Final report of intergroup trial 0122 (ECOG PE-289, RTOG 90-12): Phase II trial of neoadjuvant chemotherapy plus concurrent chemotherapy and high- dose radiation for squamous cell carcinoma of the esophagus

Bruce D. Minsky*, Donna Neuberg, David P. Kelsen, Thomas M. Pisansky, Robert J. Ginsberg, Thomas Pajak, Merle Salter, Al B Benson III

*Corresponding author for this work

Research output: Contribution to journalArticle

125 Citations (Scopus)

Abstract

Purpose: To determine the outcome of neoadjuvant chemotherapy followed by concurrent chemotherapy plus high-dose radiation therapy in patients with local/regional squamous cell carcinoma of the esophagus. Methods and Materials: Forty-five patients with clinical Stage T1-4N0-1M0 squamous cell carcinoma were entered on a prospective single-arm study, of which 38 were eligible. Patients received 3 monthly cycles of 5-FU (1000 mg/m2/24 h x 5 days) and cisplatin 100 mg/m2 day 1; neoadjuvant segment) followed by 2 additional monthly cycles of 5-FU (1000 mg/m2/24 h x 5 days) and cisplatin (75 mg/m2 day 1) plus concurrent 6480 cGy (combined modality segment). The median follow-up in surviving patients was 59 months. Results: For the 38 eligible patients, the primary tumor response rate was 47% complete, 8% partial, and 3% stable disease. The first site of clinical failure was 39% local/regional and 24% distant. For the total patient group, there were 6 deaths during treatment, of which 9% (4/45) were treatment related. The median survival was 20 months. Actuarial survival at 3 years was 30%, and at 5 years, 20%. Conclusion: This intensive neoadjuvant approach does not appear to offer a benefit compared with conventional doses and techniques of combined modality therapy. However, high dose radiation (6480 cGy) appears to be tolerable, and is being tested further in Intergroup Trial INT 0123.

Original languageEnglish (US)
Pages (from-to)517-523
Number of pages7
JournalInternational Journal of Radiation Oncology Biology Physics
Volume43
Issue number3
DOIs
StatePublished - Feb 1 1999

Fingerprint

esophagus
chemotherapy
Esophagus
Squamous Cell Carcinoma
cancer
Radiation
Drug Therapy
dosage
radiation
Fluorouracil
Cisplatin
Combined Modality Therapy
cycles
Survival
death
radiation therapy
therapy
Radiotherapy
tumors
Therapeutics

Keywords

  • Clinical trials
  • Combined modality therapy
  • Esophageal cancer
  • Neoadjuvant chemotherapy
  • Radiation therapy

ASJC Scopus subject areas

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

Cite this

@article{e69e6e4843de48dd938af6b8fc9120e5,
title = "Final report of intergroup trial 0122 (ECOG PE-289, RTOG 90-12): Phase II trial of neoadjuvant chemotherapy plus concurrent chemotherapy and high- dose radiation for squamous cell carcinoma of the esophagus",
abstract = "Purpose: To determine the outcome of neoadjuvant chemotherapy followed by concurrent chemotherapy plus high-dose radiation therapy in patients with local/regional squamous cell carcinoma of the esophagus. Methods and Materials: Forty-five patients with clinical Stage T1-4N0-1M0 squamous cell carcinoma were entered on a prospective single-arm study, of which 38 were eligible. Patients received 3 monthly cycles of 5-FU (1000 mg/m2/24 h x 5 days) and cisplatin 100 mg/m2 day 1; neoadjuvant segment) followed by 2 additional monthly cycles of 5-FU (1000 mg/m2/24 h x 5 days) and cisplatin (75 mg/m2 day 1) plus concurrent 6480 cGy (combined modality segment). The median follow-up in surviving patients was 59 months. Results: For the 38 eligible patients, the primary tumor response rate was 47{\%} complete, 8{\%} partial, and 3{\%} stable disease. The first site of clinical failure was 39{\%} local/regional and 24{\%} distant. For the total patient group, there were 6 deaths during treatment, of which 9{\%} (4/45) were treatment related. The median survival was 20 months. Actuarial survival at 3 years was 30{\%}, and at 5 years, 20{\%}. Conclusion: This intensive neoadjuvant approach does not appear to offer a benefit compared with conventional doses and techniques of combined modality therapy. However, high dose radiation (6480 cGy) appears to be tolerable, and is being tested further in Intergroup Trial INT 0123.",
keywords = "Clinical trials, Combined modality therapy, Esophageal cancer, Neoadjuvant chemotherapy, Radiation therapy",
author = "Minsky, {Bruce D.} and Donna Neuberg and Kelsen, {David P.} and Pisansky, {Thomas M.} and Ginsberg, {Robert J.} and Thomas Pajak and Merle Salter and {Benson III}, {Al B}",
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Final report of intergroup trial 0122 (ECOG PE-289, RTOG 90-12) : Phase II trial of neoadjuvant chemotherapy plus concurrent chemotherapy and high- dose radiation for squamous cell carcinoma of the esophagus. / Minsky, Bruce D.; Neuberg, Donna; Kelsen, David P.; Pisansky, Thomas M.; Ginsberg, Robert J.; Pajak, Thomas; Salter, Merle; Benson III, Al B.

In: International Journal of Radiation Oncology Biology Physics, Vol. 43, No. 3, 01.02.1999, p. 517-523.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Final report of intergroup trial 0122 (ECOG PE-289, RTOG 90-12)

T2 - Phase II trial of neoadjuvant chemotherapy plus concurrent chemotherapy and high- dose radiation for squamous cell carcinoma of the esophagus

AU - Minsky, Bruce D.

AU - Neuberg, Donna

AU - Kelsen, David P.

AU - Pisansky, Thomas M.

AU - Ginsberg, Robert J.

AU - Pajak, Thomas

AU - Salter, Merle

AU - Benson III, Al B

PY - 1999/2/1

Y1 - 1999/2/1

N2 - Purpose: To determine the outcome of neoadjuvant chemotherapy followed by concurrent chemotherapy plus high-dose radiation therapy in patients with local/regional squamous cell carcinoma of the esophagus. Methods and Materials: Forty-five patients with clinical Stage T1-4N0-1M0 squamous cell carcinoma were entered on a prospective single-arm study, of which 38 were eligible. Patients received 3 monthly cycles of 5-FU (1000 mg/m2/24 h x 5 days) and cisplatin 100 mg/m2 day 1; neoadjuvant segment) followed by 2 additional monthly cycles of 5-FU (1000 mg/m2/24 h x 5 days) and cisplatin (75 mg/m2 day 1) plus concurrent 6480 cGy (combined modality segment). The median follow-up in surviving patients was 59 months. Results: For the 38 eligible patients, the primary tumor response rate was 47% complete, 8% partial, and 3% stable disease. The first site of clinical failure was 39% local/regional and 24% distant. For the total patient group, there were 6 deaths during treatment, of which 9% (4/45) were treatment related. The median survival was 20 months. Actuarial survival at 3 years was 30%, and at 5 years, 20%. Conclusion: This intensive neoadjuvant approach does not appear to offer a benefit compared with conventional doses and techniques of combined modality therapy. However, high dose radiation (6480 cGy) appears to be tolerable, and is being tested further in Intergroup Trial INT 0123.

AB - Purpose: To determine the outcome of neoadjuvant chemotherapy followed by concurrent chemotherapy plus high-dose radiation therapy in patients with local/regional squamous cell carcinoma of the esophagus. Methods and Materials: Forty-five patients with clinical Stage T1-4N0-1M0 squamous cell carcinoma were entered on a prospective single-arm study, of which 38 were eligible. Patients received 3 monthly cycles of 5-FU (1000 mg/m2/24 h x 5 days) and cisplatin 100 mg/m2 day 1; neoadjuvant segment) followed by 2 additional monthly cycles of 5-FU (1000 mg/m2/24 h x 5 days) and cisplatin (75 mg/m2 day 1) plus concurrent 6480 cGy (combined modality segment). The median follow-up in surviving patients was 59 months. Results: For the 38 eligible patients, the primary tumor response rate was 47% complete, 8% partial, and 3% stable disease. The first site of clinical failure was 39% local/regional and 24% distant. For the total patient group, there were 6 deaths during treatment, of which 9% (4/45) were treatment related. The median survival was 20 months. Actuarial survival at 3 years was 30%, and at 5 years, 20%. Conclusion: This intensive neoadjuvant approach does not appear to offer a benefit compared with conventional doses and techniques of combined modality therapy. However, high dose radiation (6480 cGy) appears to be tolerable, and is being tested further in Intergroup Trial INT 0123.

KW - Clinical trials

KW - Combined modality therapy

KW - Esophageal cancer

KW - Neoadjuvant chemotherapy

KW - Radiation therapy

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