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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| Main Authors: | , , , , , , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2021
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| In: |
Clinical lung cancer
Year: 2020, Volume: 22, Issue: 1, Pages: 6-15.e4 |
| ISSN: | 1938-0690 |
| DOI: | 10.1016/j.cllc.2020.09.007 |
| Online Access: | 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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| Author Notes: | 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 |
| Summary: | 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. |
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| Item Description: | Epub: Sep18, 2020 Gesehen am 09.03.2021 |
| Physical Description: | Online Resource |
| ISSN: | 1938-0690 |
| DOI: | 10.1016/j.cllc.2020.09.007 |