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

Algara, M.; Rodrı́guez, Estefanı́a; Martínez-Arcelus, Francisco José; Salinas, Juan; Sanz, X.; Beato, Inmaculada; Manso, Á.; Soler, Antonio Palanca; Rodríguez, José Reyes; Frías, Andere; Calín, Ana; Juan, Germán; Meireles, Pedro; Flaquer, Amanda

doi:10.1016/j.radonc.2022.09.006

Cited by 5 publications

(3 citation statements)

References 54 publications

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“…While lymphoedema was more commonly seen in the ALND-arm, the group receiving axillary RT had a higher incidence of difficulties in moving the arm. 8 Additional trials indicating the feasibility to de-escalate regional treatment in BC are IBCSG 23-01, 21 OTOASOR, 5 OPTIMAL, 6 RAPCHEM, 9 NSABP-04 22 and the SINODAR-ONE trial. 7 Results are also awaited from the Swedish SENOMAC-trial.…”

Section: Strengths and Limitations Of This Studymentioning

confidence: 99%

“…Additional trials indicating the feasibility to de-escalate regional treatment in BC are IBCSG 23–01, 21 OTOASOR, 5 OPTIMAL, 6 RAPCHEM, 9 NSABP-04 22 and the SINODAR-ONE trial. 7 Results are also awaited from the Swedish SENOMAC-trial.…”

Section: Introductionmentioning

confidence: 99%

“…3 4 However, modern systemic therapy has significantly improved survival and decreased the incidence of locoregional recurrences. Regional recurrences are therefore today rare events, [5][6][7][8][9] and it is being questioned whether regional RT still have the same benefit for low-risk patients with limited nodal disease.…”

Section: Introductionmentioning

confidence: 99%

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Protocol for the T-REX-trial: tailored regional external beam radiotherapy in clinically node-negative breast cancer patients with 1-2 sentinel node macrometastases – an open, multicentre, randomised non-inferiority phase 3 trial

Alkner,

de Boniface,

Lundstedt

et al. 2023

BMJ Open

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IntroductionModern systemic treatment has reduced incidence of regional recurrences and improved survival in breast cancer (BC). It is thus questionable whether regional radiotherapy (RT) is still beneficial in patients with sentinel lymph node (SLN) macrometastasis. Postoperative regional RT is associated with an increased risk of arm morbidity, pneumonitis, cardiac disease and secondary cancer. Therefore, there is a need to individualise regional RT in relation to the risk of recurrence.Methods and analysisIn this multicentre, prospective randomised trial, clinically node-negative patients with oestrogen receptor-positive, HER2-negative BC and 1-2 SLN macrometastases are eligible. Participants are randomly assigned to receive regional RT (standard arm) or not (intervention arm). Regional RT includes the axilla level I–III, the supraclavicular fossa and in selected patients the internal mammary nodes. Both groups receive RT to the remaining breast. Chest-wall RT after mastectomy is given in the standard arm, but in the intervention arm only in cases of widespread multifocality according to national guidelines. RT quality assurance is an integral part of the trial.The trial aims to include 1350 patients between March 2023 and December 2028 in Sweden and Norway. Primary outcome is recurrence-free survival (RFS) at 5 years. Non-inferiority will be declared if outcome in the de-escalation arm is not >4.5 percentage units below that with regional RT, corresponding to an HR of 1.41 assuming 88% 5-year RFS with standard treatment. Secondary outcomes include locoregional recurrence, overall survival, patient-reported arm morbidity and health-related quality of life. Gene expression analysis and tumour tissue-based studies to identify prognostic and predictive markers for benefit of regional RT are included.Ethics and disseminationThe trial protocol is approved by the Swedish Ethics Authority (Dnr-2022-02178-01, 2022-05093-02, 2023-00826-02, 2023-03035-02). Results will be presented at scientific conferences and in peer-reviewed journals.Trial registration numberNCT05634889.

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