Abstract | OBJECTIVE: METHODS: Double-blind phase II randomized study in patients with first-line recurrent or primary advanced (FIGO stage IVB) cervical cancer. Patients received carboplatin- paclitaxel with oral nintedanib 200 mg BID/placebo. The primary endpoint was progression-free survival (PFS) at 1.5 years and α = 0.15, β = 80%, one sided. RESULTS: 120 patients (62 N, 58C) were randomized. Median follow-up was 35 months. Baseline characteristics were similar in both groups (total population: squamous cell carcinoma 62%, prior radiotherapy 64%, primary advanced 25%, recurrent 75%). The primary endpoint was met with a PFS at 1.5 years of 15.1% versus 12.8% in favor of the nintedanib arm (p = 0.057). Median overall survival (OS) was 21.7 and 16.4 months for N and C, respectively. Confirmed RECIST response rate was 48% for N and 39% for C. No new adverse events were noted for N. However, N was associated with numerically more serious adverse events for anemia and febrile neutropenia. Global health status during and at the end of the study was similar in both arms. CONCLUSION: The study met its primary endpoint with a prolonged PFS in the N arm. No new safety signals were observed.
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Authors | I Vergote, E Van Nieuwenhuysen, A Casado, A Laenen, D Lorusso, E I Braicu, E Guerra-Alia, P Zola, P Wimberger, P R Debruyne, E Falcó, A Ferrero, M Z Muallem, J Kerger, E García-Martinez, S Pignata, J Sehouli, T Van Gorp, C Gennigens, M J Rubio |
Journal | Gynecologic oncology
(Gynecol Oncol)
Vol. 174
Pg. 80-88
(07 2023)
ISSN: 1095-6859 [Electronic] United States |
PMID | 37167896
(Publication Type: Randomized Controlled Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2023 Elsevier Inc. All rights reserved. |
Chemical References |
- Carboplatin
- nintedanib
- Vascular Endothelial Growth Factor A
- Paclitaxel
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Topics |
- Female
- Humans
- Carboplatin
- Uterine Cervical Neoplasms
(drug therapy, etiology)
- Vascular Endothelial Growth Factor A
- Neoplasm Recurrence, Local
(pathology)
- Paclitaxel
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects)
- Double-Blind Method
- Lung Neoplasms
(drug therapy)
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