A phase II study of a paclitaxel-based chemoradiation regimen with selective surgical salvage for resectable locoregionally advanced esophageal cancer

Initial reporting of RTOG 0246

Stephen G. Swisher, Kathryn A. Winter, Ritsuko U. Komaki, Jaffer A. Ajani, Tsung T. Wu, Wayne L. Hofstetter, Andre A. Konski, Christopher G. Willett

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Abstract

Purpose: The strategy of definitive chemoradiation with selective surgical salvage in locoregionally advanced esophageal cancer was evaluated in a Phase II trial in Radiation Therapy Oncology Group (RTOG)-affiliated sites. Methods and Materials: The study was designed to detect an improvement in 1-year survival from 60% to 77.5% (α = 0.05; power = 80%). Definitive chemoradiation involved induction chemotherapy with 5-fluorouracil (5-FU) (650 mg/mg 2/day), cisplatin (15 mg/mg 2/day), and paclitaxel (200 mg/mg 2/day) for two cycles, followed by concurrent chemoradiation with 50.4 Gy (1.8 Gy/fraction) and daily 5-FU (300 mg/mg 2/day) with cisplatin (15 mg/mg 2/day) over the first 5 days. Salvage surgical resection was considered for patients with residual or recurrent esophageal cancer who did not have systemic disease. Results: Forty-three patients with nonmetastatic resectable esophageal cancer were entered from Sept 2003 to March 2006. Forty-one patients were eligible for analysis. Clinical stage was ≥T3 in 31 patients (76%) and N1 in 29 patients (71%), with adenocarcinoma histology in 30 patients (73%). Thirty-seven patients (90%) completed induction chemotherapy followed by concurrent chemoradiation. Twenty-eight patients (68%) experienced Grade 3+ nonhematologic toxicity. Four treatment-related deaths were noted. Twenty-one patients underwent surgery following definitive chemoradiation because of residual (17 patients) or recurrent (3 patients) esophageal cancer,and 1 patient because of choice. Median follow-up of live patients was 22 months, with an estimated 1-year survival of 71%. Conclusions: In this Phase II trial (RTOG 0246) evaluating selective surgical salvage after definitive chemoradiation in locoregionally advanced esophageal cancer, the hypothesized 1-year RTOG survival rate (77.5%) was not achieved (1 year, 71%; 95% confidence interval< 54%-82%).

Original languageEnglish (US)
Pages (from-to)1967-1972
Number of pages6
JournalInternational Journal of Radiation Oncology Biology Physics
Volume82
Issue number5
DOIs
StatePublished - Apr 1 2012

Fingerprint

Radiation Oncology
Esophageal Neoplasms
Paclitaxel
radiation therapy
Radiotherapy
cancer
Induction Chemotherapy
chemotherapy
Fluorouracil
Cisplatin
induction
Survival
histology
death
surgery
toxicity
confidence
grade
Histology
Adenocarcinoma

Keywords

  • Chemoradiation
  • Chemotherapy
  • Esophageal cancer
  • Radiation therapy
  • Salvage surgery

ASJC Scopus subject areas

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

Cite this

A phase II study of a paclitaxel-based chemoradiation regimen with selective surgical salvage for resectable locoregionally advanced esophageal cancer : Initial reporting of RTOG 0246. / Swisher, Stephen G.; Winter, Kathryn A.; Komaki, Ritsuko U.; Ajani, Jaffer A.; Wu, Tsung T.; Hofstetter, Wayne L.; Konski, Andre A.; Willett, Christopher G.

In: International Journal of Radiation Oncology Biology Physics, Vol. 82, No. 5, 01.04.2012, p. 1967-1972.

Research output: Contribution to journalArticle

Swisher, Stephen G. ; Winter, Kathryn A. ; Komaki, Ritsuko U. ; Ajani, Jaffer A. ; Wu, Tsung T. ; Hofstetter, Wayne L. ; Konski, Andre A. ; Willett, Christopher G. / A phase II study of a paclitaxel-based chemoradiation regimen with selective surgical salvage for resectable locoregionally advanced esophageal cancer : Initial reporting of RTOG 0246. In: International Journal of Radiation Oncology Biology Physics. 2012 ; Vol. 82, No. 5. pp. 1967-1972.
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abstract = "Purpose: The strategy of definitive chemoradiation with selective surgical salvage in locoregionally advanced esophageal cancer was evaluated in a Phase II trial in Radiation Therapy Oncology Group (RTOG)-affiliated sites. Methods and Materials: The study was designed to detect an improvement in 1-year survival from 60{\%} to 77.5{\%} (α = 0.05; power = 80{\%}). Definitive chemoradiation involved induction chemotherapy with 5-fluorouracil (5-FU) (650 mg/mg 2/day), cisplatin (15 mg/mg 2/day), and paclitaxel (200 mg/mg 2/day) for two cycles, followed by concurrent chemoradiation with 50.4 Gy (1.8 Gy/fraction) and daily 5-FU (300 mg/mg 2/day) with cisplatin (15 mg/mg 2/day) over the first 5 days. Salvage surgical resection was considered for patients with residual or recurrent esophageal cancer who did not have systemic disease. Results: Forty-three patients with nonmetastatic resectable esophageal cancer were entered from Sept 2003 to March 2006. Forty-one patients were eligible for analysis. Clinical stage was ≥T3 in 31 patients (76{\%}) and N1 in 29 patients (71{\%}), with adenocarcinoma histology in 30 patients (73{\%}). Thirty-seven patients (90{\%}) completed induction chemotherapy followed by concurrent chemoradiation. Twenty-eight patients (68{\%}) experienced Grade 3+ nonhematologic toxicity. Four treatment-related deaths were noted. Twenty-one patients underwent surgery following definitive chemoradiation because of residual (17 patients) or recurrent (3 patients) esophageal cancer,and 1 patient because of choice. Median follow-up of live patients was 22 months, with an estimated 1-year survival of 71{\%}. Conclusions: In this Phase II trial (RTOG 0246) evaluating selective surgical salvage after definitive chemoradiation in locoregionally advanced esophageal cancer, the hypothesized 1-year RTOG survival rate (77.5{\%}) was not achieved (1 year, 71{\%}; 95{\%} confidence interval< 54{\%}-82{\%}).",
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AB - Purpose: The strategy of definitive chemoradiation with selective surgical salvage in locoregionally advanced esophageal cancer was evaluated in a Phase II trial in Radiation Therapy Oncology Group (RTOG)-affiliated sites. Methods and Materials: The study was designed to detect an improvement in 1-year survival from 60% to 77.5% (α = 0.05; power = 80%). Definitive chemoradiation involved induction chemotherapy with 5-fluorouracil (5-FU) (650 mg/mg 2/day), cisplatin (15 mg/mg 2/day), and paclitaxel (200 mg/mg 2/day) for two cycles, followed by concurrent chemoradiation with 50.4 Gy (1.8 Gy/fraction) and daily 5-FU (300 mg/mg 2/day) with cisplatin (15 mg/mg 2/day) over the first 5 days. Salvage surgical resection was considered for patients with residual or recurrent esophageal cancer who did not have systemic disease. Results: Forty-three patients with nonmetastatic resectable esophageal cancer were entered from Sept 2003 to March 2006. Forty-one patients were eligible for analysis. Clinical stage was ≥T3 in 31 patients (76%) and N1 in 29 patients (71%), with adenocarcinoma histology in 30 patients (73%). Thirty-seven patients (90%) completed induction chemotherapy followed by concurrent chemoradiation. Twenty-eight patients (68%) experienced Grade 3+ nonhematologic toxicity. Four treatment-related deaths were noted. Twenty-one patients underwent surgery following definitive chemoradiation because of residual (17 patients) or recurrent (3 patients) esophageal cancer,and 1 patient because of choice. Median follow-up of live patients was 22 months, with an estimated 1-year survival of 71%. Conclusions: In this Phase II trial (RTOG 0246) evaluating selective surgical salvage after definitive chemoradiation in locoregionally advanced esophageal cancer, the hypothesized 1-year RTOG survival rate (77.5%) was not achieved (1 year, 71%; 95% confidence interval< 54%-82%).

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