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Involved-field irradiation concurrently combined with nedaplatin/5-fluorouracil for inoperable esophageal cancer on basis of (18)FDG-PET scans: a phase II study.

AbstractPURPOSE:
A prospective study was performed on chemoradiotherapy (CRT) for esophageal cancer using involved-field radiation therapy (IFRT) based on 18-fluorodeoxyglucose positron-emission tomography. The goal of this phase II study was to evaluate the efficacy of the IFRT procedure in newly diagnosed esophageal cancer.
PATIENTS AND METHODS:
Eligible patients were adults with newly diagnosed untreated, inoperable esophageal cancer in stages I-IV with lymph node metastases. Patients received nedaplatin 80mg/m(2) per day on day 1, 5-fluorouracil 800mg/m(2) on days 1-4 intravenously repeated every 28days for 2-4 cycles, and combined IFRT. Elective nodal irradiation was not performed. Irradiation was applied only to the primary tumor and positive lymph nodes.
RESULTS:
From September 2009 to July 2012, of the 63 patients enrolled, 58 were evaluable for response. The primary end point of isolated out-of-field loco-regional nodal recurrence was seen in only two patients. The expectant rate was assumed to be less than 5%. The threshold value was set as 10% to calculate the number of registrations. Progression-free and overall survival rates at 36months were 47.7% and 51.1%, respectively. The median progression-free survival was 34.6months, and overall survival was 38.4months. Salvage surgery was tried for 11 patients (17.5%) due to residual or recurrent disease.
CONCLUSION:
The primary end point of the trial was demonstrated, indicating the efficacy of IFRT in the treatment of inoperable esophageal cancer mostly of squamous cell carcinoma.
AuthorsHideomi Yamashita, Mami Omori, Ryousuke Takenaka, Kae Okuma, Reiko Kobayashi, Kuni Ohtomo, Keiichi Nakagawa
JournalRadiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology (Radiother Oncol) Vol. 113 Issue 2 Pg. 182-7 (Nov 2014) ISSN: 1879-0887 [Electronic] Ireland
PMID25466372 (Publication Type: Clinical Trial, Phase II, Journal Article)
CopyrightCopyright © 2014 Elsevier Ireland Ltd. All rights reserved.
Chemical References
  • Organoplatinum Compounds
  • nedaplatin
  • Fluorouracil
Topics
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
  • Carcinoma, Squamous Cell (diagnostic imaging, drug therapy, radiotherapy, therapy)
  • Chemoradiotherapy
  • Disease-Free Survival
  • Esophageal Neoplasms (diagnostic imaging, drug therapy, radiotherapy, therapy)
  • Esophageal Squamous Cell Carcinoma
  • Female
  • Fluorouracil (administration & dosage)
  • Humans
  • Lymphatic Metastasis
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local (diagnostic imaging, drug therapy, radiotherapy, therapy)
  • Organoplatinum Compounds (administration & dosage)
  • Positron-Emission Tomography (methods)
  • Prospective Studies
  • Radiotherapy Planning, Computer-Assisted (methods)
  • Survival Rate

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