Randomized controlled trial testing the efficacy of platinum-free interval prolongation in advanced ovarian cancer: The MITO-8,MaNGO, BGOG-Ov1, AGO-Ovar2.16, ENGOT-Ov1, GCIG study

S Pignata, Giovanni Scambia, A Bologna, S Signoriello, IB Vergote, Uwe Wagner, D Lorusso, V Murgia, R Sorio, G Ferrandina, C Sacco, G Cormio, E Breda, Saverio Cinieri, Donato Natale, G Mangili, C Pisano, SC Cecere, M Di Napoli, V SalutariF Raspagliesi, L Arenare, Alice Bergamini, J Bryce, G Daniele, MC Piccirillo, C Gallo, F Perrone

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Abstract

Purpose Platinum-based chemotherapy (PBC) for patients with progressing ovarian cancer (OC) is more effective with a longer time interval from previous platinum treatment (platinum-free interval [PFI]). In 1999, it was hypothesized that prolonging PFI with single-agent non-PBC (NPBC) may offer a strategy to improve overall outcome. MITO-8 aimed to verify this hypothesis commonly used in clinical practice although it has not been prospectively tested. Methods MITO-8 is an open-label, prospective, randomized, superiority trial. Patients with OC who experienced disease progression 6 to 12 months after their last platinum treatment were randomly assigned 1:1 to the experimental sequence of NPBC followed by PBC at subsequent relapse or the standard reverse treatment sequence. Overall survival (OS) was the primary end point. Results Two hundred fifteen patients were enrolled (standard arm [n = 108] ; experimental arm [n = 107]). The trial ended before planned because of slow enrollment. PFI was prolonged in the experimental arm(median, 7.8 v 0.01 months). Therewas no OS benefit in the experimental arm(median, 21.8 v 24.5 months; hazard ratio, 1.38; 95% CI, 0.99 to 1.94; P = .06). Progression-free survival after the sequence was significantly shorter in the experimental arm (median, 12.8 v 16.4 months; hazard ratio, 1.41; 95% CI, 1.04 to 1.92; P = .025). Global quality-of-life change after three cycles was worse in the experimental arm. Slight differences were observed in the incidence of adverse effects. Conclusion MITO-8 supports the recommendation that PBC not be delayed in favor of an NPBC in patients with partially platinum-sensitive OC. PBC should be used as a control arm in future trials of new drugs in this setting.
Original languageEnglish
Pages (from-to)3347-3353
Number of pages7
JournalJournal of Clinical Oncology
Volume35
Issue number29
DOIs
Publication statusPublished - 2017

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Platinum
Ovarian Neoplasms
Randomized Controlled Trials
Drug Therapy
Survival
Disease-Free Survival
Disease Progression
Therapeutics
Quality of Life
Recurrence
Incidence

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Randomized controlled trial testing the efficacy of platinum-free interval prolongation in advanced ovarian cancer: The MITO-8,MaNGO, BGOG-Ov1, AGO-Ovar2.16, ENGOT-Ov1, GCIG study. / Pignata, S; Scambia, Giovanni; Bologna, A; Signoriello, S; Vergote, IB; Wagner, Uwe; Lorusso, D; Murgia, V; Sorio, R; Ferrandina, G; Sacco, C; Cormio, G; Breda, E; Cinieri, Saverio; Natale, Donato; Mangili, G; Pisano, C; Cecere, SC; Di Napoli, M; Salutari, V; Raspagliesi, F; Arenare, L; Bergamini, Alice; Bryce, J; Daniele, G; Piccirillo, MC; Gallo, C; Perrone, F.

In: Journal of Clinical Oncology, Vol. 35, No. 29, 2017, p. 3347-3353.

Research output: Contribution to journalArticle

Pignata, S ; Scambia, Giovanni ; Bologna, A ; Signoriello, S ; Vergote, IB ; Wagner, Uwe ; Lorusso, D ; Murgia, V ; Sorio, R ; Ferrandina, G ; Sacco, C ; Cormio, G ; Breda, E ; Cinieri, Saverio ; Natale, Donato ; Mangili, G ; Pisano, C ; Cecere, SC ; Di Napoli, M ; Salutari, V ; Raspagliesi, F ; Arenare, L ; Bergamini, Alice ; Bryce, J ; Daniele, G ; Piccirillo, MC ; Gallo, C ; Perrone, F. / Randomized controlled trial testing the efficacy of platinum-free interval prolongation in advanced ovarian cancer: The MITO-8,MaNGO, BGOG-Ov1, AGO-Ovar2.16, ENGOT-Ov1, GCIG study. In: Journal of Clinical Oncology. 2017 ; Vol. 35, No. 29. pp. 3347-3353.
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title = "Randomized controlled trial testing the efficacy of platinum-free interval prolongation in advanced ovarian cancer: The MITO-8,MaNGO, BGOG-Ov1, AGO-Ovar2.16, ENGOT-Ov1, GCIG study",
abstract = "Purpose Platinum-based chemotherapy (PBC) for patients with progressing ovarian cancer (OC) is more effective with a longer time interval from previous platinum treatment (platinum-free interval [PFI]). In 1999, it was hypothesized that prolonging PFI with single-agent non-PBC (NPBC) may offer a strategy to improve overall outcome. MITO-8 aimed to verify this hypothesis commonly used in clinical practice although it has not been prospectively tested. Methods MITO-8 is an open-label, prospective, randomized, superiority trial. Patients with OC who experienced disease progression 6 to 12 months after their last platinum treatment were randomly assigned 1:1 to the experimental sequence of NPBC followed by PBC at subsequent relapse or the standard reverse treatment sequence. Overall survival (OS) was the primary end point. Results Two hundred fifteen patients were enrolled (standard arm [n = 108] ; experimental arm [n = 107]). The trial ended before planned because of slow enrollment. PFI was prolonged in the experimental arm(median, 7.8 v 0.01 months). Therewas no OS benefit in the experimental arm(median, 21.8 v 24.5 months; hazard ratio, 1.38; 95{\%} CI, 0.99 to 1.94; P = .06). Progression-free survival after the sequence was significantly shorter in the experimental arm (median, 12.8 v 16.4 months; hazard ratio, 1.41; 95{\%} CI, 1.04 to 1.92; P = .025). Global quality-of-life change after three cycles was worse in the experimental arm. Slight differences were observed in the incidence of adverse effects. Conclusion MITO-8 supports the recommendation that PBC not be delayed in favor of an NPBC in patients with partially platinum-sensitive OC. PBC should be used as a control arm in future trials of new drugs in this setting.",
author = "S Pignata and Giovanni Scambia and A Bologna and S Signoriello and IB Vergote and Uwe Wagner and D Lorusso and V Murgia and R Sorio and G Ferrandina and C Sacco and G Cormio and E Breda and Saverio Cinieri and Donato Natale and G Mangili and C Pisano and SC Cecere and {Di Napoli}, M and V Salutari and F Raspagliesi and L Arenare and Alice Bergamini and J Bryce and G Daniele and MC Piccirillo and C Gallo and F Perrone",
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doi = "10.1200/JCO.2017.73.4293",
language = "English",
volume = "35",
pages = "3347--3353",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
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TY - JOUR

T1 - Randomized controlled trial testing the efficacy of platinum-free interval prolongation in advanced ovarian cancer: The MITO-8,MaNGO, BGOG-Ov1, AGO-Ovar2.16, ENGOT-Ov1, GCIG study

AU - Pignata, S

AU - Scambia, Giovanni

AU - Bologna, A

AU - Signoriello, S

AU - Vergote, IB

AU - Wagner, Uwe

AU - Lorusso, D

AU - Murgia, V

AU - Sorio, R

AU - Ferrandina, G

AU - Sacco, C

AU - Cormio, G

AU - Breda, E

AU - Cinieri, Saverio

AU - Natale, Donato

AU - Mangili, G

AU - Pisano, C

AU - Cecere, SC

AU - Di Napoli, M

AU - Salutari, V

AU - Raspagliesi, F

AU - Arenare, L

AU - Bergamini, Alice

AU - Bryce, J

AU - Daniele, G

AU - Piccirillo, MC

AU - Gallo, C

AU - Perrone, F

PY - 2017

Y1 - 2017

N2 - Purpose Platinum-based chemotherapy (PBC) for patients with progressing ovarian cancer (OC) is more effective with a longer time interval from previous platinum treatment (platinum-free interval [PFI]). In 1999, it was hypothesized that prolonging PFI with single-agent non-PBC (NPBC) may offer a strategy to improve overall outcome. MITO-8 aimed to verify this hypothesis commonly used in clinical practice although it has not been prospectively tested. Methods MITO-8 is an open-label, prospective, randomized, superiority trial. Patients with OC who experienced disease progression 6 to 12 months after their last platinum treatment were randomly assigned 1:1 to the experimental sequence of NPBC followed by PBC at subsequent relapse or the standard reverse treatment sequence. Overall survival (OS) was the primary end point. Results Two hundred fifteen patients were enrolled (standard arm [n = 108] ; experimental arm [n = 107]). The trial ended before planned because of slow enrollment. PFI was prolonged in the experimental arm(median, 7.8 v 0.01 months). Therewas no OS benefit in the experimental arm(median, 21.8 v 24.5 months; hazard ratio, 1.38; 95% CI, 0.99 to 1.94; P = .06). Progression-free survival after the sequence was significantly shorter in the experimental arm (median, 12.8 v 16.4 months; hazard ratio, 1.41; 95% CI, 1.04 to 1.92; P = .025). Global quality-of-life change after three cycles was worse in the experimental arm. Slight differences were observed in the incidence of adverse effects. Conclusion MITO-8 supports the recommendation that PBC not be delayed in favor of an NPBC in patients with partially platinum-sensitive OC. PBC should be used as a control arm in future trials of new drugs in this setting.

AB - Purpose Platinum-based chemotherapy (PBC) for patients with progressing ovarian cancer (OC) is more effective with a longer time interval from previous platinum treatment (platinum-free interval [PFI]). In 1999, it was hypothesized that prolonging PFI with single-agent non-PBC (NPBC) may offer a strategy to improve overall outcome. MITO-8 aimed to verify this hypothesis commonly used in clinical practice although it has not been prospectively tested. Methods MITO-8 is an open-label, prospective, randomized, superiority trial. Patients with OC who experienced disease progression 6 to 12 months after their last platinum treatment were randomly assigned 1:1 to the experimental sequence of NPBC followed by PBC at subsequent relapse or the standard reverse treatment sequence. Overall survival (OS) was the primary end point. Results Two hundred fifteen patients were enrolled (standard arm [n = 108] ; experimental arm [n = 107]). The trial ended before planned because of slow enrollment. PFI was prolonged in the experimental arm(median, 7.8 v 0.01 months). Therewas no OS benefit in the experimental arm(median, 21.8 v 24.5 months; hazard ratio, 1.38; 95% CI, 0.99 to 1.94; P = .06). Progression-free survival after the sequence was significantly shorter in the experimental arm (median, 12.8 v 16.4 months; hazard ratio, 1.41; 95% CI, 1.04 to 1.92; P = .025). Global quality-of-life change after three cycles was worse in the experimental arm. Slight differences were observed in the incidence of adverse effects. Conclusion MITO-8 supports the recommendation that PBC not be delayed in favor of an NPBC in patients with partially platinum-sensitive OC. PBC should be used as a control arm in future trials of new drugs in this setting.

U2 - 10.1200/JCO.2017.73.4293

DO - 10.1200/JCO.2017.73.4293

M3 - Article

VL - 35

SP - 3347

EP - 3353

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 29

ER -