PT - JOURNAL ARTICLE AU - Pierre-Yves Salaun AU - Loïc Campion AU - Claire Bournaud AU - Alain Faivre-Chauvet AU - Jean-Philippe Vuillez AU - David Taieb AU - Catherine Ansquer AU - Caroline Rousseau AU - Françoise Borson-Chazot AU - Stéphane Bardet AU - Aurore Oudoux AU - Bertrand Cariou AU - Eric Mirallié AU - Chien-Hsing Chang AU - Robert M. Sharkey AU - David M. Goldenberg AU - Jean-François Chatal AU - Jacques Barbet AU - Françoise Kraeber-Bodéré TI - Phase II Trial of Anticarcinoembryonic Antigen Pretargeted Radioimmunotherapy in Progressive Metastatic Medullary Thyroid Carcinoma: Biomarker Response and Survival Improvement AID - 10.2967/jnumed.111.101865 DP - 2012 Aug 01 TA - Journal of Nuclear Medicine PG - 1185--1192 VI - 53 IP - 8 4099 - http://jnm.snmjournals.org/content/53/8/1185.short 4100 - http://jnm.snmjournals.org/content/53/8/1185.full SO - J Nucl Med2012 Aug 01; 53 AB - The prognosis of medullary thyroid carcinoma (MTC) varies from long- to short-term survival based on such prognostic factors as serum calcitonin and carcinoembryonic antigen (CEA) doubling times (DTs). This prospective phase II multicenter trial evaluated the efficacy and safety of anti-CEA pretargeted radioimmunotherapy (pRAIT) in rapidly progressing metastatic MTC patients and also how serum biomarker DTs correlate with clinical outcome. Methods: From June 2004 to January 2008, 42 patients were treated with anti-CEA × anti–diethylenetriaminepentaacetic acid (DTPA) bispecific antibody (hMN-14 × m734) (40 mg/m2), followed by 131I-di-DTPA-indium bivalent hapten (1.8 GBq/m2) 4–6 d later. Results: The disease control rate (durable stabilization plus objective response) was 76.2%. Grade 3–4 hematologic toxicity was observed in 54.7% of patients and myelodysplastic syndrome in 2, including 1 heavily treated previously. After pRAIT, 21 of 37 assessed patients (56.7%) showed a significant impact on DT (≥100% increase of pre-pRAIT calcitonin or CEA DT or prolonged decrease of the biomarker concentration after pRAIT). Pre-pRAIT DT and post-pRAIT DT were significant independent predictors for overall survival (OS) from pRAIT (pre-pRAIT: hazard ratio [HR], 0.46; 95% confidence interval [CI], 0.24–0.86; P = 0.016; and post-pRAIT: HR, 5.32; 95% CI, 1.63–17.36; P = 0.006) and OS from diagnosis (pre-pRAIT: HR, 0.21; 95% CI, 0.08–0.51; P = 0.001; and post-pRAIT: HR, 6.16; 95% CI, 1.81–20.98; P = 0.004). Conclusion: pRAIT showed antitumor activity, with manageable hematologic toxicity in progressive MTC. Increased biomarker DT after treatment correlated with increased OS.