TY - JOUR
T1 - Final Results of NRG Oncology RTOG 0246
T2 - An Organ-Preserving Selective Resection Strategy in Esophageal Cancer Patients Treated with Definitive Chemoradiation
AU - Swisher, Stephen G.
AU - Moughan, Jennifer
AU - Komaki, Ritsuko U.
AU - Ajani, Jaffer A.
AU - Wu, Tsung T.
AU - Hofstetter, Wayne L.
AU - Konski, Andre A.
AU - Willett, Christopher G.
N1 - Funding Information:
This project was supported by grants U10CA21661, U10CA37422, U10CA180868, and U10CA180822 from the National Cancer Institute. The authors thank Ms. Wanda Reese for assistance in preparing the manuscript. Dr. Ajani, Ms. Moughan, and Dr. Willett were responsible for administrative support. Ms. Kathryn Winter and Dr. Komaki (Radiotherapy: QA) were responsible for collection and assembly of data. Dr. Swisher, Ms. Moughan, and Ms. Winter were responsible for data analysis and interpretation. Dr. Swisher, Ms. Moughan, and Drs. Komaki, Ajani, Wu, Hofstetter, Konski, and Willett were responsible for manuscript writing. Drs. Swisher, Ajani, Komaki, Wu, Willett, and Komaki were responsible for conception and design.
Publisher Copyright:
© 2016 International Association for the Study of Lung Cancer
PY - 2017/2/1
Y1 - 2017/2/1
N2 - Introduction The impact of selective surgical resection for patients with esophageal cancer treated with definitive chemoradiation has not been clearly evaluated long-term. Methods NRG (National Surgical Adjuvant Breast and Bowel Project, Radiation Therapy Oncology Group, Gynecologic Oncology Group) Oncology Radiation Therapy Oncology Group 0246 was a multi-institutional, single-arm, open-label, nonrandomized phase II study that enrolled 43 patients from September 2003 to March 2008 with clinical stage T1–4N0–1M0 squamous cell or adenocarcinoma of the esophagus or gastroesophageal junction from 19 sites. Patients received induction chemotherapy with fluorouracil (650 mg/m2/d), cisplatin (15 mg/m2/d), and paclitaxel (200 mg/m2/d) for two cycles followed by concurrent chemoradiation consisting of 50.4 Gy of radiation (1.8 Gy per fraction) and daily fluorouracil (300 mg/m2/d) with cisplatin (15 mg/m2/d) over the first 5 days. After definitive chemoradiation, patients were evaluated for residual disease. Selective esophagectomy was considered only for patients with residual disease after chemoradiation (clinical incomplete response) or recurrent disease on surveillance. Results This report looks at the long-term outcome of this selective surgical strategy. With a median follow-up of 8.1 years (minimum to maximum for 12 alive patients 7.2–9.8 years), the estimated 5- and 7-year survival rates are 36.6% (95% confidence interval [CI]: 22.3–51.0) and 31.7% (95% CI: 18.3–46.0). Clinical complete response was achieved in 15 patients (37%), with 5- and 7-yearr survival rates of 53.3% (95% CI: 26.3–74.4) and 46.7% (95% CI: 21.2–68.7). Esophageal resection was not required in 20 of 41 patients (49%) on this trial. Conclusions The long-term results of NRG Oncology Radiation Therapy Oncology Group 0246 demonstrate promising efficacy of a selective surgical resection strategy and suggest the need for larger randomized studies to further evaluate this organ-preserving approach.
AB - Introduction The impact of selective surgical resection for patients with esophageal cancer treated with definitive chemoradiation has not been clearly evaluated long-term. Methods NRG (National Surgical Adjuvant Breast and Bowel Project, Radiation Therapy Oncology Group, Gynecologic Oncology Group) Oncology Radiation Therapy Oncology Group 0246 was a multi-institutional, single-arm, open-label, nonrandomized phase II study that enrolled 43 patients from September 2003 to March 2008 with clinical stage T1–4N0–1M0 squamous cell or adenocarcinoma of the esophagus or gastroesophageal junction from 19 sites. Patients received induction chemotherapy with fluorouracil (650 mg/m2/d), cisplatin (15 mg/m2/d), and paclitaxel (200 mg/m2/d) for two cycles followed by concurrent chemoradiation consisting of 50.4 Gy of radiation (1.8 Gy per fraction) and daily fluorouracil (300 mg/m2/d) with cisplatin (15 mg/m2/d) over the first 5 days. After definitive chemoradiation, patients were evaluated for residual disease. Selective esophagectomy was considered only for patients with residual disease after chemoradiation (clinical incomplete response) or recurrent disease on surveillance. Results This report looks at the long-term outcome of this selective surgical strategy. With a median follow-up of 8.1 years (minimum to maximum for 12 alive patients 7.2–9.8 years), the estimated 5- and 7-year survival rates are 36.6% (95% confidence interval [CI]: 22.3–51.0) and 31.7% (95% CI: 18.3–46.0). Clinical complete response was achieved in 15 patients (37%), with 5- and 7-yearr survival rates of 53.3% (95% CI: 26.3–74.4) and 46.7% (95% CI: 21.2–68.7). Esophageal resection was not required in 20 of 41 patients (49%) on this trial. Conclusions The long-term results of NRG Oncology Radiation Therapy Oncology Group 0246 demonstrate promising efficacy of a selective surgical resection strategy and suggest the need for larger randomized studies to further evaluate this organ-preserving approach.
KW - Definitive chemoradiation
KW - Esophageal cancer
KW - Gastroesophageal junction
KW - Selective esophagectomy
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U2 - 10.1016/j.jtho.2016.10.002
DO - 10.1016/j.jtho.2016.10.002
M3 - Article
C2 - 27729298
AN - SCOPUS:85015319052
SN - 1556-0864
VL - 12
SP - 368
EP - 374
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 2
ER -