A randomized phase III adjuvant study in high-risk cervical cancer: simultaneous radiochemotherapy with cisplatin (S-RC) versus systemic paclitaxel and carboplatin followed by percutaneous radiation (PC-R): a NOGGO-AGO Intergroup Study

Annals of Oncology : Official Journal of the European Society for Medical Oncology
J SehouliS Kuemmel

Abstract

Simultaneous adjuvant platinum-based radiochemotherapy in high-risk cervical cancer (CC) is an established treatment strategy. Sequential paclitaxel (Taxol) and platinum followed by radiotherapy may offer further advantages regarding toxicity. An open-labeled randomized phase III trial was conducted to compare paclitaxel (175 mg/m2) plus carboplatin (AUC5) followed by radiation (50.4 Gy) (experimental arm-A) versus simultaneous radiochemotherapy with cisplatin (40 mg/m2/week) (arm-B) in patients with stage IB-IIB CC after surgery. Primary objective was progression-free survival (PFS). Overall, 271 patients were randomized and 263 were eligible for evaluation; 132 in arm-A and 131 in arm-B appropriately balanced. The estimated 2-year PFS was 81.8% [95% confidence interval (CI) 74.4-89.1] in arm-B versus 87.2% (95% CI 81.2-93.3) in arm-A (P=0.235) and the corresponding 5-year survival rates were 85.8% in arm-A and 78.9% in arm-B (P=0.25). Hematological grade 3/4 toxicity was higher in arm-B. Alopecia (87.9% versus 4.1%; P<0.001) and neurotoxicity (65.9% versus 15.6%; P<0.001) were significantly higher in arm-A. Early treatment termination was significantly more frequent in arm-B than in arm-A (32.1% versus 12.9%; P=0.001). Sequen...Continue Reading

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Citations

Feb 4, 2014·Therapeutic Delivery·Xing Guo WangEkaterina Revskaya
Sep 4, 2020·International Journal of Clinical Oncology·Kaoru OkugawaKiyoko Kato
Nov 23, 2016·The Cochrane Database of Systematic Reviews·Frederico S FalcettaDaniela D Rosa
Jul 24, 2014·Molecular and Clinical Oncology·Motoaki SaitoSeiji Isonishi
Aug 4, 2018·International Journal of Gynecological Cancer : Official Journal of the International Gynecological Cancer Society·Kai-Yun YouXing-Sheng Qiu
Feb 13, 2017·The Journal of Obstetrics and Gynaecology Research·Munetaka TakekumaYasuyuki Hirashima
Jul 28, 2013·Strahlentherapie und Onkologie : Organ der Deutschen Röntgengesellschaft ... [et al]·S MarnitzM Mangler
Nov 28, 2013·Neurotoxicity Research·Senthilvelan ManoharRichard Salvi
Mar 29, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Deepak S ChauhanMurali M Yallapu
May 4, 2021·Journal of Obstetrics and Gynaecology : the Journal of the Institute of Obstetrics and Gynaecology·Fatih KilicOsman Turkmen

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