Multicenter, single-arm phase II study of modified carboplatin/ nab-paclitaxel in untreated performance status 2 patients with advanced non-small cell lung cancer: TORG1426

被引:0
作者
Ichikawa, Yasuko [1 ]
Seki, Nobuhiko [1 ]
Honda, Takeshi [1 ]
Sakugawa, Makoto [2 ]
Hosokawa, Shinobu [2 ]
Bessho, Akihiro [2 ]
Agemi, Yoko [3 ]
Shimokawa, Tsuneo [3 ]
Otani, Sakiko [4 ]
Nakahara, Yoshiro [4 ]
Naoki, Katsuhiko [4 ]
Yomota, Makiko [5 ]
Hosomi, Yukio [5 ]
Takiguchi, Yuichi [6 ]
Tokito, Takaaki [7 ]
Ando, Shuji [8 ]
Okamoto, Hiroaki [3 ]
机构
[1] Teikyo Univ, Dept Internal Med, Div Med Oncol, Sch Med, 2-11-1 Kaga,Itabashi Ku, Tokyo, 1738606, Japan
[2] Japanese Red Cross Okayama Hosp, Dept Resp Med, Okayama, Japan
[3] Yokohama Municipal Citizens Hosp, Dept Resp Med, Kanagawa, Japan
[4] Kitasato Univ Hosp, Dept Resp Med, Kanagawa, Japan
[5] Komagome Hosp, Dept Resp Med, Tokyo Metropolitan Canc & Infect Dis Ctr, Tokyo, Japan
[6] Chiba Univ, Grad Sch Med, Dept Med Oncol, Chiba, Japan
[7] Kurume Univ, Dept Internal Med, Div Respirol Neurol & Rheumatol, Sch Med, Fukuoka, Japan
[8] Tokyo Univ Sci, Dept Informat Sci, Chiba, Japan
关键词
Platinum-based chemotherapy; nab-paclitaxel; peripheral neuropathy; non-small cell lung cancer (NSCLC); performance status 2 (PS 2); COOPERATIVE-ONCOLOGY-GROUP; ELDERLY-PATIENTS; PLUS CARBOPLATIN; 1ST-LINE THERAPY; TRIAL; GEMCITABINE; CHEMOTHERAPY; COMBINATION; CISPLATIN; AGENT;
D O I
10.21037/tcr-22-2144
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background: Currently, only a few treatment options exist for performance status (PS) 2 patients with advanced non-small-cell lung cancer (NSCLC), whereas the carboplatin/nab-paclitaxel (CBDCA/nab-PTX) regimen is attracting attention as a standard of care for PS 0-1 patients because of its wide suitability and modest risk of peripheral neuropathy. However, the treatment dose and schedule should be optimized for PS 2 patients. Therefore, we planned a single-arm phase II study to characterize the efficacy and tolerability of our modified CBDCA/nab-PTX regimen for untreated PS 2 patients with advanced NSCLC.Methods: Enrolled patients were treated with CBDCA (area under the curve 5 on day 1) plus nab-PTX (70 mg/m2 on days 1, 8, and 15) every 4 weeks for up to six cycles. The primary endpoint was the progression-free survival (PFS) rate at 6 months. As exploratory analyses, the reasons for PS 2 (disease burden versus comorbidities/indeterminant) and the Charlson Comorbidity Index (CCI) were evaluated as efficacy indicators.Results: This study was terminated early because of slow accrual. Seventeen patients [median age, 68 years (range, 50-73 years)] received a median of three cycles. The 6-month PFS rate, median PFS, and median overall survival were 20.8% [95% confidence interval (CI): 0-41.6], 3.0 months (95% CI: 1.7-4.3), and 9.5 months (95% CI: 5.0-14.0), respectively. Exploratory analyses suggested better overall survival in patients whose PS was not attributable to the disease burden (median, 9.5 vs. 7.2 months) or whose CCI was <= 3 (median, 15.5 vs. 7.2 months). Grade 3-4 adverse events occurred in 12 (71%) patients, and grade 5 pleural infection occurred in one (6%) patient. Meanwhile, only one (6%) patient each experienced grade 1 peripheral neuropathy and grade 2 interstitial pneumonitis.Conclusions: No conclusion could be drawn from this study because of its early termination. However, our modified CBDCA/nab-PTX regimen might be useful for PS 2 patients who hesitate to use regimens other than nab-PTX, and particularly patients concerned about peripheral neuropathy or interstitial pneumonitis. The potential role of PS 2 and CCI as efficacy predictors for this regimen should be further examined.
引用
收藏
页码:873 / 886
页数:14
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