Nanoparticle albumin-bound paclitaxel plus carboplatin induction followed by nanoparticle albumin-bound paclitaxel maintenance in squamous non-small-cell lung cancer (ABOUND.sqm): a phase III randomized clinical trial
Background - We evaluated maintenance nanoparticle albumin-bound (nab) paclitaxel in the treatment of advanced squamous non-small-cell lung cancer. - Patients and Methods - Patients with treatment-naive squamous non-small-cell lung cancer received four 21-day cycles of nab-paclitaxel 100 mg/m2 on da...
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
2021
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| In: |
Clinical lung cancer
Year: 2020, Jahrgang: 22, Heft: 1, Pages: 6-15.e4 |
| ISSN: | 1938-0690 |
| DOI: | 10.1016/j.cllc.2020.09.007 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.cllc.2020.09.007 Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S1525730420302709 
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| Verfasserangaben: | David R. Spigel, Robert M. Jotte, Santiago Ponce Aix, Laurent Gressot, Daniel Morgensztern, Michael McCleod, Mark A. Socinski, Davey Daniel, Oscar Juan-Vidal, Kathryn F. Mileham, Howard West, Ray Page, Niels Reinmuth, Jeanna Knoble, Tianlei Chen, Rafia Bhore, Marianne Wolfsteiner, Teng Jin Ong, Cesare Gridelli, Michael Thomas, on behalf of the ABOUND.sqm Investigators |
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| 245 | 1 | 0 | |a Nanoparticle albumin-bound paclitaxel plus carboplatin induction followed by nanoparticle albumin-bound paclitaxel maintenance in squamous non-small-cell lung cancer (ABOUND.sqm) |b a phase III randomized clinical trial |c David R. Spigel, Robert M. Jotte, Santiago Ponce Aix, Laurent Gressot, Daniel Morgensztern, Michael McCleod, Mark A. Socinski, Davey Daniel, Oscar Juan-Vidal, Kathryn F. Mileham, Howard West, Ray Page, Niels Reinmuth, Jeanna Knoble, Tianlei Chen, Rafia Bhore, Marianne Wolfsteiner, Teng Jin Ong, Cesare Gridelli, Michael Thomas, on behalf of the ABOUND.sqm Investigators |
| 264 | 1 | |c 2021 | |
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| 500 | |a Epub: Sep18, 2020 | ||
| 500 | |a Gesehen am 09.03.2021 | ||
| 520 | |a Background - We evaluated maintenance nanoparticle albumin-bound (nab) paclitaxel in the treatment of advanced squamous non-small-cell lung cancer. - Patients and Methods - Patients with treatment-naive squamous non-small-cell lung cancer received four 21-day cycles of nab-paclitaxel 100 mg/m2 on days 1, 8, 15 plus carboplatin area under the curve 6 on day 1 as induction therapy. Patients without disease progression after induction were randomized 2:1 to maintenance nab-paclitaxel 100 mg/m2 (days 1 and 8 every 21 days) plus best supportive care (BSC) or BSC alone. The primary endpoint was progression-free survival (PFS). Secondary endpoints included safety and overall survival (OS). - Results - Overall, 420 patients had received induction therapy; 202 (nab-paclitaxel plus BSC, 136; BSC, 66) had received maintenance therapy. Enrollment was discontinued after a preplanned interim futility analysis (patients could remain in the study at the investigator’s discretion). The median PFS was 3.12 months for nab-paclitaxel plus BSC and 2.60 months for BSC; the difference was not statistically significant (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.61-1.19; P = .36). The median OS (median follow-up, 24.2 months) was 17.18 months for nab-paclitaxel plus BSC and 12.16 months for BSC (HR, 0.70; 95% CI, 0.48-1.02; nominal P = .07). An updated analysis (median follow-up, 28.4 months) revealed a median OS of 17.61 months for nab-paclitaxel plus BSC and 12.16 months for BSC (HR, 0.68; 95% CI, 0.47-0.98; nominal P = .037). The most frequent grade 3 and 4 treatment-emergent adverse events for the entire study were neutropenia (53.1% [nab-paclitaxel plus BSC] vs. 50.0% [BSC]) and anemia (33.1% [nab-paclitaxel plus BSC] vs. 32.3% [BSC]). Only peripheral neuropathy had occurred in ≥ 5% of patients during maintenance therapy (13.1%; nab-paclitaxel plus BSC). - Conclusions - The results of the ABOUND.sqm did not meet the primary endpoint of PFS. An updated OS analysis revealed a trend favoring nab-paclitaxel plus BSC. | ||
| 534 | |c 2020 | ||
| 650 | 4 | |a Carboplatin | |
| 650 | 4 | |a Maintenance therapy | |
| 650 | 4 | |a Nab-paclitaxel | |
| 650 | 4 | |a Quality of life | |
| 650 | 4 | |a Squamous NSCLC | |
| 700 | 1 | |a Jotte, Robert M. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Aix, Santiago Ponce |e VerfasserIn |4 aut | |
| 700 | 1 | |a Gressot, Laurent |e VerfasserIn |4 aut | |
| 700 | 1 | |a Morgensztern, Daniel |e VerfasserIn |4 aut | |
| 700 | 1 | |a McCleod, Michael |e VerfasserIn |4 aut | |
| 700 | 1 | |a Socinski, Mark A. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Daniel, Davey |e VerfasserIn |4 aut | |
| 700 | 1 | |a Juan-Vidal, Oscar |e VerfasserIn |4 aut | |
| 700 | 1 | |a Mileham, Kathryn F. |e VerfasserIn |4 aut | |
| 700 | 1 | |a West, Howard |e VerfasserIn |4 aut | |
| 700 | 1 | |a Page, Ray |e VerfasserIn |4 aut | |
| 700 | 1 | |a Reinmuth, Niels |d 1970- |e VerfasserIn |0 (DE-588)122316592 |0 (DE-627)705858936 |0 (DE-576)293216266 |4 aut | |
| 700 | 1 | |a Knoble, Jeanna |e VerfasserIn |4 aut | |
| 700 | 1 | |a Chen, Tianlei |e VerfasserIn |4 aut | |
| 700 | 1 | |a Bhore, Rafia |e VerfasserIn |4 aut | |
| 700 | 1 | |a Wolfsteiner, Marianne |e VerfasserIn |4 aut | |
| 700 | 1 | |a Ong, Teng Jin |e VerfasserIn |4 aut | |
| 700 | 1 | |a Gridelli, Cesare |e VerfasserIn |4 aut | |
| 700 | 1 | |a Thomas, Michael |e VerfasserIn |0 (DE-588)1054438781 |0 (DE-627)79152213X |0 (DE-576)41027089X |4 aut | |
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