Welslau Manfred, Potthoff Karin, Zaiss Matthias, Müller Lothar, Brucker Cosima, Salat Christoph, Untch Michael, Meiler Johannes, Lüftner Diana, Welt Anja, Dörfel Steffen, Hagen Volker, Stein Alexander, Liersch Rüdiger, Kuhn Thomas, Siebenbach Hans Ulrich, Bing Gerlinde, Vannier Corinne, Marschner Norbert, Gratzke Katja
Klinikum Aschaffenburg-Alzenau, Medizinische Klinik IV, Hämatologie/Onkologie, Aschaffenburg, Germany.
Medical Department, iOMEDICO, Freiburg, Germany.
Oncol Res Treat. 2025;48(1-2):14-25. doi: 10.1159/000542459. Epub 2024 Nov 15.
The INGE-B trial (NCT02894398) aimed to confirm the efficacy and safety data from the PALOMA trials for patients treated first line (1L) with palbociclib (PAL) and letrozole or 1L and later line with PAL and fulvestrant. In addition, so far lacking evidence for efficacy and safety on the combination of PAL with anastrozole, exemestane (1L), or letrozole (later line) was investigated.
The prospective, multicenter, multicohort phase 2 trial INGE-B enrolled adult patients with locally advanced, inoperable, or metastatic HR+/HER2- breast cancer in Germany. The primary endpoint was the clinical benefit rate (CBR) in patients with measurable disease according to RECIST v1.1. Secondary endpoints were overall response rate, progression-free survival (PFS), overall survival (OS), safety, and quality of life. Data were analyzed with descriptive statistics.
Between 2016 and 2018, 388 patients were enrolled at 64 German sites. Among patients with measurable disease treated with PAL in 1L (n = 157), the CBR was 63.7% (100/157). Among all patients treated with PAL 1L (n = 219), PFS was 20.1 months (95% CI 14.6-24.0), and OS was 40.9 months (95% CI 35.1-49.2). The most common grade 3/4 adverse event was neutropenia (33.4% n = 77). There were no treatment-related deaths.
The INGE-B trial demonstrated good efficacy and tolerability of PAL with letrozole (1L) or fulvestrant (first and later line) in accordance with the PALOMA trials. In addition, the so far lacking proof of efficacy and safety of PAL in combination with anastrozole or exemestane in 1L and with letrozole in later line was provided by INGE-B.
The INGE-B trial (NCT02894398) aimed to confirm the efficacy and safety data from the PALOMA trials for patients treated first line (1L) with palbociclib (PAL) and letrozole or 1L and later line with PAL and fulvestrant. In addition, so far lacking evidence for efficacy and safety on the combination of PAL with anastrozole, exemestane (1L), or letrozole (later line) was investigated.
The prospective, multicenter, multicohort phase 2 trial INGE-B enrolled adult patients with locally advanced, inoperable, or metastatic HR+/HER2- breast cancer in Germany. The primary endpoint was the clinical benefit rate (CBR) in patients with measurable disease according to RECIST v1.1. Secondary endpoints were overall response rate, progression-free survival (PFS), overall survival (OS), safety, and quality of life. Data were analyzed with descriptive statistics.
Between 2016 and 2018, 388 patients were enrolled at 64 German sites. Among patients with measurable disease treated with PAL in 1L (n = 157), the CBR was 63.7% (100/157). Among all patients treated with PAL 1L (n = 219), PFS was 20.1 months (95% CI 14.6-24.0), and OS was 40.9 months (95% CI 35.1-49.2). The most common grade 3/4 adverse event was neutropenia (33.4% n = 77). There were no treatment-related deaths.
The INGE-B trial demonstrated good efficacy and tolerability of PAL with letrozole (1L) or fulvestrant (first and later line) in accordance with the PALOMA trials. In addition, the so far lacking proof of efficacy and safety of PAL in combination with anastrozole or exemestane in 1L and with letrozole in later line was provided by INGE-B.
INGE - B试验（NCT02894398）旨在确认PALOMA试验中一线（1L）接受哌柏西利（PAL）与来曲唑治疗或一线及后续线次接受PAL与氟维司群治疗的患者的疗效和安全性数据。此外，还对目前缺乏的PAL与阿那曲唑、依西美坦（一线）或来曲唑（后续线次）联合使用的疗效和安全性证据进行了研究。
前瞻性、多中心、多队列2期INGE - B试验在德国招募了患有局部晚期、无法手术或转移性HR + /HER2 - 乳腺癌的成年患者。主要终点是根据RECIST v1.1标准评估的可测量疾病患者的临床获益率（CBR）。次要终点包括总缓解率、无进展生存期（PFS）、总生存期（OS）、安全性和生活质量。采用描述性统计方法对数据进行分析。
2016年至2018年期间，德国64个研究点共纳入388例患者。在一线接受PAL治疗的可测量疾病患者中（n = 157），CBR为63.7%（100/157）。在所有一线接受PAL治疗的患者中（n = 219），PFS为20.1个月（95%CI 14.6 - 24.0），OS为40.9个月（95%CI 35.1 - 49.2）。最常见的3/4级不良事件是中性粒细胞减少（33.4%，n = 77）。没有与治疗相关的死亡病例。
INGE - B试验表明，与PALOMA试验一致，PAL与来曲唑（一线）或氟维司群（一线及后续线次）联合使用具有良好的疗效和耐受性。此外，INGE - B试验还提供了目前缺乏的PAL与阿那曲唑或依西美坦在一线联合使用以及与来曲唑在后续线次联合使用的疗效和安全性证据。
INGE - B试验（NCT02894398）旨在确认PALOMA试验中一线（1L）接受哌柏西利（PAL）与来曲唑治疗或一线及后续线次接受PAL与氟维司群治疗的患者的疗效和安全性数据。此外，还对目前缺乏的PAL与阿那曲唑、依西美坦（一线）或来曲唑（后续线次）联合使用的疗效和安全性证据进行了研究。
前瞻性、多中心、多队列2期INGE - B试验在德国招募了患有局部晚期、无法手术或转移性HR + /HER2 - 乳腺癌的成年患者。主要终点是根据RECIST v1.1标准评估的可测量疾病患者的临床获益率（CBR）。次要终点包括总缓解率、无进展生存期（PFS）、总生存期（OS）、安全性和生活质量。采用描述性统计方法对数据进行分析。
2016年至2018年期间，德国64个研究点共纳入388例患者。在一线接受PAL治疗的可测量疾病患者中（n = 157），CBR为63.7%（100/157）。在所有一线接受PAL治疗的患者中（n = 219），PFS为20.1个月（95%CI 14.6 - 24.0），OS为40.9个月（95%CI 35.1 - 49.2）。最常见的3/4级不良事件是中性粒细胞减少（33.4%，n = 77）。没有与治疗相关的死亡病例。
INGE - B试验表明，与PALOMA试验一致，PAL与来曲唑（一线）或氟维司群（一线及后续线次）联合使用具有良好的疗效和耐受性。此外，INGE - B试验还提供了目前缺乏的PAL与阿那曲唑或依西美坦在一线联合使用以及与来曲唑在后续线次联合使用的疗效和安全性证据。
