Sentinel lymph node biopsy versus axillary lymph node dissection in breast cancer patients undergoing mastectomy with one to two metastatic sentinel lymph nodes: sub-analysis of the SINODAR-ONE multicentre randomized clinical trial and reopeni
Corrado Tinterri, Giuseppe Canavese, Wolfgang Gatzemeier, Erika Barbieri, Alberto Bottini, Andrea Sagona, Giulia Caraceni, Alberto Testori, Simone Di Maria Grimaldi, Carla Dani, Luca Boni, Paolo Bruzzi, Bethania Fernandes, Marta Scorsetti, Alberto Zambelli, Damiano Gentile, Massimo Maria Grassi, Olindo Custodero, Vito Leopoldo Troilo, Mario Taffurelli, Maria Cristina Cucchi, Valentina Galluzzo, Carlo Cabula, Roberta Cabula, Maria Grazia Lazzaretti, Francesco Caruso, Gaetano Castiglione, Simona Grossi, Maria Saveria Tavoletta, Camilla Rossi, Annalisa Curcio, Daniele Friedman, Piero Fregatti, Carla Magni, Giovanni Tazzioli, Simona Papi, Riccardo Giovanazzi, Camelia Chifu, Rossella Bettini, Modestino Pezzella, Silvia Michieletto, Tania Saibene, Manuela Roncella, Matteo Ghilli, Andrea Sibilio, Anna Cariello, Saverio Coiro, Giuseppe Falco, Emanuele Zarba Meli, Lucio Fortunato, Luigi Ciuffreda, Roberto Murgo, Claudio Battaglia, Luca Rubino, Nicoletta Biglia, Valentina Bounous, Francesca Angela Rovera, Corrado Chiappa, Giovanni Pollini, Sara Mirandola, Graziano Meneghini, Francesco Di Bartolo, Oreste Davide Gentilini,- Surgery
Abstract
Background
The initial results of the SINODAR-ONE randomized clinical trial reported that patients with T1–2 breast cancer and one to two macrometastatic sentinel lymph nodes treated with breast-conserving surgery, sentinel lymph node biopsy only, and adjuvant therapy did not present worse 3-year survival, regional recurrence, or distant recurrence rates compared with those treated with axillary lymph node dissection. To extend the recommendation of axillary lymph node dissection omission even in patients treated with mastectomy, a sub-analysis of the SINODAR-ONE trial is presented here.
Methods
Patients with T1–2 breast cancer and no more than two metastatic sentinel lymph nodes undergoing mastectomy were analysed. After sentinel lymph node biopsy, patients were randomly assigned to receive either axillary lymph node dissection followed by adjuvant treatment (standard arm) or adjuvant treatment alone (experimental arm). The primary endpoint was overall survival. The secondary endpoint was recurrence-free survival.
Results
A total of 218 patients were treated with mastectomy; 111 were randomly assigned to the axillary lymph node dissection group and 107 to the sentinel lymph node biopsy-only group. At a median follow-up of 33.0 months, there were three deaths (two deaths in the axillary lymph node dissection group and one death in the sentinel lymph node biopsy-only group). There were five recurrences in each treatment arm. No axillary lymph node recurrence was observed. The 5-year overall survival rates were 97.8 and 98.7 per cent in the axillary lymph node dissection treatment arm and the sentinel lymph node biopsy-only treatment arm, respectively (P = 0.597). The 5-year recurrence-free survival rates were 95.7 and 94.1 per cent in the axillary lymph node dissection treatment arm and the sentinel lymph node biopsy treatment arm, respectively (P = 0.821).
Conclusion
In patients with T1–2 breast cancer and one to two macrometastatic sentinel lymph nodes treated with mastectomy, the overall survival and recurrence-free survival rates of patients treated with sentinel lymph node biopsy only were not inferior to those treated with axillary lymph node dissection. To strengthen the conclusion of the trial, the enrolment of patients treated with mastectomy was reopened as a single-arm experimental study.
Registration number
NCT05160324 (http://www.clinicaltrials.gov)