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 Journal Article


Authors: Minsky, B. D.; Neuberg, D.; Kelsen, D. P.; Pisansky, T. M.; Ginsberg, R. J.; Pajak, T.; Salter, M.; Benson, A. B. 3rd
Article 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: adult; clinical article; aged; middle aged; survival analysis; treatment failure; squamous cell carcinoma; carcinoma, squamous cell; cisplatin; fluorouracil; cancer combination chemotherapy; cancer adjuvant therapy; cancer radiotherapy; radiation dose; chemotherapy, adjuvant; combined modality therapy; cancer staging; prospective studies; nephrotoxicity; blood toxicity; antineoplastic combined chemotherapy protocols; radiotherapy dosage; disease progression; radiation therapy; neoadjuvant chemotherapy; esophagus carcinoma; clinical trials; esophageal neoplasms; esophageal cancer; humans; human; male; female; priority journal; article
Journal Title: International Journal of Radiation Oncology, Biology, Physics
Volume: 43
Issue: 3
ISSN: 0360-3016
Publisher: Elsevier Inc.  
Date Published: 1999-02-01
Start Page: 517
End Page: 523
Language: English
DOI: 10.1016/s0360-3016(98)00463-5
PUBMED: 10078631
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 16 August 2016 -- Source: Scopus
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  1. Bruce Minsky
    306 Minsky
  2. Robert J Ginsberg
    178 Ginsberg
  3. David P Kelsen
    537 Kelsen