BACKGROUND:Capecitabine and temozolomide combination (CAPTEM) is associated with high response rates in patients with advanced neuroendocrine neoplasms (NENs). We evaluated the real-world activity and safety of CAPTEM from 3 NEN centers. METHODS:Clinicopathological characteristics and outcomes of patients treated with CAPTEM for bulky or progressive disease (PD) were retrospectively analyzed. -Results: Seventy-nine patients with gastroenteropancreatic (grades 1-2 [n = 38], grade 3 [n = 24]) and lung/thymic (n = 17) NENs were included. Median treatment duration was 12.1 months (range 0.6-55.6). Overall, partial responses (PRs) occurred in 23 (29.1%), stable (SD) in 24 (30.4%), and PD in 28 (35.4%) patients. Median progression-free survival (PFS) and overall survival (OS) were 10.1 (6-14.2) and 102.9 months (43.3-162.5), respectively. On univariate analysis, NENs naive to chemotherapy and low Ki67 were associated with favorable responses (partial response [PR] + SD; p = 0.011 and 0.045), PFS (p < 0.0001 and 0.002) and OS (p = 0.005 and 0.001). Primary site (pancreas and lung/thymus) was also a significant prognostic factor for PFS (p < 0.0001) and OS (p < 0.0001). On multivariate analysis, gastrointestinal and unknown primary NENs (hazard ratio [HR] 0.3, 95% CI 0.1-0.8, p = 0.009 and p = 0.018) and prior surgery (HR 2.4, 95% CI 11-4.9, p = 0.021) were independent prognostic factors for PFS. Ki-67 was a poor predictor for favorable response in receiver operating characteristic analysis (area under the curve 0.678). Safety analysis of CAPTEM indicated rare events of serious (grades 3-4) toxicities (n = 4) and low discontinuation rates (n = 8) even in patients with prolonged administration (>12 months). CONCLUSIONS:CAPTEM treatment can be an effective and safe treatment even after prolonged administration for patients with NENs of various sites and Ki67 labeling index, associated with significant favorable responses and PFS.

Smoking and additional exposure to occupational factors such as coal dust, can cause changes in the lungs and also in other organs. We did the comparative analysis of the prevalence and nature of extra-nodular lesions and extra-pulmonary findings seen in low-dose computed tomographies (LDCT) done in 533 participants of the Pilot Silesian Study of Early Lung Cancer Detection. The study cohort consisted of miners (n=59) and people without occupational exposure (n=474). Statistical analysis was performed using Statistica 13.0 PL. Statistical significance was set at a p value below 0.05. Distribution of variables was evaluated by the Shapiro-Wilk test. The two groups were compared with the U Mann-Whitney test in case of non-normal data distribution. Chi-square test was used. The value of 'pack-years' for miners was statistically higher than for people without occupational exposure (M: 37 v 30, p=0.01). Emphysema was more often found in the group of miners (44,07 % v 31,50%, p = 0.05). COPD was also diagnosed more often in people exposed to coal dust than without occupational risk (45,76% v 32,07%, p=0.035). Extrapulmonary findings were reported in 86,44% of miners and 62,45% of people without occupational exposure (p=0.00027). Degenerative changes in the skeleton, osteoporosis, calcification in vessels were found statistically more frequently in miners. Long-term smoking, exposure to coal dust, physical work could contribute to a faster development of COPD and osteoarticular diseases.

A high percentage of false positive results observed in lung cancer screening (LCS) studies with LDCT was the reason for the modification of radiological assessment methods. Originally, all non-calcified nodules with a dimension ≥4 mm were considered as positive, whereas the implementation of the Lung-RADS ™ recommends additional testing only for nodules ≥6 mm in categories 3 and 4. This allowed for the reduction of false positive results and avoiding the effect of "overdiagnosis" (unnecessary interventions). We retrospectively analyzed 601 of first round LDCT scans, performed in 2010-2012 in asymptomatic volunteers of Pilot Silesian Study of Early Lung Cancer Detection with Low-Dose CT, with a smoking history of at least 20 pack-years, who actively smoked tobacco or quit smoking in the last 15 years. The analysis of non-invasive (additional examinations with contrast CT) and invasive interventions (bronchoscopy, EBUS, biopsies, surgery) done in screening participants was performed, followed by assessment of nodules according to the Lung-RADS ™ system, grouping them to 2, 3, 4A and 4B categories. Then the percentage of interventions that could be avoided using the ACR LungRADS ™ criteria was estimated. In total, 1016 nodules of solid, partial-solid and non-solid morphology were identified in 265 participants. In the entire screening cohort 87 interventions were performed, including 58 (66.6%) non-invasive and 29 (33.3%) invasive. Among nodules belonging to category 4A and B, 8 invasive lung cancers were identified, 1lung cancer was overlooked (false negative) and in 1 case metastases from colorectal cancer were diagnosed. With the using of LungRADS ™ criteria, 34.4% of non-invasive and 8% of invasive interventions in categories 2 and 3 could be avoided. The LungRADS ACR classification system proved to be a practical tool for assessing lung nodules, which allowed to significantly reduce the effect of "overdiagnosis" especially in category 2 where the probability of lung cancer is low (<1%).

Lung cancer still remains the leading cause of cancer deaths worldwide. Screening with low-dose computed tomography (LDCT) has been demonstrated to shift detected lesions towards lower stages, thus reducing lung cancer mortality. The aim of the study was to evaluate the results of a Pilot Silesian Study for Early Lung Cancer Detection with LDCT. In total 602 asymptomatic volunteers over 50 years of age with a smoking history of at least 20 pack-years have been undergoing LDCT screening annually or in shorter intervals, if required. One patient was excluded from statistical analysis due to symptoms related to advanced lung cancer. Since 2010 to 2017 there were 1019 CT scans performed. Of the whole cohort 146 participants (24.3%) underwent more than one round of LDCT. Maximal number of rounds was 8. Per protocol the positive result was defined as a presence of solid or part-solid nodule equal to or larger than 5 mm or non-solid equal to or larger than 8 mm. For the subsequent rounds the positive result was defined as an enlargement of preexisting non-calcified nodules by more than 2 mm or appearance of a new nodule. Lung nodules were detected in 265 individuals (44.1%). Lung cancer was diagnosed in 11 patients (1.8%) – 7 cases in the first round, 3 in the second and 1 in the third round. Stage I of non-small cell lung cancer was detected in 8 patients (72.7%), stage II – 0 (0.0%), stage III -3 (27.3%). In pathology reports 5 squamous cell lung cancers, 3 adenocarcinomas, 1 large cell carcinoma were identified. One lesion had mixed pathology and in one individual 2 adjacent lesions occurred indicating the distinct neuroendocrine pathology, i.e. small cell and large cell lung cancer. The rate of positive results in the first round in our study was 219 (36.4%). Of 601 participants, the diagnostic assessment of positive results more often involved further CT scans in 87 individuals (14.5%) than invasive procedures as bronchoscopy/EBUS – 23 (3.8%), transthoracic biopsy – 11 (1.8%) or VATS – 1 (0.2%). Fifteen participants (2.5%) underwent surgical resection (10 because of malignant; 5 benign lesions). The detection rate of lung cancer in our study is relatively low (1.8%). The majority of detected lung cancers were diagnosed at an early stage and were treated with curative intent. The results of our study were similar to large international studies such as NLST.

Pulmonary emphysema is known to be related to an increased incidence of lung cancer. The risk factors of emphysema and lung cancer are smoking history and environmental pollution. Low-dose chest CT is useful method for imaging both: emphysema and solitary pulmonary nodules (SPN). We have enrolled a total of 602 healthy volunteers to the Pilot Silesian Study of Early Lung Cancer Detection with LDCT. Retrospectively we analyzed the baseline round of LDCT scans. One person was excluded due to presence of lung cancer symptoms. Gradual accrual period lasted for two years, from 2010 to 2012. The positive result was defined as a presence of solid or part-solid nodule equal to or larger than 5 mm or non-solid equal to or larger than 8 mm. Participants were stratified by exposure to tobacco smoke into five groups: A) current smokers with a history of at least 40 years of smoking - chronic smokers; B) current smokers with a history of smoking at least 40 cigarettes per day - intensive smokers; C) former smokers who quit smoking fewer than 5 years ago; D) former smokers who quit smoking at least 10 years ago; E) exposed to a second-hand tobacco smoke. With the statistical methods we analyzed correlations between this five groups depending on tobacco exposure and demographic features. We identified 1016 lung nodules in 265 individuals. A total of 410 nodules coexisted with emphysema in 99 individuals. In group with emphysema we diagnosed 3 early lung cancers, unlike to the group without emphysema, in which we diagnosed 4 cancers (HR=0.7 95% CI 0.16-1.02). Subsolid morphology and diameter of a nodule larger than 5 mm were associated with higher risk of malignancy. Emphysema and lung nodules were more often found in the group of chronic smokers (>40 years) - 8.1% (A), in comparison to the group of intensive smokers – 0.8% (B). There were no statistically significant differences in both subcohorts of former smokers (for group C and D, 2.1% and 2.3%, respectively). In the subgroup of chronic smokers emphysema and lung nodules were more likely to occur. Additional risk factors for the presence of lung nodules and emphysema were: age (above 65 years) and occupational exposure (especially coal miners and welders).

6147 Background: Today, in oncological treatment most of patients are treating with new agents in clinical trials. For every one making decision of taking part in that study is not so easy. In new Regional Cancer Center in Poland (Olsztyn) we provided a questionnaire study to evaluate the most important factors which influent in patient's decision of take part in clinical trials. Methods: We made a questionnaire for two groups of patients.The questionnaire consisted of one 4 multiple-choice questions.The first group (group A) was the 41 patients with advanced breast or lung cancer, who already participated, in clinical trials. The second group (group B) consisted of 39 patients who were treated with conventional methods, but declared what, treatment in clinical trials was for them interesting option. In study patients were choosing the most important things which help them in consent to take part in clinical trial. Results: Twenty eight patients (68%) of group A and twenty one (54%) of group B regarded that discussion with physician and physician's opinions are more important. Nine patients (22%) of group A and eleven (28%) of group B thought that the most important is them family opinion. Other patients regarded that the information from press and internet and hope for better treatment results is the factor which making them sure in taking part in clinical trial. Conclusions: For most of cancer patients very helpful in making decision of taking part in clinical trial is discussion with them physician. The opinion of physician is the fundamental for both, patients who already participated in trials and who don't take part in that trial yet. No significant financial relationships to disclose.

Recently adjuvant treatment of breast cancer has become more advisable than the CMF program replaced by antracyclines-containing schemes. There is tendency to make therapeutical decisions by both: the doctor and the patient. We've tried to analyze the criteria of qualifications of patients to different programs of adjuvant treatment, focusing on the role of patient in making therapeutical decision. From June 2002 to July 2003 we treated radically 207 patients with breast cancer. Five physicians were asked to present the order of prognostic factors which are taken into consideration when the decision about the kind of adjuvant treatment was made. Decision about of adjuvant chemotherapy was made together with patient in 61 cases (short questionnaire about the criteria of choice of chemotherapy program was used in these cases). In the remaining 14 patients decision about chemotherapy was made by a doctor. For physicians the most important factor was metastases to axillary lymph nodes, then age of patient, grading (G3) and also the size of breast tumor and preferences of the patients. For patients the most important factor was the duration of treatment (62% of patients), then the amount of necessary visits during chemotherapy (for 31% women this factor was the most important one), then probability of alopecia (only for 3.2% of patients this factor was the most important one), probability of other complications and the necessity to take cytotoxic drug orally. 93% of patients preferred treatment consisting of 4 courses of AC. In contemporary oncology it is becoming more important to make therapeutical decisions by both: the doctor and the patient. According to the above analysis of the factors influencing the choice of the kind of adjuvant therapy, some of the factors were emphases in the process of making therapeutical decisions by both a doctor and a patient. The most important factors for patients were duration of chemotherapy and the amount of necessary visits in oncological center.

Advanced cervical cancer responds poorly to current treatment modalities. The response rates are low and brief duration. Cisplatin was an active drugs in cervical cancer, 5-fluorouracil was also an interesting drug that showed promising activity on cervical cancer. We conducted trial to determine the efficacy and safety of 5-fluorouracil and cisplatin combination in cervical carcinoma. From July 2002 to July 2003, twenty one patients with recurrent, persistent or metastatic cervical cancer were treated with a combination of cisplatin 75 mg/m2 and 5-fluoruracil 600 mg/m2, day 1, every 21 days. Eligibility criteria included: age >18 yrs, PS <2, <2 prior chemotherapy regimens, adequate bone marrow, kidney and liver function, measurable or evaluable disease. Median age is 45,1 years (range 30–68). Histology were 19 squamous cell, 1 adenocarcinoma and one adenosquamous cell carcinoma. Two patients had received prior chemotherapy for recurrent disease, twelve had received prior radiochemotherapy. Seventeen patients are evaluable for response and all for toxicity. Median chemotherapy cycles was 4,5 (range 1–9). The overall response rate is 43%. Complete response was not observed. Stable disease was achieved in 24% of patients. 33% of patients progressed while on treatment. Median time to progression and overall survival had not been reached. Toxicity was manageable. In 28% of patients grade 3 anaemia was documented, in 7% grade 4 neutropenia and grade 2 trombocytopenia. Grade 3 vomiting/nausea was observed in 28% of patients. In one case grade 3 diarrhoea with mucositis was documented. 5-fluorouracil with combination with cisplatin is an active regimen for recurrent, persistent or metastatic cervical cancer (ORR- 43%). This combination is well tolerated and less toxic. More data will be provided in future on the disease free survival and overall survival.