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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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

RELEVENT Trial : Phase II Trial of Ramucirumab, Carboplatin, and Paclitaxel in Previously Untreated Thymic Carcinoma/B3 Thymoma With Area of Carcinoma. / Imbimbo, Martina; Vitali, Milena; Fabbri, Alessandra; Ottaviano, Margaret; Pasello, Giulia; Petrini, Iacopo; Palmieri, Giovannella; Berardi, Rossana; Zucali, Paolo ; Ganzinelli, Monica ; Marabese, Mirko ; Broggini, Massimo ; Marino, Mirella ; Trama, Annalisa ; Rulli, Eliana; Hollander, Lital; Pruneri, Giancarlo ; Torri, Valter ; Garassino, Marina Chiara.

In: Clinical Lung Cancer, Vol. 19, No. 5, 09.2018, p. e811-e814.

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

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

Imbimbo, Martina ; Vitali, Milena ; Fabbri, Alessandra ; Ottaviano, Margaret ; Pasello, Giulia ; Petrini, Iacopo ; Palmieri, Giovannella ; Berardi, Rossana ; Zucali, Paolo ; Ganzinelli, Monica ; Marabese, Mirko ; Broggini, Massimo ; Marino, Mirella ; Trama, Annalisa ; Rulli, Eliana ; Hollander, Lital ; Pruneri, Giancarlo ; Torri, Valter ; Garassino, Marina Chiara. / RELEVENT Trial : Phase II Trial of Ramucirumab, Carboplatin, and Paclitaxel in Previously Untreated Thymic Carcinoma/B3 Thymoma With Area of Carcinoma. In: Clinical Lung Cancer. 2018 ; Vol. 19, No. 5. pp. e811-e814.

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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.",

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AU - Ottaviano, Margaret

AU - Pasello, Giulia

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AU - Trama, Annalisa

AU - Rulli, Eliana

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AU - Pruneri, Giancarlo

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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.

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