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Background: Late recurrence of breast cancer after 5 years accounts for about 50% of recurrences in hormone receptor (HR)-positive early breast cancer (EBC). TAILORx established non-inferiority of adjuvant endocrine therapy (ET) given for at least 5 years to chemotherapy plus ET (CET) in EBC and a 21-gene recurrence score (RS) of 11-25, although there was some chemotherapy benefit in women Methods: Eligibility criteria included women 18-75 years with HR-positive, HER2-negative, T1b-T2N0 EBC who agreed to have CT assigned or randomized based on the RS assay. The primary endpoint was invasive disease-free survival (iDFS) in the RS 11-25 group. The “primary analysis” refers to the original prespecified analysis for the primary IDFS endpoint (836 IDFS events at full information in the RS 11-25 group) after a median of 7.5 years. The “updated analysis” was performed after a median followup of 11.0 and 10.4 years in the randomized and overall populations, respectively. Results:10,253 eligible women enrolled between 4/7/06-10/6/10.The updated analysis includes substantially more events that the primary analysis, including IDFS events (1819 vs. 1210), distant recurrences (561 vs. 384), locoregional +/- distant recurrences (764 vs. 543), and deaths (910 vs. 499). The table provides 5 and 12-year event rates (and standard errors) for all arms, and comparisons of the randomized arms. The primary trial conclusions remain unchanged: ET was non-inferior to CET in the randomized group with a RS 11-25. Although recurrence occurred in < 10% by 12 years for a RS 0-25, late recurrence events beyond 5 years exceeded earlier recurrence. Non-recurrence events occurred in about 13% at 12 years (~1%/year), contributing substantially to the IDFS rates. For women Conclusions: The current updated analysis confirms findings from the original primary analysis that ET is non-inferior to CET in HR-positive, HER2-negative, node-negative EBC and a RS 11-25. As in the original primary analysis, the subgroup of women Citation Format: Joseph Sparano, Robert J. Gray, Della Makower, Kathy S. Albain, Daniel F. Hayes, Charles Geyer, Elizabeth Dees, Matthew P. Goetz, John A. Olson Jr, Tracy G. Lively, Sunil Badve, Thomas Saphner, Lynne I. Wagner, Timothy Whelan, Virginia Kaklamani, George Sledge. Trial Assigning Individualized Options for Treatment (TAILORx): An Update Including 12-Year Event Rates [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr GS1-05.

Uncontrolled studies suggest that the addition of high dose rate intraluminal brachytherapy (HDRIB) to external beam radiotherapy (EBR) may improve palliation for patients with advanced non-small cell lung cancer (NSCLC). The purpose of this study was to evaluate the potential clinical benefit of adding HDRIB to EBR in a multicenter randomized trial.Patients with symptomatic stage III or IV NSCLC with endobronchial disease were randomized to EBR (20Gy in 5 daily fractions or 30Gy in 10 daily fractions) or the same EBR+HDRIB (14Gy in 2 fractions over two weeks). The primary outcome was the proportion of patients who achieved symptomatic improvement in patient-reported overall lung cancer symptoms on the Lung Cancer Symptom Scale (LCSS) at 6 weeks following randomization. Secondary outcomes included improvement in individual symptoms, symptom progression free survival, overall survival and toxicity. The planned sample size was 250 patients based on detection of symptomatic improvement from 40 to 60% with a two-sided α of 0.05 and 80% power.134 patients were randomized over 4.5 years: 67 to each arm. The study closed early due to slow accrual. The mean age was 69.8 years, and 67% had metastatic disease. At six weeks 19 patients (28.4%) in the EBR arm and 20 patients (29.9%) in the EBR+HDRIB arm experienced an improvement in lung cancer symptoms (p=0.84). When limited to patients who completed the LCSS percentages were 40.4% vs 47.6%, respectively, p=0.49. Between group differences in mean change scores (0.3-0.5 standard deviations) in favor of EBR+HDRIB were observed for overall symptoms, but only hemoptysis was significantly improved (p=0.03). No significant differences were observed in progression free or overall survival. Grade 3/4 toxicity was similar between groups.Small to moderate improvements were seen in symptom relief with the combined therapy, but they did not reach statistical significance. Further research is necessary before recommending HDRIB in addition to EBR for palliation of lung cancer symptoms.

The study of print culture and the history of the book in the eighteenth century has benefited significantly in the past three decades from studies that have placed varying degrees of emphasis on the three key components of print culture—author, publisher, and reader—and their interwoven relationships. This scholarship has also spurred new research on the literary and print culture of evangelical Anglicans, Methodists, Quakers, Calvinistic Methodists, Baptists, Moravians, and Independents in Great Britain and America, including specific studies related to the transatlantic nature of the printing histories of Philip Doddridge and Jonathan Edwards. This chapter seeks to further this discussion by exploring three areas of eighteenth-century evangelical print culture in England: the interplay between readers, writers, and producers with informal and formal sources; the ecclesiastical/topographical reconstruction of reading/selling communities of chapel-goers and neighboring (and usually like-minded) booksellers; and the interaction of these two elements in the publishing history of one representative text, Samuel James’s An Abstract of the Gracious Dealings of God with Several Eminent Christians (1760).