nab-paclitaxel-based therapy in underserved patient populations

The ABOUND.70+ study in elderly patients with advanced NSCLC

Corey J. Langer, Edward S. Kim, Eric Anderson, Robert M. Jotte, Manuel Modiano, Daniel E. Haggstrom, Matei P. Socoteanu, David A. Smith, Christopher Dakhil, Kartik Konduri, Tymara Berry, Teng J. Ong, Alexandra Sanford, Katayoun Amiri, Jonathan W. Goldman, Jared Weiss

Research output: Contribution to journalArticle

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Abstract

The phase 4 ABOUND.70+ trial assessed the safety and efficacy of nab-paclitaxel/carboplatin continuously or with a 1-week break between cycles in elderly patients with advanced non-small cell lung cancer (NSCLC). Patients ≥70 years with locally advanced/metastatic NSCLC were randomized 1:1 to first-line nab-paclitaxel days 1, 8, 15 plus carboplatin day 1 of a 21-day cycle (21d) or the same nab-paclitaxel/carboplatin regimen with a 1-week break between cycles (21d + break; 28d). The primary endpoint was the percentage of patients with grade ≥ 2 peripheral neuropathy (PN) or grade ≥ 3 myelosuppression. Other key endpoints included progression-free survival (PFS), overall survival (OS), and overall response rate (ORR). A total of 143 patients were randomized (71 to 21d, 72 to 21d + break). The percentage of patients with grade ≥ 2 PN or grade ≥ 3 myelosuppression was similar between the 21d and 21d + break arms (76.5 and 77.1%; P = 0.9258). Treatment exposure was lower in the 21d arm compared with the 21d + break arm. Median OS was 15.2 and 16.2 months [hazard ratio (HR) 0.72, 95% CI 0.44-1.19; P = 0.1966], median PFS was 3.6 and 7.0 months (HR 0.48, 95% CI 0.30-0.76; P < 0.0019), and ORR was 23.9 and 40.3% (risk ratio 1.68, 95% CI 1.02-2.78; P = 0.0376) in the 21d and 21d + break arms, respectively. In summary, the 1-week break between treatment cycles significantly improved PFS and ORR but did not significantly reduce the percentage of grade ≥ 2 PN or grade ≥ 3 myelosuppression. Overall, the findings support the results of prior subset analyses on the safety and efficacy of first-line nab-paclitaxel/carboplatin in elderly patients with advanced NSCLC.

Original languageEnglish (US)
Article number262
JournalFrontiers in Oncology
Volume8
Issue numberJUL
DOIs
StatePublished - Jul 24 2018

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Vulnerable Populations
Non-Small Cell Lung Carcinoma
Carboplatin
Peripheral Nervous System Diseases
Disease-Free Survival
Therapeutics
Safety
Survival
130-nm albumin-bound paclitaxel
Odds Ratio

Keywords

  • Advanced non-small cell lung cancer
  • Carboplatin
  • Elderly
  • Nab-paclitaxel
  • Phase 4
  • Randomized trial

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

nab-paclitaxel-based therapy in underserved patient populations : The ABOUND.70+ study in elderly patients with advanced NSCLC. / Langer, Corey J.; Kim, Edward S.; Anderson, Eric; Jotte, Robert M.; Modiano, Manuel; Haggstrom, Daniel E.; Socoteanu, Matei P.; Smith, David A.; Dakhil, Christopher; Konduri, Kartik; Berry, Tymara; Ong, Teng J.; Sanford, Alexandra; Amiri, Katayoun; Goldman, Jonathan W.; Weiss, Jared.

In: Frontiers in Oncology, Vol. 8, No. JUL, 262, 24.07.2018.

Research output: Contribution to journalArticle

Langer, CJ, Kim, ES, Anderson, E, Jotte, RM, Modiano, M, Haggstrom, DE, Socoteanu, MP, Smith, DA, Dakhil, C, Konduri, K, Berry, T, Ong, TJ, Sanford, A, Amiri, K, Goldman, JW & Weiss, J 2018, 'nab-paclitaxel-based therapy in underserved patient populations: The ABOUND.70+ study in elderly patients with advanced NSCLC', Frontiers in Oncology, vol. 8, no. JUL, 262. https://doi.org/10.3389/fonc.2018.00262
Langer, Corey J. ; Kim, Edward S. ; Anderson, Eric ; Jotte, Robert M. ; Modiano, Manuel ; Haggstrom, Daniel E. ; Socoteanu, Matei P. ; Smith, David A. ; Dakhil, Christopher ; Konduri, Kartik ; Berry, Tymara ; Ong, Teng J. ; Sanford, Alexandra ; Amiri, Katayoun ; Goldman, Jonathan W. ; Weiss, Jared. / nab-paclitaxel-based therapy in underserved patient populations : The ABOUND.70+ study in elderly patients with advanced NSCLC. In: Frontiers in Oncology. 2018 ; Vol. 8, No. JUL.
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abstract = "The phase 4 ABOUND.70+ trial assessed the safety and efficacy of nab-paclitaxel/carboplatin continuously or with a 1-week break between cycles in elderly patients with advanced non-small cell lung cancer (NSCLC). Patients ≥70 years with locally advanced/metastatic NSCLC were randomized 1:1 to first-line nab-paclitaxel days 1, 8, 15 plus carboplatin day 1 of a 21-day cycle (21d) or the same nab-paclitaxel/carboplatin regimen with a 1-week break between cycles (21d + break; 28d). The primary endpoint was the percentage of patients with grade ≥ 2 peripheral neuropathy (PN) or grade ≥ 3 myelosuppression. Other key endpoints included progression-free survival (PFS), overall survival (OS), and overall response rate (ORR). A total of 143 patients were randomized (71 to 21d, 72 to 21d + break). The percentage of patients with grade ≥ 2 PN or grade ≥ 3 myelosuppression was similar between the 21d and 21d + break arms (76.5 and 77.1{\%}; P = 0.9258). Treatment exposure was lower in the 21d arm compared with the 21d + break arm. Median OS was 15.2 and 16.2 months [hazard ratio (HR) 0.72, 95{\%} CI 0.44-1.19; P = 0.1966], median PFS was 3.6 and 7.0 months (HR 0.48, 95{\%} CI 0.30-0.76; P < 0.0019), and ORR was 23.9 and 40.3{\%} (risk ratio 1.68, 95{\%} CI 1.02-2.78; P = 0.0376) in the 21d and 21d + break arms, respectively. In summary, the 1-week break between treatment cycles significantly improved PFS and ORR but did not significantly reduce the percentage of grade ≥ 2 PN or grade ≥ 3 myelosuppression. Overall, the findings support the results of prior subset analyses on the safety and efficacy of first-line nab-paclitaxel/carboplatin in elderly patients with advanced NSCLC.",
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AU - Anderson, Eric

AU - Jotte, Robert M.

AU - Modiano, Manuel

AU - Haggstrom, Daniel E.

AU - Socoteanu, Matei P.

AU - Smith, David A.

AU - Dakhil, Christopher

AU - Konduri, Kartik

AU - Berry, Tymara

AU - Ong, Teng J.

AU - Sanford, Alexandra

AU - Amiri, Katayoun

AU - Goldman, Jonathan W.

AU - Weiss, Jared

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N2 - The phase 4 ABOUND.70+ trial assessed the safety and efficacy of nab-paclitaxel/carboplatin continuously or with a 1-week break between cycles in elderly patients with advanced non-small cell lung cancer (NSCLC). Patients ≥70 years with locally advanced/metastatic NSCLC were randomized 1:1 to first-line nab-paclitaxel days 1, 8, 15 plus carboplatin day 1 of a 21-day cycle (21d) or the same nab-paclitaxel/carboplatin regimen with a 1-week break between cycles (21d + break; 28d). The primary endpoint was the percentage of patients with grade ≥ 2 peripheral neuropathy (PN) or grade ≥ 3 myelosuppression. Other key endpoints included progression-free survival (PFS), overall survival (OS), and overall response rate (ORR). A total of 143 patients were randomized (71 to 21d, 72 to 21d + break). The percentage of patients with grade ≥ 2 PN or grade ≥ 3 myelosuppression was similar between the 21d and 21d + break arms (76.5 and 77.1%; P = 0.9258). Treatment exposure was lower in the 21d arm compared with the 21d + break arm. Median OS was 15.2 and 16.2 months [hazard ratio (HR) 0.72, 95% CI 0.44-1.19; P = 0.1966], median PFS was 3.6 and 7.0 months (HR 0.48, 95% CI 0.30-0.76; P < 0.0019), and ORR was 23.9 and 40.3% (risk ratio 1.68, 95% CI 1.02-2.78; P = 0.0376) in the 21d and 21d + break arms, respectively. In summary, the 1-week break between treatment cycles significantly improved PFS and ORR but did not significantly reduce the percentage of grade ≥ 2 PN or grade ≥ 3 myelosuppression. Overall, the findings support the results of prior subset analyses on the safety and efficacy of first-line nab-paclitaxel/carboplatin in elderly patients with advanced NSCLC.

AB - The phase 4 ABOUND.70+ trial assessed the safety and efficacy of nab-paclitaxel/carboplatin continuously or with a 1-week break between cycles in elderly patients with advanced non-small cell lung cancer (NSCLC). Patients ≥70 years with locally advanced/metastatic NSCLC were randomized 1:1 to first-line nab-paclitaxel days 1, 8, 15 plus carboplatin day 1 of a 21-day cycle (21d) or the same nab-paclitaxel/carboplatin regimen with a 1-week break between cycles (21d + break; 28d). The primary endpoint was the percentage of patients with grade ≥ 2 peripheral neuropathy (PN) or grade ≥ 3 myelosuppression. Other key endpoints included progression-free survival (PFS), overall survival (OS), and overall response rate (ORR). A total of 143 patients were randomized (71 to 21d, 72 to 21d + break). The percentage of patients with grade ≥ 2 PN or grade ≥ 3 myelosuppression was similar between the 21d and 21d + break arms (76.5 and 77.1%; P = 0.9258). Treatment exposure was lower in the 21d arm compared with the 21d + break arm. Median OS was 15.2 and 16.2 months [hazard ratio (HR) 0.72, 95% CI 0.44-1.19; P = 0.1966], median PFS was 3.6 and 7.0 months (HR 0.48, 95% CI 0.30-0.76; P < 0.0019), and ORR was 23.9 and 40.3% (risk ratio 1.68, 95% CI 1.02-2.78; P = 0.0376) in the 21d and 21d + break arms, respectively. In summary, the 1-week break between treatment cycles significantly improved PFS and ORR but did not significantly reduce the percentage of grade ≥ 2 PN or grade ≥ 3 myelosuppression. Overall, the findings support the results of prior subset analyses on the safety and efficacy of first-line nab-paclitaxel/carboplatin in elderly patients with advanced NSCLC.

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