| Autor: |
O’Donnell, Michael A., Singh, Sharwan, Sood, Rajeev, Amlani, Jitendra, Krishnamoorthy, H., Shukla, Ketan, Mohanty, Nayan, Bhatia, Sushil, Chakraborty, Bhaswat, Desai, Nirav, Modi, Rajiv, Shukla, Chandreshwar, Vachhani, Kapil, Patel, Rashmi, Kundu, Anup, Khamar, Bakulesh |
| Zdroj: |
Bladder Cancer; August 2019, Vol. 5 Issue: 2 p171-180, 10p |
| Abstrakt: |
CADI-05, a TLR-2 agonist, induces Th1 immune response following intradermal administration and has been found useful in management of lung cancer and melanoma. To evaluate CADI-05 in patients with BCG recurrent and unresponsive Non-muscle invasive bladder cancer (NMIBC) for 15-months recurrence free survival (RFS) rate. In BCG unresponsive (BU) or recurrent (BR) NMIBC, CADI-05 was administered intradermally every two weeks for 3 months followed by every month for 3 months and subsequently every 2 months for 6 months following transurethral resection (TUR) in a single arm study (ClinicalTrials.gov: NCT00694798). Cystoscopy, cytology, and sonography were performed for the presence/recurrence of NMIBC at 3, 6, 9, 12, 15 months and beyond and confirmed by biopsy. Evaluation of preoperative biopsy for Desmocollin-3 (DSC3) expression and tumor infiltrating lymphocytes (TIL) was optional. Twenty patients with NMIBC received intradermal CADI-05. RFS at 15 and 30 months was 35% (7/20) patients. The median RFS was also better for BU compared to BR group (HR, 0.329; 95% CI, 0.071 to 1.532). DSC3 expression was present in 68.8% (11/16) patients. TIL and RFS beyond 30 months were seen 2.3 times and 2.8 times more often in DSC3 expressing NMIBC respectively. No grade IV or V adverse events occurred. Local site reactions were the most common adverse event. Intradermal CADI-05 following TUR is associated with 35% RFS at 30 months. |
| Databáze: |
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