A phase II trial of concurrent 3D-CRT/IMRT and oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX) in gastric cancer patients with R0 gastrectomy and D2 lymph node dissection

Gastric Cancer. 2016 Jan;19(1):245-54. doi: 10.1007/s10120-015-0461-8. Epub 2015 Jan 22.

Abstract

Background: To evaluate the safety and efficacy of a concurrent three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) plus oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX) regimen in completely resected gastric cancer patients with D2 lymph node dissection.

Materials and methods: Patients with stage IB-IIIC gastric cancer (per the AJCC, 7th edition) who had undergone R0 and D2 gastrectomy were recruited. Two cycles of FOLFOX with concurrent 3D-CRT or IMRT (50.4 Gy/28f) were administered. One and an additional five cycles of FOLFOX were delivered before and after concurrent chemoradiotherapy, respectively. Primary endpoints were relapse-free survival (RFS) and overall survival (OS), with adverse events as secondary endpoints.

Results: From 2008 to 2011, 110 patients were evaluable. The 1-, 2- and 3-year RFS and OS were 86.2, 72.2, 67.8 and 94.7, 87.2, 77.6%, respectively. On multivariate analysis, stage (≤ IIIA vs. >IIIA) was a statistically significant factor affecting both RFS and OS. Additionally, the T-category (≤ T4a vs. = T4b) was a statistically significant factor affecting only the RFS. The most commonly observed grade 3 or 4 adverse events were nausea and vomiting, decreased appetite, leukopenia/neutropenia and fatigue, each of which occurred in 14.5, 11.8, 9.1 and 6.4% patients, respectively.

Conclusions: Adjuvant 3D-CRT/IMRT to a dose of 50.4 Gy/28f with concurrent FOLFOX is safe and effective in patients following radical gastrectomy with D2 lymph node dissection.

Keywords: 3D-CRT; Adjuvant chemoradiotherapy; D2 lymph node dissection; Gastric cancer; IMRT.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Chemoradiotherapy / methods
  • Chemoradiotherapy, Adjuvant / methods
  • Female
  • Fluorouracil / administration & dosage
  • Fluorouracil / therapeutic use
  • Gastrectomy / methods
  • Humans
  • Leucovorin / administration & dosage
  • Leucovorin / therapeutic use
  • Lymph Node Excision
  • Male
  • Middle Aged
  • Organoplatinum Compounds / administration & dosage
  • Organoplatinum Compounds / therapeutic use
  • Oxaliplatin
  • Radiotherapy, Conformal / methods*
  • Radiotherapy, Intensity-Modulated
  • Stomach Neoplasms / pathology
  • Stomach Neoplasms / therapy*
  • Survival Rate
  • Treatment Outcome
  • Young Adult

Substances

  • Organoplatinum Compounds
  • Oxaliplatin
  • Leucovorin
  • Fluorouracil

Supplementary concepts

  • Folfox protocol