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Local Control and Toxicity of a Simultaneous Integrated Boost for Dose Escalation in Locally Advanced Esophageal Cancer: Interim Results from a Prospective Phase I/II Trial.
J Thorac Oncol 2017; 12(2):375-382JT

Abstract

INTRODUCTION

Approximately 50% of recurrences after standard-dose chemoradiation for locally advanced esophageal cancer occur within the gross tumor volume (GTV). In this prospective phase I/II clinical trial, we explored the use of a simultaneous integrated boost (SIB) dose to the GTV.

METHODS

Forty-four patients with unresectable esophageal cancer received chemoradiation with an SIB of 58.8 to 63 Gy to the GTV and 50.4 Gy to the planning target volume, all in 28 fractions, with 5 weeks of concurrent docetaxel and fluorouracil or capecitabine. The end points were maximum tolerated dose, time to local failure, and clinical response.

RESULTS

Excluding those with less than 6 months of follow-up, 38 patients were evaluated at the time of analysis. The median age was 65 years (range 37-84). Most patients (71%) were men; 84% had T3 disease, 37% had N1 disease, 26% had N2 disease, 13% had M1 disease, and 50% had adenocarcinoma. The maximum tolerated SIB dose was 63 Gy. None experienced Common Terminology Criteria for Adverse Events grade 4 or 5 toxicity. At a median follow-up time of 13.3 months (range 1.2-36.2), 11 (29%) had local failure (median time to local failure 2.5 months [range 1.5-23.9]). A comparison with 97 similar patients who received 50.4 Gy without an SIB showed that the SIB reduced the local failure rate for patients with node-positive disease (13% versus 56%, p = 0.04), adenocarcinoma (26% versus 59%, p = 0.02), or stage III-IV disease (29% versus 55%, p = 0.04).

CONCLUSIONS

SIB intensity-modulated radiation therapy to gross primary disease may improve local control for patients with unresectable locally advanced esophageal cancer, especially those with adenocarcinoma.

Authors+Show Affiliations

Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas. Electronic address: jwelsh@mdanderson.org.Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.Department of Thoracic and Cardiovascular Surgery, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.Department of Gastrointestinal Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.Department of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado.Division of Surgery, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.Department of Gastrointestinal Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.Department of Diagnostic Radiology-Thoracic Imaging, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.Department of Gastroenterology, Hepatology, Nutrition, University of Texas M. D. Anderson Cancer Center, Houston, Texas.Department of Gastroenterology, Hepatology, Nutrition, University of Texas M. D. Anderson Cancer Center, Houston, Texas.Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.

Pub Type(s)

Clinical Trial, Phase I
Clinical Trial, Phase II
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27794500

Citation

Welsh, James W., et al. "Local Control and Toxicity of a Simultaneous Integrated Boost for Dose Escalation in Locally Advanced Esophageal Cancer: Interim Results From a Prospective Phase I/II Trial." Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer, vol. 12, no. 2, 2017, pp. 375-382.
Welsh JW, Seyedin SN, Allen PK, et al. Local Control and Toxicity of a Simultaneous Integrated Boost for Dose Escalation in Locally Advanced Esophageal Cancer: Interim Results from a Prospective Phase I/II Trial. J Thorac Oncol. 2017;12(2):375-382.
Welsh, J. W., Seyedin, S. N., Allen, P. K., Hofstetter, W. L., Ajani, J. A., Chang, J. Y., ... Komaki, R. U. (2017). Local Control and Toxicity of a Simultaneous Integrated Boost for Dose Escalation in Locally Advanced Esophageal Cancer: Interim Results from a Prospective Phase I/II Trial. Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer, 12(2), pp. 375-382. doi:10.1016/j.jtho.2016.10.013.
Welsh JW, et al. Local Control and Toxicity of a Simultaneous Integrated Boost for Dose Escalation in Locally Advanced Esophageal Cancer: Interim Results From a Prospective Phase I/II Trial. J Thorac Oncol. 2017;12(2):375-382. PubMed PMID: 27794500.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Local Control and Toxicity of a Simultaneous Integrated Boost for Dose Escalation in Locally Advanced Esophageal Cancer: Interim Results from a Prospective Phase I/II Trial. AU - Welsh,James W, AU - Seyedin,Steven N, AU - Allen,Pamela K, AU - Hofstetter,Wayne L, AU - Ajani,Jaffer A, AU - Chang,Joe Y, AU - Gomez,Daniel R, AU - Amini,Arya, AU - Swisher,Stephen G, AU - Blum,Mariela A, AU - Younes,Ahmed I, AU - Nguyen,Quynh-Nhu, AU - Minsky,Bruce D, AU - Erasmus,Jeremy J, AU - Lee,Jeffrey H, AU - Bhutani,Manoop, AU - Komaki,Ritsuko U, Y1 - 2016/10/26/ PY - 2016/09/01/received PY - 2016/10/12/revised PY - 2016/10/15/accepted PY - 2016/10/31/pubmed PY - 2017/11/29/medline PY - 2016/10/31/entrez KW - Adenocarcinoma KW - Dose escalation KW - Esophageal cancer KW - Local control KW - Simultaneous integrated boost SP - 375 EP - 382 JF - Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer JO - J Thorac Oncol VL - 12 IS - 2 N2 - INTRODUCTION: Approximately 50% of recurrences after standard-dose chemoradiation for locally advanced esophageal cancer occur within the gross tumor volume (GTV). In this prospective phase I/II clinical trial, we explored the use of a simultaneous integrated boost (SIB) dose to the GTV. METHODS: Forty-four patients with unresectable esophageal cancer received chemoradiation with an SIB of 58.8 to 63 Gy to the GTV and 50.4 Gy to the planning target volume, all in 28 fractions, with 5 weeks of concurrent docetaxel and fluorouracil or capecitabine. The end points were maximum tolerated dose, time to local failure, and clinical response. RESULTS: Excluding those with less than 6 months of follow-up, 38 patients were evaluated at the time of analysis. The median age was 65 years (range 37-84). Most patients (71%) were men; 84% had T3 disease, 37% had N1 disease, 26% had N2 disease, 13% had M1 disease, and 50% had adenocarcinoma. The maximum tolerated SIB dose was 63 Gy. None experienced Common Terminology Criteria for Adverse Events grade 4 or 5 toxicity. At a median follow-up time of 13.3 months (range 1.2-36.2), 11 (29%) had local failure (median time to local failure 2.5 months [range 1.5-23.9]). A comparison with 97 similar patients who received 50.4 Gy without an SIB showed that the SIB reduced the local failure rate for patients with node-positive disease (13% versus 56%, p = 0.04), adenocarcinoma (26% versus 59%, p = 0.02), or stage III-IV disease (29% versus 55%, p = 0.04). CONCLUSIONS: SIB intensity-modulated radiation therapy to gross primary disease may improve local control for patients with unresectable locally advanced esophageal cancer, especially those with adenocarcinoma. SN - 1556-1380 UR - https://www.unboundmedicine.com/medline/citation/27794500/Local_Control_and_Toxicity_of_a_Simultaneous_Integrated_Boost_for_Dose_Escalation_in_Locally_Advanced_Esophageal_Cancer:_Interim_Results_from_a_Prospective_Phase_I/II_Trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1556-0864(16)31178-9 DB - PRIME DP - Unbound Medicine ER -