Methods: Randomized (1:1), open-label trial. TPEx showed a median overall survival of 14.0 months. The primary endpoint is OS. CoC : NL-66391377 HHS
Fuchs H, Pammer J, Minichsdorfer C, Posch D, Kornek G, Aretin MB, Fuereder T. Med Oncol. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR) at 12 weeks, tolerance and compliance. Assuming a 2-sided type I error of 0.05, observing 295 deaths will provide a 80% power to detect a hazard ratio of 0.72. Newest Articles Epub 2018 Sep 7. For this population, development of efficacious and safer therapies is still needed. Reviewers
The Evolving Role of Taxanes in Combination With Cetuximab for the Treatment of Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck: Evidence, Advantages, and Future Directions.
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1 The taxane-based TPEx requires less chemotherapy cycles and may be less toxic and more efficacious that EXTREME. | Background: After promising results from the GORTEC TPEx phase II trial, the role of taxane instead of 5FU in 1st-line R/M HNSCC chemotherapy (CT) remained to be confirmed by comparing TPEx to the reference EXTREME regimen. Request PDF | TPExtreme randomized trial: TPEx versus Extreme regimen in 1st line recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Copyright © 2020 Elsevier B.V. or its licensors or contributors. Copyright © 2015 European Society for Medical Oncology. Delays in administration were more frequent in the reference arm (27% vs 10%). Less pts in arm A started maintenance than in arm B (53% vs 73%). TAPUR Study. Patients had a good general status (performance status ≤1) and were under 71 years. CancerLinQ ASCO Career Center Despite lack of significant OS increase, taxane-based TPEx regimen comes with a shorter time on chemotherapy and was associated with less toxicity than the EXTREME treatment. T. +31 88 1269 340 The TPEx regimen showed promising activity as first-line treatment in fit patients with recurrent/metastatic HNSCC. No significant improvement in OS was observed. 2015 Sep;26(9):1941-1947. doi: 10.1093/annonc/mdv268. 6002-6002.
published online before print GORTEC (France), AIO-Studien-gGmbH (Germany), TTCC (Spain) joint trial in collaboration with French GETTEC, GERCOR, H&N UNICANCER groups. doi: 10.1097/MD.0000000000013717. Building Infrastructures - Design, Management and Advice, Installation, Maintenance, Operations and Certification, Video Conferencing, Global Video Productions, Interpretation Services, AV Meeting Services. Cetuximab, docetaxel, and cisplatin as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma: a multicenter, phase II GORTEC study. Furthermore, prolonged intermittent treatment with cetuximab seems to participate in the improved survival associated with preserved quality of life. Results: 539 pts were enrolled in 37 mo. Contact Us If cisplatin is not tolerated or its total cumulative dose reaches 600 mg/m², it must be replaced by carboplatin AUC5.
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Despite lack of significant OS increase, taxane based TPEx regimen appears to be a new option in 1st line R/M HNSCC, with a shorter time on CT and significantly lower toxicity than the EXTREME regimen. A randomized trial testing the TPEx regimen (docetaxel-cisplatin-cetuximab) against the standard EXTREME regimen (5-FU-platinum-cetuximab) showed encouraging survival results of the TPEx regimen. ASCO Daily News Reference EXTREME regimen (arm A: 6 cycles every 3 weeks (Q3W) of 5FU–cisplatin-cetuximab (cetux) followed by weekly cetux maintenance) was compared to TPEx regimen (arm B: 4 cycles Q3W of docetaxel 75mg/m²–cisplatin 75mg/m²- cetux 250mg/m² with mandatory G-CSF support followed by every 2W cetux 500mg/m² maintenance). Median overall and progression-free survivals were, respectively, 14 months (95% CI 11.3–17.3) and 6.2 months (95% CI 5.4–7.2). Most frequent grade ≥3 adverse events included neutropenia (EXTREME 49%, TPEx 24%), leukopenia (EXTREME 38%, TPEx 23%), magnesium disorder (EXTREME 22%, TPEx 13%) and vomiting (EXTREME 11%, TPEx 4%). JCO Precision Oncology, ASCO Educational Book 1. Chow, Video interview with Prof. Jean-Pascal Machiels, Video interview with Geertjan van Tienhoven, Video interview with Prof. Jonathan Ledermann, Video interview with Prof. Bernard Escudier, Video interview with Prof. Daniel Petrylak, Video-interview with Prof. Dr. Nicholas James, Video-interview with Prof. Dr. Günter von Minckwitz, Video interview with prof. dr. E. Van Cutsem, Video interview with Prof. Wiebren Tjalma, Video interview with Prof. Dr. Veronique Cocquyt, Video interview with professor J. O'Sullivan, Video interview with Professor E. van Cutsem, Video interview with Prof. Philippe Collard, PODCAST Javier Cortes about the KEYNOTE-355 trial, PODCAST Nadia Harbeck about the KAITLIN study, PODCAST: Egbert Smit about the DESTINY-Lung01 trial, PODCAST Maha Hussain about the IMvigor010 study, PODCAST Luis Paz-Ares about the CASPIAN study, PODCAST with prof. Bruno Sangro about the CheckMate 459 trial, Podcast with dr. Manish R. Patel about the efficacy and safety of entrectinib in NTRK fusion-positive gastrointestinal cancers, PODCAST with dr. Mayer about the PALLAS study regarding adjuvant palbociclib for HR+/HER2- early breast cancer, PODCAST with dr. Eggermont about pembrolizumab after complete resection of high-risk stage III melanoma, PODCAST with dr. Banerjee about the impact of COVID-19 on oncology professionals, PODCAST with dr. Bardia about the ASCENT study examining sacituzumab govitecan in metastatic triple-negative breast cancer. Cetuximab in combination with platinum and 5-fluorouracil is the standard of care in the first-line treatment of patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). Our products and services are geared towards the virtualization of infrastructures and processes.
Guigay J, Tahara M, Licitra L, Keilholz U, Friesland S, Witzler P, Mesía R. Front Oncol. 2019 Jun 25;20(8):65. doi: 10.1007/s11864-019-0664-z. |
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