The effect of omission of adjuvant radiotherapy after neoadjuvant chemotherapy and breast conserving surgery with a pathologic complete response

Mandish, Steven; Gaskins, Jeremy; Yusuf, Mehran; Amer, Yomna; Eldredge-Hindy, Harriet

doi:10.1080/0284186x.2020.1797161

Cited by 7 publications

(6 citation statements)

References 29 publications

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“…As radiotherapy in primary breast cancer reduces recurrence with at least a factor 2.5, LR at 5 years without radiotherapy could be in the range of 0-8.75% for pCR patients [32].…”

Section: Sample Size Calculation and Safety Analysismentioning

confidence: 99%

De-ESCAlating RadioTherapy in breast cancer patients with pathologic complete response to neoadjuvant systemic therapy: DESCARTES study

Hemert

Olmen

Boersma

et al. 2023

Breast Cancer Res Treat

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Purpose Neoadjuvant systemic therapy (NST) is increasingly used in breast cancer patients and depending on subtype, 10-89% of patients will attain pathologic complete response (pCR). In patients with pCR, risk of local recurrence (LR) after breast conserving therapy is low. Although adjuvant radiotherapy after breast conserving surgery (BCS) reduces LR further in these patients, it may not contribute to overall survival. However, radiotherapy may cause early and late toxicity. The aim of this study is to show that omission of adjuvant radiotherapy in patients with a pCR after NST will result in acceptable low LR rates and good quality of life. Methods The DESCARTES study is a prospective, multicenter, single arm study. Radiotherapy will be omitted in cT1-2N0 patients (all subtypes) who achieve a pCR of the breast and lymph nodes after NST followed by BCS plus sentinel node procedure. A pCR is defined as ypT0N0 (i.e. no residual tumor cells detected). Primary endpoint is the 5-year LR rate, which is expected to be 4% and deemed acceptable if less than 6%. In total, 595 patients are needed to achieve a power of 80% (one-side alpha of 0.05). Secondary outcomes include quality of life, Cancer Worry Scale, disease specific and overall survival. Projected accrual is five years. Conclusion This study bridges the knowledge gap regarding LR rates when adjuvant radiotherapy is omitted in cT1-2N0 patients achieving pCR after NST. If the results are positive, radiotherapy may be safely omitted in selected breast cancer patients with a pCR after NST. Trial registration: This study is registered at ClinicalTrials.gov on June 13th 2022 (NCT05416164). Protocol version 5.1 (15-03-2022).

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“…As radiotherapy in primary breast cancer reduces recurrence with at least a factor 2.5, LR at 5 years without radiotherapy could be in the range of 0-8.75% for pCR patients [32].…”

Section: Sample Size Calculation and Safety Analysismentioning

confidence: 99%

De-ESCAlating RadioTherapy in breast cancer patients with pathologic complete response to neoadjuvant systemic therapy: DESCARTES study

Hemert

Olmen

Boersma

et al. 2023

Breast Cancer Res Treat

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“…76 Mandish et al, reported in their ASTRO 2020 abstract, that adjuvant radiation omission for patients above 70-year-old of age following BCS with complete response does not impact OS. 77 Some unanswered questions for clinical scenarios based on chemotherapy response for initially clinically-positive nodal disease are being addressed in ongoing trials discussed in surgery section. These findings can be translated with caution to omit radiation for elderly patients who undergo mastectomy or BSC with complete response in elderly group based on other factors for risk assessment.…”

Section: Omission Of Radiotherapymentioning

confidence: 99%

Section: Adjuvant Radiotherapymentioning

confidence: 99%

Breast Cancer in Geriatric Patients: Current Landscape and Future Prospects

Abdel‐Razeq¹,

Rous²,

Abuhijla³

et al. 2022

CIA

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Breast cancer is the most common cancer diagnosed among women worldwide and more than half are diagnosed above the age of 60 years. Life expectancy is increasing and the number of breast cancer cases diagnosed among older women are expected to increase. Undertreatment, mostly due to unjustifiable fears of advanced-age and associated comorbidities, is commonly practiced in this group of patients who are under-represented in clinical trials and their management is not properly addressed in clinical practice guidelines. With modern surgery and anesthesia, breast surgeries are considered safe and is usually associated with very low complication rates, regardless of extent of surgery. However, oncoplastic surgery and management of the axilla can be tailored based on patients'-and disease-related factors. Most of chemotherapeutic agents, along with targeted therapy and anti-Human epidermal growth factor receptor-2 (HER2) drugs can be safely given for older patients, however, dose adjustment and close monitoring of potential adverse events might be needed. The recently introduced cyclin-D kinase (CDK) 4/6-inhibitors in combination with aromatase inhibitors (AI) or fulvestrant, which changed the landscape of breast cancer therapy, are both safe and effective in older patients and had substituted more aggressive and potentially toxic interventions. Despite its proven efficacy, adjusting or even omitting adjuvant radiation therapy, at least in low-risk older patients, is safe and frequently practiced. In this paper, we review existing data related to breast cancer management among older patients across the continuum; from resection of the primary tumor through adjuvant chemotherapy, radiation and endocrine therapy up to the management of recurrent and advanced-stage disease.

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“…The multivariate analysis confirmed this outcome (P=0.3181). 33 Although this study identified a subset of patients eligible for a further prospective study, in the absence of evidence of level I in the selected population, we will continue to irradiate patients with pCR after NACT and BCS. Therefore, prospective studies are needed.…”

Section: Nact In Patients With High-risk Early Breast Cancer In Patho...mentioning

confidence: 99%

Current Trends and Challenges in Real-World Breast Cancer Adjuvant Radiotherapy: A Practical Review.

Lazzari¹,

Solazzo²,

Benevento³

et al. 2022

Arch Breast Cancer

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Background: The treatment of breast cancer (BC) remains a constant and rapidly evolving issue for multidisciplinary breast cancer teams. Considering the emerging understanding and advances in the biological course of this disease, new trends in radiotherapy fractionation, systemic therapies, and oncoplastic surgical techniques are revolutionizing adjuvant treatment approaches to BC. Novel challenges are questioning the integration of adjuvant radiotherapy (ART) into the real-world clinical setting. Methods: PubMed literature search was conducted in order to extract data supporting the role of new trends in breast cancer adjuvant approach according to rising issues in the multidisciplinary team discussion such as sequencing with chemotherapy (CT) plus whole breast hypofractionated radiotherapy (HF-WBRT); the role of ART after neoadjuvant CT (NACT) followed by breast conservative surgery (BCS) in early BC achieving pathological complete remission (pCR); and the integration of ART in immediate autologous breast oncoplastic reconstruction after mastectomy (a-IBR). Furthermore, there are still several concerns about toxicity with adjuvant trastuzumab emtansine (T-DM1) or breast re-irradiation after BCS relapse in long-term survivors refusing mastectomy. Results: Among 40 hits, only 12 studies answered to these issues. Many of them were retrospective studies. Less than 500 patients met the criteria for these issues and several conclusions were found exhaustive. Conclusion: Few issues seem to have literature solutions, while there are still open questions in regard to these new trends. Novel strategies through prospective or randomized studies and new consensus guidelines are required.

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The effect of omission of adjuvant radiotherapy after neoadjuvant chemotherapy and breast conserving surgery with a pathologic complete response

Cited by 7 publications

References 29 publications

De-ESCAlating RadioTherapy in breast cancer patients with pathologic complete response to neoadjuvant systemic therapy: DESCARTES study

De-ESCAlating RadioTherapy in breast cancer patients with pathologic complete response to neoadjuvant systemic therapy: DESCARTES study

Breast Cancer in Geriatric Patients: Current Landscape and Future Prospects

Current Trends and Challenges in Real-World Breast Cancer Adjuvant Radiotherapy: A Practical Review.

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