Wide local excision with negative pathologic margins is the treatment of choice for most desmoid tumors. Function-sparing resection is appropriate because adjuvant radiation therapy can offset the adverse impact of positive margins. Unresectable disease should be treated with definitive radiation therapy.
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)
Spermatic cord sarcoma has a high propensity for local recurrence after surgery. Nodal relapse is less frequent than commonly believed. Because of the relatively high local failure rate seen in surgery alone and durable local control noted in 3 patients treated with surgery plus radiotherapy, combined modality treatment should be considered in those with spermatic cord sarcoma who are believed to be at high risk for local failure.
This simulation-based study investigated the relationship between Tumor Treating Fields (TTFields) dosimetry and survival in 340 patient cases from the phase 3 EF-14 study. Delivery of TTFields to the patients was simulated and the spatial distribution of the fields analyzed. The analysis yielded a robust definition for TTFields dose, which was correlated to patient survival. This work sets a conceptual framework for defining TTFields dosimetry and treatment planning procedures. Introduction: Tumor Treating Fields (TTFields) are approved for glioblastoma based on improved overall survival (OS) and progression-free survival (PFS) in the phase 3 EF-14 trial of newly diagnosed glioblastoma. To test the hypothesis that increasing TTFields dose at the tumor site improves patient outcomes, we performed a simulation-based study investigating the association between TTFields dose and survival (OS and PFS) in patients treated with TTFields in EF-14. Methods and Materials: EF-14 patient cases (N Z 340) were included. Realistic head models were derived from T1-contrast images captured at baseline. The transducer array layout on each patient was obtained from EF-14 records; average compliance (fraction of time patient was on active treatment) and average electrical current delivered to the patient were derived from log files of the TTFields devices used by patients. TTFields intensity distributions and power densities were calculated using the finite element method. Local minimum dose density (LMiDD) was defined as the product of TTFields intensity, tissue-specific conductivities, and patient compliance. The average LMiDD within a tumor bed comprising the gross tumor volume and the 3-mm-wide peritumoral boundary zone was calculated. Results: The median OS and PFS were significantly longer when the average LMiDD in the tumor bed was !0.77 mW/cm 3 : OS was 25.2 versus 20.4 months (P Z .003, hazard ratio [HR] Z 0.611) and PFS was 8.5 versus 6.7 months (P Z .02,
EOO should be considered clinically and therapeutically distinct from osseous osteosarcoma. Radiographic response rates and pathologic complete response rates to doxorubicin-based systemic therapy are low.
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