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- W1966458076 abstract "A prospective phase II trial of short course radiation therapy (SCRT) followed by four cycles of mFOLFOX6 prior to extirpative surgery was recently completed at our institution. Favorable rates of downstaging (DS), local control (LC), and disease free survival (DFS) were previously reported. Here we present the patient-reported quality of life (QOL) outcomes. 80 patients with cT3/T4, any N, any M rectal adenocarcinoma planned for resection were enrolled between 2009 and 2012. Preoperative treatment included SCRT (25 Gy to involved mesorectum, 20 Gy to elective nodes in 5 fractions), followed by 4 cycles of mFOLFOX6 prior to resection. QOL data was obtained prospectively using the FACT-C questionnaire (Version 4) prior to RT, prior to surgery, and 1-year post-surgery. All five categories of the questionnaire were analyzed for each time point. A previously validated minimally important difference (MID) of five QOL points was used to determine clinically significant changes in QOL for each patient. The FACT-C questionnaire was completed by 97% of patients prior to RT, 85% immediately prior to surgery, and 62% 1-year post-surgery. Mean FACT-C scores for all five categories were not significantly different for pre-treatment (20.6 +/- 5.6), pre-surgery (20.2 +/- 5.4), or post-surgery time points (20.0 +/- 5.4) (p = 0.8). In patients with an ostomy, FACT-C scores for functional well-being 1-year post-surgery were significantly reduced (lower QOL) compared to patients without ostomy (13.2 vs 19.2, p = 0.01). Comparing QOL at diagnosis with 1-year post-surgery, 50% had an MID QOL reduction and 36% had an MID QOL improvement. We observed that patients with a global QOL improvement generally reported higher scores in emotional (56%) and functional well-being (50%), while patients with a QOL reduction generally reported lower scores in physical (50%) and functional well-being (68%). Among ostomy-free patients, 8.5% of the patients reported having no control of their bowels pre-treatment, compared to 6.5% 1-year post-surgery. Thirty-two percent of patients reported “very good” control of their bowels at diagnosis, compared to 16% at 1-year post-surgery. SCRT and sequential mFOLFOX6 as preoperative therapy for rectal cancer results in stable patient reported QOL outcomes 1-year post-surgery. Improvement in QOL was observed, and was seen predominantly in functional and emotional well-being, while QOL decrements were seen predominantly in functional and physical wellbeing. These findings in conjunction with previously reported favorable oncologic outcomes support further evaluation of this regimen in a phase III setting." @default.
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- W1966458076 date "2014-09-01" @default.
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- W1966458076 title "Patient-Reported QOL Outcomes From a Prospective Phase 2 Trial of Short Course Radiation Therapy Followed by FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer" @default.
- W1966458076 doi "https://doi.org/10.1016/j.ijrobp.2014.05.2084" @default.
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