The 2016 Assisi Think Tank Meeting on breast cancer: white paper

Aristei, Cynthia; Kaidar‐Person, Orit; Arenas, Meritxell; Coles, Charlotte E.; Offersen, Birgitte Vrou; Bourgier, C.; Frezza, G.; Leonardi, Maria Cristina; Valentini, Vincenzo; Poortmans, Philip

doi:10.1007/s10549-016-3998-2

Cited by 17 publications

(13 citation statements)

References 51 publications

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“…The radiation schedule was normofractionated RT (50 Gy at 2 Gy/day on the breast and 16 Gy at 2 Gy/day on the tumor bed, 5 days/week) or hypofractionated RT (40 Gy at 2.67 Gy/day, 5 days/week) [ 19 , 20 ]. Thirty percent of the patients received irradiation of regional lymph nodes, according to existing risk factors [ 21 , 22 ]. During RT, a weekly acute toxicity assessment was performed using the criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer [ 23 ].…”

Section: Methodsmentioning

confidence: 99%

Effect of radiotherapy on activity and concentration of serum paraoxonase-1 in breast cancer patients

et al. 2017

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Paraoxonase-1 (PON1) is an intra-cellular antioxidant enzyme found also in the circulation associated with high-density lipoproteins. The activity of this enzyme has been shown to be decreased in breast cancer (BC) patients. The aims of our study were to investigate the changes produced by radiotherapy (RT) on activity and concentration of serum PON1 in BC patients, and to evaluate the observed variations in relation to clinical and pathological characteristics of patients and tumors, and the response to treatment. We studied 200 women with BC who were scheduled to receive RT following excision of the tumor. Blood for analyses was obtained before and after the irradiation procedure. The control group was composed of 200 healthy women. Relative to control, BC patients had significantly lower serum PON1 activities pre-RT, while PON1 concentrations were at similar levels. RT was associated with a significant increase in serum PON1 activities and concentrations. We observed significant differences in serum PON1 concentrations post-RT between patients with luminal A or luminal B tumors. Serum PON1 concentration post-RT was markedly lower in BC patients with metastases. We conclude that benefit from RT accrues to the BC patients not only through its direct effect on cancer cells but also indirectly by improving the organism’s anti-oxidant defense mechanisms. In addition, our preliminary evidence suggests that the measurement of serum PON1 concentration post-RT could be an efficient prognostic biomarker, and may be used as an index of the efficacy of the RT.

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Section: Methodsmentioning

confidence: 99%

Effect of radiotherapy on activity and concentration of serum paraoxonase-1 in breast cancer patients

et al. 2017

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“…Thus, the OPTIMAL trial was designed to outline an evidence-based strategy for the treatment of BC patients with limited nodal involvement by determining the non-inferiority of incidental radiation of the axillary nodes in comparison with intentional radiation. The ESTRO (European SocieTy for Radiotherapy and Oncology) meeting in Assisi stated the importance of further investigations on regional lymph node treatment and highlighted the design and expected results of the OPTIMAL, SENOMA, and POSTNOC studies, all of them focused on the treatment of patients with limited axillary disease [25].…”

Section: Discussionmentioning

confidence: 99%

OPTimizing Irradiation through Molecular Assessment of Lymph node (OPTIMAL): a randomized open label trial.

Algara

Rodrı́guez

Flaquer

et al. 2020

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BackgroundConservative surgery followed by breast and nodal irradiation is the standard loco-regional treatment for early breast cancer (BC) patients with four or more involved lymph nodes. However, the treatment strategy when fewer nodes are involved remains unclear, especially when lymphadenectomy has not been performed. Sensitive molecular techniques for nodal status assessment such as the OSNA (One-Step Nucleic Acid Amplification) assay can contribute to the definition and standardization of the treatment strategy. Therefore, the OPTIMAL study aims to demonstrate the feasibility of the incidental irradiation of axillary nodes in patients with early-stage BC and limited involvement of the SLN.MethodsBC patients with conservative surgery and a total tumour load of sentinel lymph nodes assessed with OSNA ranged between 250–15.000 copies/µL will be eligible. Patients will be randomized to receive irradiation on breast, tumour bed, axillary and supraclavicular lymph node areas (intentional arm) or only on breast and tumour bed (incidental arm). All areas, including the internal mammary chain, will be contoured. The mean, median, D5% and D95% doses received in all volumes will be calculated. The primary endpoint is the non-inferiority of incidental irradiation of axillary nodes compared with the intentional irradiation in terms of 5-year disease free survival. Secondary endpoints comprise the comparison of acute and chronic toxicity, loco-regional and distant disease recurrence rates.DiscussionStandardizing the treatment and diagnosis of BC patients with few nodes affected is crucial due to the lack of consensus on the therapeutic strategies in these patients. Hence, the quantitative score for metastatic burden of SLN provided by OSNA can contribute to improve the discrimination of BC patients with a limited nodal involvement who can benefit from incidental radiation as an adjuvant treatment strategy.Trial registrationClinicalTrial.gov, NCT02335957; https://clinicaltrials.gov/ct2/show/NCT02335957

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“…Thus, the OPTIMAL trial was designed to outline an evidence-based strategy for the treatment of BC patients with limited nodal involvement by determining the non-inferiority of incidental radiation of the axillary nodes in comparison with intentional radiation. The ESTRO (European Society for Radiotherapy and Oncology) meeting in Assisi stated the importance of further investigations on regional lymph node treatment and highlighted the design and expected results of the OPTIMAL, SENOMAC, and POSNOC studies, all of them focused on the treatment of patients with limited axillary disease [ 28 ].…”

Section: Methodsmentioning

confidence: 99%

OPTimizing Irradiation through Molecular Assessment of Lymph node (OPTIMAL): a randomized open label trial

et al. 2020

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Background Conservative surgery followed by breast and nodal irradiation is the standard loco-regional early breast cancer (BC) treatment for patients with four or more involved lymph nodes. However, the treatment strategy when fewer nodes are involved remains unclear, especially when lymphadenectomy has not been performed. Sensitive nodal status assessment molecular techniques as the One-Step Nucleic Acid Amplification (OSNA) assay can contribute to the definition and standardization of the treatment strategy. Therefore, the OPTIMAL study aims to demonstrate the feasibility of incidental irradiation of axillary nodes in patients with early-stage BC and limited involvement of the SLN. Methods BC patients who underwent conservative surgery and whose SLN total tumour load assessed with OSNA ranged between 250–15,000 copies/µL will be eligible. Patients will be randomized to receive irradiation on the breast, tumour bed, axillary and supraclavicular lymph node areas (intentional arm) or only on the breast and tumour bed (incidental arm). All areas, including the internal mammary chain, will be contoured. The mean, median, D5% and D95% doses received in all volumes will be calculated. The primary endpoint is the non-inferiority of the incidental irradiation of axillary nodes compared to the intentional irradiation in terms of 5-year disease free survival. Secondary endpoints comprise the comparison of acute and chronic toxicity and loco-regional and distant disease recurrence rates. Discussion Standardizing the treatment and diagnosis of BC patients with few nodes affected is crucial due to the lack of consensus. Hence, the quantitative score for the metastatic burden of SLN provided by OSNA can contribute by improving the discrimination of which BC patients with limited nodal involvement can benefit from incidental radiation as an adjuvant treatment strategy. Trial registration ClinicalTrial.gov, NCT02335957; https://clinicaltrials.gov/ct2/show/NCT02335957

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The 2016 Assisi Think Tank Meeting on breast cancer: white paper

Cited by 17 publications

References 51 publications

Effect of radiotherapy on activity and concentration of serum paraoxonase-1 in breast cancer patients

Effect of radiotherapy on activity and concentration of serum paraoxonase-1 in breast cancer patients

OPTimizing Irradiation through Molecular Assessment of Lymph node (OPTIMAL): a randomized open label trial.

OPTimizing Irradiation through Molecular Assessment of Lymph node (OPTIMAL): a randomized open label trial

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