Department of Urology, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt -
Center of Excellence of Genome and Cancer Research, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.
Minerva Urol Nephrol. 2024 Aug;76(4):474-483. doi: 10.23736/S2724-6051.23.05515-5. Epub 2024 May 17.
The aim of this study is to investigate the impact of the intradermal injection of purified protein derivative (PPD) and PPD skin test reactions on the oncological outcomes of patients with non-muscle invasive bladder cancer (NMIBC) treated by trans-urethral resection of bladder tumor (TURBT) and adjuvant intravesical BCG.
The study included 100 consecutive patients with NMIBC prospectively given intradermal PPD 1-2 weeks before starting BCG therapy. Another 100 patients with NMIBC not given intradermal PPD before starting BCG were chosen as a historical control. The control group was chosen to be matching with the study group regarding baseline characteristics. The study group was divided into 2 subgroups with positive and negative reaction to PPD skin test. Oncological outcomes, immunological markers (TNF-α and IL-6) changes and BCG side effects were evaluated.
There were no significant differences between patients who received PPD or not regarding the 2-year recurrence free survival (RFS) rates and progression-free survival (PFS) rates and immunological markers changes. The 2-year RFS and PFS rates were significantly higher in patients with positive reactions. Post-induction values of immunological markers increased in all patients with a significant increase in patients with positive reactions. BCG side effects were significantly higher in patients with positive reactions.
The intradermal injection of PPD before intravesical BCG has no impact on oncological outcomes of patients with NMIBC treated with TURBT and intravesical BCG. However, the PPD skin test reactions before BCG therapy can predict the oncological outcomes, BCG side effects and the immunological outcomes of patients.
本研究旨在探讨经尿道膀胱肿瘤切除术(TURBT)联合膀胱内卡介苗(BCG)辅助治疗非肌层浸润性膀胱癌(NMIBC)患者皮内注射纯化蛋白衍生物(PPD)和 PPD 皮肤试验反应对肿瘤结局的影响。
本研究纳入 100 例 NMIBC 患者,前瞻性地在开始 BCG 治疗前 1-2 周给予皮内 PPD。另选择 100 例未在开始 BCG 前给予皮内 PPD 的 NMIBC 患者作为历史对照。对照组的选择是为了与研究组在基线特征上相匹配。研究组根据 PPD 皮肤试验的反应分为阳性和阴性反应亚组。评估了肿瘤学结局、免疫标志物(TNF-α和 IL-6)变化和 BCG 副作用。
接受或未接受 PPD 的患者在 2 年无复发生存率(RFS)和无进展生存(PFS)率以及免疫标志物变化方面无显著差异。阳性反应患者的 2 年 RFS 和 PFS 率明显较高。所有患者的免疫标志物在诱导后均升高,阳性反应患者的升高更为显著。阳性反应患者的 BCG 副作用明显更高。
TURBT 和膀胱内 BCG 治疗 NMIBC 患者在接受膀胱内 BCG 治疗前皮内注射 PPD 对肿瘤结局无影响。然而,BCG 治疗前的 PPD 皮肤试验反应可以预测患者的肿瘤结局、BCG 副作用和免疫反应。