دورية أكاديمية
Phase II trial of neoadjuvant systemic chemotherapy followed by extirpative surgery in patients with high grade upper tract urothelial carcinoma
| العنوان: | Phase II trial of neoadjuvant systemic chemotherapy followed by extirpative surgery in patients with high grade upper tract urothelial carcinoma |
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| المؤلفون: | Margulis, Vitaly, Puligandla, Maneka, Trabulsi, Edouard J, Plimack, Elizabeth R, Kessler, Elizabeth R, Matin, Surena F, Godoy, Guilherme, Alva, Ajjai, Hahn, Noah M, Carducci, Michael A, Hoffman-Censits, Jean, Ruggeri, Antony |
| المصدر: | Oncology |
| بيانات النشر: | Advocate Aurora Health Institutional Repository |
| سنة النشر: | 2020 |
| المجموعة: | Aurora Health Care Digital Repository |
| مصطلحات موضوعية: | Adult, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Transitional Cell, Disease-Free Survival, Drug Administration Schedule, Female, Humans, Kidney Neoplasms, Male, Middle Aged, Neoadjuvant Therapy, Neoplasm Grading, Nephroureterectomy, Prospective Studies, Ureteral Neoplasms, Urothelium, Urology |
| الوصف: | PURPOSE: Data supporting neoadjuvant chemotherapy of high grade upper tract urothelial carcinoma are scant. In this multi-institution, prospective, phase II trial we investigated pathological complete responses after neoadjuvant chemotherapy of high grade upper tract urothelial carcinoma. MATERIALS AND METHODS: Patients with high grade upper tract urothelial carcinoma in whom nephroureterectomy was planned were assigned to 4 neoadjuvant chemotherapy cycles of accelerated methotrexate, vinblastine, doxorubicin and cisplatin in those with baseline creatinine clearance greater than 50 ml per minute or gemcitabine and carboplatin in those with creatinine clearance 30 to 50 ml per minute or less. The study primary end point was a pathological complete response (ypT0N0). The accrual goal was 30 patients per arm. An 18% pathological complete response was considered worth further study while a 4% pathological complete response would not have justified pursuing this regimen. With 28 eligible patients per arm success was defined as 3 or more pathological complete responses (10.7%) in a given arm. Secondary end points included safety, renal function and oncologic outcomes. RESULTS: A total of 30 patients enrolled in the accelerated methotrexate, vinblastine, doxorubicin and cisplatin arm from 2015 to 2017. Six patients enrolled in the gemcitabine and carboplatin arm, which closed due to poor accrual. Of the 29 patients eligible for accelerated methotrexate, vinblastine, doxorubicin and cisplatin, including 23 men and 6 women with a median age of 65 years (range 40 to 84), 80% completed all planned treatments, 3 (10.3%) achieved ypT0N0 and 1 achieved ypT0Nx for a pathological complete response in 13.8% (90% CI 4.9-28.8). In 1 patient receiving accelerated methotrexate, vinblastine, doxorubicin and cisplatin nephroureterectomy was deferred due to grade 4 sepsis. The grade 3-4 toxicity rate was 23% in the accelerated methotrexate, vinblastine, doxorubicin and cisplatin arm with no grade 5 event. CONCLUSIONS: Accelerated ... |
| نوع الوثيقة: | text |
| اللغة: | unknown |
| العلاقة: | https://institutionalrepository.aah.org/onc/154Test; https://xk8bg6rv9a.search.serialssolutions.com/?sid=Entrez:PubMed&id=pmid:31702432Test |
| DOI: | 10.1097/JU.0000000000000644 |
| الإتاحة: | https://doi.org/10.1097/JU.0000000000000644Test https://institutionalrepository.aah.org/onc/154Test https://xk8bg6rv9a.search.serialssolutions.com/?sid=Entrez:PubMed&id=pmid:31702432Test |
| رقم الانضمام: | edsbas.AA97FEB7 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1097/JU.0000000000000644 |
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