TY - JOUR
T1 - Nanoparticle Albumin-bound Paclitaxel Plus Carboplatin Induction Followed by Nanoparticle Albumin-bound Paclitaxel Maintenance in Squamous Non–Small-cell Lung Cancer (ABOUND.sqm)
T2 - A Phase III Randomized Clinical Trial
AU - ABOUND.sqm investigators
AU - Spigel, David R.
AU - Jotte, Robert M.
AU - Aix, Santiago Ponce
AU - Gressot, Laurent
AU - Morgensztern, Daniel
AU - McCleod, Michael
AU - Socinski, Mark A.
AU - Daniel, Davey
AU - Juan-Vidal, Oscar
AU - Mileham, Kathryn F.
AU - West, Howard
AU - Page, Ray
AU - Reinmuth, Niels
AU - Knoble, Jeanna
AU - Chen, Tianlei
AU - Bhore, Rafia
AU - Wolfsteiner, Marianne
AU - Ong, Teng Jin
AU - Gridelli, Cesare
AU - Thomas, Michael
N1 - Funding Information:
The present study was supported by Bristol Myers Squibb . The sponsor was involved in the design of the research and the analysis and interpretation of the data. The named authors of the present report were involved in writing the report and agreed with the decision to submit the article for publication. The authors thank the patients who participated in the study and their families. In addition, the authors thank the investigators, nurses, and research staff across the participating centers, as well as the independent data monitoring committee. Statistical and programming support was provided by Olivia (Yu) Tian. Medical writing assistance was provided by Aaron Runkle, PhD, MediTech Media, Ltd, funded by Bristol Myers Squibb . The authors were fully responsible for all content and editorial decisions for the present report. D.R.S. had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Data requests may be submitted to Celgene, a Bristol Myers Squibb Company (at: https://vivli.org/ourmember/celgene/ ), and must include a description of the research proposal.
Funding Information:
D.R.S. has been in a consulting or advisory role for which his institution received funds from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Genentech/Roche, Lilly, Novartis, and Pfizer; and his institution has received research funding from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Genentech/Roche, Lilly, Merck, Novartis, Pfizer, and University of Texas Southwestern Medical Center, Simmons Cancer Center. R.M.J. has received honoraria from, been on the speakers? bureau for, and received travel, accommodations, and/or expenses from Bristol Myers Squibb. D.M. has been a consultant for AbbVie, Bristol Myers Squibb, PharmaMar, and Takeda. M.A.S. has received honoraria from AstraZeneca, Bristol Myers Squibb, Celgene, and Genentech, been a consultant or advisor for Genentech, and been on the speakers? bureau for AstraZeneca, Boehringer Ingelheim, Bristol Myers Squib, and Genentech; and his institution has received research funding from Genentech and Pfizer. O.J.-V. has been an advisory board member for AstraZeneca, AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Merck Sharp & Dohme, and Roche/Genentech. K.F.M. has been a consultant or advisor for Boehringer Ingelheim, AstraZeneca, and Novartis, on the speakers? bureau for Merck, and has received research funding from Celgene. H.W. has been a consultant or advisor for ARIAD, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Genentech/Roche, Guardant Health, Merck, and Novartis and has been on the speakers? bureau for ARIAD and Genentech/Roche. R.P. is an employee of The Center for Cancer and Blood Disorders; has received honoraria from AmerisourceBergen, Astellas Medivation, and Community Oncology Alliance; has been a consultant or advisor for Via Oncology; and has received research funding from Sarah Cannon Research Institute. N.R. has received honoraria from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Lilly, MSD, Novartis, Pfizer, Roche, Takeda. J.K. has been on the speakers? bureau for Alexion Pharmaceuticals, Celgene, and Novartis and has received research funding from Celgene. T.C., R.B., and T.J.O. are employees of, and hold stock in, Bristol Myers Squibb. M.W. is contracted for medical review by Bristol Myers Squibb. M.T. has received honoraria from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Lilly, MSD, Novartis, Pfizer, and Roche; been a consultant or advisor for AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Lilly, MSD, Novartis, Pfizer, and Roche; and has received travel, accommodations, and/or expenses from Boehringer Ingelheim, Bristol Myers Squibb, Lilly, MSD, Novartis, Pfizer, and Roche. The remaining authors have stated that they have no conflicts of interest.The present study was supported by Bristol Myers Squibb. The sponsor was involved in the design of the research and the analysis and interpretation of the data. The named authors of the present report were involved in writing the report and agreed with the decision to submit the article for publication. The authors thank the patients who participated in the study and their families. In addition, the authors thank the investigators, nurses, and research staff across the participating centers, as well as the independent data monitoring committee. Statistical and programming support was provided by Olivia (Yu) Tian. Medical writing assistance was provided by Aaron Runkle, PhD, MediTech Media, Ltd, funded by Bristol Myers Squibb. The authors were fully responsible for all content and editorial decisions for the present report. D.R.S. had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Data requests may be submitted to Celgene, a Bristol Myers Squibb Company (at: https://vivli.org/ourmember/celgene/), and must include a description of the research proposal.
Publisher Copyright:
© 2020
PY - 2021/1
Y1 - 2021/1
N2 - 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.
AB - 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.
KW - Carboplatin
KW - Maintenance therapy
KW - Nab-paclitaxel
KW - Quality of life
KW - Squamous NSCLC
UR - http://www.scopus.com/inward/record.url?scp=85093981903&partnerID=8YFLogxK
U2 - 10.1016/j.cllc.2020.09.007
DO - 10.1016/j.cllc.2020.09.007
M3 - Article
C2 - 33097414
AN - SCOPUS:85093981903
SN - 1525-7304
VL - 22
SP - 6-15.e4
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
IS - 1
ER -