Benefit of Erlotinib in Patients with Non-Small-Cell Lung Cancer Is Related to Smoking Status, Gender, Skin Rash and Radiological Response but Not to Histology and Treatment Line

Faehling, Martin; Eckert, R.; Kuom, S.; Kamp, T.; Stoiber, K; Schümann, Christian

doi:10.1159/000315731

Cited by 35 publications

(16 citation statements)

References 46 publications

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“…In the BR.21 placebocontrolled phase III trial of erlotinib in previously treated patients with advanced NSCLC, the median survival for erlotinib-treated patients who did not experience skin toxicity was 3 months compared with 7 and 11 months for those with grade 1 or 2/3 skin toxicity, respectively [18]. Similar relationships have been observed in the clinical trials of erlotinib in NSCLC [19][20][21][22][23][24].…”

supporting

confidence: 53%

Skin Rash as Useful Marker of Erlotinib Efficacy in NSCLC and Its Impact on Clinical Practice

Fiala¹,

Pešek²,

Fínek³

et al. 2012

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Erlotinib is an epidermal growth factor receptor tyrosine kinase inhibitor used in treatment of advanced NSCLC. Patients harboring EGFR or KRAS mutations represent minority of all patients in caucasian population and there is no available predictor for a predominant group of patients harboring the wild-type EGFR and wild-type KRAS genes. Skin rash is the most frequent manifestation of cutaneous toxicity of erlotinib. Rash is associated with a good therapeutic response. We aimed at the evaluation of rash as a predictor of therapeutic effect of erlotinib in patients harboring the wild-type EGFR and KRAS wild-type genes and to assess its possible usage in a clinical practice.Totally 184 patients with advanced stage NSCLC (IIIB, IV) harboring the wild-type EGFR and wild-type KRAS genes were analysed. Comparison of ORR, PFS and OS according to the occurrence of rash was performed. In order to assess the impact of rash in clinical practice it was conducted landmark analysis of the group of patients whose rash was observed during first month of treatment (n=124). Patients in whom progression was observed during the first month of treatment were excluded from the landmark analysis. The comparison of ORR was performed using Fisher's exact test, visualization of survival was performed using Kaplan-Meier survival curves and the differences in survival were tested using the log-rank test. Median PFS in patients who were observed with rash during the treatment was 3.0 vs. 1.2 months in patients with no rash (p<0.001), median of OS in patients who were observed with rash during the treatment was 13.9 vs. 5.8 months in patients with no rash (p<0.001). ORR in patients who were observed with rash during the treatment was 17.4% vs. 3.3% in patients with no rash (p=0.001). Median of PFS after 1 month of treatment in patients who were observed with rash during the first month was 2.9 vs. 1.1 months in patients with no rash (p=0.027). Median of OS after 1 month of treatment in patients who were observed with rash during the first month was 13.8 vs. 9.9 months in patients with no rash (p=0.082). Rash is strongly associated with better survival and ORR in patients harboring wild-type EGFR and wild-type KRAS genes. Occurrence of rash during the first month of treatment is a useful predictor of better effect of erlotinib after one month of treatment. Patients who were not observed with rash during the first month of treatment are in high risk of progression. Optimization of the treatment of these patients can contribute restaging after two months of treatment, assessment of plasma levels of erlotinib and eventually attempt to dose escalation.

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supporting

confidence: 53%

Skin Rash as Useful Marker of Erlotinib Efficacy in NSCLC and Its Impact on Clinical Practice

Fiala¹,

Pešek²,

Fínek³

et al. 2012

neo

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“…We showed longer survival of patients occurring with skin rash compared to those without (PFS: 3.6 vs. 2.4 months, P=0.007; OS: 11.6 vs. 5.5 months of patients, P<0.001). Thus we confirmed the role of skin rash as a marker of erlotinib efficacy, a fact that has been previously reported [20][21][22]. An important finding in our study was longer PFS of never-smokers or former-smokers in comparison with current-smokers (3.1 vs. 2.8 months, P=0.028).…”

Section: Discussionsupporting

confidence: 91%

Erlotinib in the treatment of advanced squamous cell NSCLC

Fiala¹,

Pešek²,

Fínek³

et al. 2014

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Erlotinib is an epidermal growth factor receptor tyrosine-kinase inhibitor. Clinical trials have shown its efficacy in advanced non-small cell lung cancer (NSCLC). We conducted a large retrospective study based on clinical experience aiming to prove erlotinib's efficacy and safety in patients with advanced-stage squamous cell NSCLC. Totally 375 patients with advanced-stage (IIIB, IV) squamous cell NSCLC were treated with erlotinib. Erlotinib was continued until disease progression or intolerable toxicity. 1 (0.3%) complete response (CR), 28 (7.5%) partial responses (PR) and 198 (52.8%) stable diseases (SD) were achieved. Overall response rate (ORR) and disease control rate (DCR) were 7.8% and 60.5%, respectively. Median progression-free survival (PFS) was 3.0 months and median overall survival (OS) was 7.6 months. PFS of patients with CR/PR, SD and PD were 7.6, 3.9 and 1.0 months, respectively (P<0.001). OS of patients with CR/PR, SD and PD were 13.3, 10.9 and 3.8 months, respectively (P<0.001). The most common adverse effects were rash and diarrhoea. In conclusion erlotinib is effective and well-tolerated in patients with advanced-stage squamous cell NSCLC.

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“…Of these, 166 articles were excluded for various reasons. Finally, 33 studies [5], [7], [8], [9], [10], [11], [12], [14], [15], [16], [17], [18], [19], [20], [21], [22], [23], [24], [25], [26], [27], [28], [29], [30], [31], [32], [33], [34], [35], [36], [37], [38], [39] with 6,798 patients were included in the meta-analysis. The characteristics of the eligible studies are summarized in Table 1.…”

Section: Resultsmentioning

confidence: 99%

Skin Rash could Predict the Response to EGFR Tyrosine Kinase Inhibitor and the Prognosis for Patients with Non-Small Cell Lung Cancer: A Systematic Review and Meta-Analysis

Liu

Wu²,

et al. 2013

PLoS ONE

129

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BackgroundThe aim of this study was to assess the role of skin rash in predicting the efficacy of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) and the prognosis of patients with non-small cell lung cancer (NSCLC).MethodWe systematically searched for eligible articles investigating the association between rash and the efficacy of EGFR-TKIs and the prognosis of patients with NSCLC. The summary risk ratio (RR) and hazard ratio (HR) were calculated using meta-analysis.ResultsWe identified 33 eligible trials involving 6,798 patients. We used two different standards to group the patients [standard 1: rash vs. no rash, standard 2: rash (≥ stage 2) vs. rash (stage 0, 1)]. For standard 1, the objective response rate (ORR) and disease control rate (DCR) of the rash group were significantly higher than the no rash group [RR = 3.28; 95% CI: 2.41–4.47(corrected RR = 2.225, 95% CI: 1.658–2.986); RR = 1.96, 95% CI: 1.58–2.43]. The same results were observed for standard 2. For standards 1 and 2, the progression-free survival (PFS) (HR = 0.45, 95% CI: 0.37–0.53; HR = 0.57, 95% CI: 0.50–0.65) and overall survival (OS) (HR = 0.40, 95% CI: 0.28–0.52; HR = 0.53, 95% CI: 0.35–0.71) of the rash group were significantly longer than the control group, and the same results were observed in the subgroup analysis.Conclusionsskin rash after EGFR-TKI treatment may be an efficient clinical marker for predicting the response of patients with NSCLC to EGFR-TKIs. Furthermore, skin rash is also the prognostic factor of patients with NSCLC. Patients with skin rash have a longer PFS and OS.

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Benefit of Erlotinib in Patients with Non-Small-Cell Lung Cancer Is Related to Smoking Status, Gender, Skin Rash and Radiological Response but Not to Histology and Treatment Line

Cited by 35 publications

References 46 publications

Skin Rash as Useful Marker of Erlotinib Efficacy in NSCLC and Its Impact on Clinical Practice

Skin Rash as Useful Marker of Erlotinib Efficacy in NSCLC and Its Impact on Clinical Practice

Erlotinib in the treatment of advanced squamous cell NSCLC

Skin Rash could Predict the Response to EGFR Tyrosine Kinase Inhibitor and the Prognosis for Patients with Non-Small Cell Lung Cancer: A Systematic Review and Meta-Analysis

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