RELEVENT Trial: Phase II Trial of Ramucirumab, Carboplatin, and Paclitaxel in Previously Untreated Thymic Carcinoma/B3 Thymoma With Area of Carcinoma

Martina Imbimbo; Milena Vitali; Alessandra Fabbri; Margaret Ottaviano; Giulia Pasello; Iacopo Petrini; Giovannella Palmieri; Rossana Berardi; Paolo Zucali; Monica Ganzinelli; Mirko Marabese; Massimo Broggini; Mirella Marino; Annalisa Trama; Eliana Rulli; Lital Hollander; Giancarlo Pruneri; Valter Torri; Marina Chiara Garassino

doi:10.1016/j.cllc.2018.06.005

RELEVENT Trial: Phase II Trial of Ramucirumab, Carboplatin, and Paclitaxel in Previously Untreated Thymic Carcinoma/B3 Thymoma With Area of Carcinoma

Martina Imbimbo, Milena Vitali, Alessandra Fabbri, Margaret Ottaviano, Giulia Pasello, Iacopo Petrini, Giovannella Palmieri, Rossana Berardi, Paolo Zucali, Monica Ganzinelli, Mirko Marabese, Massimo Broggini, Mirella Marino, Annalisa Trama, Eliana Rulli, Lital Hollander, Giancarlo Pruneri, Valter Torri, Marina Chiara Garassino

Research output: Contribution to journal › Article › peer-review

Abstract

Thymic epithelial tumors are rare malignancies. Thymic carcinoma represents about 20% of all thymic epithelial tumors and has aggressive behavior, with a greater tendency to metastatic spread. Thymic carcinoma is often diagnosed in advanced stages for which systemic treatment is the main therapeutic option. The association of chemotherapy and antiangiogenic agents in the first-line setting has never been investigated in this very rare cancer. However, preclinical and clinical evidence has suggested that inhibition of angiogenesis could be beneficial. The RELEVENT trial is a multicenter, open-label, single-arm, phase II study aimed at investigating the activity and safety of ramucirumab combined with paclitaxel and carboplatin in chemotherapy-naive patients affected by thymic carcinoma or B3 thymoma with area of carcinoma. The primary endpoint of the trial is the overall response rate. Progression-free survival, overall survival, and safety are secondary endpoints. Patient-reported outcomes will be collected at each visit. The mutational status of a subset of genes, polymorphisms, and selected micro-RNA expression will be evaluated.

Original language	English
Pages (from-to)	e811-e814
Journal	Clinical Lung Cancer
Volume	19
Issue number	5
DOIs	https://doi.org/10.1016/j.cllc.2018.06.005
Publication status	Published - Sep 2018

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10.1016/j.cllc.2018.06.005

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Imbimbo, M., Vitali, M., Fabbri, A., Ottaviano, M., Pasello, G., Petrini, I., Palmieri, G., Berardi, R., Zucali, P., Ganzinelli, M., Marabese, M., Broggini, M., Marino, M., Trama, A., Rulli, E., Hollander, L., Pruneri, G., Torri, V., & Garassino, M. C. (2018). RELEVENT Trial: Phase II Trial of Ramucirumab, Carboplatin, and Paclitaxel in Previously Untreated Thymic Carcinoma/B3 Thymoma With Area of Carcinoma. Clinical Lung Cancer, 19(5), e811-e814. https://doi.org/10.1016/j.cllc.2018.06.005

Imbimbo, M, Vitali, M, Fabbri, A, Ottaviano, M, Pasello, G, Petrini, I, Palmieri, G, Berardi, R, Zucali, P , Ganzinelli, M , Marabese, M , Broggini, M , Marino, M , Trama, A , Rulli, E, Hollander, L, Pruneri, G , Torri, V & Garassino, MC 2018, 'RELEVENT Trial: Phase II Trial of Ramucirumab, Carboplatin, and Paclitaxel in Previously Untreated Thymic Carcinoma/B3 Thymoma With Area of Carcinoma', Clinical Lung Cancer, vol. 19, no. 5, pp. e811-e814. https://doi.org/10.1016/j.cllc.2018.06.005

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title = "RELEVENT Trial: Phase II Trial of Ramucirumab, Carboplatin, and Paclitaxel in Previously Untreated Thymic Carcinoma/B3 Thymoma With Area of Carcinoma",

abstract = "Thymic epithelial tumors are rare malignancies. Thymic carcinoma represents about 20% of all thymic epithelial tumors and has aggressive behavior, with a greater tendency to metastatic spread. Thymic carcinoma is often diagnosed in advanced stages for which systemic treatment is the main therapeutic option. The association of chemotherapy and antiangiogenic agents in the first-line setting has never been investigated in this very rare cancer. However, preclinical and clinical evidence has suggested that inhibition of angiogenesis could be beneficial. The RELEVENT trial is a multicenter, open-label, single-arm, phase II study aimed at investigating the activity and safety of ramucirumab combined with paclitaxel and carboplatin in chemotherapy-naive patients affected by thymic carcinoma or B3 thymoma with area of carcinoma. The primary endpoint of the trial is the overall response rate. Progression-free survival, overall survival, and safety are secondary endpoints. Patient-reported outcomes will be collected at each visit. The mutational status of a subset of genes, polymorphisms, and selected micro-RNA expression will be evaluated.",

author = "Martina Imbimbo and Milena Vitali and Alessandra Fabbri and Margaret Ottaviano and Giulia Pasello and Iacopo Petrini and Giovannella Palmieri and Rossana Berardi and Paolo Zucali and Monica Ganzinelli and Mirko Marabese and Massimo Broggini and Mirella Marino and Annalisa Trama and Eliana Rulli and Lital Hollander and Giancarlo Pruneri and Valter Torri and Garassino, {Marina Chiara}",

year = "2018",

month = sep,

doi = "10.1016/j.cllc.2018.06.005",

language = "English",

volume = "19",

pages = "e811--e814",

journal = "Clinical Lung Cancer",

issn = "1525-7304",

publisher = "Elsevier Inc.",

number = "5",

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TY - JOUR

T1 - RELEVENT Trial

T2 - Phase II Trial of Ramucirumab, Carboplatin, and Paclitaxel in Previously Untreated Thymic Carcinoma/B3 Thymoma With Area of Carcinoma

AU - Imbimbo, Martina

AU - Vitali, Milena

AU - Fabbri, Alessandra

AU - Ottaviano, Margaret

AU - Pasello, Giulia

AU - Petrini, Iacopo

AU - Palmieri, Giovannella

AU - Berardi, Rossana

AU - Zucali, Paolo

AU - Ganzinelli, Monica

AU - Marabese, Mirko

AU - Broggini, Massimo

AU - Marino, Mirella

AU - Trama, Annalisa

AU - Rulli, Eliana

AU - Hollander, Lital

AU - Pruneri, Giancarlo

AU - Torri, Valter

AU - Garassino, Marina Chiara

PY - 2018/9

Y1 - 2018/9

N2 - Thymic epithelial tumors are rare malignancies. Thymic carcinoma represents about 20% of all thymic epithelial tumors and has aggressive behavior, with a greater tendency to metastatic spread. Thymic carcinoma is often diagnosed in advanced stages for which systemic treatment is the main therapeutic option. The association of chemotherapy and antiangiogenic agents in the first-line setting has never been investigated in this very rare cancer. However, preclinical and clinical evidence has suggested that inhibition of angiogenesis could be beneficial. The RELEVENT trial is a multicenter, open-label, single-arm, phase II study aimed at investigating the activity and safety of ramucirumab combined with paclitaxel and carboplatin in chemotherapy-naive patients affected by thymic carcinoma or B3 thymoma with area of carcinoma. The primary endpoint of the trial is the overall response rate. Progression-free survival, overall survival, and safety are secondary endpoints. Patient-reported outcomes will be collected at each visit. The mutational status of a subset of genes, polymorphisms, and selected micro-RNA expression will be evaluated.

AB - Thymic epithelial tumors are rare malignancies. Thymic carcinoma represents about 20% of all thymic epithelial tumors and has aggressive behavior, with a greater tendency to metastatic spread. Thymic carcinoma is often diagnosed in advanced stages for which systemic treatment is the main therapeutic option. The association of chemotherapy and antiangiogenic agents in the first-line setting has never been investigated in this very rare cancer. However, preclinical and clinical evidence has suggested that inhibition of angiogenesis could be beneficial. The RELEVENT trial is a multicenter, open-label, single-arm, phase II study aimed at investigating the activity and safety of ramucirumab combined with paclitaxel and carboplatin in chemotherapy-naive patients affected by thymic carcinoma or B3 thymoma with area of carcinoma. The primary endpoint of the trial is the overall response rate. Progression-free survival, overall survival, and safety are secondary endpoints. Patient-reported outcomes will be collected at each visit. The mutational status of a subset of genes, polymorphisms, and selected micro-RNA expression will be evaluated.

U2 - 10.1016/j.cllc.2018.06.005

DO - 10.1016/j.cllc.2018.06.005

M3 - Article

C2 - 30033090

VL - 19

SP - e811-e814

JO - Clinical Lung Cancer

JF - Clinical Lung Cancer

SN - 1525-7304

IS - 5

ER -

RELEVENT Trial: Phase II Trial of Ramucirumab, Carboplatin, and Paclitaxel in Previously Untreated Thymic Carcinoma/B3 Thymoma With Area of Carcinoma

Abstract

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