Safety of mFOLFOX6/XELOX as adjuvant chemotherapy after curative resection of stage III colon cancer: phase II clinical study (The FACOS study).

PURPOSE: Adjuvant chemotherapy with oxaliplatin combined with a fluoropyrimidine derivative is widely accepted as standard therapy for patients with stage III colon cancer, since few clinical data are available for Japanese patients. The FACOS trial investigated the tolerability of modified FOLFOX6 (mFOLFOX6) and XELOX regimens in Japanese colon cancer patients. METHODS: Twelve cycles of mFOLFOX6 or 8 cycles of XELOX were given to patients with eligibility: stage III curatively resected colon cancer, performance status of 0-1, age from 20 to 75 years, and adequate organ function. The primary endpoint was 3-year disease-free survival. Secondary endpoints were the incidence of adverse events (AEs) and the completion rate of study therapy. RESULTS: From April 2010 to April 2014, a total of 132 patients were enrolled. Safety was analyzed in 130 patients, with finalized data from 73 patients receiving mFOLFOX6 and 57 patients receiving XELOX. A total of 130 patients (100%) experienced AEs (any grade), and 52 patients (40.0%) experienced AEs of grade ≥ 3. No significant difference in the frequency of grade ≥ 3 AEs was observed between mFOLFOX6 and XELOX groups. Continuation of the planned cycle rate of protocol treatment was 69.9% in the mFOLFOX6 group and 68.4% in the XELOX group. Treatment was discontinued because of AEs in 14 patients (19.2%) in the mFOLFOX6 group and 8 (14.0%) in the XELOX group. Mean relative dose intensity for oxaliplatin was 78.0% in the mFOLFOX6 group and 82.8% in the XELOX group. CONCLUSION: As adjuvant chemotherapy for stage III colon cancer, mFOLFOX6/XELOX regimens are acceptable.

Application of Vacuum-Assisted Closure Therapy and Hyperbaric Oxygen Therapy for an Exposed Titanium Plate After Mandible Reconstruction.

The authors report a case of an 84-year-old woman with an exposed mandibular plate after reconstruction, which finally healed with combination therapy using vacuum-assisted closure therapy and hyperbaric oxygen therapy. The woman was diagnosed with mucosal carcinoma of the right oral cavity. During reconstruction after segmental excision of the mandible, a titanium plate was selected based on several risk factors. After the operation, the plate became exposed at the center of the chin. A second surgery was deemed inappropriate because of her age, malnutrition, and recurrent aspiration pneumonia. Instead, combination therapy consisting of vacuum-assisted closure therapy and hyperbaric oxygen therapy was initiated, leading to epithelizaion of the wound. Adapt Barrier Rings was effectively used to generate a stable negative pressure at the complicated craniofacial wound. A surgical or conservative approach is chosen as salvage treatment of an exposed plate. In this patient, only conservative treatment involving combination therapy resulted in complete healing of the wound with plate exposure. This patient highlights 2 important clinical issues: combination therapy was effective for an exposed mandibular plate, and a dressing technique using Adapt Barrier Rings enabled stable negative pressure in the craniofacial wound.