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Investigation of Re...
Investigation of Relation of Radiation Therapy Quality With Toxicity and Survival in LAP07 Phase 3 Trial for Locally Advanced Pancreatic Carcinoma
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- Giraud, Paul (författare)
- Sorbonne Univ, Inst Univ Canc, Tenon Hosp, AP HP,Dept Radiat Oncol, Paris, France.
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- Racadot, Severine (författare)
- Ctr Leon Berard, Dept Radiat Oncol, Lyon, France.
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- Vernerey, Dewi (författare)
- CHU Besancon, Methodol & Qual Life Oncol Unit EA 3181, Besancon, France.;CHU Besancon, Qual Life & Canc Clin Res Platform, Besancon, France.
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- Goldstein, David (författare)
- Prince Wales Hosp, Dept Med Oncol, Randwick, NSW, Australia.
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- Glimelius, Bengt (författare)
- Uppsala universitet,Institutionen för immunologi, genetik och patologi
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- Van Houtte, Paul (författare)
- Inst Jules Bordet, Dept Radiat Oncol, Brussels, Belgium.
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- Gubanski, Michael (författare)
- Karolinska Institutet
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- Spry, Nigel (författare)
- Sir Charles Gairdner Hosp, Dept Radiat Oncol, Nedlands, WA, Australia.
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- Van Laethem, Jean Luc (författare)
- Univ Libre Bruxelles, Erasme Hosp, Dept Gastroenterol, Brussels, Belgium.;Univ Libre Bruxelles, Erasme Hosp, Gastrointestinal Canc Unit, Brussels, Belgium.
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- Hammel, Pascal (författare)
- Beaujon Hosp, AP HP, Serv Gastroenterol Pancreatol, Clichy, France.
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- Huguet, Florence (författare)
- Sorbonne Univ, Inst Univ Canc, Tenon Hosp, AP HP,Dept Radiat Oncol, Paris, France.
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Sorbonne Univ, Inst Univ Canc, Tenon Hosp, AP HP,Dept Radiat Oncol, Paris, France Ctr Leon Berard, Dept Radiat Oncol, Lyon, France. (creator_code:org_t)
- Elsevier, 2021
- 2021
- Engelska.
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Ingår i: International Journal of Radiation Oncology, Biology, Physics. - : Elsevier. - 0360-3016 .- 1879-355X. ; 110:4, s. 993-1002
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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http://kipublication...
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Abstract
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- Purpose: The LAP07 multicenter randomized study assessed whether chemoradiation therapy increases overall survival versus continuation chemotherapy in patients whose locally advanced pancreatic cancer was controlled after 4 months of induction chemotherapy. This analysis investigated whether failure to adhere to radiation therapy (RT) guidelines influenced survival and toxicity. Methods and Materials: This is a planned analysis of secondary objectives in the framework of a randomized international phase 3 trial. The protocol included detailed written RT guidelines. All participating institutions undertook an initial benchmark case to check adherence to protocol guidelines. Centers with major deviation were not allowed to include patients until they achieved a significant improvement and rigorously followed the guidelines. On-trial RT quality assurance consisted of a central review of treatment plan with dose-volume histograms for each patient. Adherence to guidelines was graded as per protocol (PP), minor deviation (MiD), or major deviation (MaD). Results: Fifty-seven benchmark cases were evaluated, 26% were classified as PP, 60% were MiD, and 14% were MaD. Among the 442 included patients, 133 patients were randomized in the chemoradiation therapy arm, and 117 patients were assessable for RT quality analysis. RT quality was graded as PP in 38.5% of patients, MiD in 43.6% of patients, and MaD in 17.9% of patients. The most frequent protocol violations were dose distribution heterogeneities. Median overall survival was 17 months with PP and MiD versus 13.4 months with MaD (hazard ratio [HR], 1.63; 95% confidence interval [CI], 0.99-2.71; P = .055). There was no difference in terms of progression-free survival (HR, 1.09; 95% CI, 0.66-1.8; P = .72). Patients with MaD had more nausea than patients treated PP or with MiD (P = .0045). Conclusions: MaD was associated with a trend for worst survival. There was no difference in terms of progression-free survival. Because of the low rate of major deviations, their effects on the LAP07 trial results may be negligeable. (C) 2021 Elsevier Inc. All rights reserved.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
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Giraud, Paul
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Racadot, Severin ...
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Vernerey, Dewi
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Goldstein, David
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Glimelius, Bengt
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Van Houtte, Paul
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Gubanski, Michae ...
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Spry, Nigel
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Van Laethem, Jea ...
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Hammel, Pascal
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Huguet, Florence
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