| Autor: |
Langer CJ; Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, United States., Kim ES; Levine Cancer Institute, Carolinas Healthcare System, Charlotte, NC, United States., Anderson EC; Knight Cancer Institute, Oregon Health & Science University, Portland, OR, United States., Jotte RM; Rocky Mountain Cancer Centers, Denver, CO, United States., Modiano M; Arizona Clinical Research Center, Tucson, AZ, United States., Haggstrom DE; Levine Cancer Institute, Carolinas Healthcare System, Charlotte, NC, United States., Socoteanu MP; Texas Oncology, Longview, TX, United States., Smith DA; Compass Oncology, Vancouver, WA, United States., Dakhil C; Cancer Center of Kansas, Wichita, KS, United States., Konduri K; Baylor Charles A. Sammons Cancer Center, Texas Oncology PA, Dallas, TX, United States., Berry T; Celgene Corporation, Summit, NJ, United States., Ong TJ; Celgene Corporation, Summit, NJ, United States., Sanford A; Celgene Corporation, Summit, NJ, United States., Amiri K; Celgene Corporation, Summit, NJ, United States., Goldman JW; David Geffen School of Medicine at UCLA, Los Angeles, CA, United States., Weiss J; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, United States. |
| Abstrakt: |
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. |
