A Phase II study of a paclitaxel-based chemoradiation regimen with selective surgical salvage for resectable locoregionally advanced esophageal cancer: initial reporting of RTOG 0246.

Abstract

PURPOSE:

The strategy of definitive chemoradiation with selective surgical salvage in locoregionally advanced esophageal cancer was evaluated in a Phase II trial in Radiation Therapy Oncology Group (RTOG)-affiliated sites.

METHODS AND MATERIALS:

The study was designed to detect an improvement in 1-year survival from 60% to 77.5% (α = 0.05; power = 80%). Definitive chemoradiation involved induction chemotherapy with 5-fluorouracil (5-FU) (650 mg/mg(2)/day), cisplatin (15 mg/mg(2)/day), and paclitaxel (200 mg/mg(2)/day) for two cycles, followed by concurrent chemoradiation with 50.4 Gy (1.8 Gy/fraction) and daily 5-FU (300 mg/mg(2)/day) with cisplatin (15 mg/mg(2)/day) over the first 5 days. Salvage surgical resection was considered for patients with residual or recurrent esophageal cancer who did not have systemic disease.

RESULTS:

Forty-three patients with nonmetastatic resectable esophageal cancer were entered from Sept 2003 to March 2006. Forty-one patients were eligible for analysis. Clinical stage was ≥T3 in 31 patients (76%) and N1 in 29 patients (71%), with adenocarcinoma histology in 30 patients (73%). Thirty-seven patients (90%) completed induction chemotherapy followed by concurrent chemoradiation. Twenty-eight patients (68%) experienced Grade 3+ nonhematologic toxicity. Four treatment-related deaths were noted. Twenty-one patients underwent surgery following definitive chemoradiation because of residual (17 patients) or recurrent (3 patients) esophageal cancer,and 1 patient because of choice. Median follow-up of live patients was 22 months, with an estimated 1-year survival of 71%.

CONCLUSIONS:

In this Phase II trial (RTOG 0246) evaluating selective surgical salvage after definitive chemoradiation in locoregionally advanced esophageal cancer, the hypothesized 1-year RTOG survival rate (77.5%) was not achieved (1 year, 71%; 95% confidence interval< 54%-82%).

• Authors: Stephen G Swisher, Kathryn A Winter, Ritsuko U Komaki, Jaffer A Ajani, Tsung T Wu, Wayne L Hofstetter, Andre A Konski, Christopher G Willett
• Journal: International journal of radiation oncology, biology, physics (Int J Radiat Oncol Biol Phys) Vol. 82 Issue 5 Pg. 1967-72 (Apr 01 2012) ISSN: 1879-355X [Electronic] United States
• PMID: 21507583 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural)
• Copyright: Copyright © 2012 Elsevier Inc. All rights reserved.

Chemical References

• Paclitaxel
• Cisplatin
• Fluorouracil

Topics

• Adenocarcinoma (mortality, pathology, therapy)
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Carcinoma, Squamous Cell (mortality, pathology, therapy)
• Chemoradiotherapy (methods, mortality)
• Cisplatin (administration & dosage)
• Esophageal Neoplasms (mortality, pathology, therapy)
• Female
• Fluorouracil (administration & dosage)
• Humans
• Induction Chemotherapy (methods, mortality)
• Male
• Middle Aged
• Neoplasm Recurrence, Local (surgery)
• Neoplasm Staging (methods)
• Neoplasm, Residual
• Paclitaxel (administration & dosage)
• Radiotherapy Dosage
• Salvage Therapy (methods, mortality)
• Survival Rate