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Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer
by
Baldoni, Alessandra
, Palluzzi, Eleonora
, Rulli, Eliana
, Tognon, Germana
, Scambia, Giovanni
, Colombo, Nicoletta
, Torri, Valter
, Zaccarelli, Eleonora
, Fossati, Roldano
, D‘Incalci, Maurizio
, Galli, Francesca
, Pesenti Gritti, Angela
, Poli, Davide
, Lissoni, Andrea A.
, Ferrero, Annamaria
, Farina, Gabriella
, Frezzini, Simona
, Negri, Emanuele
, Gerardi, Chiara
, Rubino, Daniela
, Biagioli, Elena
in
631/67/1517/1709
/ 692/4028/67/1517
/ Aged
/ Antineoplastic Combined Chemotherapy Protocols - adverse effects
/ Antineoplastic Combined Chemotherapy Protocols - therapeutic use
/ Bevacizumab
/ Bevacizumab - administration & dosage
/ Bevacizumab - adverse effects
/ Biomedical and Life Sciences
/ Biomedicine
/ Cancer Research
/ Carboplatin
/ Carboplatin - administration & dosage
/ Carboplatin - adverse effects
/ Carcinoma, Ovarian Epithelial - drug therapy
/ Drug Resistance
/ Epidemiology
/ Female
/ Humans
/ Immunotherapy
/ Kaplan-Meier Estimate
/ Middle Aged
/ Molecular Medicine
/ Monoclonal antibodies
/ Oncology
/ Ovarian cancer
/ Ovarian Neoplasms - drug therapy
/ Platinum
/ Progression-Free Survival
/ Safety
/ Survival Rate
/ Targeted cancer therapy
/ Toxicity
/ Trabectedin - administration & dosage
/ Trabectedin - adverse effects
/ Tumor microenvironment
/ Tumors
2019
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Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer
by
Baldoni, Alessandra
, Palluzzi, Eleonora
, Rulli, Eliana
, Tognon, Germana
, Scambia, Giovanni
, Colombo, Nicoletta
, Torri, Valter
, Zaccarelli, Eleonora
, Fossati, Roldano
, D‘Incalci, Maurizio
, Galli, Francesca
, Pesenti Gritti, Angela
, Poli, Davide
, Lissoni, Andrea A.
, Ferrero, Annamaria
, Farina, Gabriella
, Frezzini, Simona
, Negri, Emanuele
, Gerardi, Chiara
, Rubino, Daniela
, Biagioli, Elena
in
631/67/1517/1709
/ 692/4028/67/1517
/ Aged
/ Antineoplastic Combined Chemotherapy Protocols - adverse effects
/ Antineoplastic Combined Chemotherapy Protocols - therapeutic use
/ Bevacizumab
/ Bevacizumab - administration & dosage
/ Bevacizumab - adverse effects
/ Biomedical and Life Sciences
/ Biomedicine
/ Cancer Research
/ Carboplatin
/ Carboplatin - administration & dosage
/ Carboplatin - adverse effects
/ Carcinoma, Ovarian Epithelial - drug therapy
/ Drug Resistance
/ Epidemiology
/ Female
/ Humans
/ Immunotherapy
/ Kaplan-Meier Estimate
/ Middle Aged
/ Molecular Medicine
/ Monoclonal antibodies
/ Oncology
/ Ovarian cancer
/ Ovarian Neoplasms - drug therapy
/ Platinum
/ Progression-Free Survival
/ Safety
/ Survival Rate
/ Targeted cancer therapy
/ Toxicity
/ Trabectedin - administration & dosage
/ Trabectedin - adverse effects
/ Tumor microenvironment
/ Tumors
2019
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Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer
by
Baldoni, Alessandra
, Palluzzi, Eleonora
, Rulli, Eliana
, Tognon, Germana
, Scambia, Giovanni
, Colombo, Nicoletta
, Torri, Valter
, Zaccarelli, Eleonora
, Fossati, Roldano
, D‘Incalci, Maurizio
, Galli, Francesca
, Pesenti Gritti, Angela
, Poli, Davide
, Lissoni, Andrea A.
, Ferrero, Annamaria
, Farina, Gabriella
, Frezzini, Simona
, Negri, Emanuele
, Gerardi, Chiara
, Rubino, Daniela
, Biagioli, Elena
in
631/67/1517/1709
/ 692/4028/67/1517
/ Aged
/ Antineoplastic Combined Chemotherapy Protocols - adverse effects
/ Antineoplastic Combined Chemotherapy Protocols - therapeutic use
/ Bevacizumab
/ Bevacizumab - administration & dosage
/ Bevacizumab - adverse effects
/ Biomedical and Life Sciences
/ Biomedicine
/ Cancer Research
/ Carboplatin
/ Carboplatin - administration & dosage
/ Carboplatin - adverse effects
/ Carcinoma, Ovarian Epithelial - drug therapy
/ Drug Resistance
/ Epidemiology
/ Female
/ Humans
/ Immunotherapy
/ Kaplan-Meier Estimate
/ Middle Aged
/ Molecular Medicine
/ Monoclonal antibodies
/ Oncology
/ Ovarian cancer
/ Ovarian Neoplasms - drug therapy
/ Platinum
/ Progression-Free Survival
/ Safety
/ Survival Rate
/ Targeted cancer therapy
/ Toxicity
/ Trabectedin - administration & dosage
/ Trabectedin - adverse effects
/ Tumor microenvironment
/ Tumors
2019
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Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer
Journal Article
Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer
2019
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Overview
Background
Trabectedin, in addition to its antiproliferative effect, can modify the tumour microenvironment and this could be synergistic with bevacizumab. The efficacy and safety of trabectedin and bevacizumab ± carboplatin have never been investigated.
Methods
In this phase 2 study, women progressing between 6 and 12 months since their last platinum-based therapy were randomised to Arm BT: bevacizumab, trabectedin every 21 days, or Arm BT+C: bevacizumab, trabectedin and carboplatin every 28 days, from cycles 1 to 6, then trabectedin and bevacizumab as in Arm BT. Primary endpoints were progression-free survival rate (PFS-6) and severe toxicity rate (ST-6) at 6 months, assuming a PFS-6 ≤35% for BT and ≤40% for BT+C as not of therapeutic interest and, for both arms, a ST-6 ≥ 30% as unacceptable.
Results
BT+C (21 patients) did not meet the safety criteria for the second stage (ST-6 45%; 95%CI: 23%–69%) but PFS-6 was 85% (95%CI: 62%–97%). BT (50 patients) had 75% PFS-6 (95%CI: 60%–87%) and 16% ST-6 (95%CI 7%–30%).
Conclusions
BT compared favourably with other platinum- and non-platinum-based regimens. The combination with carboplatin needs to be assessed further in a re-modulated safer schedule to confirm its apparent strong activity.
Clinical Trial Registration
NCT01735071 (Clinicaltrials.gov).
Publisher
Nature Publishing Group UK,Nature Publishing Group
Subject
/ Aged
/ Antineoplastic Combined Chemotherapy Protocols - adverse effects
/ Antineoplastic Combined Chemotherapy Protocols - therapeutic use
/ Bevacizumab - administration & dosage
/ Bevacizumab - adverse effects
/ Biomedical and Life Sciences
/ Carboplatin - administration & dosage
/ Carboplatin - adverse effects
/ Carcinoma, Ovarian Epithelial - drug therapy
/ Female
/ Humans
/ Oncology
/ Ovarian Neoplasms - drug therapy
/ Platinum
/ Safety
/ Toxicity
/ Trabectedin - administration & dosage
/ Trabectedin - adverse effects
/ Tumors
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