Clinical Outcomes of HER2-Negative Metastatic Breast Cancer Patients in Italy in the Last Decade: Results of the GIM 13-AMBRA Study

Author:

Cazzaniga Marina Elena12,Pronzato Paolo3,Amoroso Domenico4,Bernardo Antonio5,Biganzoli Laura6,Bisagni Giancarlo7,Blasi Livio8,Bria Emilio9,Cognetti Francesco10,Crinò Lucio11,De Laurentiis Michelino12,Del Mastro Lucia3ORCID,De Placido Sabino13,Beano Alessandra14,Ferraù Francesco15,Foladore Silva16,Forcignanò Rosachiara17,Gamucci Teresa18,Garrone Ornella19ORCID,Gennari Alessandra20,Giordano Monica21,Giotta Francesco22ORCID,Giovanardi Filippo23ORCID,Latini Luciano24,Livi Lorenzo25,Marchetti Paolo26,Mattioli Rodolfo27,Michelotti Andrea28,Montemurro Filippo29ORCID,Putzu Carlo30ORCID,Riccardi Ferdinando31,Ricciardi Giuseppina32,Romagnoli Emanuela33,Sarobba Giuseppina34,Spazzapan Simon35ORCID,Tagliaferri Pierosandro36,Tinari Nicola37ORCID,Tonini Giuseppe38,Turletti Anna39,Verusio Claudio40,Zambelli Alberto41ORCID,Mustacchi Giorgio42ORCID

Affiliation:

1. Fondazione IRCCS San Gerardo dei Tintori, 20900 Monza, Italy

2. School of Medicine and Surgery, Università Milano Bicocca, 20900 Monza, Italy

3. Oncologia Medica IRCCS IRST San Martino, 16100 Genova, Italy

4. Oncologia Medica, Ospedale Versilia USL Nord Ovest Toscana, 55041 Lido di Camaiore, Italy

5. Oncologia Istituti Clinici Scientifici Maugeri Spa Società Benefit, 27100 Pavia, Italy

6. U.O. Oncologia Medica, Ospedale Santo Stefano, 59100 Prato, Italy

7. Oncologia Medica, IRCCS Arcispedale S. Maria Nuova, 42121 Reggio Emilia, Italy

8. Oncologia Medica, ARNAS Civico–Di Cristina-Benfratelli, Presidio Ospedaliero ‘Civico e Benfratelli’, 20121 Palermo, Italy

9. Oncologia Medica, A.O.U. Integrata Verona, Ospedale Borgo Roma, 37100 Verona, Italy

10. Oncologia Medica 1, Istituto Nazionale Tumori “Regina Elena”, 00042 Roma, Italy

11. Oncologia, Ospedale S. Maria della Misericordia, 06121 Perugia, Italy

12. Breast Oncology Unit, INT Fondazione Giovanni Pascale-IRCCS, 80013 Napoli, Italy

13. Oncologia Medica, Dipartimento di Medicina Clinica e Chirurgia, Università degli Studi Federico II, 80013 Napoli, Italy

14. Oncologia Medica, Città della Salute e della Scienza, ASL “Città di Torino”, 10024 Torino, Italy

15. Oncologia Medica, Ospedale S. Vincenzo, 98039 Taormina, Italy

16. SSD Oncologica e dell’apparato Riproduttivo Femminile, Azienda Sanitaria Universitaria “Giuliano Isontina, 34121 Trieste, Italy

17. Oncologia Medica, Ospedale Vito Fazzi, 73100 Lecce, Italy

18. Oncologia Medica, ASL Roma 2, 00042 Roma, Italy

19. Oncologia Medica, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, 20100 Milano, Italy

20. Oncologia Medica, Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara, Dipartimento di Medicina e Chirurgia, Università degli Studi del Piemonte Orientale, 28100 Novara, Italy

21. SC Oncologia, Asst-Lariana, 22100 Como, Italy

22. Oncologia, IRCCS Istituto Tumori ‘Giovanni Paolo II’, 70100 Bari, Italy

23. UOS Day Hospital Oncologico, AUSL Reggio Emilia, Presidio Ospedaliero di Guastalla, 42016 Guastalla, Italy

24. Oncologia, Ospedale di Macerata, 62100 Macerata, Italy

25. Dipartimento di Scienze Biomediche, Sperimentali e Cliniche ‘Mario Serio’, Università degli Studi di Firenze, UOC Radioterapia, A.O.U. Careggi, 50100 Firenze, Italy

26. Oncologia Medica, IDI IRCCS, 00042 Roma, Italy

27. Oncologia Medica, A.O. Ospedali Riuniti Marche Nord-Ospedale Santa Croce, 61032 Fano, Italy

28. Oncologia Medica, Azienda Ospedaliera Pisana, 56121 Pisa, Italy

29. Fondazione del Piemonte per l’Oncologia-Istituto di Ricovero e Cura a Carattere Scientifico (I.R.C.C.S.), 10024 Torino, Italy

30. Oncologia Medica, AOU Sassari, 07100 Sassari, Italy

31. Oncologia Medica, Azienda Ospedaliera ‘A. Cardarelli’ (AORN), 80013 Napoli, Italy

32. Oncologia Medica, Ospedale Papardo, 98121 Messina, Italy

33. Oncologia Medica, AV Macerata, 62100 Macerata, Italy

34. Oncologia Medica, Ospedale ‘San Francesco’, Azienda Sanitaria Locale 3 Nuoro, 08100 Nuoro, Italy

35. Centro di Riferimento Oncologico, IRCCS, 33081 Aviano, Italy

36. Oncologia Medica, A.O.U. ‘Mater Domini’, 88100 Catanzaro, Italy

37. Oncologia Medica, Policlinico ‘SS. Annunziata’, 66100 Chieti, Italy

38. Policlinico Universitario Campus Biomedico, 00042 Roma, Italy

39. Presidio Ospedaliero Martini, ASL TO1, 10024 Torino, Italy

40. Oncologia Medica, ASST della Valle Olona, Ospedale di Saronno, 21047 Saronno, Italy

41. Oncologia Medica, ASST Papa Giovanni XXIII, Ospedale Papa Giovanni XXIII, 24100 Bergamo, Italy

42. Università degli Studi di Trieste, 34100 Trieste, Italy

Abstract

GIM 13-AMBRA is a longitudinal cohort study aimed at describing therapeutic strategies and the relative outcome parameters in 939 HER2-ve MBC patients. Taxanes–based regimens, or taxanes + targeted agents, mainly Bevacizumab, were the preferred first choice in both Luminal (30.2%) and TNBC (33.3%) patients. The median PFS1 was 12.5 months (95% CI 16.79–19.64), without any significant difference according to subtypes, while the median Time to first Treatment Change (TTC1) was significantly lower in TNBC patients (7.7 months—95% CI 5.7–9.2) in comparison to Luminal A (13.2 months, 95% CI 11.7–15.1) and Luminal B patients (11.8 months, 95% CI 10.3–12.8). PFS2 was significantly shorter in TNBC patients (5.5 months, 95% CI 4.3–6.5 vs. Luminal A—9.4, 95% CI 8.1–10.7, and Luminal B—7.7 95% CI 6.8–8.2, F-Ratio 4.30, p = 0.014). TTC2 was significantly lower in patients with TNBC than in those with the other two subtypes. The median OS1 was 35.2 months (95% CI 30.8–37.4) for Luminal A patients, which was significantly higher than that for both Luminal B (28.9 months, 95% CI 26.2–31.2) and TNBC (18.5 months, 95% CI 16–20.1, F-ratio 7.44, p = 0.0006). The GIM 13—AMBRA study is one of the largest collections ever published in Italy and provides useful results in terms of time outcomes for first, second, and further lines of treatment in HER2- MBC patients.

Funder

Celgene srl to Gruppo Italiano Mammella

Oncotech srl

Publisher

MDPI AG

Subject

Cancer Research,Oncology

Reference19 articles.

1. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries;Sung;CA Cancer J. Clin.,2021

2. Breast Cancer in Italy: Stage and Region Distribution;Mangone;Breast Cancer,2022

3. (2020). I Numeri del Cancro in Italia 2020, Intermedia Editore.

4. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications;Perou;Proc. Natl. Acad. Sci. USA,2001

5. Metastatic behavior of breast cancer subtypes;Kennecke;J. Clin. Oncol.,2010

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