Axillary dissection versus no axillary dissection in patients with breast cancer and sentinel-node micrometastases (IBCSG 23-01): 10-year follow-up of a randomised, controlled phase 3 trial

Galimberti, Viviana; Cole, Bernard F.; Viale, Giuseppe; Veronesi, Paolo; Vicini, Elisa; Intra, Mattia; Mazzarol, Giovanni; Massarut, Samuele; Žgajnar, Janez; Taffurelli, Mario; Littlejohn, David R. G.; Knauer, Michael; Tondini, Carlo; Leo, Angelo Di; Colleoni, Marco; Regan, Meredith M.; Coates, Alan S.; Gelber, Richard D.; Goldhirsch, Aron; Boyle, Frances M.; Jérusalem, Guy; Stahel, Rolf A.; Aebi, Stefan; Green, Michael; Karlsson, Per; Kössler, Ingrid; Làng, István; Hiltbrunner, Anita; Bernhard, Jürg; Fournarakou, Stamatina; Kammler, Roswitha; Maibach, Rudolf; Rabaglio, Manuela; Ribi, Karin; Roschitzki, Heidi; Roux, Susanne; Ruepp, Barbara; Mahoney, Caitlin; Price, Karen N.; Blacher, L. J.; Scolese, Tara; Scott, Karolyn; Lippert, Sandra; Zielinski, Theresa Julia; Mastropasqua, Mauro G.; Andrighetto, Stefania; Dell’Orto, Patrizia; Renne, Giuseppe; Pruneri, Giancarlo; Dellapasqua, Silvia; Iorfida, Monica; Cancello, Giuseppe; Montagna, Emilia; Cardillo, Anna; Peruzzotti, G.; Ghisini, R.; Luini, Alberto; Veronesi, Umberto; Gentilini, Oreste; Zurrida, Stefano; Curigliano, Giuseppe; Nolè, Franco; Orecchia, Roberto; Leonardi, Marisa Cristina; Baratella, Paola; Chifu, Camelia; Sargenti, Manuela; Crivellari, Diana; Morassut, Sandro; Mileto, Mario; Piccoli, Erica; Veronesi, Andreas; Magri, Marisa Donatella; Buonadonna, Angelo; Candiani, Ezio; Carbone, Antonino; Perin, Tiziana; Volpe, Rachele; Roncadin, M.; Arcicasa, M.; Coran, Francesco; Lagrassa, Manuela; Recalcati, Angelo; Limonta, Maria Emanuela; Tricomi, Paolo; Fenaroli, P.; Candiago, E.; Cattaneo, Laura; Gianatti, Alberto; Santini, Donatella; Maweja, Sylvie; Delvenne, Philippe; Rorive, Andrée; Collignon, Joëlle; Garbay, Jean-Rémi; Mathieu, Marie‐Christine; Galatius, Hanne; Hoffmann, J; Schousen, Peer; Lanng, Charlotte; Hoerby, John; Rasmussen, Birgitte; Holtveg, Helle; Talman, Maj-Lis Moeller; Abugattas, Julio; Cotrina, José M.; Dyer, Richard; Lindtner, Jurij; Majdič, Elga; Frković‐Grazio, Snjez̆ana; Oehlschlegel, Christian; Ries, Gerhard; Töpfer, Michael; Lorenz, Ute; Schiltknecht, Otto; Späti, Bruno; Ehrsam, Andreas; Bamert, Monika; Egli-Tupaj, Martina; Rageth, Christoph; Saurenmann, Elisabeth; Tausch, Christoph; Caduff, Rosmarie; Moch, H.; Varga, Zsuzsanna; Sarlos, Dimitri; Kralidis, Elena; Grobholz, Rainer; Pagani, Olivia; Bronz, Lucia; Ghielmini, Michele; Mazzucchelli, Luca; Rusca, Tiziana; Gyr, Thomas; Leidi, L.; Caccia, Giorgio; Wyss, Daniel F.; Fey, Martin F.; Müller, Michael; Günthert, Andreas R.; Berclaz, Gilles; Fleischmann, Achim; Delaloye, J.-F.; Treboux, Assia; Lehr, Hans‐Anton; Fiche, Maryse; Perey, L; Zaman, Lucien; Sozzi, Wendy Jeanneret; Forbes, John F.; Lindsay, Dianne; Preece, Dan; Hill, Jane; Jeal, P. N.; Smart, Philip; Collins, J.; Mann, G. Bruce; Millar, R. Scott; Murphy, Craig; Buchanan, Malcolm; Murugasu, Anand; French, James; Elder, Elisabeth; Mann, Lynette; Moon, David; Bilous, A. Michael; Pathmanathan, Nirmala; Howard, Virginia J.; Gill, P.G.; Kollias, James; Bochner, Melissa; Madigan, Linda; Rippy, Elisabeth; Whitfield, Robert J.; Farshidi, Fereshte; Moore, K.; Sywak, Mark; Tan, Lee K.; Ross, William; Briscoe, Karen; Jones, Allison; Shah, Aashit; Lim, Elgene; Macindoe, Robert; Spillane, Andrew J.; Bonar, S. Fiona; Carmalt, Hugh; West, Richard H.; Mak, Cindy; McKENZIE, P. E.; Harman, Richard; Gerred, Susanne; Juhász, Éva; Allpress, Stephen; Craik, Julie; Campbell, Ian; Chin, P.K.Y.; Hayes, Lori; Mayall, Frederick; Thorburn, Marigold J.

doi:10.1016/s1470-2045(18)30380-2

Cited by 408 publications

(284 citation statements)

References 29 publications

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“…6,8,9 Several clinical trials have indicated that surgical excision of tumor-draining LNs has no effect on the long-term survival of patients with cancer. [10][11][12] These findings suggest that tumor cells are seeded throughout the body at the stage where micrometastasis exists in the LNs, and as a result, surgical dissection does not affect the longterm survival of cancer patients; this result would support the validity of the LN-mediated hematogenous metastasis theory.…”

mentioning

confidence: 63%

“…Kodama et al demonstrated that the initiation of hematogenous metastasis is tumor cell invasion from the marginal sinus of a LN into the extranodal veins, and the authors advocated the theory of LN‐mediated hematogenous metastasis . Several clinical trials have indicated that surgical excision of tumor‐draining LNs has no effect on the long‐term survival of patients with cancer . These findings suggest that tumor cells are seeded throughout the body at the stage where micrometastasis exists in the LNs, and as a result, surgical dissection does not affect the long‐term survival of cancer patients; this result would support the validity of the LN‐mediated hematogenous metastasis theory.…”

Section: Introductionmentioning

confidence: 99%

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Treatment of false‐negative metastatic lymph nodes by a lymphatic drug delivery system with 5‐fluorouracil

et al. 2019

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Metastatic lymph nodes ( LN s) may be the origin of systemic metastases. It will be important to develop a strategy that prevents systemic metastasis by treating these LN s at an early stage. False‐negative metastatic LN s, which are found during the early stage of metastasis development, are those that contain tumor cells but have a size and shape similar to LN s that do not host tumor cells. Here, we show that 5‐fluorouracil (5‐ FU ), delivered by means of a novel lymphatic drug delivery system ( LDDS ), can treat LN s with false‐negative metastases in a mouse model. The effects of 5‐ FU on four cell lines were investigated using in vitro cytotoxicity and cell survival assays. The therapeutic effects of LDDS ‐administered 5‐ FU on false‐negative metastatic LN s were evaluated using bioluminescence imaging, high‐frequency ultrasound ( US ), and histology in MHX 10/Mo‐ lpr / lpr mice. These experimental animals develop LN s that are similar in size to human LN s. We found that all cell lines showed sensitivity to 5‐ FU in the in vitro assays. Furthermore, a concentration‐dependent effect of 5‐ FU to inhibit tumor growth was observed in tumor cells with low invasive growth characteristics, although a significant reduction in metastatic LN volume was not detected in MHX 10/Mo‐ lpr / lpr mice. Adverse effects of 5‐ FU were not detected. 5‐Fluorouracil administration with a LDDS is an effective treatment method for false‐negative metastatic LN s. We anticipate that the delivery of anticancer drugs by a LDDS will be of great benefit in the prevention and treatment of cancer metastasis via LN s.

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confidence: 63%

Section: Introductionmentioning

confidence: 99%

Treatment of false‐negative metastatic lymph nodes by a lymphatic drug delivery system with 5‐fluorouracil

et al. 2019

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“…Other randomized trials such as the International Breast Cancer Study Group (IBCSG) Trial 23‐01 and the After Mapping of the Axilla: Radiotherapy Or Surgery (AMAROS) trial have shown that ALND can be safely omitted in specific situations. The IBCSG Trial 23‐01 with the recent 10‐year follow‐up results, showed that for patients with micrometastases in the sentinel nodes, there is no difference in locoregional recurrence or disease free survival whether an ALND was performed or not.…”

Section: Discussionmentioning

confidence: 99%

Effect of the American College of Surgeons Oncology Group Z0011 trial on axillary management in breast cancer patients in the Australian setting

2019

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The American College of Surgeons Oncology Group Z0011 Trial demonstrated that early breast cancer patients with positive axillary sentinel lymph nodes treated with breast‐conserving surgery and breast radiotherapy had no additional oncologic benefit of proceeding to an axillary lymph node dissection (ALND). The extent to which practice has changed in Australia remains unclear. The aim of this study was to investigate the effect of the Z0011 trial on the management of positive axillary sentinel nodes at an Australian institutional level. We reviewed all breast cancer cases treated at the Sydney Adventist Hospital over a 10‐year period from 1 January 2008 to 31 December 2017. Patients who fulfilled the Z0011 trial criteria were selected. These patients were divided into two groups according to the year of surgery, before and after 1 January 2011 when the Z0011 study was published. Clinicopathologic data and axillary surgical management were compared. Of the 237 patients fulfilling the Z0011 trial criteria, there were 73 patients before and 158 patients after 1 January 2011. In the earlier group the rate of proceeding to an ALND following a positive sentinel node was 78.1% compared to 43.7% in the latter group (P < 0.0001). There was a significant decline in the rate of ALND over this 10‐year period (r = −0.79, P = 0.006). The Z0011 trial has influenced the surgical management of the axilla leading to a significant reduction in the rate of an ALND in patients fulfilling the Z0011 trial criteria at our institution.

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“…With a median follow-up of 9.7 years, 10-year DFS was 76.8% (95% CI, 72.5e81.0) in the non-ALND group compared with 74.9% (70.5e79.3) in the ALND group (HR 0.85; 95% CI, 0.65e1.11; log-rank p ¼ 0.24; p ¼ 0.0024 for non-inferiority). 10year OS was 90.8% (95% CI, 87.9e93.8) in the non-ALND group and 88.2% (84.8e91.6) in the ALND group (HR 0.78; 95% CI, 0.53e1.14; log-rank p ¼ 0.20) [12].…”

Section: Recently Published Prospective Trialsmentioning

confidence: 95%

Management of the axilla in patients with breast cancer and positive sentinel lymph node biopsy: An evidence-based update in a European breast center

Garcia–Etienne

Ferrari

Valle

et al. 2020

European Journal of Surgical Oncology

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Axillary dissection versus no axillary dissection in patients with breast cancer and sentinel-node micrometastases (IBCSG 23-01): 10-year follow-up of a randomised, controlled phase 3 trial

Cited by 408 publications

References 29 publications

Treatment of false‐negative metastatic lymph nodes by a lymphatic drug delivery system with 5‐fluorouracil

Treatment of false‐negative metastatic lymph nodes by a lymphatic drug delivery system with 5‐fluorouracil

Effect of the American College of Surgeons Oncology Group Z0011 trial on axillary management in breast cancer patients in the Australian setting

Management of the axilla in patients with breast cancer and positive sentinel lymph node biopsy: An evidence-based update in a European breast center

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