Randomized phase II-III study of bevacizumab in combination with chemotherapy in previously untreated extensive small-cell lung cancer : results from the IFCT-0802 trial†
© The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissionsoup.com..
BACKGROUND: This randomized phase II-III trial sought to evaluate the efficacy and safety of adding bevacizumab (Bev) following induction chemotherapy (CT) in extensive small-cell lung cancer (SCLC).
PATIENTS AND METHODS: Enrolled SCLC patients received two induction cycles of CT. Responders were randomly assigned 1:1 to receive four additional cycles of CT alone or CT plus Bev (7.5 mg/kg), followed by single-agent Bev until progression or unacceptable toxicity. The primary end point was the percentage of patients for whom disease remained controlled (still in response) at the fourth cycle.
RESULTS: In total, 147 patients were enrolled. Partial response was observed in 103 patients, 74 of whom were eligible for Bev and randomly assigned to the CT alone group (n = 37) or the CT plus Bev group (n = 37). Response assessment at the end of the fourth cycle showed that disease control did not differ between the two groups (89.2% versus 91.9% of patients remaining responders in CT alone versus CT plus Bev, respectively; Fisher's exact test: P = 1.00). Progression-free survival (PFS) since randomization did not significantly differ, with a median PFS of 5.5 months [95% confidence interval (CI) 4.9% to 6.0%] versus 5.3 months (95% CI 4.8% to 5.8%) in the CT alone and CT plus Bev groups, respectively [hazard ratio (HR) for CT alone: 1.1; 95% CI 0.7% to 1.7%; unadjusted P = 0.82]. Grade ≥2 hypertension and grade ≥3 thrombotic events were observed in 40% and 11% of patients, respectively, in the CT plus Bev group. Serum vascular endothelial growth factor (VEGF) and soluble VEGF receptor titrations failed to identify predictive biomarkers.
CONCLUSION: Administering 7.5 mg/kg Bev after induction did not improve outcome in extensive SCLC patients.
| Errataetall: | |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2015 |
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| Erschienen: |
2015 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:26 |
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| Enthalten in: |
Annals of oncology : official journal of the European Society for Medical Oncology - 26(2015), 5 vom: 17. Mai, Seite 908-914 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Pujol, J-L [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 19.05.2016 Date Revised 19.04.2022 published: Print-Electronic ClinicalTrials.gov: NCT00930891 CommentIn: Ann Oncol. 2015 Sep;26(9):2003. - PMID 26113649 Citation Status MEDLINE |
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| doi: |
10.1093/annonc/mdv065 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
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| 245 | 1 | 0 | |a Randomized phase II-III study of bevacizumab in combination with chemotherapy in previously untreated extensive small-cell lung cancer |b results from the IFCT-0802 trial† |
| 264 | 1 | |c 2015 | |
| 336 | |a Text |b txt |2 rdacontent | ||
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| 500 | |a Date Completed 19.05.2016 | ||
| 500 | |a Date Revised 19.04.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT00930891 | ||
| 500 | |a CommentIn: Ann Oncol. 2015 Sep;26(9):2003. - PMID 26113649 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissionsoup.com. | ||
| 520 | |a BACKGROUND: This randomized phase II-III trial sought to evaluate the efficacy and safety of adding bevacizumab (Bev) following induction chemotherapy (CT) in extensive small-cell lung cancer (SCLC) | ||
| 520 | |a PATIENTS AND METHODS: Enrolled SCLC patients received two induction cycles of CT. Responders were randomly assigned 1:1 to receive four additional cycles of CT alone or CT plus Bev (7.5 mg/kg), followed by single-agent Bev until progression or unacceptable toxicity. The primary end point was the percentage of patients for whom disease remained controlled (still in response) at the fourth cycle | ||
| 520 | |a RESULTS: In total, 147 patients were enrolled. Partial response was observed in 103 patients, 74 of whom were eligible for Bev and randomly assigned to the CT alone group (n = 37) or the CT plus Bev group (n = 37). Response assessment at the end of the fourth cycle showed that disease control did not differ between the two groups (89.2% versus 91.9% of patients remaining responders in CT alone versus CT plus Bev, respectively; Fisher's exact test: P = 1.00). Progression-free survival (PFS) since randomization did not significantly differ, with a median PFS of 5.5 months [95% confidence interval (CI) 4.9% to 6.0%] versus 5.3 months (95% CI 4.8% to 5.8%) in the CT alone and CT plus Bev groups, respectively [hazard ratio (HR) for CT alone: 1.1; 95% CI 0.7% to 1.7%; unadjusted P = 0.82]. Grade ≥2 hypertension and grade ≥3 thrombotic events were observed in 40% and 11% of patients, respectively, in the CT plus Bev group. Serum vascular endothelial growth factor (VEGF) and soluble VEGF receptor titrations failed to identify predictive biomarkers | ||
| 520 | |a CONCLUSION: Administering 7.5 mg/kg Bev after induction did not improve outcome in extensive SCLC patients | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a anti-angiogenesis therapy | |
| 650 | 4 | |a bevacizumab | |
| 650 | 4 | |a chemotherapy | |
| 650 | 4 | |a small-cell lung cancer | |
| 650 | 7 | |a Angiogenesis Inhibitors |2 NLM | |
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| 700 | 1 | |a Oster, J P |e verfasserin |4 aut | |
| 700 | 1 | |a Chatellain, P |e verfasserin |4 aut | |
| 700 | 1 | |a Barre, P |e verfasserin |4 aut | |
| 700 | 1 | |a Jeannin, G |e verfasserin |4 aut | |
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| 700 | 1 | |a Westeel, V |e investigator |4 oth | |
| 700 | 1 | |a Poudenx, M |e investigator |4 oth | |
| 700 | 1 | |a Mazieres, J |e investigator |4 oth | |
| 700 | 1 | |a Martinet, Y |e investigator |4 oth | |
| 700 | 1 | |a Gury, J-P |e investigator |4 oth | |
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| 700 | 1 | |a Zaegel, M |e investigator |4 oth | |
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| 700 | 1 | |a Berard, H |e investigator |4 oth | |
| 700 | 1 | |a Raspaud, C |e investigator |4 oth | |
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