Phase II Study of a Radiotherapy Total Dose Increase in Hypoxic Lesions Identified by 18 F-Misonidazole PET/CT in Patients with Non-Small Cell Lung Carcinoma (RTEP5 Study)

See an invited perspective on this article on page 1043.This multicenter phase II study investigated a selective radiotherapy dose increase to tumor areas with significant F-misonidazole ( F-FMISO) uptake in patients with non-small cell lung carcinoma (NSCLC). Eligible patients had locally advanced...

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Veröffentlicht in:Journal of Nuclear Medicine 2017-07, Vol.58 (7), p.1045-1053
Hauptverfasser: Vera, Pierre, Thureau, Sébastien, Chaumet-Riffaud, Philippe, Modzelewski, Romain, Bohn, Pierre, Vermandel, Maximilien, Hapdey, Sébastien, Pallardy, Amandine, Mahé, Marc-André, Lacombe, Marie, Boisselier, Pierre, Guillemard, Sophie, Olivier, Pierre, Beckendorf, Veronique, Salem, Naji, Charrier, Nathalie, Chajon, Enrique, Devillers, Anne, Aide, Nicolas, Danhier, Serge, Denis, Fabrice, Muratet, Jean-Pierre, Martin, Etienne, Riedinger, Alina Berriolo, Kolesnikov-Gauthier, Helène, Dansin, Eric, Massabeau, Carole, Courbon, Fredéric, Farcy Jacquet, Marie-Pierre, Kotzki, Pierre-Olivier, Houzard, Claire, Mornex, Francoise, Vervueren, Laurent, Paumier, Amaury, Fernandez, Philippe, Salaun, Mathieu, Dubray, Bernard
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Zusammenfassung:See an invited perspective on this article on page 1043.This multicenter phase II study investigated a selective radiotherapy dose increase to tumor areas with significant F-misonidazole ( F-FMISO) uptake in patients with non-small cell lung carcinoma (NSCLC). Eligible patients had locally advanced NSCLC and no contraindication to concomitant chemoradiotherapy. The F-FMISO uptake on PET/CT was assessed by trained experts. If there was no uptake, 66 Gy were delivered. In F-FMISO-positive patients, the contours of the hypoxic area were transferred to the radiation oncologist. It was necessary for the radiotherapy dose to be as high as possible while fulfilling dose-limiting constraints for the spinal cord and lungs. The primary endpoint was tumor response (complete response plus partial response) at 3 mo. The secondary endpoints were toxicity, disease-free survival (DFS), and overall survival at 1 y. The target sample size was set to demonstrate a response rate of 40% or more (bilateral α = 0.05, power 1-β = 0.95). Seventy-nine patients were preincluded, 54 were included, and 34 were F-FMISO-positive, 24 of whom received escalated doses of up to 86 Gy. The response rate at 3 mo was 31 of 54 (57%; 95% confidence interval [CI], 43%-71%) using RECIST 1.1 (17/34 responders in the F-FMISO-positive group). DFS and overall survival at 1 y were 0.86 (95% CI, 0.77-0.96) and 0.63 (95% CI, 0.49-0.74), respectively. DFS was longer in the F-FMISO-negative patients ( = 0.004). The radiotherapy dose was not associated with DFS when adjusting for the F-FMISO status. One toxic death (66 Gy) and 1 case of grade 4 pneumonitis (>66 Gy) were reported. Our approach results in a response rate of 40% or more, with acceptable toxicity. F-FMISO uptake in NSCLC patients is strongly associated with poor prognosis features that could not be reversed by radiotherapy doses up to 86 Gy.
ISSN:0161-5505
1535-5667
2159-662X
DOI:10.2967/jnumed.116.188367