Journal of Radiation Oncology Biology Physics. 2012 ; Vol. 83, No. 4.
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abstract = "Purpose: To investigate whether high-dose thoracic radiation given twice daily during cisplatin-etoposide chemotherapy for limited small-cell lung cancer (LSCLC) improves survival, acute esophagitis, and local control rates relative to findings from Intergroup trial 0096 (47{\%}, 27{\%}, and 64{\%}). Patients and Methods: Patients were accrued over a 3-year period from 22 US and Canadian institutions. Patients with LSCLC and good performance status were given thoracic radiation to 61.2 Gy over 5 weeks (daily 1.8-Gy fractions on days 1-22, then twice-daily 1.8-Gy fractions on days 23-33). Cisplatin (60 mg/m 2 IV) was given on day 1 and etoposide (120 mg/m 2 IV) on days 1-3 and days 22-24, followed by 2 cycles of cisplatin plus etoposide alone. Patients who achieved complete response were offered prophylactic cranial irradiation. Endpoints included overall and progression-free survival; severe esophagitis (Common Toxicity Criteria v 2.0) and treatment-related fatalities; response (Response Evaluation Criteria in Solid Tumors); and local control. Results: Seventy-two patients were accrued from June 2003 through May 2006; 71 were evaluable (median age 63 years; 52{\%} female; 58{\%} Zubrod 0). Median survival time was 19 months; at 2 years, the overall survival rate was 36.6{\%} (95{\%} confidence interval [CI] 25.6{\%}-47.7{\%}), and progression-free survival 19.7{\%} (95{\%} CI 11.4{\%}-29.6{\%}). Thirteen patients (18{\%}) experienced severe acute esophagitis, and 2 (3{\%}) died of treatment-related causes; 41{\%} achieved complete response, 39{\%} partial response, 10{\%} stable disease, and 6{\%} progressive disease. The local control rate was 73{\%}. Forty-three patients (61{\%}) received prophylactic cranial irradiation. Conclusions: The overall survival rate did not reach the projected goal; however, rates of esophagitis were lower, and local control higher, than projected. This treatment strategy is now one of three arms of a prospective trial of chemoradiation for LSCLC (Radiation Therapy Oncology Group 0538/Cancer and Leukemia Group B 30610).",
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AU - Paulus, Rebecca

AU - Ettinger, David S.

AU - Videtic, Gregory M M

AU - Bradley, Jeffrey D.

AU - Glisson, Bonnie S.

AU - Langer, Corey J.

AU - Sause, William T.

AU - Curran, Walter J.

AU - Choy, Hak

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N2 - Purpose: To investigate whether high-dose thoracic radiation given twice daily during cisplatin-etoposide chemotherapy for limited small-cell lung cancer (LSCLC) improves survival, acute esophagitis, and local control rates relative to findings from Intergroup trial 0096 (47%, 27%, and 64%). Patients and Methods: Patients were accrued over a 3-year period from 22 US and Canadian institutions. Patients with LSCLC and good performance status were given thoracic radiation to 61.2 Gy over 5 weeks (daily 1.8-Gy fractions on days 1-22, then twice-daily 1.8-Gy fractions on days 23-33). Cisplatin (60 mg/m 2 IV) was given on day 1 and etoposide (120 mg/m 2 IV) on days 1-3 and days 22-24, followed by 2 cycles of cisplatin plus etoposide alone. Patients who achieved complete response were offered prophylactic cranial irradiation. Endpoints included overall and progression-free survival; severe esophagitis (Common Toxicity Criteria v 2.0) and treatment-related fatalities; response (Response Evaluation Criteria in Solid Tumors); and local control. Results: Seventy-two patients were accrued from June 2003 through May 2006; 71 were evaluable (median age 63 years; 52% female; 58% Zubrod 0). Median survival time was 19 months; at 2 years, the overall survival rate was 36.6% (95% confidence interval [CI] 25.6%-47.7%), and progression-free survival 19.7% (95% CI 11.4%-29.6%). Thirteen patients (18%) experienced severe acute esophagitis, and 2 (3%) died of treatment-related causes; 41% achieved complete response, 39% partial response, 10% stable disease, and 6% progressive disease. The local control rate was 73%. Forty-three patients (61%) received prophylactic cranial irradiation. Conclusions: The overall survival rate did not reach the projected goal; however, rates of esophagitis were lower, and local control higher, than projected. This treatment strategy is now one of three arms of a prospective trial of chemoradiation for LSCLC (Radiation Therapy Oncology Group 0538/Cancer and Leukemia Group B 30610).

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