INOVATYON/ ENGOT-ov5 study : Randomized phase III international study comparing trabectedin/pegylated liposomal doxorubicin (PLD) followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line
© 2023. The Author(s)..
BACKGROUND: This trial investigated the hypothesis that the treatment with trabectedin/PLD (TP) to extend the platinum-free interval (TFIp) can improve overall survival (OS) in patients with recurrent ovarian cancer (OC).
METHODS: Patients with OC (up to two previous platinum-based lines), with a TFIp of 6-12 months, were randomised to receive carboplatin/PLD (CP) or TP followed by platinum therapy at relapse. The primary endpoint was OS (HR: 0.75).
RESULTS: The study enrolled 617 patients. The median TFIp was 8.3 months and 30.3% of patients had received two previous platinum lines. 74% and 73.9% of patients, respectively, received a subsequent therapy (ST) in the CP and TP arm; in the latter TP arm 87.2% of ST was platinum-based, as per protocol. The median OS was 21.4 for CP and 21.9 months for TP (HR 1.13; 95% CI: 0.94-1.35; p = 0.197). Grade 3-5 adverse reactions occurred in 37.1% of patients in the CP arm and 69.7% of patients in the TP arm, and the most frequent were neutropenia (22.8% CP, 39.5% TP), gastrointestinal (7.1% CP, 17.4% TP), hepatic (0.7% CP, 19.1% TP).
CONCLUSIONS: This study did not meet the primary endpoint. CP combination remains the standard for patients with recurrent OC and a 6-12 months TFIp; TP is an effective treatment in patients suffering from persistent platinum toxicities.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, number NCT01379989.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:128 |
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| Enthalten in: |
British journal of cancer - 128(2023), 8 vom: 09. Apr., Seite 1503-1513 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Colombo, N [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 05.04.2023 Date Revised 24.07.2023 published: Print-Electronic ClinicalTrials.gov: NCT01379989 Citation Status MEDLINE |
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| doi: |
10.1038/s41416-022-02108-7 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM352695048 |
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| 245 | 1 | 0 | |a INOVATYON/ ENGOT-ov5 study |b Randomized phase III international study comparing trabectedin/pegylated liposomal doxorubicin (PLD) followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line |
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| 500 | |a Date Completed 05.04.2023 | ||
| 500 | |a Date Revised 24.07.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT01379989 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a BACKGROUND: This trial investigated the hypothesis that the treatment with trabectedin/PLD (TP) to extend the platinum-free interval (TFIp) can improve overall survival (OS) in patients with recurrent ovarian cancer (OC) | ||
| 520 | |a METHODS: Patients with OC (up to two previous platinum-based lines), with a TFIp of 6-12 months, were randomised to receive carboplatin/PLD (CP) or TP followed by platinum therapy at relapse. The primary endpoint was OS (HR: 0.75) | ||
| 520 | |a RESULTS: The study enrolled 617 patients. The median TFIp was 8.3 months and 30.3% of patients had received two previous platinum lines. 74% and 73.9% of patients, respectively, received a subsequent therapy (ST) in the CP and TP arm; in the latter TP arm 87.2% of ST was platinum-based, as per protocol. The median OS was 21.4 for CP and 21.9 months for TP (HR 1.13; 95% CI: 0.94-1.35; p = 0.197). Grade 3-5 adverse reactions occurred in 37.1% of patients in the CP arm and 69.7% of patients in the TP arm, and the most frequent were neutropenia (22.8% CP, 39.5% TP), gastrointestinal (7.1% CP, 17.4% TP), hepatic (0.7% CP, 19.1% TP) | ||
| 520 | |a CONCLUSIONS: This study did not meet the primary endpoint. CP combination remains the standard for patients with recurrent OC and a 6-12 months TFIp; TP is an effective treatment in patients suffering from persistent platinum toxicities | ||
| 520 | |a CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, number NCT01379989 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Clinical Trial, Phase III | |
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| 700 | 1 | |a Fossati, Roldano |e investigator |4 oth | |
| 700 | 1 | |a Funari, Giuseppe |e investigator |4 oth | |
| 700 | 1 | |a Carlucci, Luciano |e investigator |4 oth | |
| 700 | 1 | |a Poli, Davide |e investigator |4 oth | |
| 700 | 1 | |a Caudana, Maria Clara |e investigator |4 oth | |
| 700 | 1 | |a Tasca, Giulia |e investigator |4 oth | |
| 700 | 1 | |a Nicoletto, Maria Ornella |e investigator |4 oth | |
| 700 | 1 | |a Tognon, Germana |e investigator |4 oth | |
| 700 | 1 | |a DeCensi, Andrea |e investigator |4 oth | |
| 700 | 1 | |a De Giorgi, Ugo |e investigator |4 oth | |
| 700 | 1 | |a Zola, Paolo |e investigator |4 oth | |
| 700 | 1 | |a Katsaros, Dionyssios |e investigator |4 oth | |
| 700 | 1 | |a Benedetti Panici, Pierluigi |e investigator |4 oth | |
| 700 | 1 | |a Palaia, Innocenza |e investigator |4 oth | |
| 700 | 1 | |a Aglietta, Massimo |e investigator |4 oth | |
| 700 | 1 | |a Arcangeli, Valentina |e investigator |4 oth | |
| 700 | 1 | |a Zamagni, Claudio |e investigator |4 oth | |
| 700 | 1 | |a Bologna, Alessandra |e investigator |4 oth | |
| 700 | 1 | |a Bertolini, Alessandro |e investigator |4 oth | |
| 700 | 1 | |a Caroti, Cinzia |e investigator |4 oth | |
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| 700 | 1 | |a Di Costanzo, Gianna |e investigator |4 oth | |
| 700 | 1 | |a Zaniboni, Alberto |e investigator |4 oth | |
| 700 | 1 | |a Surico, Daniela |e investigator |4 oth | |
| 700 | 1 | |a Buosi, Roberta |e investigator |4 oth | |
| 700 | 1 | |a Cortesi, Enrico |e investigator |4 oth | |
| 700 | 1 | |a Zafarana, Elena |e investigator |4 oth | |
| 700 | 1 | |a Fusco, Vittorio |e investigator |4 oth | |
| 700 | 1 | |a Zavallone, Laura |e investigator |4 oth | |
| 700 | 1 | |a Gamucci, Teresa |e investigator |4 oth | |
| 700 | 1 | |a Narducci, Filomena |e investigator |4 oth | |
| 700 | 1 | |a Musacchi, Valentina |e investigator |4 oth | |
| 700 | 1 | |a Babilonti, Luciana |e investigator |4 oth | |
| 700 | 1 | |a Ferrero, Annamaria |e investigator |4 oth | |
| 700 | 1 | |a Cavanna, Luigi |e investigator |4 oth | |
| 700 | 1 | |a Sabbatini, Roberto |e investigator |4 oth | |
| 700 | 1 | |a Tamberi, Stefano |e investigator |4 oth | |
| 700 | 1 | |a Gentili, Maria Rosa |e investigator |4 oth | |
| 700 | 1 | |a Artioli, Grazia |e investigator |4 oth | |
| 700 | 1 | |a Ardizzoia, Antonio |e investigator |4 oth | |
| 700 | 1 | |a Caldara, Alessia |e investigator |4 oth | |
| 700 | 1 | |a Sirotovà, Zuzana |e investigator |4 oth | |
| 700 | 1 | |a Casartelli, Clelia |e investigator |4 oth | |
| 700 | 1 | |a Aieta, Michele |e investigator |4 oth | |
| 700 | 1 | |a Cinieri, Saverio |e investigator |4 oth | |
| 700 | 1 | |a De Marino, Elvira |e investigator |4 oth | |
| 700 | 1 | |a Gori, Stefania |e investigator |4 oth | |
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| 700 | 1 | |a Bover, Isabel |e investigator |4 oth | |
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| 700 | 1 | |a Ortega, Eugenia |e investigator |4 oth | |
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| 700 | 1 | |a Heinrich, Georg |e investigator |4 oth | |
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| 700 | 1 | |a Mustea, Alexander |e investigator |4 oth | |
| 700 | 1 | |a Fehm, Tanja |e investigator |4 oth | |
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