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Purpose: Hypofractionated radiotherapy is the standard of care for adjuvant whole breast radiotherapy (RT). However, adoption has been slow. The indication for regional nodal irradiation has been expanded to include patients with 0–3 involved lymph nodes. We investigated the impact of the publication of the updated German S3 guidelines in 2017 on adoption of hypofractionation and enrollment of patients with lymph node involvement within a randomized controlled phase III trial. Methods: In the experimental arm of the HYPOSIB trial (NCT02474641), hypofractionated RT with simultaneous integrated boost (SIB) was used. In the standard arm, RT could be given as hypofractionated RT with sequential boost (HFseq), normofractionated RT with sequential boost (NFseq), or normofractionated RT with SIB (NFSIB). The cutoff date for the updated German S3 guidelines was December 17, 2017. Temporal trends were analyzed by generalized linear regression models. Multiple logistic regression models were used to investigate the influence of time (prior to/after guideline) and setting (university hospital/other institutions) on the fractionation patterns. Results: Enrollment of patients with involved lymph nodes was low throughout the trial. Adoption of HFseq increased over time and when using the guideline publication date as cutoff. Results of the multiple logistic regressions showed an interaction between time and setting. Furthermore, the use of HFseq was significantly more common in university hospitals. Conclusion: The use of HFseq in the standard arm increased over the course of the HYPOSIB trial and after publication of the S3 guideline update. This was primarily driven by patients treated in university hospitals. Enrolment of patients with lymph node involvement was low throughout the trial. [ABSTRACT FROM AUTHOR]

Purpose: We report results of a multicenter prospective single-arm phase II trial (ARO-2013-04, NCT01948726) of moderately accelerated hypofractionated radiotherapy with a simultaneous integrated boost (SIB) in patients with breast cancer receiving adjuvant radiotherapy after breast-conserving surgery. Methods: The eligibility criteria included unifocal breast cancer with an indication for adjuvant radiotherapy to the whole breast and boost radiotherapy to the tumor bed. The whole breast received a dose of 40 Gy and the tumor bed a total dose of 48 Gy in 16 fractions of 2.5 and 3 Gy, respectively. Radiotherapy could be given either as 3D conformal RT (3D-CRT) or as intensity-modulated radiotherapy (IMRT). The study was designed as a prospective single-arm trial to evaluate the acute toxicity of the treatment regimen. The study hypothesis was that the frequency of acute skin reaction grade ≥2 would be 20% or less. Results: From November 2013 through July 2014, 149 patients were recruited from 12 participating centers. Six patients were excluded, leaving 143 patients for analysis. Eighty-four patients (58.7%) were treated with 3D-CRT and 59 (41.3%) with IMRT. Adherence to the treatment protocol was high. The rate of grade ≥2 skin toxicity was 14.7% (95% confidence interval 9.8–21.4%). The most frequent grade 3 toxicity (11%) was hot flashes. Conclusion: This study demonstrated low toxicity of and high treatment adherence to hypofractionated adjuvant radiotherapy with SIB in a multicenter prospective trial, although the primary hypothesis was not met. [ABSTRACT FROM AUTHOR]

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Purpose: To evaluate the feasibility of hypofractionation with SIB in all settings in Germany to prepare a multicenter treatment comparison.Methods: Eligible patients had histopathologically confirmed breast cancer operated by BCS. Patients received WBI 40.0 Gy in 16 fractions of 2.5 Gy. A SIB with 0.5 Gy per fraction was administered to the tumor bed, thereby giving 48.0 Gy in 16 fractions to the boost-PTV sparing heart, LAD, lung, contralateral breast. The primary study objective was feasibility, administration of specified dose in 16 fractions within 22-29 days with adherence to certain dose constraints (heart; LAD; contralateral breast); secondary endpoints were toxicity, QoL.Results: 151 patients were recruited from 7 institutions between 07/11-10/12. 10 patients met exclusion criteria prior to irradiation. All but two patients (99%) received the prescribed dose in the PTVs. Adherence to dose constraints and time limits was achieved in 89% (95% CI 82% to 93%). 11 AE were reported in 10 patients; five related to concurrent endocrine therapy. Two of the AEs were related to radiotherapy: grade 3 hot flushes in two cases. QoL remained unchanged.Conclusion: Hypofractionation with a SIB is feasible and was well tolerated in this study. [ABSTRACT FROM AUTHOR]

Copyright of Strahlentherapie und Onkologie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Preoperative radiochemotherapy (RCT) is a standard of care for patients with locally advanced rectal cancer (LARC; stages II and III). Results of our phase II study (BevXelOx-RT) have shown that this regimen is feasible but without a significant improvement of pathological complete response. Whether preoperatively administered bevacizumab, due to its specific toxicity profile, leads to increased rates of surgical complications is currently a subject for debate. This analysis focusses on the surgery-associated spectrum of complications. Methods: Data from 62 patients with rectal cancer (uT3-4; N0/1, M0) of the phase II trial were analyzed. Patients received radiotherapy (50.4/1.8 Gy fractions), simultaneous bevacizumab 5 mg/kg (d1, d15, d29), and capecitabine 825 mg/m twice daily (d1-14, d22-35), oxaliplatin 50 mg/m (d1, d8, d22, d29). Four to six weeks after RCT, surgical resection was performed. Results: Overall, 69/69 patients underwent surgery, and 66 (95.7 %) patients had R0 resection. Surgery was mainly conducted (in 66 %) by highly experienced surgeons (>20 resections of rectal cancer/year) with differences between the institutions due to the operative procedures but without effects on the rate of R0 resection or complications. The average duration of surgery was 239 min (±10). Frequency of multivisceral resections (11 %), intraoperative (8 %) and postoperative (43 %) complications were all in the expected range. In particular, we did not observe an increased rate of postoperative bleedings (3 %). The postoperative mortality rate was 0 %. Conclusions: Quantity and the kind of surgery-associated spectrum of complications followed by a preoperative bevacizumab-containing RCT regimen in patients with LARC were in line with comparable trials of bevacizumab-based approaches. [ABSTRACT FROM AUTHOR]

Copyright of Strahlentherapie und Onkologie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Strahlentherapie und Onkologie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)