Cazzaniga Marina Elena, Pronzato Paolo, Amoroso Domenico, Bernardo Antonio, Biganzoli Laura, Bisagni Giancarlo, Blasi Livio, Bria Emilio, Cognetti Francesco, Crinò Lucio, De Laurentiis Michelino, Del Mastro Lucia, De Placido Sabino, Beano Alessandra, Ferraù Francesco, Foladore Silva, Forcignanò Rosachiara, Gamucci Teresa, Garrone Ornella, Gennari Alessandra, Giordano Monica, Giotta Francesco, Giovanardi Filippo, Latini Luciano, Livi Lorenzo, Marchetti Paolo, Mattioli Rodolfo, Michelotti Andrea, Montemurro Filippo, Putzu Carlo, Riccardi Ferdinando, Ricciardi Giuseppina, Romagnoli Emanuela, Sarobba Giuseppina, Spazzapan Simon, Tagliaferri Pierosandro, Tinari Nicola, Tonini Giuseppe, Turletti Anna, Verusio Claudio, Zambelli Alberto, Mustacchi Giorgio
Fondazione IRCCS San Gerardo dei Tintori, 20900 Monza, Italy.
School of Medicine and Surgery, Università Milano Bicocca, 20900 Monza, Italy.
Cancers (Basel). 2023 Dec 25;16(1):117. doi: 10.3390/cancers16010117.
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, = 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, = 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.
GIM 13-AMBRA是一项纵向队列研究，旨在描述939例HER2阴性转移性乳腺癌（MBC）患者的治疗策略及相关预后参数。基于紫杉烷的方案，或紫杉烷+靶向药物，主要是贝伐单抗，是Luminal型（30.2%）和三阴型乳腺癌（TNBC，33.3%）患者的首选一线治疗方案。无进展生存期1（PFS1）的中位数为12.5个月（95%置信区间16.79 - 19.64），各亚型之间无显著差异，而三阴型乳腺癌患者首次治疗变更时间（TTC1）的中位数（7.7个月，95%置信区间5.7 - 9.2）显著低于Luminal A型（13.2个月，95%置信区间11.7 - 15.1）和Luminal B型患者（11.8个月，95%置信区间10.3 - 12.8）。三阴型乳腺癌患者的无进展生存期2（PFS2）显著更短（5.5个月，95%置信区间4.3 - 6.5，而Luminal A型为9.4个月，95%置信区间8.1 - 10.7，Luminal B型为7.7个月，95%置信区间6.8 - 8.2，F值4.30，P = 0.014）。三阴型乳腺癌患者的第二次治疗变更时间（TTC2）显著低于其他两种亚型的患者。Luminal A型患者的总生存期1（OS1）中位数为35.2个月（95%置信区间30.8 - 37.4），显著高于Luminal B型（28.9个月，95%置信区间26.2 - 31.2）和三阴型乳腺癌（18.5个月，95%置信区间16 - 20.1，F值7.44，P = 0.0006）。GIM 13-AMBRA研究是意大利迄今发表的最大规模研究之一，为HER2阴性转移性乳腺癌患者一线、二线及后续治疗的时间结局提供了有用的结果。
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