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J. Skrickova



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    P1.10 - Poster Session 1 - Chemotherapy (ID 204)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.10-016 - TULUNG registry: Analysis of data from PS 0-1 patients with advanced/metastatic non-squamous NSCLC (adenocarcinoma, large cell carcinoma) treated in second line with pemetrexed (ID 962)

      09:30 - 09:30  |  Author(s): J. Skrickova

      • Abstract

      Background
      The TULUNG registry is an independent national non-interventional clinical registry, focused on collection and analysis of epidemiologic and clinical data of non-small cell lung cancer (NSCLC) patients who have been treated with pemetrexed (Alimta®), erlotinib (Tarceva®), gefitinib (Iressa®) and/or bevacizumab (Avastin®) in 10 centers of complex thoracic oncology care in the Czech Republic. The report is based on data analysis of 476 advanced/metastatic non-squamous (adenocarcinoma or large cell carcinoma) NSCLC patients, who had good performance status (PS 0-1), were treated with pemetrexed in the second line of treatment, and whose data were recorded in TULUNG registry as of March 18, 2013.

      Methods
      There were analyzed baseline demographic data, information about treatment aministered and efficacy and safety clinical outcomes of pemetrexed second line treatment in this selected registry patient population, using descriptive statistics.

      Results
      In analyzed group of 476 patients slightly prevailed men (56.9%) over women, median age at start of pemetrexed treatment was 62 years (range 27-81 let). Majority of patiens were current smokers and ex-smokers (41.0% and 32.8% resp.). 95% of tumours had adenocarcinoma histology. Vast majority of analyzed patiens (87.4%) had metastatic disease at start of second line pemetrexed treatment, the rest had stage IIIb. 83.8% of patiens had ECOG PS 1 at start of second line pemetrexed treatment and 87.4% of patiens received pemetrexed in monotherapy. At the moment of analysis, pemetrexed treatment was already terminated in 408 patients out of 476 patients (the most frequent reasons for discontinuation of treatment were disease progression in 56.9% and planned completion of treatment in 28.2%), treatment was at moment of analysis ongoing in 68 patients. Median duration of treatment with pemetrexed was 12.3 weeks (corresponds with 4 cycles). When focusing on the subset of patients with finished pemetrexed treatment, the disease control rate (i.e. CR+PR+SD) was reported in 59.6% of patients, while progressive disease (PD) was reported in 33.3%. For 7,1% of patiens there were missing data on treatment response. Median overall survival was 11.3 months (95% CI 9.6 – 13.0) and median progression-free survival was 3.3 months (95% CI 2.7 – 3.8). 1-year survival rate from start of pemetrexed treatment was 47,5%. Adverse events were reported to registry for 21.8% of pemetrexed treated patiens from analysed population. The most frequent (>5% patients) reported adverse events were neutropenia (9.7%), anemia (6.5%), leukocytopenia (6.1%), and fatigue (6.1%).

      Conclusion
      Reported efficacy and safety outcomes from registry are more favourable than results of published controlled randomized registrational trial. It probably reflects the different methodology of data collection and more prudent approach to patient selection for pemetrexed second line treatment in real clinical practice in the Czech Republic in participating centers. Based on registry data, pemetrexed treatment was in suitable patiens with good PS very well tolerated (78.2% of patiens without reported adverse events in registry) and allowed for reaching disease control in almost 60% of treated patiens, with median OS approaching one year from starting second line therapy.

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    P1.11 - Poster Session 1 - NSCLC Novel Therapies (ID 208)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.11-013 - Gefitinib for the first-line treatment of NSCLC patients with EGFR mutations in exons 19 or 21: analysis of 74 patients from Czech Republic (ID 1231)

      09:30 - 09:30  |  Author(s): J. Skrickova

      • Abstract

      Background
      Gefitinib (Iressa®) is a potent oral non-cytotoxic anthraquinone. It is the active and selective EGFR-TKI (epidermal growth factor receptor tyrosine kinase inhibitor). In the Czech Republic NSCLC patients with EGFR activated mutations were treated with gefitinib in first line from 2/2011 in 10 institutions. This study evaluates treatment outcomes in 74 NSCLC with EGFR activated mutations in exons 19 and/or 21 treated between 2/2011 and 3/2013.

      Methods
      Patients with advanced NSCLC and with EGFR activated mutations in exons 19 and/or 21 were treated with gefitinib in first line between 2/2011 and 3/2013. Retrospective analyses were carried out to assess the effectiveness of treatment and to evaluate the safety of targeted therapy.This study evaluates treatment outcomes in 74 patients. The outcomes include following: response, median overall survival (mOS) and median progression free survival (mPFS). Response was assessed by imaging techniques after 4-6 weeks of treatment and was confirmed one month later by chest X-ray and/or CT scanning. The difference in response relative to baseline characteristics was determined using Pearson Chi-square test. Differences in OS and PFS relative to baseline characteristics were evaluated for significance using Log-rank test.

      Results
      Out of 74 treated patients, 46 had EGFR mutations in exon 19 and 28 had EGFR mutations in exon 21. 53 patients (71.6%) were woman, 21 patients (28.4%) were man. At the time of treatment initiation with gefitinib, the following characteristics were recorded. The median age of patients was 67 years. 9 patients (12.1%) were smokers, 19 patients (25.7%) were former smokers, 46 patients (62.2%) were non-smokers; performance status (PS) was 0 in 16 patients (21.6%), 1 in 49 patients (66.2%) and 2 in 9 patients (12.2%); adenocarcinoma was confirmed in 67 patients (90.5%); most of the patients were in stage IV (64 patients, 86.5%). As on the date of data analysis (18 March 2013), treatment was terminated in 32 patients (43.2%). The median duration of treatment was 19.0 weeks (mean 24.7). Among patients in which treatment was terminated, complete response was not achieved in a single case; partial response was achieved in 10 patients (31.3%), stable disease in 10 patients (31.3%), progressive disease in 7 patients (21.9%) and treatment response was not evaluated in 5 patients (15.6%). Adverse effects during treatment with gefitinib were reported in 23 patients (31.1%). Median progression-free survival from gefitinib treatment initiation is 8.1 months (95% CI: 6.9; 9.3). Median overall survival (OS) was not reached.

      Conclusion
      In a group of 74 patients with advanced NSCLC and with activated mutations who were treated with gefitinib in first line, the therapy was well tolerated, median progression-free survival from gefitinib treatment initiation is 8.1 months (95% CI: 6.9; 9.3) and median overall survival (OS) was not reached.

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    P1.12 - Poster Session 1 - NSCLC Early Stage (ID 203)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.12-009 - Oral vinorelbine in combination with cisplatin or carboplatin in adjuvant chemotherapy of non-small cell lung cancer: a prospective multicentre study of tolerability and survival. (ID 1476)

      09:30 - 09:30  |  Author(s): J. Skrickova

      • Abstract

      Background
      Adjuvant cisplatinum-based chemotherapy is recommended for routine use in patients with stages IIA, IIB, and IIIA of non small-cell lung cancer (NSCLC) after radical resection. Results in stage IB were not conclusive. Vinorelbine is a preferable drug in this indication and a randomized study proved the comparable effectiveness and tolerability of vinorelbine given both orally or intravenously (i.v.) in advanced NSCLC, meanwhile oral vinorelbine gives better comfort to patients. Also tolerance of carboplatin (CBDCA) in better than tolerance of cisplatin (CDDP). Randomized studies in adjuvant chemotherapy (ACT) settings are missing.

      Methods
      This prospective multicenter study evaluates the tolerance and survival parameters of the ACT based on CDDP (75mg/m[2]) or CBDCA (AUC 5) with vinorelbine (25 mg/m[2] D1 i.v. and 35 mg/m2 D8 given orally). After radical resection, ACT (4 cycles of 21 day, out-patient regimen) was applied to patients with stage IB, II, and IIIA of NSCLC. Selection of CDDP or CBDCA was based on individual center preference. During the follow-up period of 42.2 months (m) survival was evaluated according to gender, smoking, age, tumor histology, stage and grading, surgical procedure, CDDP or CBDCA treatment.

      Results
      ACT was applied to 154 eligible patients (110 men, 44 women, median of age 63 years). Surgically determined stages were IB in 46 pts, II in 46 pts, and IIIA in 52 pts. CBDCA was given to 77 patients and CDDP to 77 patients,11 of whom switched to CBDCA due to toxicity. Mean age was 63.6 years in CBDCA group and 61.7 years in CDDP group. Altogether 586 cycles were administered, 82.6% of patients finished four cycles of planned ACT. Mean number of cycles was 3.79 per patient (3.76 in CDDP and 3.83 in CBDCA). The most frequent WHO grade 3/4 of toxicity were neutropenia in 16.8%, leucopenia in 7.9%, anemia in 1.2%, thrombocytopenia in 0.5%, alopecia in 2.9%, vomiting in 2.3%, neurotoxicity, diarrhoea and mucositis in 0.2% of cycles. Neutropenia, nausea and vomiting were more frequent in CDDP group. Relative dose intensity (RDI) was 94 % for vinorelbine i.v. and 88.6 % for vinorelbine p.o. In CBDCA RDI was significantly higher than CDDP (94 % vs 90 %, p 0.009). Three years overall survival (OS) was 68.2%, 5-year OS was 55.0% and 79 pts still live, 66 live without progression of the disease. OS was significantly longer in stage IB and II than in stage IIIA (p 0.007) and in CBDCA than CDDP treatment (p 0.01). Disease free survival (DFS) was 41.6 m, it was longer in men (p 0.049), in stage IB and II (p 0.041) and in DBDCA treatment (p 0.021).

      Conclusion
      Both applied regimen were tolerable. Survival was influenced by stage of the tumor. Patients treated with CBDCA experienced less toxicity, obtained higher RDI of planned treatment and lived longer than those treated with CDDP. Study showed that both CBDCA and CDDP can be used in combination with oral vinorelbine in ACT of NSCLC. This study was supported by Grant NT-13569 and NS-9959-3 of the Czech Ministry of Health

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    P2.10 - Poster Session 2 - Chemotherapy (ID 207)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 2
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      P2.10-010 - Full oral vinorelbine (NVBO) on D1 and D8 with carboplatin (CBDCA) as first line treatment in advanced non-small lung cancer (NSCLC) patients: results of a prospective study in nonrandomized and unselected population of 396 patient (ID 911)

      09:30 - 09:30  |  Author(s): J. Skrickova

      • Abstract

      Background
      Lung cancer is the leading cause of cancer mortality in the Czech Republic. Approximately 80%are NSCLC and 65% of patients have advanced disease at the time of diagnosis. Most patients who receive first-line chemotherapy experience disease progression within 3 to 6 months of initiating therapy and the median survival time observed is 8 to 10 months. In this situation, there is a need to find effective therapeutic regimen with an administration as simple as possible and the most favorable toxicity profile. The purpose of this study was to evaluate the activity and feasibility of CBDCA together with full oral vinorelbin (NVBO).

      Methods
      Patients with advanced NSCLC received NVBO 80 mg/m² on D1 and D8 with CBDCA AUC5 on D1 every three weeks. In stage III, chemotherapy was followed by external radiotherapy. The outcomes include following: response, median overall survival (mOS) and median progression free survival (mPFS). Response was assessed by imaging techniques after 4-6 weeks of treatment and was confirmed one month later by chest X-ray and/or CT scanning. The difference in response relative to baseline characteristics was determined using Pearson Chi-square test. Differences in OS and PFS relative to baseline characteristics were evaluated for significance using Log-rank test.

      Results
      396 patients were treated: 311 men (78,5) and 50 women (21,5%), median age 65 years. ECOG performance status at inclusion was PS 0 in 51 (12,9% patients, PS 1 in 287 (72,7%) and PS 2 in 57 (14,4%) patients. Most patients had stage IIIB 116 (29,3%) and stage IV NSCLC 257 (64,9), only 32 (5,84%) were stage IIIA . Adenocarcinoma was confirmed in 90 patients (22,7%), squamous-cell carcinoma in 238 (60,1%), large-cell carcinoma 11 and other in 57 (17,2%). Complete response was confirmed in 2 (0,5%) patient, partial response in 136 (34,3%), stable disease in 104 (26,3%), 154 (38,9%) patients progressed. The regimen was well tolerated. Median cycles was 4, the dosage of NVBO was without changes in 268 (67,7%) patients, the dosage of NVBO was reduced in 28 (7,1%) and escalated in 77 (19,48%). In 23 (5,8%)of patients was the dosage of NVBO reduced after escalation. Major toxicities (Grade 3-4) were neutropenia in 29%, leucopenia in 20,8%, anemia in 3,3% and thrombocytopenia in 1,8% patients. Febrile neutropenia was observed in 6,1% patients. Gastrointestinal toxicity grade 3-4 was observed in 4,6% patients. The mPFS was 7,4 moths and mOS was 9,92 months by median follow-up 8,5 months. The differences between groups of pts according to PS (0+1 vs. 2) were statistically significant (p < 0,001) better for patiens with PS 0+1. The differences between groups of pts according histology were not statistically significant (p=0,3975).

      Conclusion
      In this group of 396 unselected patients with advanced NSCLC was the treatment with full NVBO and-CBDCA in first line more convenient and well tolerated with evidence of high antitumour activity. This combination was active in all groups patients according histology (mOS was 9,92 and mPFS was 7,4 months). Statistically significant better were the results in patients with PS 0+1.

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      P2.10-011 - Pemetrexed in combination with cisplatin in the first-line treatment of non-squamous NSCLC: Czech experience with 233 patients (ID 1228)

      09:30 - 09:30  |  Author(s): J. Skrickova

      • Abstract

      Background
      Pemetrexed in combination with cisplatin in the first-line treatment of advanced non-squamous NSCLC (non-smal-cell lung cancer) has been administered in the Czech Republic since 10/2010. The purpose of this study was to evaluate the activity and feasibility of pemetrexed in first-line treatment of NSCLC in combination with cisplatin.

      Methods
      Patients with advanced non-squamous NSCLC were treated with pemetrexed in first line and in combination with cisplatin between 10/2012 and 03/2013 in 12 institutions. Retrospective analyses were carried out to assess the effectiveness of treatment and applied regimens, and to evaluate the safety of targeted therapy. The outcomes include following: response, median overall survival (mOS) and median progression free survival (mPFS). Response was assessed by imaging techniques after 4-6 weeks of treatment and was confirmed one month later by chest X-ray and/or CT scanning. The difference in response relative to baseline characteristics was determined using Pearson Chi-square test. Differences in OS and PFS relative to baseline characteristics were evaluated for significance using Log-rank test.

      Results
      Out of 233 treated patients, 125 were men (53.6%) and 108 were women (46.4%). At the time of treatment initiation with pemetrexed, the following characteristics were recorded. The median age of patients was 61 years. 97 patients (41.6%) were smokers, 72 patients (30.9%) were former smokers, 64 patients (27.5%) were non-smokers. Performance status (PS) was 0 in 53 patients (22.7%), 1 in 172 patients (73.8%) and 2 in 8 patients (3.4%). Adenocarcinoma) was confirmed in 226 patients (97.0%), large-cell carcinoma was reported in 7 patients (3.0%). Most of the patients were diagnosed in stage IV (186 patients, 80.2%) and treatment of most patients was also initiated in stage IV (84.5%). As on the date of data analysis (18 March 2013), treatment was terminated in 185 patients (79.4%), and the median duration of treatment in these patients was 12.1 weeks. Adverse effects during treatment with pemetrexed were reported in 73 patients (31.3%). Complete response was achieved in 4 patients (1.7%), partial response in 58 patients (24.9%), stable disease in 79 patients (33.9%) and progressive disease in 38 patients (16.3%); treatment response was not evaluated in 54 patients (23.2%). Median overall survival (OS) starting from treatment initiation with pemetrexed was 11.6 months (95% CI: 7.0; 16.3). Median progression-free survival (PFS) starting from treatment initiation with pemetrexed was 4.2 months (95% CI: 3.4; 5.1).

      Conclusion
      In a group of 233 patients with advanced non-squamous NSCLC who were treated with pemetrexed in first line and in combination with cisplatin, the therapy was well tolerated: termination of treatment due to adverse events was reported only in 3.8% of patients. Median overall was 11.6 months, median progression-free survival was 4.2 months

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    P2.12 - Poster Session 2 - NSCLC Early Stage (ID 205)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P2.12-009 - Adjuvant chemotherapy with oral vinorelbine used in doublet with carboplatin in non-small cell lung cancer after radical resection - tolerability and short term survival. (ID 1244)

      09:30 - 09:30  |  Author(s): J. Skrickova

      • Abstract

      Background
      Adjuvant cisplatinum-based chemotherapy is recommended for routine use in patients with stages IIA, IIB, and IIIA of non small-cell lung cancer (NSCLC) after radical resection. Results in stage IB were not conclusive. Vinorelbine is a preferable drug in this indication and a randomized study proved the comparable effectiveness and tolerability of vinorelbine given both orally or intravenously (i.v.) in advanced NSCLC, meanwhile oral vinorelbine gives better comfort to patients. Only few studies evaluated the position of vinorelbine in doublet with carboplatin (CBDCA) none of them used oral vinorelbine in this doublet as adjuvant chemotherapy (ACT).

      Methods
      This prospective multicentre study evaluates the feasibility, toxicity and short time survival of ACT based on CBDCA (AUC 5) with oral vinorelbine after radical resection. Vinorelbine was applied orally 80 mg/m[2] D1 and D8 after the first cycle of 60mg/m[2]. ACT (4 cycles of 21 day regimen) was applied to patients with stage IB, II, and IIIA of NSCLC (6[th] TNM revision) in 16 centres. Therapy was applied from the 1[st] of April 2009 to the 28[th] of February 2010. Median of follow-up period was 31 months Histology of tumor, type of surgery, grading, visceral pleura and angio-invasion were evaluated as potencial predictors of survival.

      Results
      ACT was applied to 104 eligible patients (72 men, 32 women, median of age 64 years). Out of them 41 were smokers, 57 ex-smokers and 5 non smokers. Surgically determined stages were IB in 32 pts, II in 36 pts and IIIA in 36 pts. Altogether 399.5 cycles (mean no 3.82) were administered, 86,5 % of patients finished four cycles of planned ACT. The reasons for 14 (13.5%) patients ending ACT prematurely were hematological toxicity in 8 pts, non-hematological toxicity in 3 pts, other reasons in 3 pts . Relative dose intensity (RDI) was 80.8% for vinorelbine and 95.4% for CBDCA. The most frequent WHO grade 3/4 of toxicity were neutropenia in 10.6%, leucopenia in 5.6%, anemia in 1.3%, thrombocytopenia in 1.3%, alopecia in 3.3%, nausea in 4.8%, neurotoxicity, nephrotoxicity, diarrhoea and mucositis in 0.3%. During the median of follow-up period, 45 (43.2%) pts died and 38 (36.5%) out of them died on lung cancer. Median DFS was 29.1 months, 2-year survival was 70.6%, 2.5-year survival was 63.9%. Predictors of significantly better DFS and 2.5 year survival were stage IB (p = 0.0045) and lobectomy (p = 0.0465). Trend of better DFS and 2.5 year survival was observed in cases without angioinvasion and pleural invasion.

      Conclusion
      Applied ACT had excellent tolerability, high RDI was achieved and preliminary parameters of survival are acceptable. Study is ongoing and long term survival results will be evaluated in the future. This study was supported by Grant NT- 13569 and NS-9959-3 of the Czech Ministry of Health

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    P2.24 - Poster Session 2 - Supportive Care (ID 157)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Supportive Care
    • Presentations: 1
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      P2.24-032 - Bronchoscopy in the Czech Republic, 2012 (ID 2338)

      09:30 - 09:30  |  Author(s): J. Skrickova

      • Abstract

      Background
      The incidence of lung cancer in the Czech Republic has been unacceptably high for decades. It has reached 91/100 000 in men and 31/100 000 in women. Bronchoscopy plays an important role in the diagnostic process. To assess the quality and density of the bronchological net and to determine the current situation in the implementation of bronchoscopy in the Czech Republic we decided to carry out a national survey.

      Methods
      A bronchological questionnaire was sent by e-mail to every pneumologist performing bronchoscopy. With the help of repeated e–mails and additional telephone interviews we achieved a response rate of more than 95%.

      Results
      In 2012 there were 56 centers performing bronchoscopy in adults and 9 in children in the Czech Republic. The bronchological units of adult clinics employed 169 bronchologists using 231 fiberscopes, out of which 88 were video bronchoscopes and 79 rigid bronchoscopes. Altogether 30 354 bronchoscopies were performed in adults. General anesthesia was used in 2 146 cases, the rest was carried out under local anesthesia. The total number also includes 1767 bronchoscopies performed using rigid instrumentation. Cytological examination of the material obtained during bronchoscopy was carried out by a pathologist (Department of Clinical Pathology) at 34 centers, by a pneumologist trained in cytology at 13 centers and by both the pathologist and the pneumologist at 9 centers. Interventional bronchoscopic procedures (laser, electrocautery, stenting, brachytherapy, cryocautery and the introduction of endobronchial valves) were used in 17 departments. Altogether the above mentioned procedures were performed 654 times during one year. All 9 children's bronchological departments employed 12 bronchoscopists, using a total number of 29 fiberscopes, out of which 17 were video bronchoscopes. Seven pediatric bronchoscopy centers also used rigid instrumentation. The total number of pediatric bronchoscopies performed in 2012 was 682, the majority of them (621) under general anesthesia. Out of all bronchoscopies, the rigid bronchoscopy was performed in 32 cases. At five centers cytology examination was performed by a pathologist, at 3 centers by a pneumologist trained in cytology and at one center by both specialists together. Further analysis of the specialized bronchological procedures (endobronchial ultrasound, autofluorescence), including a comparison with previous surveys will be given in the lecture or on the poster.

      Conclusion
      The level of bronchological service offered in the Czech Republic is comparable with the most developed countries and serves a prompt and exact diagnostics of patients with respiratory disorders including lung cancer. "Supported by Projects (Ministry of Health) of conceptual development of research organization 00064203 (FN Motol, Prague, Czech Republic)".

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    P3.11 - Poster Session 3 - NSCLC Novel Therapies (ID 211)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.11-009 - Tulung registry: data analysis of patients with non-squamous NSCLC (adenocarcinoma, large cell carcinoma) and PS 0-1 treated with erlotinib in second line setting (ID 971)

      09:30 - 09:30  |  Author(s): J. Skrickova

      • Abstract

      Background
      We conducted a systematic review of data from patients reported in the TULUNG registry (data cut-off 18-Mar-13). The TULUNG registry prospectively collects data from all NSCLC patients treated by erlotinib in the Czech Republic.

      Methods
      Our analysis was performed on a subgroup of patients with non-squamous NSCLC (adenocarcinoma or large-cell carcinoma) with good performance status (PS 0-1), treated with erloninib in a second-line setting.

      Results
      521 of 2365 patients reported in the the TULUNG registry met the above-mentioned criteria. Of 521 patients analyzed, 51,2% were female; the median age at erlotinib treatment initiation was 64 years (range 29-88). The majority of patients were smokers and ex-smokers (34.4% and 34.0% respectively) and 93.1% of tumours were adenocarcinomas by histology. 86.1% patients were at the metastatic stage at the initiation of second-line erlotinib treatment, 12.8% of patients were in stage IIIb and only 1.1% of patients in stage IIIa. The majority of patients (87.7%) was in PS 1 at the initiation of second-line erlotinib treatment. From 521 of all analyzed patients, erlotinib therapy was terminated in 410 (78.7%) patients at data cut-off (the most frequent reasons for termination were disease progression, in 74.6% and death in 11.5% of patients) and treatment was ongoing in 111 (21.3%) patients. In 410 of patients with terminated treatment, the median duration of treatment was 3.0 months (95% CI 0.7 – 16.9), ORR assessment showed CR in 0.7%, PR in 8.3% and SD in 54.6% of patients. Median progression free survival was 4.0 months (95% CI 3.5 – 4.5), median overall survival 11.8 months (95% CI 9.6 – 14.0). 1-year survival from erlotinib treatment initiation was 49.4%. Adverse events were reported in 42.8% of patients, the most frequently reported adverse events (in >5% of patients) were skin toxicity (35.3%) and diarrhea (13.6%). Grade ≥3 adverse events were reported in 10.5% of patients, G≥3 skin toxicity 7.5% and G≥3 diarrhea in 1.3% of patients.

      Conclusion
      Erlotinib therapy of advanced metastatic adenocarcinoma or large cell carcinoma in a second-line setting was very well tolerated in eligible patients with PS 0-1; only 3.4% of patients had to discontinue erlotinib therapy due to adverse effects. In patients with completed erlotinib therapy 63.6% disease control rate was reached with a median survival of approximately 1 year from initiation of second-line erlotinib therapy.