Meta-Analysis to Assess the Efficacy and Toxicity of Docetaxel-Based Doublet Compared with Docetaxel Alone for Patients with Advanced NSCLC who Failed First-Line Treatment

Jin, Ying; Sun, Yan; Shi, Xun; Zhao, Jun; Shi, Lei; Hong, Wei; Yu, Xinmin

doi:10.1016/j.clinthera.2014.08.015

Cited by 7 publications

(3 citation statements)

References 38 publications

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“…As these trials were conducted over almost two decades, it also allowed us to investigate trends in treatment outcomes. Several meta-analyses of second-line therapies in advanced NSCLC have previously been published to estimate the comparative effectiveness and safety of the various therapeutic options [19][20][21][22] and assessed for predictive [20,21] and prognostic factors [22]. To the best of our knowledge, this is the first study focusing on heterogeneity in treatment outcome from the same docetaxel monotherapy as second-line therapy in advanced NSCLC.…”

Section: Discussionmentioning

confidence: 99%

Benchmarking single-arm studies against historical controls from non-small cell lung cancer trials – an empirical analysis of bias

et al. 2019

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Background: Recent trials of novel agents in 'rare' molecular subtypes of non-small cell lung cancer (NSCLC) have used single-arm trial designs and benchmarked outcomes against historical controls. We assessed the consistency of historical control outcomes using docetaxel data from published NSCLC randomized controlled trials (RCTs). Material and methods: Advanced NSCLC RCTs including a docetaxel monotherapy arm were included. Heterogeneity in tumor objective response rates (ORRs), progression-free survival (PFS) and overall survival (OS), and correlations between outcomes and year of trial commencement were assessed. Results: Among 63 trials (N ¼ 10,633) conducted between 2000 and 2017, ORR ranged from 0% to 26% (I 2 ¼ 76.1%, p heterogeneity < .0001). Mean of the median PFS was 3.0 months (range: 1.4-6.4), 3month PFS ranged from 25% to 85% (I 2 ¼ 86.0%, p heterogeneity < .0001). Mean of the median OS was 9.1 months (range: 4.7-22.9), 9-month OS ranged from 23% to 79% (I 2 ¼ 83.0%, p heterogeneity < .0001). Each later year of trial commencement was associated with 0.3% (p ¼ .046), 0.5% (p ¼ .11) and 0.9% (p ¼ .001) improvement in ORR, 3-month PFS and 9-month OS rates, respectively. Conclusions: There was significant heterogeneity and an improving trend in docetaxel outcomes across trials conducted over 20 years. Benchmarking biomarker-targeted agents against historical controls may not be a valid approach to replace RCTs. Innovative study designs involving a concurrent control arm should be considered.

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Section: Discussionmentioning

confidence: 99%

Benchmarking single-arm studies against historical controls from non-small cell lung cancer trials – an empirical analysis of bias

et al. 2019

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“… 28 , 29 Docetaxel plays an important role, and has been proved to be the main therapy for advanced NSCLC. 30 There are also novel or classical drugs for advanced NSCLC treatment, such as vinca alkaloid and pemetrexed. Vinca alkaloid is a commonly used anticancer drug for NSCLC treatment that is similar to docetaxel in terms of the mechanism of its interactions with tubulin and disruption of microtubule function, particularly when microtubules comprise the mitotic spindle apparatus, directly causing metaphase arrest.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of docetaxel for advanced non-small-cell lung cancer: a meta-analysis of Phase III randomized controlled trials

He¹,

Wang²,

2015

OTT

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BackgroundSeveral clinical trials have performed risk–benefit analyses comparing docetaxel and pemetrexed or docetaxel and vinca alkaloid, but the efficacy and safety remain uncertain. The aim was to conduct a meta-analysis to compare the efficacy and safety of docetaxel and pemetrexed or docetaxel and vinca alkaloid for non-small-cell lung cancer.MethodsThis meta-analysis of Phase III randomized controlled trials was performed after searching PubMed, Embase, the Cochrane Library, and the ISI Web of Knowledge for randomized controlled trials. Outcome analyses were overall survival, progression-free survival, and overall response rate with 95% confidence intervals and major grade 3/4 toxicity.ResultsSeven eligible trials involving 2,080 patients were retrieved for analysis. Docetaxel enhanced progression-free survival and overall response rate compared with vinca alkaloid as first-line treatment (P<0.05). However, there was no difference between docetaxel and pemetrexed as both first-line and second-line treatment (P>0.05). With regard to the grade 3/4 toxicity, compared with pemetrexed, docetaxel led to higher neutropenia and febrile neutropenia (P<0.05), but there was no difference in non-hematological toxicity (P>0.05). Docetaxel led to a lower rate of anemia as first-line treatment (P<0.05). Moreover, docetaxel caused less grade 3/4 hematological and non-hematological toxicity compared with vinca alkaloid.ConclusionDocetaxel leads to a better result than vinca alkaloid in effectiveness and safety on patients with advanced non-small-cell lung cancer as first-line therapy. Docetaxel also causes lower toxicity as second-line therapy compared with vinca alkaloid. However, the differences in efficacy and safety between docetaxel and pemetrexed are not obvious. Further clinical study with more details, such as sex, age, histology, and so on, should be considered for illustrating the differences between these two drugs.

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“…Taxanes are a widely used class of potent chemotherapy agents for breast, lung, head and neck, pancreatic, esophageal, gastric, anal, and ovarian cancers [1][2][3][4][5][6][7]. The first taxane, named paclitaxel, was purified from the bark of the pacific yew tree, Taxus brevifolia, as a part of a large plant-screening program led by the US National Cancer Institute and Department of Agriculture [8][9][10].…”

Section: Introductionmentioning

confidence: 99%

Clinical characteristics of colitis induced by taxane-based chemotherapy

Chen

Abu-Sbeih

Thirumurthi

et al. 2019

aog

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Background Limited data are available concerning the clinical features of toxic gastrointestinal (GI) effects of taxane-based therapy. We describe the clinical, endoscopic and histologic features of taxane-induced colitis. Methods This retrospective study included cancer patients who received taxane therapy and underwent colonoscopy for GI symptoms from 2000-2018. Results Of the 45,527 patients who received taxane therapy during the study period, 76 (0.2%) met the inclusion criteria. Most patients (54%) received paclitaxel, 37% docetaxel, and 9% nab-paclitaxel. The median time from taxane therapy initiation to colitis symptom onset was 31 days. The median duration of colitis symptoms was 30 days. Colitis treatment comprised immunosuppressive therapy in 8 patients (11%), antibiotics in 17 (22%), antimotility agents in 18 (24%), and octreotide or somatostatin in 2 (3%). Thirty-five patients (46%) required hospitalization and seven (9%) required admission to the intensive care unit (ICU). Endoscopy revealed mucosal ulceration in 19 patients (25%), nonulcerative inflammation in 32 (42%), and normal findings in 25 (33%). Seventeen patients (22%) had features of lymphocytic colitis. One patient had spontaneous colonic perforation that required surgical intervention. Colitis symptoms recurred in 7 patients (9%) after initial improvement. Patients who received nab-paclitaxel developed GI toxicity earlier (P=0.003), required colitis-related hospitalization more frequently (P=0.005), and received intravenous fluids more frequently (P=0.025), compared with patients who received other taxanes. Conclusions Taxane-related colitis can present with significant inflammation on colonoscopy, and in a minority of patients as microscopic colitis. Taxane-induced colitis, although uncommon, can lead to ICU admission and colonic perforation.

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Meta-Analysis to Assess the Efficacy and Toxicity of Docetaxel-Based Doublet Compared with Docetaxel Alone for Patients with Advanced NSCLC who Failed First-Line Treatment

Cited by 7 publications

References 38 publications

Benchmarking single-arm studies against historical controls from non-small cell lung cancer trials – an empirical analysis of bias

Benchmarking single-arm studies against historical controls from non-small cell lung cancer trials – an empirical analysis of bias

Efficacy and safety of docetaxel for advanced non-small-cell lung cancer: a meta-analysis of Phase III randomized controlled trials

Clinical characteristics of colitis induced by taxane-based chemotherapy

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