IMPORTANCE The most appropriate dose-fractionation for whole breast irradiation (WBI) remains uncertain. OBJECTIVE To assess acute and six-month toxicity and quality of life (QoL) with conventionally fractionated WBI (CF-WBI) versus hypofractionated WBI (HF-WBI). DESIGN Unblinded randomized trial of CF-WBI (n=149; 50 Gy/25 fractions + boost [10–14 Gy/5–7 fractions]) versus HF-WBI (n=138; 42.56 Gy/16 fractions + boost [10–12.5 Gy/4–5 fractions]). SETTING Community-based and academic cancer centers. PARTICIPANTS 287 women age ≥ 40 years with stage 0–II breast cancer treated with breast-conserving surgery for whom whole breast irradiation without addition of a third field was recommended. 76% (n=217) were overweight or obese. Patients were enrolled from February 2011 through February 2014. INTERVENTION(S) FOR CLINICAL TRIALS CF-WBI versus HF-WBI. MAIN OUTCOME MEASURES Physician-reported acute and six-month toxicities using NCICTCv4.0 and patient-reported QoL using the FACT-B version 4. All analyses were intention-to-treat, with outcomes compared using chi-square, Cochran-Armitage test, and ordinal logistic regression. Patients were followed for a minimum of 6 months. RESULTS Treatment arms were well-matched for baseline characteristics including FACT-B total score (P=0.46) and individual QoL items such as lack of energy (P=0.86) and trouble meeting family needs (P=0.54). Maximal physician-reported acute dermatitis (P<0.001), pruritus (P<0.001), breast pain (P=0.001), hyperpigmentation (P=0.002), and fatigue (P=0.02) during radiation were lower in patients randomized to HF-WBI. Overall grade ≥2 acute toxicity was less with HF-WBI vs. CF-WBI (47% vs. 78%; P<0.001). Six months after radiation, physicians reported less fatigue in patients randomized to HF-WBI (P=0.01), and patients randomized to HF-WBI reported less lack of energy (P<0.001) and less trouble meeting family needs (P=0.01). Multivariable regression confirmed the superiority of HF-WBI in terms of patient-reported lack of energy (OR 0.39, 95% CI 0.24–0.63) and trouble meeting family needs (OR 0.34, 95% CI 0.16–0.75). CONCLUSIONS AND RELEVANCE HF-WBI appears to yield less acute toxicity than CF-WBI, as well as less fatigue and trouble meeting family needs six months after completing radiation. These findings should be communicated to patients as part of shared decision-making. TRIAL REGISTRATION NCT01266642 (https://clinicaltrials.gov/ct2/show/NCT01266642)

BACKGROUND: Pharyngoesophageal defects traditionally have been reconstructed using a jejunal or radial forearm flap. In 2002, the authors began using the anterolateral thigh flap for pharyngoesophageal reconstruction, and it has become our preferred method. The purpose of this study was to analyze the clinical and functional outcomes achieved using this technique. METHODS: The medical records of 91 male and 23 female patients who underwent pharyngoesophageal reconstruction using an anterolateral thigh flap were retrospectively reviewed. Outcomes analyzed included length of hospital and intensive care unit stay, fistula and anastomotic stricture formation and other complications, swallowing and tracheoesophageal speech function, and survival. Most patients had primary (27%) or recurrent (42%) squamous cell carcinoma. Before reconstruction, 71% of patients had undergone surgery, radiotherapy, or both. There were 67 circumferential and 47 near-circumferential defects. RESULTS: Mean intensive care unit stay was 1.9 AE 2.2 days, and mean hospital stay was 9.0 AE 4.7 days. Two patients experienced total flap loss, and 1 patient had partial flap necrosis. Pharyngocutaneous fistulas and strictures occurred in 9% and 6% of patients, respectively. Ninety-one percent of patients tolerated an oral diet without the need for tube feeding. Tracheoesophageal puncture was performed for speech rehabilitation in 51 patients. Eight-one percent of patients with a secondary tracheoesophageal puncture achieved fluent speech versus 41% of patients with a primary tracheoesophageal puncture. CONCLUSIONS: This series demonstrates that excellent clinical and functional outcomes, with minimal donor site morbidity and quick recovery, are possible with pharyngoesophageal reconstruction using an anterolateral thigh flap.

Therapeutic, IV.