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 Journal Article
| Authors: | Minsky, B. D.; Neuberg, D.; Kelsen, D. P.; Pisansky, T. M.; Ginsberg, R.; Benson, A. 3rd |
| Article 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). |
| Keywords: | adult; cancer survival; clinical article; aged; disease-free survival; middle aged; survival rate; treatment failure; clinical trial; carcinoma, squamous cell; cisplatin; fluorouracil; cancer combination chemotherapy; diarrhea; dose response; cancer adjuvant therapy; cancer radiotherapy; combined modality therapy; neurotoxicity; anorexia; nephrotoxicity; phase 2 clinical trial; blood toxicity; nausea; stomatitis; vomiting; antineoplastic combined chemotherapy protocols; dehydration; drug administration schedule; clinical protocol; dysphagia; hypotension; sepsis; leukocyte count; esophagus carcinoma; esophageal neoplasms; humans; human; male; female; priority journal; article |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 14 |
| Issue: | 1 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 1996-01-01 |
| Start Page: | 149 |
| End Page: | 155 |
| Language: | English |
| PUBMED: | 8558190 |
| PROVIDER: | scopus |
| DOI: | 10.1200/JCO.1996.14.1.149 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 22 November 2017 -- Source: Scopus |
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