TY - JOUR
T1 - Oral maintenance metronomic vinorelbine versus best supportive care in advanced non-small-cell lung cancer after platinum-based chemotherapy
T2 - The MA.NI.LA. multicenter, randomized, controlled, phase II trial
AU - Platania, Marco
AU - Pasini, Felice
AU - Porcu, Luca
AU - Boeri, Mattia
AU - Verderame, Francesco
AU - Modena, Yasmina
AU - Del Conte, Alessandro
AU - Nichetti, Federico
AU - Garassino, Marina Chiara
AU - Martinetti, Antonia
AU - Sottotetti, Elisa
AU - Cavanna, Luigi
AU - Vattemi, Emanuela
AU - Pozzessere, Daniele
AU - Bertolini, Alessandro
AU - Irtelli, Luciana
AU - Verri, Carla
AU - Sozzi, Gabriella
AU - Proto, Claudia
AU - Pastorino, Ugo
AU - Torri, Valter
AU - Fraccon, Anna Paola
AU - Spinnato, Francesca
AU - Signorelli, Diego
AU - Lo Russo, Giuseppe
AU - Tuzi, Alessandro
AU - Gallucci, Rosaria
AU - Cinieri, Saverio
AU - Mencoboni, Manlio
AU - Antonelli, Paola
AU - Giacomelli, Luca
AU - de Braud, Filippo
PY - 2019/6
Y1 - 2019/6
N2 - Background: Oral vinorelbine administered at the maximum tolerated dose has already showed activity and a good safety profile in advanced non-small-cell lung cancer (NSCLC). The MA.NI.LA study was a phase II, multicenter, randomized, controlled trial that aimed to assess the effects of a 'switched maintenance’ regimen with oral metronomic vinorelbine (OMV) in patients with NSCLC who had not progressed after first-line platinum-based chemotherapy. Patients and methods: Patients were randomly assigned in a 1:1 ratio to either OMV (50 mg three-times weekly) as maintenance treatment or best supportive care (BSC). The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective disease control rate (DCR, CR + PR + SD), safety and quality of life. Results: In total, 61 and 59 patients were assigned to OMV and BSC, respectively. At a median follow-up of 23.9 (IQR 10.2–38.2) months, patients treated with OMV reported a significantly lower progression rate compared to patient in the BSC arm (89% [54/61] vs 96% [56/58]; HR 0.73; 90% CI 0.53-0.999, p = 0.049). Median PFS for patients treated with vinorelbine was 4.3 months (95% CI 2.8–5.6) vs 2.8 months (95% CI 1.9–4.5) for patients receiving BSC. This benefit was specifically evident in patients aged ≥70 years, in current smokers, and in those who reported disease stabilization as best response to induction chemotherapy. OS and response rate and quality of life were similar in the two arms. Drop-out rate for major toxicity with OMV was unexpectedly high (25%, 14/61) mainly due to grade 3–4 neutropenia (11%, 7/61). Conclusions In patients with unselected NSCLC achieving disease control after platinum-based chemotherapy switch maintenance therapy with OMV prolonged PFS compared to BSC; however, the optimal dose of OMV requires further investigation.
AB - Background: Oral vinorelbine administered at the maximum tolerated dose has already showed activity and a good safety profile in advanced non-small-cell lung cancer (NSCLC). The MA.NI.LA study was a phase II, multicenter, randomized, controlled trial that aimed to assess the effects of a 'switched maintenance’ regimen with oral metronomic vinorelbine (OMV) in patients with NSCLC who had not progressed after first-line platinum-based chemotherapy. Patients and methods: Patients were randomly assigned in a 1:1 ratio to either OMV (50 mg three-times weekly) as maintenance treatment or best supportive care (BSC). The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective disease control rate (DCR, CR + PR + SD), safety and quality of life. Results: In total, 61 and 59 patients were assigned to OMV and BSC, respectively. At a median follow-up of 23.9 (IQR 10.2–38.2) months, patients treated with OMV reported a significantly lower progression rate compared to patient in the BSC arm (89% [54/61] vs 96% [56/58]; HR 0.73; 90% CI 0.53-0.999, p = 0.049). Median PFS for patients treated with vinorelbine was 4.3 months (95% CI 2.8–5.6) vs 2.8 months (95% CI 1.9–4.5) for patients receiving BSC. This benefit was specifically evident in patients aged ≥70 years, in current smokers, and in those who reported disease stabilization as best response to induction chemotherapy. OS and response rate and quality of life were similar in the two arms. Drop-out rate for major toxicity with OMV was unexpectedly high (25%, 14/61) mainly due to grade 3–4 neutropenia (11%, 7/61). Conclusions In patients with unselected NSCLC achieving disease control after platinum-based chemotherapy switch maintenance therapy with OMV prolonged PFS compared to BSC; however, the optimal dose of OMV requires further investigation.
KW - Metronomic therapy
KW - NSCLC
KW - Vinorelbine
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U2 - 10.1016/j.lungcan.2019.04.001
DO - 10.1016/j.lungcan.2019.04.001
M3 - Article
C2 - 31097088
AN - SCOPUS:85063982040
VL - 132
SP - 17
EP - 23
JO - Lung Cancer
JF - Lung Cancer
SN - 0169-5002
ER -