Initial safety and efficacy results of erlotinib in previously treated patients with advanced non-small cell lung cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18183-18183
Author(s):  
S. Zhou ◽  
C. Zhou ◽  
L. Yan ◽  
Q. Xu ◽  
J. Xu
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Smoking Status ◽  
Small Cell ◽  
Small Cell Lung ◽  
Significant Difference ◽  
Previously Treated ◽  
Nsclc Patients ◽  
Severe Rash

18183 Background: Erlotinib is an orally available selective HER1/EGFR tyrosine kinase inhibitor. In the BR.21 trial, erlotinib significantly improved survival and quality of life in non-small cell lung cancer(NSCLC) patients (pts). The study evaluated the initial efficacy and safety of erlotinib in previously treated advanced or metastatic NSCLC patients in Shanghai, China. Methods: Eligibility criteria included stage IIIb/IV or recurrent NSCLC pts who failed from prior chemotherapy, PS = 0–2, weight loss less than 5%, and no urgent symptoms. Pts received oral erlotinib 150 mg po/day until objective or symptomatic progression. Results: 50 pts were enrolled from Oct 1 to Sept 30. Demographics: M 68%/F 32%; median age 55 y [range 28–68]; stage IV 86%; PS 0/1/2:2 (4%)/44 (88%)/4 (8%); adenocarcinoma/non-adenocarcinoma 39 (78%)/11 (22%); smoking status: 26 (52%) /no 24 (48%). The major toxicity was rash: 48 (96%), 10 (20%) of them are grade 3/4; other toxicity included grade 1/2 diahhrea: 5 (10%); grade 1/2 liver dysfunction: 4 (8%); grade 2 leucocytopenia: 2 (4%); grade 1 thrombocytopenia: 1(2%); fatigue and dyspnea. 3 patients discontinued for dyspnea, pneumonitis and fatigue respectively. No pts had pulmonary fibrosis and dose reduction. 47 pts were followed long enough for efficacy evaluation, which indentified 18 (38%) with PR, 21 (45%) with SD, 8 (17%) with PD. Subgroup analysis showed the resposes to erlotinib have no relation with gender, age, smoking status, performance status, histology and stages, however, significant difference existed in the subgroup patients with severe rash and less symptoms such as dyspnea and fatigue ( Table 1 ). Conclusions: Erlotinib is active and well tolerated in patients with advanced NSCLC failed to previously chemotherapy. Preliminary results suggest patients with severe rash, less dyspnea and fatigue are accociated with better response. The study in ongoing. Table 1 Response of erlotinib in advanced treated NSCLC pts. * P values less than 0.05. [Table: see text] No significant financial relationships to disclose.

Pemetrexed versus gefitinib versus erlotinib in previously treated non-small cell lung cancer by retrospective analysis

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e19103-e19103
Author(s):  
E. Cho ◽  
J. Hong ◽  
S. Kyung ◽  
Y. Kim ◽  
S. Shim ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Retrospective Analysis ◽  
Cell Lung Cancer ◽  
Performance Status ◽  
Small Cell ◽  
Small Cell Lung ◽  
Folate Supplementation ◽  
Significant Difference ◽  
Previously Treated

e19103 Background: The standards in 2nd-line therapy with advanced non-small cell lung cancer (NSCLC) were erlotinib or pemetrexed as well as docetaxel. To evaluate the efficacies and safeties of pemetrexed, gefitinib, and erlotinib in previously treated NSCLC we analyzed the datas retrospectively. Methods: Eligible patents were 1) histologically confirmed pretreated advanced (stage IIIB or IV) NSCLC, 2) with at least one measurable lesion, 3) age over 18 years, 4) performance status (PS) 0–2, and 5) should never experience other two drugs as previous therapy. Patients of pemetrexed group received IV infusion of 500mg/m2 pemetrexed mixed with normal saline every 3 weeks with vitamin B12 and folate supplementation. Patients of gefitinib group received gefitinib 250mg PO daily and of erlotinib took erlotinib 150mg PO daily. Cycles of IV pemetrexed or taking PO drugs were continued until disease progression or unacceptable toxicity. Results: we analyzed 57 patients (pemetrexed; 20, gefitnib; 20, and erlotinib; 17). The response rates were 5.3%, 25.0%, and 12.5% (P=0.22), and the disease control rate were 5.3%, 40.0%, and 50.0% respectively (P<0.01). Median progression-free survival (PFS) of pemetrexed, gefitinib, and erlotinib were 1.7, 3.5 and 4.4 months (P<0.01) and median overall survival (OS) were 5.6, 21.8 and 21.5 months respectively (P=0.04). In subgroup analysis, patients with non-squamous carcinoma, smokers and good PS (0 or 1) showed longer PFS and OS in gefitinib and erlotinib compared with in pemetrexed. All of these agents showed mild and tolerable toxicity. Conclusions: In retrospective analysis, the patients with gefitinib or erlotinib had longer PFS and OS than pemetrexed, eventhough there was no significant difference for response rate in three group. These results have to confirm by large randomized prospective study because the sample size was small and it was not randomized. No significant financial relationships to disclose.

Molecular Predictors of Outcome With Gefitinib and Docetaxel in Previously Treated Non–Small-Cell Lung Cancer: Data From the Randomized Phase III INTEREST Trial

2010 ◽  
Vol 28 (5) ◽  
pp. 744-752 ◽  
Author(s):  
Jean-Yves Douillard ◽  
Frances A. Shepherd ◽  
Vera Hirsh ◽  
Tony Mok ◽  
Mark A. Socinski ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Copy Number ◽  
Egfr Mutation ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
Significant Difference ◽  
Previously Treated

PurposeIn the phase III INTEREST trial, 1,466 pretreated patients with advanced non–small cell lung cancer (NSCLC) were randomly assigned to receive gefitinib or docetaxel. As a preplanned analysis, we prospectively analyzed available tumor biopsies to investigate the relationship between biomarkers and clinical outcomes.MethodsBiomarkers included epidermal growth factor receptor (EGFR) copy number by fluorescent in situ hybridization (374 assessable samples), EGFR protein expression by immunohistochemistry (n = 380), and EGFR (n = 297) and KRAS (n = 275) mutations.ResultsFor all biomarker subgroups analyzed, survival was similar for gefitinib and docetaxel, with no statistically significant differences between treatments and no significant treatment by biomarker status interaction tests. EGFR mutation–positive patients had longer progression-free survival (PFS; hazard ratio [HR], 0.16; 95% CI, 0.05 to 0.49; P = .001) and higher objective response rate (ORR; 42.1% v 21.1%; P = .04), and patients with high EGFR copy number had higher ORR (13.0% v 7.4%; P = .04) with gefitinib versus docetaxel.ConclusionThese biomarkers do not appear to be predictive factors for differential survival between gefitinib and docetaxel in this setting of previously treated patients; however, subsequent treatments may have influenced the survival results. For secondary end points of PFS and ORR, some advantages for gefitinib over docetaxel were seen in EGFR mutation–positive and high EGFR copy number patients. There was no statistically significant difference between gefitinib and docetaxel in biomarker-negative patients. This suggests gefitinib can provide similar overall survival to docetaxel in patients across a broad range of clinical subgroups and that EGFR biomarkers such as mutation status may additionally identify which patients are likely to gain greatest PFS and ORR benefit from gefitinib.

Correlation of gefitinib and its metabolites with gefitinib induced rash in patients with non-small cell lung cancer (NSCLC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21712-e21712
Author(s):  
Shaoxing Guan ◽  
Xi Chen ◽  
Min Huang ◽  
Li Zhang ◽  
Xueding Wang
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Multivariate Logistic Regression Analysis ◽  
Small Cell ◽  
Therapeutic Drug ◽  
Small Cell Lung ◽  
Cutoff Values ◽  
Nsclc Patients ◽  
Severe Rash

e21712 Background: Gefitinib induced rash is the most common adverse reaction and severe rash of gefitinib often leads to discontinuation or termination of treatment. The concentrations of drug and its metabolites may affect drug induced toxicities, however, the association of gefitinib/metabolites with gefitinib-induced rash are poorly investigated. Therefore, we explored the association between concentrations of gefitinib and its four metabolites with gefitinib-induced rash in non-small cell lung cancer (NSCLC) patients. Methods: A total of 180 advanced NSCLC patients carrying EGFR sensitive mutations receiving gefitinib were enrolled. The concentrations of gefitinib, and its four metabolites including M537194, M387783, M523595 and M605211 were determined by liquid chromatography–tandem mass spectrometry (LC–MS/MS). The associations between concentration of gefitinib/its metabolites and gefitinib-induced rash were analyzed by Mann-Whiney U test. Operating characteristic curves(ROC) were used to determine gefitinib/metabolites cutoff values for gefitinib-induced rash. Results: M605211 was first detected in plasma in NSCLC patients. The concentrations of gefitinib and M605211, M537194 were found to be correlated with the incidence of gefitinib-induced rash ( P= 0.0002, 0.027 and 0.0097, respectively), moreover, the concentration of gefitinib was correlated with severe rash (Grade 0,1 vs. 2+, P= 0.017). Multivariate Logistic regression analysis showed that only gefitinib concentration was independent risk factor for gefitinib-induced rash (grade 0 vs grade1+, OR = 1.006, 95%CI (1.002-1.009), P = 0.00078; grade0,1 vs grade2+, OR = 1.003, 95%CI (1.001-1.005), P = 0.015, respectively). The cutoff values of gefitinib were 160.2 ng/ml (grade 0 vs grade1+, sensitivity = 78.7%, specificity = 47.7%, area under the curve (AUC) = 0.686, P = 0.0002, 95% CI (0.592-0.779)) and 201.7ng/ml (grade0,1 vs grade2+, sensitivity = 69.3%, specificity = 47.6%, AUC = 0.605, P = 0.0168, 95%CI (0.521-0.689)). Conclusions: This research demonstrated that the concentration of gefitinib and its metabolites were associated with gefitinib induced rash in NSCLC patients. Therapeutic drug monitoring of gefitinib concentration may have potential improvement for optimization of treatment with gefitinib. Clinical trial information: NCT01994057.

Phase II study of a novel taxane (Cabazitaxel-XRP 6258) in previously treated advanced non-small cell lung cancer (NSCLC) patients

2016 ◽  
Vol 78 (3) ◽  
pp. 509-515 ◽  
Author(s):  
Ankit Madan ◽  
Benjamin S. Jones ◽  
Rodolfo Bordoni ◽  
Mansoor N. Saleh ◽  
Mary S. Jerome ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Cell Lung Cancer ◽  
Phase Ii Study ◽  
Small Cell ◽  
Small Cell Lung ◽  
Previously Treated ◽  
Nsclc Patients

scholarly journals Prognostic Roles of mRNA Expression of S100 in Non-Small-Cell Lung Cancer

2018 ◽  
Vol 2018 ◽  
pp. 1-11 ◽  
Author(s):  
Ying Liu ◽  
Jian Cui ◽  
Yun-Liang Tang ◽  
Liang Huang ◽  
Cong-Yang Zhou ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Mrna Expression ◽  
Cell Lung Cancer ◽  
Prognostic Value ◽  
Smoking Status ◽  
S100 Protein ◽  
Small Cell ◽  
Small Cell Lung ◽  
Nsclc Patients

The S100 protein family is involved in cancer cell invasion and metastasis, but its prognostic value in non-small-cell lung cancer (NSCLC) has not been elucidated. In the present study we investigated the prognostic role of mRNA expression of each individual S100 in NSCLC patients through the Kaplan–Meier plotter (KM plotter) database. Expression of 14 members of the S100 family correlated with overall survival (OS) for all NSCLC patients; 18 members were associated with OS in adenocarcinoma, but none were associated with OS in squamous cell carcinoma. In particular, high mRNA expression level of S100B was associated with better OS in NSCLC patients. The prognostic value of S100 according to smoking status, pathological grades, clinical stages, and chemotherapeutic treatment of NSCLC was further assessed. Although the results should be further verified in clinical trials our findings provide new insights into the prognostic roles of S100 proteins in NSCLC and might promote development of S100-targeted inhibitors for the treatment of NSCLC.

scholarly journals Randomized Phase II Study of Docetaxel plus Personalized Peptide Vaccination versus Docetaxel plus Placebo for Patients with Previously Treated Advanced Wild Type EGFR Non-Small-Cell Lung Cancer

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Koichi Takayama ◽  
Shunichi Sugawara ◽  
Yasuo Saijo ◽  
Makoto Maemondo ◽  
Atsushi Sato ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Clinical Investigation ◽  
Small Cell ◽  
Rank Test ◽  
Peptide Vaccination ◽  
Small Cell Lung ◽  
Significant Difference ◽  
Previously Treated

Objectives. To evaluate the efficacy and safety of personalized peptide vaccination (PPV) combined with chemotherapy for patients with previously treated advanced non-small-cell lung cancer (NSCLC).Patients and Methods. Previously treated PS0-1 patients with IIIB/IV EGFR (epidermal growth factor receptor) wild genotype NSCLC were randomly assigned to docetaxel (60 mg/m2on Day 1) plus PPV based on preexisting host immunity or docetaxel plus placebo. Docetaxel administration was repeated every 3 weeks until disease progression. Personalized peptides or placebo was injected subcutaneously weekly in the first 8 weeks and biweekly in subsequent 16 weeks. The primary efficacy endpoint was progression-free survival (PFS).Results. PPV related toxicity was grade 2 or less skin reaction. The median PFS for placebo arm and PPV arm was 52 days and 59 days, respectively. There was no significant difference between two arms by log-rank test (p=0.42). Interestingly, PFS and overall survival (OS) in humoral immunological responder were significantly longer than those in nonresponder.Conclusion. PPV did not improve the survival in combination with docetaxel for previously treated advanced NSCLC. However, PPV may be efficacious for the humoral immunological responders and a further clinical investigation is needed.

Interleukin-6 is Increased in Breath Condensate of Patients with Non-Small Cell Lung Cancer

2002 ◽  
Vol 17 (2) ◽  
pp. 141-145 ◽  
Author(s):  
G.E. Carpagnano ◽  
O. Resta ◽  
M.P. Foschino-Barbaro ◽  
E. Gramiccioni ◽  
F. Carpagnano
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Exhaled Breath Condensate ◽  
Small Cell ◽  
Exhaled Breath ◽  
Small Cell Lung ◽  
Significant Difference ◽  
Nsclc Patients ◽  
Breath Condensate

Despite recent advances in the diagnosis and treatment of non-small cell lung cancer (NSCLC), most patients still present with advanced stage disease at the time of diagnosis. Recent studies suggest that IL-6 is involved in the development of lung cancer. The aim of the present study was to investigate whether the measurement of IL-6 levels in the breath condensate of NSCLC patients could be used to bring forward the moment of diagnosis and to monitor the progression of the disease. Twenty patients with histological evidence of NSCLC (14 men and 6 women, age 63±8 years) and 15 healthy controls (8 men and 7 women, age 45±6 years) were enrolled in the study. IL6 was measured in the exhaled breath condensate of patients and controls by means of a specific enzyme immunoassay kit. Higher concentrations of exhaled IL-6 were found in NSCLC patients (9.6±0.3 pg/mL) than in controls (3.5±0.2 pg/mL). A statistically significant difference was observed between patients with NSCLC at different stages: higher concentrations of IL-6 (10.9±0.5 pg/mL) were found in patients with metastatic disease than in those with stage III (9.7±0.4 pg/mL), stage II (8.9±0.3 pg/mL) and stage I disease (7.9±0.3 pg/mL). These findings suggest that the measurement of IL-6 in the breath condensate of patients with NSCLC could be proposed as a parameter to take into account in early diagnosis and disease monitoring.

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