Randomized phase-III-trial of concurrent chemoradiation for locally advanced head and neck cancer comparing dose reduced radiotherapy with paclitaxel/cisplatin to standard radiotherapy with fluorouracil/cisplatin: The PacCis-trial

Fietkau R, Hecht M, Hofner B, Lubgan D, Iro H, Gefeller O, Rödel C, Hautmann MG, Kölbl O, Salay A, Rübe C, Melchior P, Breinl P, Krings W, Gripp S, Wollenberg B, Keerl R, Schreck U, Siekmeyer B, Grabenbauer GG, Balermpas P (2020)

Publication Type: Journal article

Publication year: 2020

Journal

Book Volume: 144

Pages Range: 209-217

DOI: 10.1016/j.radonc.2020.01.016

Abstract

Background and purpose: This multicenter, phase 3 trial investigates whether the incorporation of concurrent paclitaxel and cisplatin together with a reduced total dose of radiotherapy is superior to standard fluorouracil–cisplatin based CRT. Materials and methods: Patients with SCCHN, stage III–IVB, were randomized to receive paclitaxel/cisplatin (PacCis)–CRT (arm A; paclitaxel 20 mg/m² on days 2, 5, 8, 11 and 25, 30, 33, 36; cisplatin 20 mg/m², days 1–4 and 29–32; RT to a total dose of 63.6 Gy) or fluorouracil/cisplatin (CisFU)–CRT (arm B; fluorouracil 600 mg/m²; cisplatin 20 mg/m², days 1–5 and 29–33; RT: 70.6 Gy). Endpoint was 3-year-disease free survival (3y-DFS). Results: A total of 221 patients were enrolled between 2010 and 2015. With a median follow-up of 3.7 years, 3y-DFS in the CisFU arm and PacCis arm was 58.2% and 48.4%, respectively (HR 0.82, 95% CI 0.56–1.21, p = 0.52). The 3y-OS amounted to 64.6% in the CisFU arm, and to 59.2% in the PacCis arm (HR 0.82, 95% CI 0.54–1.24, p = 0.43). In the subgroup of p16-positive oropharyngeal carcinomas, 3y-DFS and 3y-OS was 84.6% vs 83.9% (p = 0.653), and 92.3% vs. 83.5% (p = 0.76) in arm A and B, respectively. Grade 3–4 hematological toxicities were significantly reduced in arm A (anemia, p = 0.01; leukocytopenia, p = 0.003), whereas grade 3 infections were reduced in arm B (p = 0.01). Conclusion: Paclitaxel/cisplatin–CRT with a reduced RT-dose is not superior to standard fluorouracil/cisplatin–CRT. Subgroup analyses indicate that a reduced radiation dose seems to be sufficient for p16+ oropharyngeal cancer or non-smokers. Clinical trial information: NCT01126216; EudraCT Number 2005-003484-23.

Authors with CRIS profile

Involved external institutions

Brüderkrankenhaus St. Josef Paderborn Germany (DE) Universitätsklinikum Frankfurt am Main (KGU) Germany (DE) Universitätsklinikum Düsseldorf Germany (DE) Universitätsklinikum Schleswig-Holstein (UKSH) Germany (DE) Universitätsklinikum des Saarlandes (UKS) Germany (DE) Klinikum St. Elisabeth Straubing GmbH Germany (DE) Klinikum Coburg Germany (DE) Alb Fils Kliniken Germany (DE) Klinikum Mutterhaus der Borromäerinnen Germany (DE) Universitätsklinikum Regensburg Germany (DE) Kliniken Maria Hilf GmbH Germany (DE) Kliniken München Pasing und Perlach Germany (DE)

How to cite

APA:

Fietkau, R., Hecht, M., Hofner, B., Lubgan, D., Iro, H., Gefeller, O.,... Balermpas, P. (2020). Randomized phase-III-trial of concurrent chemoradiation for locally advanced head and neck cancer comparing dose reduced radiotherapy with paclitaxel/cisplatin to standard radiotherapy with fluorouracil/cisplatin: The PacCis-trial. Radiotherapy and Oncology, 144, 209-217. https://doi.org/10.1016/j.radonc.2020.01.016

MLA:

Fietkau, Rainer, et al. "Randomized phase-III-trial of concurrent chemoradiation for locally advanced head and neck cancer comparing dose reduced radiotherapy with paclitaxel/cisplatin to standard radiotherapy with fluorouracil/cisplatin: The PacCis-trial." Radiotherapy and Oncology 144 (2020): 209-217.

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