Safety and efficacy of neoadjuvant durvalumab plus gemcitabine/cisplatin or carboplatin in patients with operable high-risk upper tract urothelial carcinoma: the iNDUCT trial.

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Tác giả: Christine Abraham, François Audenet, Karim Bensalah, Thierry Chevallier, Stéphane Droupy, Hélène Gauthier, Gwenaëlle Gravis, Nadine Houédé, Loïc Jaffrelot, Brigitte Laguerre, Guillaume Luquiens, Alexandra Masson-Lecomte, Yann Neuzillet, Géraldine Pignot, Damien Pouessel, Mathieu Roumiguié, Morgan Rouprêt, Alain Ruffion, Sophie Tartas, Constance Thibault, Evanguelos Xylinas

Ngôn ngữ: eng

Ký hiệu phân loại: 912.01 Philosophy and theory

Thông tin xuất bản: United States : Journal of clinical oncology : official journal of the American Society of Clinical Oncology , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 58654

 PURPOSE: After radical nephroureterectomy (RNU) for upper tract urothelial carcinoma (UTUC), prognosis is poor for high-risk patients. This study evaluated safety and efficacy of neoadjuvant chemotherapy (cisplatin or carboplatin + gemcitabine) in combination with durvalumab in these patients. PATIENTS AND METHODS: This phase II trial (NCT04617756) included patients with non-metastatic, high-grade UTUC, based on the ureteroscopic biopsy or urine cytology, and/or infiltrative aspect of the renal pelvis/ureteral wall by CT imaging. Before RNU, patients received durvalumab plus gemcitabine/cisplatin (cohort 1) or durvalumab plus gemcitabine/carboplatin (cohort 2) every 3 weeks for a total of four cycles (cohort choice based on the glomerular filtration rate). The primary objective was the pathological complete response (ypT0) rate in each cohort. RESULTS: Fifty patients were enrolled between 2021 and 2024 (31 in cohort 1
  19 in cohort 2). Median age was 68 years (range 38-79), 59% were men. Forty-five patients received 4 cycles of treatment, three patients 3 cycles, and one patient 2 cycles. Five patients switched to carboplatin during treatment. At surgery (n=45 patients), rates of pT0 were 13% (4/29) in cohort 1 and 5% (1/19) in cohort 2. Fifty percent (15/29) of patients were pTa /pT1 in cohort 1, and 42% (8/19) in cohort 2. No severe immunotherapy-mediated toxicity was observed. Four patients had chemotherapy-related grade 3 neutropenia, one grade 4
  one patient had grade 3 thrombopenia, one grade 4
  four patients had grade 3 anemia. CONCLUSION: While our negative study did not meet its primary endpoint in either cohort, the combination of durvalumab and platin-based chemotherapy, especially cisplatin, showed promising results in terms of downstaging. The safety profile was good and the surgical risk was not increased.
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