Judith Passildas Jahanmohan, Maureen Bernadach, Mélanie Pouget, Fabrice Kwiatkowski, Isabelle Vanpraagh-Doreau, Pascale Dubray-Longeras, Catherine Abrial, Jean-Marc Nabholtz, Hervé Curé, Valérie Delecroix, Philippe Chollet, Marie-Ange Mouret-Reynier
Service d'Oncologie médicale Centre Jean Perrin Clermont-Ferrand France.
IMoST Centre Jean Perrin, INSERM, U1240 Imagerie Moléculaire et Stratégies Théranostiques, Université Clermont Auvergne Clermont-Ferrand France.
Health Sci Rep. 2024 Sep 16;7(9):e70052. doi: 10.1002/hsr2.70052. eCollection 2024 Sep.
In this study, we investigated whether the association of curcumin and docetaxel among advanced and metastatic breast cancer patients in first or second-line treatment potentiated the objective response rate.
PATIENTS/METHODS: A multicentre, randomized, open label, phase-II study was conducted and included 42 patients from July 2009 to January 2017. The primary endpoint was the objective response rate of the docetaxel-curcumin combination in comparison with docetaxel alone. The secondary endpoints were the assessment of clinical benefit, overall survival, time-to-progression, progression-free survival, compliance, and safety. An interim analysis was planned to evaluate safety and efficacy.
In this interim analysis conducted on 37 patients (19 in the control group vs. 18 in the experimental group), no difference was observed for the objective response rate ( = 0.25, control 73.7% vs. experimental 55.6%). Concerning clinical benefit, overall survival and time-to-progression, we also failed to show any difference between the two arms. A slight tendency towards longer progression-free survival at 12 months after randomization was observed in the curcumin group (65.5% vs. 41.4%) but this difference did not reach significance ( = 0.14).
In this study, we showed for the first time that adding oral curcumin for advanced and metastatic breast cancer patients treated with first or second-line docetaxel was not efficacious, although safe. Consequently, this study was stopped for reasons of futility. Further studies with a larger number of patients, a different curcumin preparation, a longer treatment period and a pharmacokinetic evaluation of curcumin are needed to explore the real efficacy of this compound.
在本研究中，我们调查了晚期和转移性乳腺癌患者在一线或二线治疗中使用姜黄素与多西他赛联合用药是否能提高客观缓解率。
患者/方法：进行了一项多中心、随机、开放标签的II期研究，从2009年7月至2017年1月共纳入42例患者。主要终点是多西他赛 - 姜黄素联合用药与单用多西他赛相比的客观缓解率。次要终点包括临床获益评估、总生存期、疾病进展时间、无进展生存期、依从性和安全性。计划进行中期分析以评估安全性和疗效。
在对37例患者（对照组19例，试验组18例）进行的中期分析中，客观缓解率未观察到差异（P = 0.25，对照组73.7%，试验组55.6%）。关于临床获益、总生存期和疾病进展时间，两组之间也未显示出任何差异。在随机分组后12个月时，姜黄素组观察到无进展生存期有轻微延长的趋势（65.5%对41.4%），但这种差异未达到显著水平（P = 0.14）。
在本研究中，我们首次表明，对于接受一线或二线多西他赛治疗的晚期和转移性乳腺癌患者，添加口服姜黄素虽然安全，但并无疗效。因此，本研究因无效而停止。需要进行更多患者、不同姜黄素制剂、更长治疗期以及姜黄素药代动力学评估的进一步研究，以探索该化合物的实际疗效。
