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Post Operative Adjuvant Therapy

Post Operative Adjuvant TherapyThere is no difference in overall survival between 5Fu/Leucovrin versus gemcitabine following surgery. The median survival is between 23.0 and 23.6 months. This is no different than that which was observed in the original Gastrointestinal Tumor Study Group using 5FU and radiation initially reported in the 1970’s. If either 5FU or gemcitabine have minimal activity in the treatment of advanced disease, why should we expect significant activity in the adjuvant setting? I have much more confidence using combination chemotherapy as the only therapeutic modality in the adjuvant setting. Options would include Abraxane and gemcitabine, FOLFIORINOX (at a modified reduced dose), gemcitabine, 5FU, leucovorin, irinotecan, cisplatin (GFLIP), or 5FU, leucovorin, Mitomycin-C. The RTOG 97-04 study comparing pre and post-chemo radiation 5FU with pre and post-chemo radiation gemcitabine for post-operative adjuvant treatment showed no significant difference between the two arms. The overall survival was not observed to be different than single agent gemcitabine. Why add the toxicity of radiation therapy without achieving a significant benefit?