A randomised phase II trial of intra-dermal G-CSF infiltration in radiation induced skin reactions

Introduction and Aim: Radiation induced skin reactions (RISR) often delays the treatment affecting compliance and outcomes. Granulocyte colony stimulating factor (G-CSF) is known to recruit dermo-genic stem cells and help in healing. Very few studies are there to evaluate its potential in this regard. This study evaluates intradermal infiltration of G-CSF for its effectiveness, effect on treatment delay and quality of life in comparison to conventional treatment for grade 3/4 RISR.   Materials and Methods: Patients experiencing advanced RISR due to any regimen of external beam radiation above 50 Gy of 2 Gy equivalent doses were randomized to undergo treatment either with intradermal G-CSF infiltration at margin and bases of lesion along with conventional therapies or with only conventional anti-inflammatory/ antibiotic therapy. The experimental arm and the control arm had 62 and 60 patients respectively analyzed for time taken for re-epithelization and treatment delay. Also.pre and two weeks post-treatment global quality of life and pain scores were taken for qualitative comparison between the arms.   Results: G-CSF arm took a mean 5.2 (95percent CI=4.4-5.7) days, significantly less than conventional treatment arm (Mean=7.5 days, 95percent CI= 6.8-8.1,p=0.002) for re-epithelization. Grade of toxicity adjusted hazard ratio of non-resolution in 10 days  time was 2.98 for the control arm over the experimental arm(p=.046). Treatment gap was significantly less in the G-CSF arm (48.4 percent vs 68.3percent, p=0.026), with average delay of treatment being significantly reduced (p 0.001). A ten-day delay adjusted survival was significantly better in the experimental arm (Mantel-Cox Log rank test, X2=12.26, p 0.001).   Conclusion: Intradermal perilesional G-CSF infiltration for advanced RISR hastens wound healing compared to conventional treatment and significantly reduces the chances of treatment delay.