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Introduction: Partial breast irradiation (PBI) has increased in utilization, with the postoperative lumpectomy cavity and clips used to guide target volumes. The ideal timing to perform computed tomography (CT)-based treatment planning for this technique is unclear. Prior studies have examined change in volume over time from surgery but not the effect of patient characteristics on lumpectomy cavity volume. We sought to investigate patient and clinical factors that may contribute to larger postsurgical lumpectomy cavities and therefore predict for larger PBI volumes. Methods: A total of 351 consecutive women with invasive or in situ breast cancer underwent planning CT after breast-conserving surgery at a single institution during 2019 and 2020. Lumpectomy cavities were contoured, and volume was retrospectively computed using the treatment planning system. Univariate and multivariate analyses were performed to evaluate the associations between lumpectomy cavity volume and patient and clinical factors. Results: Median age was 61.0 years (range, 30-91), 23.9% of patients were Black people, 52.1% had hypertension, the median body mass index (BMI) was 30.4 kg/m², 11.4% received neoadjuvant chemotherapy, 32.5% were treated prone, mean interval from surgery to CT simulation was 54.1 days ± 45.9, and mean lumpectomy cavity volume was 42.2 cm3 ± 52.0. Longer interval from surgery was significantly associated with smaller lumpectomy cavity volume on univariate analysis, p = 0.048. Race, hypertension, BMI, the receipt of neoadjuvant chemotherapy, and prone position remained significant on multivariate analysis (p < 0.05 for all). Prone position vs. supine, higher BMI, the receipt of neoadjuvant chemotherapy, the presence of hypertension, and race (Black people vs. White people) were associated with larger mean lumpectomy cavity volume. Discussion: These data may be used to select patients for which longer time to simulation may result in smaller lumpectomy cavity volumes and therefore smaller PBI target volumes. Racial disparity in cavity size is not explained by known confounders and may reflect unmeasured systemic determinants of health. Larger datasets and prospective evaluation would be ideal to confirm these hypotheses. [ABSTRACT FROM AUTHOR]

Background: We used two models to simulate a proposed noninferiority trial of radiotherapy (RT) omission in low-risk invasive breast cancer to illustrate how modeling could be used to predict the trial's outcomes, inform trial design, and contribute to practice debates.Methods: The proposed trial was a prospective randomized trial of no-RT vs RT in women age 40 to 74 years undergoing lumpectomy and endocrine therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative, stage I breast cancer with an Oncotype DX score of 18 or lower. The primary endpoint was recurrence-free interval (RFI), including locoregional recurrence, distant recurrence, and breast cancer death. Noninferiority required the two-sided 90% confidence interval of the RFI hazard ratio (HR) for no-RT vs RT to be entirely below 1.7. Model inputs included published data. The trial was simulated 1000 times, and results were summarized as percent concluding noninferiority and mean (standard deviation) of hazard ratios for Model GE and Model M, respectively.Results: Noninferiority was demonstrated in 18.0% and 3.7% for the two models. The respective means (SD) of the RFI hazard ratios were 1.8 (0.7) and 2.4 (0.9); most were locoregional recurrences. The mean five-year RFI rates for no-RT vs RT (SD) were 92.7% (2.9%) vs 95.5% (2.2%) and 88.4% (2.0%) vs 94.5% (1.6%). Both models showed little or no difference in breast cancer-specific or overall survival. Alternative definitions of low risk based on combinations of age and grade produced similar results.Conclusions: The proposed trial was unlikely to show noninferiority of omitting radiotherapy even using alternative definitions of low-risk, as the endpoint included local recurrence. Future trials regarding radiotherapy should address absolute reduction in recurrence and impact of type of recurrence on the patient. [ABSTRACT FROM AUTHOR]

Background: Radiotherapy after breast conservation has become the standard of care. Prior meta-analyses on effects of radiotherapy predated availability of gene expression profiling (GEP) to assess recurrence risk and/or did not include all relevant outcomes. This analysis used GEP information with pooled individual-level data to evaluate the impact of omitting radiotherapy on recurrence and mortality.Methods: We considered trials that evaluated or administered radiotherapy after lumpectomy in women with low-risk breast cancer. Women included had undergone lumpectomy and were treated with hormonal therapy for stage I, ER+ and/or PR+, HER2- breast cancer with Oncotype scores no greater than 18. Recurrence-free interval (RFI), type of RFI (locoregional or distant), and breast cancer-specific and overall survival were compared between no radiotherapy and radiotherapy using adjusted Cox models. All statistical tests were two-sided.Results: The final sample included 1778 women from seven trials. Omission of radiotherapy was associated with an overall adjusted hazard ratio of 2.59 (95% confidence interval [CI] = 1.38 to 4.89, P = .003) for RFI. There was a statistically significant increase in any first locoregional recurrence (P = .001), but not distant recurrence events (P = .90), or breast cancer-specific (P = .85) or overall survival (P = .61). Five-year RFI rate was high (93.5% for no radiotherapy vs 97.9% for radiotherapy; absolute reduction = 4.4%, 95% CI = 0.7% to 8.1%, P = .03). The effects of radiotherapy varied across subgroups, with lower RFI rates for those with Oncotype scores of less than 11 (vs 11-18), older (vs younger), and ER+/PR+ status (vs other).Conclusions: Omission of radiotherapy in hormone-sensitive patients with low recurrence risk may lead to a modest increase in locoregional recurrence event rates, but does not appear to increase the rate of distant recurrence or death. [ABSTRACT FROM AUTHOR]

Purpose: The success of partial breast irradiation critically depends on proper target localization. We examined the use of fluorodeoxyglucose-positron emission tomography (FDG-PET)/computed tomography (CT) for improved lumpectomy cavity (LC) delineation and treatment planning. Methods and Materials: Twelve breast cancer patients underwent FDG-PET/CT on a GE Discovery scanner with a median time from surgery to PET/CT of 49 days. The LC was contoured on the CT scan by a radiation oncologist and, together with a nuclear medicine physician, on the PET/CT scan. The volumes were calculated and compared in each patient. Treatment planning target volumes (PTVs) were calculated by expanding the margin 2 cm beyond the LC, maintaining a 5-mm margin from the skin and chest wall, and the treatment plans were evaluated. In addition, a study with a patient-like phantom was conducted to evaluate the effect that the window/level settings might have on contouring. Results: The margin of the LC was well visualized on all FDG-PET images. The phantom results indicated that the difference between the known volume and the FDG-PET-delineated volume was <10%, regardless of the window/level settings. The PET/CT volumes were larger than the CT volumes in all cases (median volume ratio, 1.68; range, 1.24–2.45; p = 0.004). The PET/CT-based PTVs were also larger than the CT-based PTV (median volume ratio, 1.16; range, 1.08–1.64; p = 0.006). In 9 of 12 patients, a CT-based treatment plan did not provide adequate coverage of the PET/CT-based PTV (99% of the PTV received <95% of the prescribed dose), resulting in substantial cold spots in some plans. In these cases, treatment plans were generated which were specifically designed to cover the larger PET/CT-based PTV. Although these plans showed an increased dose to the normal tissues, the increases were modest: the non–target breast volume receiving ≥50 Gy, lung volume receiving ≥30 Gy, and heart volume receiving ≥5 Gy increased by 5.7%, 0.8%, and 0.2%, respectively. The normal tissue dose–volume objectives were still met with these plans. Conclusion: The results of our study have shown that FDG-PET/CT can be used to define the LC volume. The increased FDG uptake was likely a result of postoperative inflammation in the LC. The targets defined using PET/CT were significantly larger than those defined with CT alone. Our results have shown that treatment plans can be generated to cover these larger PET/CT target volumes with only a modest increase in irradiated tissue volume compared with CT-determined PTVs. [Copyright &y& Elsevier]