Neoadjuvant chemotherapy plus concurrent chemotherapy and high-dose radiation for squamous cell carcinoma of the esophagus: A preliminary analysis of the phase II intergroup trial 0122

B. D. Minsky*, D. Neuberg, D. P. Kelsen, T. M. Pisansky, R. Ginsberg, A. Benson

*Corresponding author for this work

Research output: Contribution to journalArticle

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Abstract

Purpose: To determine the preliminary acute toxicity and survival results of neoadjuvant chemotherapy followed by concurrent chemotherapy plus high- dose radiation therapy in patients with local/regional squamous cell carcinoma of the esophagus. Materials and Methods: Forty-five patients with clinical stage T1-4N0-1M0 squamous cell carcinoma were entered onto the trial. Eight patients were declared ineligible after registration. Patients received three monthly cycles of fluorouracil (5-FU; 1,000 mg/m2/24hr for 5 days) and cisplatin (100 mg/m2 on day 1) (neoadjuvant segment) followed by two additional monthly cycles of 5-FU (1,000 mg/m2/24hr for 5 days) and cisplatin (75 mg/m2 on day 1) plus concurrent 64.8 Gy (combined modality segment). Results: With a median follow-up of 15 months in surviving patients, the incidence of total grade 3+ toxicity during the neoadjuvant chemotherapy segment was 61%, and during the combined modality segment was 72%. Of the 33 patients who started radiation therapy, 91% were able to complete the full course. There were six deaths during treatment, five of which (11%), because of nadir sepsis and/or dehydration, were treatment- related. For the 37 eligible patients, the median disease-free survival duration was 9 months, and the overall median survival was 20 months. Conclusion: The preliminary analysis of this trial demonstrated that the incidence of grade 3+ toxicity was similar to that reported in the combined modality arm of the prior Radiation Therapy Oncology Group (RTOG) intergroup esophageal trial RTOG 85-01. However, because of the increased incidence of treatment-related mortality, this treatment program will not be used as an experimental arm of intergroup trial INT 0123 (RTOG 94-05).

Original languageEnglish (US)
Pages (from-to)149-155
Number of pages7
JournalJournal of Clinical Oncology
Volume14
Issue number1
DOIs
StatePublished - Jan 1 1996

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Esophagus
Squamous Cell Carcinoma
Radiation
Drug Therapy
Radiotherapy
Radiation Oncology
Fluorouracil
Cisplatin
Incidence
Survival
Therapeutics
Dehydration
Disease-Free Survival
Sepsis
Mortality

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

@article{b70d118468c64c99bd57ee6ada28f2a8,
title = "Neoadjuvant chemotherapy plus concurrent chemotherapy and high-dose radiation for squamous cell carcinoma of the esophagus: A preliminary analysis of the phase II intergroup trial 0122",
abstract = "Purpose: To determine the preliminary acute toxicity and survival results of neoadjuvant chemotherapy followed by concurrent chemotherapy plus high- dose radiation therapy in patients with local/regional squamous cell carcinoma of the esophagus. Materials and Methods: Forty-five patients with clinical stage T1-4N0-1M0 squamous cell carcinoma were entered onto the trial. Eight patients were declared ineligible after registration. Patients received three monthly cycles of fluorouracil (5-FU; 1,000 mg/m2/24hr for 5 days) and cisplatin (100 mg/m2 on day 1) (neoadjuvant segment) followed by two additional monthly cycles of 5-FU (1,000 mg/m2/24hr for 5 days) and cisplatin (75 mg/m2 on day 1) plus concurrent 64.8 Gy (combined modality segment). Results: With a median follow-up of 15 months in surviving patients, the incidence of total grade 3+ toxicity during the neoadjuvant chemotherapy segment was 61{\%}, and during the combined modality segment was 72{\%}. Of the 33 patients who started radiation therapy, 91{\%} were able to complete the full course. There were six deaths during treatment, five of which (11{\%}), because of nadir sepsis and/or dehydration, were treatment- related. For the 37 eligible patients, the median disease-free survival duration was 9 months, and the overall median survival was 20 months. Conclusion: The preliminary analysis of this trial demonstrated that the incidence of grade 3+ toxicity was similar to that reported in the combined modality arm of the prior Radiation Therapy Oncology Group (RTOG) intergroup esophageal trial RTOG 85-01. However, because of the increased incidence of treatment-related mortality, this treatment program will not be used as an experimental arm of intergroup trial INT 0123 (RTOG 94-05).",
author = "Minsky, {B. D.} and D. Neuberg and Kelsen, {D. P.} and Pisansky, {T. M.} and R. Ginsberg and A. Benson",
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Neoadjuvant chemotherapy plus concurrent chemotherapy and high-dose radiation for squamous cell carcinoma of the esophagus : A preliminary analysis of the phase II intergroup trial 0122. / Minsky, B. D.; Neuberg, D.; Kelsen, D. P.; Pisansky, T. M.; Ginsberg, R.; Benson, A.

In: Journal of Clinical Oncology, Vol. 14, No. 1, 01.01.1996, p. 149-155.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Neoadjuvant chemotherapy plus concurrent chemotherapy and high-dose radiation for squamous cell carcinoma of the esophagus

T2 - A preliminary analysis of the phase II intergroup trial 0122

AU - Minsky, B. D.

AU - Neuberg, D.

AU - Kelsen, D. P.

AU - Pisansky, T. M.

AU - Ginsberg, R.

AU - Benson, A.

PY - 1996/1/1

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N2 - Purpose: To determine the preliminary acute toxicity and survival results of neoadjuvant chemotherapy followed by concurrent chemotherapy plus high- dose radiation therapy in patients with local/regional squamous cell carcinoma of the esophagus. Materials and Methods: Forty-five patients with clinical stage T1-4N0-1M0 squamous cell carcinoma were entered onto the trial. Eight patients were declared ineligible after registration. Patients received three monthly cycles of fluorouracil (5-FU; 1,000 mg/m2/24hr for 5 days) and cisplatin (100 mg/m2 on day 1) (neoadjuvant segment) followed by two additional monthly cycles of 5-FU (1,000 mg/m2/24hr for 5 days) and cisplatin (75 mg/m2 on day 1) plus concurrent 64.8 Gy (combined modality segment). Results: With a median follow-up of 15 months in surviving patients, the incidence of total grade 3+ toxicity during the neoadjuvant chemotherapy segment was 61%, and during the combined modality segment was 72%. Of the 33 patients who started radiation therapy, 91% were able to complete the full course. There were six deaths during treatment, five of which (11%), because of nadir sepsis and/or dehydration, were treatment- related. For the 37 eligible patients, the median disease-free survival duration was 9 months, and the overall median survival was 20 months. Conclusion: The preliminary analysis of this trial demonstrated that the incidence of grade 3+ toxicity was similar to that reported in the combined modality arm of the prior Radiation Therapy Oncology Group (RTOG) intergroup esophageal trial RTOG 85-01. However, because of the increased incidence of treatment-related mortality, this treatment program will not be used as an experimental arm of intergroup trial INT 0123 (RTOG 94-05).

AB - Purpose: To determine the preliminary acute toxicity and survival results of neoadjuvant chemotherapy followed by concurrent chemotherapy plus high- dose radiation therapy in patients with local/regional squamous cell carcinoma of the esophagus. Materials and Methods: Forty-five patients with clinical stage T1-4N0-1M0 squamous cell carcinoma were entered onto the trial. Eight patients were declared ineligible after registration. Patients received three monthly cycles of fluorouracil (5-FU; 1,000 mg/m2/24hr for 5 days) and cisplatin (100 mg/m2 on day 1) (neoadjuvant segment) followed by two additional monthly cycles of 5-FU (1,000 mg/m2/24hr for 5 days) and cisplatin (75 mg/m2 on day 1) plus concurrent 64.8 Gy (combined modality segment). Results: With a median follow-up of 15 months in surviving patients, the incidence of total grade 3+ toxicity during the neoadjuvant chemotherapy segment was 61%, and during the combined modality segment was 72%. Of the 33 patients who started radiation therapy, 91% were able to complete the full course. There were six deaths during treatment, five of which (11%), because of nadir sepsis and/or dehydration, were treatment- related. For the 37 eligible patients, the median disease-free survival duration was 9 months, and the overall median survival was 20 months. Conclusion: The preliminary analysis of this trial demonstrated that the incidence of grade 3+ toxicity was similar to that reported in the combined modality arm of the prior Radiation Therapy Oncology Group (RTOG) intergroup esophageal trial RTOG 85-01. However, because of the increased incidence of treatment-related mortality, this treatment program will not be used as an experimental arm of intergroup trial INT 0123 (RTOG 94-05).

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