Publications by authors named "Sergiusz Nawrocki"

22 Publications

  • Page 1 of 1

Treatment patterns and real-world evidence for stage III non-small cell lung cancer in Central and Eastern Europe.

Radiol Oncol 2020 10 11;54(4):447-454. Epub 2020 Oct 11.

Department of Oncology, University of Warmia and Mazury in Olsztyn, Olsztyn, Poland.

Background The aim of this project was to collect real-world evidence and describe treatment patterns for stage III non-small cell lung cancer in Central and Eastern Europe. Based on real-world evidence, an expert opinion was developed, and the unmet needs and quality indicators were identified. Patients and methods A systematic literature search and a multidisciplinary expert panel of 10 physicians from 7 countries used a modified Delphi process to identify quality indicators and unmet needs in patients with stage III non-small cell lung cancer. The profound questionnaire was used to characterize treatment patterns used for stage III non-small cell lung cancer, and a systematic review identified patterns in Central and Eastern Europe. The first questionnaire was completed by a group of medical oncologists, radiation oncologists and pneumologists. The panel of experts attended an in-person meeting to review the results of the questionnaire and to process a second round Delphi. An additional survey was then compiled and completed by the panel. Results A complete consensus was reached by the panel of experts on a set of evidence-based clinical recommendations. The experience-based questionnaire generated a highly variable map of treatment patterns within the region. A list of unmet needs and barriers to quality care were developed with near-unanimous consent of the panel of experts. Conclusions The current landscape of diagnostic and therapeutic approaches in Central and Eastern European countries is highly variable. We identified several significant barriers, mainly related to the availability of diagnostic and imaging methods and low rates of chemoradiotherapy with curative intention as initial treatment for unresectable stage III NSCLC.
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http://dx.doi.org/10.2478/raon-2020-0058DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7585343PMC
October 2020

Patients' Non-Medical and Organizational Needs during Cancer Diagnosis and Treatment.

Int J Environ Res Public Health 2020 08 12;17(16). Epub 2020 Aug 12.

Department of Oncology, Collegium Medicum, University of Warmia and Mazury in Olsztyn, Al. Wojska Polskiego 37, 10-228 Olsztyn, Poland.

The aim of this cross-sectional study was to determine non-medical and organizational needs among cancer patients during diagnosis and treatment. The study included 384 cancer patients treated in five oncological centers in Poland. A questionnaire designed for the study was used. Most of the patients received psychological support from their partner/family/friends (88%), to a lesser extent from a psychologist (21%) and priests (4%). Forty-three percent of patients received social support from their partner/family/friends and only 7% of respondents received support from a social worker. Most patients stated they would like to have a professional who would help them with their non-medical problems during the diagnostic process and cancer treatment. The youth, with a higher education level who were professionally active and living in cities seemed to be more aware of their needs. Improvements to the oncological system in Poland should focus on expanding patient access to professional support of non-medical needs.
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http://dx.doi.org/10.3390/ijerph17165841DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7459913PMC
August 2020

Study protocol: watchful observation of patients with limited small cell lung cancer instead of the PCI-prospective, multi-center one-arm study.

BMC Cancer 2020 Mar 18;20(1):231. Epub 2020 Mar 18.

Katedra Onkologii, Wydział Lekarski, Collegium Medicum, Uniwersytet Warmińsko-Mazurski w Olsztynie, Olsztyn, Poland.

Background: Prophylactic cranial irradiation (PCI) is a current standard of care after confirmed response to radical chemoradiotherapy for limited disease small cell lung cancer (LD-SCLC). This standard is mostly based on results of old randomized studies when brain imaging with magnetic resonance (MRI) was not available. Survival benefit of PCI in extended disease SCLC was recently challenged by the results of randomized phase III study from Japan.

Methods: Eighty patients with LD-SCLC after response to chest chemoradiotherapy will be enrolled. Patients will be followed up by brain MRI every 3 to 6 months up to 3 years. Neurocognitive function tests will be performed at baseline and after 12 and 24 months. Patients who develop brain metastases will be irradiated with stereotactic (SRT) or whole brain RT (WBRT). The primary endpoint is overall survival. The secondary endpoints are: response rate to radiotherapy of early detected brain metastases, analysis of efficacy of SRT and WBRT; assessment and analysis of neurocognitive functions and QoL in the studied cohorts: QLQ-C30 questionnaire and the California Verbal Learning Test, Color connection test, Benton visual retention test, and verbal fluency test will be carried out.

Discussion: The results of this trial may contribute to changing of LD-SCLC clinical management by deescalating the treatment. There is a lack of prospective, recent studies in LD-SCLC patients with omission of PCI and modern radiation therapy technologies for developed brain metastases. The comprehensive neurocognitive function testing will help to assess the impact of modern radiotherapy (SRT) compared with WBRT and no-PCI in SCLC patients. A subgroup of long-term survivors, who will not develop brain metastases, will not be exposed to unnecessary brain irradiation with its deleterious consequences. The limitation of our study is a lack of parallel randomized control arm. This is a potential source of bias; however, randomized study will be difficult to complete for two major reasons: (1) limited population of LD-SCLC eligible for the study and (2) opinions of our patients, who after information and discussion about benefits and potential harms of PCI, often choose to omit PCI in our practice.

Trial Registration: ClinicalTrials.gov Identifier: NCT04168281, 19 Nov. 2019.
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http://dx.doi.org/10.1186/s12885-020-06721-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7079435PMC
March 2020

SHARP hypofractionated stereotactic radiotherapy for localized prostate cancer: a biochemical response to treatment.

J BUON 2019 Sep-Oct;24(5):2099-2106

Department of Oncology, Collegium Medicum, School of Medicine, University of Warmia and Mazury in Olsztyn, Poland.

Purpose: The standard treatment for patients with early-stage prostate cancer are operation and radiotherapy. Stereotactic body radiation therapy (SBRT) is one of the new radiotherapy methods. The aim of the study was to analyze tumor control of prostate cancer patients treated with SBRT.

Methods: A prospective single-institution clinical study was conducted among previously untreated patients with histologically confirmed localized prostate cancer. Patients were treated with SBRT: 33.5 Gy in 5 fractions.

Results: A total of 68 men with clinical stage of prostate cancer T1c-T2cN0M0 were included in the study. The median combined Gleason score was 6, the median PSA level was 10ng/mL. The median follow-up period was 48 months. Five years after the end of radiotherapy, the median PSA levels were as follows: 0.29ng/mL for all patients, 0.39ng/mL for those who did not receive androgen deprivation therapy, 0.25ng/mL for patients who underwent 6 months and 0.31ng/mL for patients who underwent 2-3 years of hormone therapy. Median nadir PSA levels were 0.025ng/mL for all patients and 0.48ng/mL for patients without hormone therapy. Low PSA nadir (<0.5ng/ml) was noted in 50% of patients without hormone therapy and in 70% of all other patients. Only in 4 patients (out of those who did not receive hormone therapy) PSA failure was observed (nadir plus 2ng/mL). No cases of PSA failure were noted among patients who underwent 6 months or 2-3 years of androgen deprivation therapy.

Conclusion: A good biochemical control was observed in prostate cancer patients treated with SBRT at 5 years follow-up.
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April 2020

Primarily resectable pancreatic adenocarcinoma - to operate or to refer the patient to an oncologist?

Crit Rev Oncol Hematol 2019 Mar 25;135:95-102. Epub 2019 Jan 25.

Department of Radiotherapy, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia, Katowice, Poland.

The aim of this work is to investigate the optimal therapeutic sequence of resectable pancreatic cancer - primary surgery with adjuvant therapy or neoadjuvant followed by resection. Application of the neoadjuvant approach in routine treatment of pancreatic cancer is rapidly growing every year, despite the lack of final results from randomized trials. Recent advancements in the adjuvant therapy, due to the more effective chemotherapy regimens, favor the upfront surgery strategy. On the other hand, theoretical background and metaanalyses favor the neoadjuvant strategy. Currently, primary resection with adjuvant chemotherapy remains the standard approach in resectable pancreatic cancer, but the first recommendations considering the neoadjuvant approach as an option seem to arise among the scientific societies with a global impact. Preliminary results of Prodige 24 study and PREOPANC-1 trial demonstrates that both options are worth further evaluation in clinical trials. Their results should soon provide more answers to this important clinical questions.
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http://dx.doi.org/10.1016/j.critrevonc.2019.01.010DOI Listing
March 2019

The Waiting Time of Prostate Cancer Patients in Poland.

Int J Environ Res Public Health 2019 01 26;16(3). Epub 2019 Jan 26.

Department of Oncology, Collegium Medicum, School of Medicine, University of Warmia and Mazury in Olsztyn, 10-228 Olsztyn, Al. Wojska Polskiego 37, Poland.

: Prostate cancer is the second most common reason of mortality due to cancer among men in Poland. The study aimed to determine the waiting time for diagnosis and treatment of prostate cancer. : The study was carried out on patients treated for prostate cancer from May 2014 to February 2015 at five oncological centres in Poland. The median waiting time was measured from the time cancer was suspected to the histopathological diagnosis (SDI), from the cancer suspicion to the start of treatment (STI) and from the diagnosis to the start of treatment (DTI). : 123 males treated for prostate cancer were included for analysis. The median time for SDI, STI and DTI was 7.7, 18.7 and 8.7 weeks, respectively. Place of residence was the only factor which influenced STI ( = 0.003). For patients, who started treatment with radiation therapy DTI was longer than for other patients ( < 0.001). : Median times of STI, SDI and DTI for prostate cancer patients in Poland are similar to the intervals described in other countries. Patients, who lived further from an oncology centre waited longer for treatment. The impact of waiting time in the case of prostate cancer on improving the prognosis is still unclear.
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http://dx.doi.org/10.3390/ijerph16030342DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6388381PMC
January 2019

Molecular profiling of tumours for precision oncology - high hopes versus reality.

Contemp Oncol (Pozn) 2018 Mar 5;22(1A):3-6. Epub 2018 Mar 5.

Oncology and Radiotherapy Chair, Medical University of Silesia, Katowice, Poland.

Treatment based on molecular profiling of tumor is advertised however there are very limited clinical data supporting this approach so far. Only one, relatively small, randomized clinical trial (SHIVA) have not met its primary endpoint - prolongation of PFS. Some other unpublished series were reported during ASCO 2017 and are discussed in this review. There are many issues to be resolved before the tumor profiling will enter the clinical practice with significant benefit for patients, eg. spatial and temporal heterogeneity of tumor cells in individual patient, wide access to targeted therapies, toxicity of combined targeted therapies.
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http://dx.doi.org/10.5114/wo.2018.73873DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5885080PMC
March 2018

How Long Are Cancer Patients Waiting for Oncological Therapy in Poland?

Int J Environ Res Public Health 2018 03 23;15(4). Epub 2018 Mar 23.

Department of Oncology and Radiotherapy, Medical University of Silesia in Katowice, Ul. Ceglana 35, 40-514 Katowice, Poland.

Background: The five-year relative survival rate in Poland is approximately 10% lower compared with the average for Europe. One of the factors that may contribute to the inferior treatment results in Poland could be the long time between cancer suspicion and the beginning of treatment. The aim of the study was to determine the real waiting time for cancer diagnosis and treatment in Poland.

Methods: The study was carried out in six cancer centers on a group of 1373 patients, using a questionnaire to interview patients. The median waiting time was estimated as follows: (A) from suspicion (the date of the first visit, with symptoms, to a doctor or a preventive or screening test) until histopathological diagnosis; (B) from suspicion until initial treatment; and (C) from diagnosis until initial treatment.

Results: The median times from suspicion to treatment, from suspicion to diagnosis, and from diagnosis to treatment, were 10.6, 5.6, and 5.0 weeks, respectively. Using multivariate analysis, the strongest influence was estimated, in a case of tumor localization, to be the method of initial treatment and facilities.

Conclusion: The waiting time for cancer treatment in Poland is too long. The highest influence on waiting time was determined, in the case of tumors, as the type of cancer and factors related to the health care system.
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http://dx.doi.org/10.3390/ijerph15040577DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5923619PMC
March 2018

Consensus statement on a screening programme for the detection of early lung cancer in Poland.

Adv Respir Med 2018 ;86(1):53-74

Department of Thoracic Surgery, Medical University of Gdansk, Sklodowskiej Curie 3a, 80-210 Gdansk, Poland.

Introduction: Lung cancer is the most common cancer in Poland and worldwide, and the leading cause of cancer-related deaths. Compared to the present day, the annual number of new cases of lung cancer will have increased by approximately 50%, by 2030. The overall ratio of mortality to incidence totals 0.87 and is among the highest. The five-year survival rate in Poland has recently achieved 13.4%. In 2015, lung cancer screening using low-dose computed tomography (LDCT) was introduced to routine clinical practice in the United States following the publication of the largest randomised study, The National Lung Screening Trial. The implementation of screening programmes in Poland and the rest of Europe also seems unavoidable. Due to the differences, both in the socioeconomic considerations and healthcare funding, compared to that in the United States, the current approach comes down to the awaited results of the European randomised study, NELSON.

Material And Methods: During the meeting of an expert panel at the "Torakoneptunalia 2016" conference in Jastarnia, Poland, a decision was made to summarise and publish the current data on LDCT lung cancer screening in the form of recommendations, or a position statement. The document was prepared by a team composed of a radiologist, thoracic surgeons, pulmonologists, clinical oncologists, epidemiologists, internists, health prevention specialists and pathologists. It reflects the current body of knowledge about lung cancer, its diagnosis and treatment, and provides recommendations on early detection of lung cancer using LDCT. The recommendations address the screening procedure, the requirements for the teams conducting the screening, and the requirements for radiologists, pathologists and surgeons involved in the diagnosis and treatment of patients.

Results: While awaiting the results of the NELSON study and the European position statement on lung cancer screening methodology, the multidisciplinary group of experts presents their position, laying grounds for the development of an action plan for early detection of lung cancer in the upcoming future in Poland.

Conclusions: Primary and secondary prophylaxis are the principal ways to reduce lung cancer mortality. While smoking cessation is a task of utmost importance, it must be accompanied by an effective screening programme if the outcome of the disease is to be improved.
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http://dx.doi.org/10.5603/ARM.2018.0009DOI Listing
September 2018

Diagnostic and therapeutic guidelines for gastro-entero-pancreatic neuroendocrine neoplasms (recommended by the Polish Network of Neuroendocrine Tumours).

Endokrynol Pol 2017 ;68(2):79-110

Klinika Endokrynologii i Nowotworów Neuroendokrynnych, Katedra Patofizjologii i Endokrynologii, Śląski Uniwersytet Medyczny.

Progress in the diagnostics and therapy of gastro-entero-pancreatic (GEP) neuroendocrine neoplasms (NEN), the published results of new randomised clinical trials, and the new guidelines issued by the European Neuroendocrine Tumour Society (ENETS) have led the Polish Network of Neuroendocrine Tumours to update the 2013 guidelines regarding management of these neoplasms. We present the general recommendations for the management of NENs, developed by experts during the Third Round Table Conference - Diagnostics and therapy of gastro-entero-pancreatic neuroendocrine neoplasms: Polish recommendations in view of current European recommenda-tions, which took place in December 2016 in Żelechów near Warsaw. Drawing from the extensive experience of centres dealing with this type of neoplasms, we hope that we have managed to develop the optimal management system, applying the most recent achievements in the field of medicine, for these patients, and that it can be implemented effectively in Poland. These management guidelines have been arranged in the following order: gastric and duodenal NENs (including gastrinoma); pancreatic NENs; NENs of the small intestine and appendix, and colorectal NENs.
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http://dx.doi.org/10.5603/EP.2017.0015DOI Listing
July 2017

SHARP hypofractionated stereotactic radiotherapy is well tolerated in prostate cancer : Toxicity and quality of life assessment.

Strahlenther Onkol 2016 Jul 25;192(7):449-57. Epub 2016 May 25.

Department of Oncology and Radiotherapy, Medical University of Silesia, Katowice, Poland.

Background: Quality of life (QoL) is one of the most significant issues in prostate cancer treatment decisions. This study aimed to investigate the toxicity of hypofractionated stereotactic radiotherapy (SBRT) and QoL after treatment in localized prostate cancer patients.

Materials And Methods: A prospective single-center clinical study was performed in low- and intermediate-risk prostate cancer patients. Patients received 33.5 Gy in 5 fractions (SHARP regimen). Acute and late toxicity was assessed according to RTOG/EORTC score. Patients filled out EORTC QLQ-C30 and prostate cancer-specific QLQ-PR25 questionnaires.

Results: The analysis included 68 prostate cancer patients (55-83 years, median 73) with clinical stage T1c-T2cN0M0, median combined Gleason score of 6 (3-8), and median prostate-specific antigen (PSA) level of 10 ng/mL (4-20 ng/mL). Neoadjuvant androgen deprivation therapy was given to 52 patients (76.5 %), and stopped in 31 patients (45.5 %) after 6 months; in 21 patients (31 %) after 2-3 years. Average and median follow-up was 24 months (18-45). Median nadir PSA level was 0.03 ng/mL for all patients and 0.6 ng/mL for patients without hormone treatment. No patients had PSA failure. There were no acute grade IV toxicities. One patient (1.5 %) developed grade III and 24 patients (35.3 %) grade II acute bladder toxicity. No one developed grade III and 7 patients (10.3 %) grade II acute rectal toxicity. No grade III or IV late gastrointestinal or genitourinary toxicities were reported. Grade II late urinary symptoms were observed in 8 patients (11.8 %) and gastrointestinal symptoms in 3 patients (4.4 %). Global health status/QoL was good and improved during the observational period.

Conclusion: SBRT for prostate cancer patients is a well-tolerated treatment in terms of toxicity and QoL, has no negative impact on functioning and everyday life, with the important benefit of a short treatment period. However, long-term follow-up data are needed.
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http://dx.doi.org/10.1007/s00066-016-0971-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4919372PMC
July 2016

[Treatment costs of malignant cervical cancer in Poland in 2011-2012--the case of Silesian Voivodeship].

Ginekol Pol 2015 Nov;86(11):849-55

Objectives: As far as health economics is concerned, it is hard to determine the only useful tool which would disclose the actual costs associated with cancer. We analyzed hospitalization costs, which create the highest rate among all malignant cervical cancer-related medical costs. The main aim of the study was to evaluate the real costs of medical treatment in the case of patients diagnosed with cervical cancer based on the group with the primary and coexisting diagnoses.

Material And Methods: The analyzed data from 2011-2012 were obtained from the Silesian branch of the National Health Fund, which financed medical expenses due to the diagnosis of cancer in health facilities which have the agreement for such treatment.

Results: A total of 4 540 hospitalization-related health benefits were realized, with the final total cost was PLN 8 766 547, in the presented group of 2261 patients. The most popular procedures in patients with the diagnosis from the C53 group, included chemotherapy together with oncological hospitalization (over 62%). The vast majority of the realized procedures were treatments of the reproductive system (38%) and teleradiotherapy (about 31%).

Conclusions: Lack of efficient procedures of data collection for cancer advancement hinders the economic analyses, which should constitute the foundation for the discussion about cost effectiveness of selected procedures. Adequate methods for the monitoring of direct and indirect costs associated with cervical cancer treatment ought to be created.
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November 2015

The outcomes of Polish patients with advanced BRAF-positive melanoma treated with vemurafenib in a safety clinical trial.

Contemp Oncol (Pozn) 2015 28;19(4):280-3. Epub 2015 Sep 28.

Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland.

Aim Of The Study: The BRAF inhibitor vemurafenib has improved progression-free survival and overall survival in patients with BRAFV600-mutation-positive metastatic melanoma. Here we present the results of an open-label safety study with vemurafenib in patients with metastatic melanoma enrolled in Polish oncological centres.

Material And Methods: Patients with untreated or previously treated Stage IIIC/IV BRAFV600 mutation-positive melanoma were treated with oral vemurafenib in an initial dose of 960 mg twice daily. Assessments for safety and efficacy were made every 28 days. For the survival analysis the Kaplan-Meier estimator was used with the log-rank tests for bivariate comparisons.

Results: In total, 75 Polish patients were enrolled in the safety study across four centres. At data cut-off, 28 patients died (37%), mainly (26) due to disease progression; 33 (44%) patients continued vemurafenib after disease progression. The objective response rate was 46%, including two patients with a complete response and 29 with a partial response. Median progression-free survival was 7.4 months. The one-year overall survival rate was 61.9% (median overall survival was not reached). Seventy-three (97.3%) patients reported adverse events (AEs), and grade 3-5 toxicity was reported in 49.4% (37) patients. The most common AEs were: skin lesions (including rash and photosensitivity), arthralgia, and fatigue.

Conclusions: The overall safety profile and response rate of vemurafenib were comparable to those reported in previous studies of this drug. Our study confirmed the value of well-established prognostic features for overall survival, such as initial LDH (lactate dehydrogenase) level and AJCC staging.
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http://dx.doi.org/10.5114/wo.2015.54082DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4631301PMC
November 2015

CA-SSR1 Polymorphism in Intron 1 of the EGFR Gene in Patients with Malignant Tumors Who Develop Acneiform Rash Associated with the Use of Cetuximab.

Mol Diagn Ther 2015 Apr;19(2):79-89

Department of Oncology, University of Warmia and Mazury, Olsztyn, Poland.

Background And Objective: Epidermal growth factor receptor (EGFR) inhibitors are not equally effective in all cancer patients. One potential clinical factor that could help in selecting patients who may benefit from treatment with cetuximab is acneiform rash, which correlates with the clinical response to EGFR inhibitors. Some previous studies have suggested that the tendency to develop rash may depend on polymorphisms in the EGFR gene. In this investigation, the association of degree of CA dinucleotide polymorphism with skin rash and cetuximab therapy outcome was examined.

Methods: The study included 60 patients treated with cetuximab. For each patient, the severity of acneiform rash was assessed, and the type of polymorphism was determined by genotyping. Associations between genotypes, the acneiform rash, and response to treatment were determined by using the chi-square test and Spearman's rank correlation. The cutoffs S≤17(CA), L>17(CA), n(CA)≤35, and n(CA)>35 were tested, as well as the sum of the two allele repetitions.

Results: A correlation was found between body surface area covered by rash and the sum of the two allele repetitions (p=0.030). No statistically significant relationship between genotype and response to treatment was observed. However, in patients who have had partial remission, we noticed a higher incidence of polymorphism, with less CA dinucleotide repetitions and early onset of rash.

Conclusion: A correlation between genotype and severity of rash was observed. That is, the severity of rash decreased with an increased number of CA repetitions.
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http://dx.doi.org/10.1007/s40291-015-0132-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4555232PMC
April 2015

Assessment of the safety and efficiency of sunitinib malate in metastatic neuroendocrine tumours of the pancreas (NEN G1/G2) depending on the number and type of earlier therapeutic lines - initial report.

Endokrynol Pol 2014 ;65(6):472-8

Division of Radiotherapy and Oncology, Department of Clinical Oncology, Silesian Medical University, Katowice, Poland.

Introduction: The objective of this paper was to assess the safety and efficacy of sunitinib malate in patients with well-differentiated metastatic pancreatic neuroendocrine neoplasms (PNENs) who relapsed on standard therapy.

Material And Methods: Overall, eight patients with well-differentiated pancreatic neuroendocrine tumours/neoplasm (NET/NEN G1/G2, Ki-67 < 20%), who had relapsed on a standard therapy approach, were treated. All had non-resectable, progressive disease. All received therapy using a standard dose of sunitinib malate. Adverse events were evaluated using NCI-CTC AE v. 3.0.

Results: Of the eight patients, seven had non-secretor and single secretor tumour (gastrinoma). Partial remission (PR) was noted in three patients (one after a single therapeutic line, two after two lines), five patients had stabilisation (SD) - including three individuals after three lines, one patient after two lines and another after a single line. Haematological adverse events: leukopenia (25%) - occurred in one patient after three lines and in one patient after two lines; anaemia (25%) - in one patient after three lines and in one patient after one therapeutic line. Mucocutaneous lesions were noted in 37.5% of patients after 2-3 lines of treatment. All of them experienced fatigue syndrome irrespective of the number of therapies. The majority of the patients simultaneously received somatostatin analogues, which did not exacerbate the toxicity profile. The median progression-free survival time (PFS) was 11 months.

Conclusions: Sunitinib may be considered as a fairly well-tolerated and effective therapeutic option in progressive non-resectable PNEN patients in the second and subsequent lines of treatment, irrespective of the types of treatment previously applied.
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http://dx.doi.org/10.5603/EP.2014.0066DOI Listing
December 2016

Tecemotide (L-BLP25) versus placebo after chemoradiotherapy for stage III non-small-cell lung cancer (START): a randomised, double-blind, phase 3 trial.

Lancet Oncol 2014 Jan 9;15(1):59-68. Epub 2013 Dec 9.

University Health Network, Princess Margaret Cancer Centre, Toronto, ON, Canada.

Background: Effective maintenance therapies after chemoradiotherapy for lung cancer are lacking. Our aim was to investigate whether the MUC1 antigen-specific cancer immunotherapy tecemotide improves survival in patients with stage III unresectable non-small-cell lung cancer when given as maintenance therapy after chemoradiation.

Methods: The phase 3 START trial was an international, randomised, double-blind trial that recruited patients with unresectable stage III non-small-cell lung cancer who had completed chemoradiotherapy within the 4-12 week window before randomisation and received confirmation of stable disease or objective response. Patients were stratified by stage (IIIA vs IIIB), response to chemoradiotherapy (stable disease vs objective response), delivery of chemoradiotherapy (concurrent vs sequential), and region using block randomisation, and were randomly assigned (2:1, double-blind) by a central interactive voice randomisation system to either tecemotide or placebo. Injections of tecemotide (806 μg lipopeptide) or placebo were given every week for 8 weeks, and then every 6 weeks until disease progression or withdrawal. Cyclophosphamide 300 mg/m(2) (before tecemotide) or saline (before placebo) was given once before the first study drug administration. The primary endpoint was overall survival in a modified intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00409188.

Findings: From Feb 22, 2007, to Nov 15, 2011, 1513 patients were randomly assigned (1006 to tecemotide and 507 to placebo). 274 patients were excluded from the primary analysis population as a result of a clinical hold, resulting in analysis of 829 patients in the tecemotide group and 410 in the placebo group in the modified intention-to-treat population. Median overall survival was 25.6 months (95% CI 22.5-29.2) with tecemotide versus 22.3 months (19.6-25.5) with placebo (adjusted HR 0.88, 0.75-1.03; p=0.123). In the patients who received previous concurrent chemoradiotherapy, median overall survival for the 538 (65%) of 829 patients assigned to tecemotide was 30.8 months (95% CI 25.6-36.8) compared with 20.6 months (17.4-23.9) for the 268 (65%) of 410 patients assigned to placebo (adjusted HR 0.78, 0.64-0.95; p=0.016). In patients who received previous sequential chemoradiotherapy, overall survival did not differ between the 291 (35%) patients in the tecemotide group and the 142 (35%) patients in the placebo group (19.4 months [95% CI 17.6-23.1] vs 24.6 months [18.8-33.0], respectively; adjusted HR 1.12, 0.87-1.44; p=0.38). Grade 3-4 adverse events seen with a greater than 2% frequency with tecemotide were dyspnoea (49 [5%] of 1024 patients in the tecemotide group vs 21 [4%] of 477 patients in the placebo group), metastases to central nervous system (29 [3%] vs 6 [1%]), and pneumonia (23 [2%] vs 12 [3%]). Serious adverse events with a greater than 2% frequency with tecemotide were pneumonia (30 [3%] in the tecemotide group vs 14 [3%] in the placebo group), dyspnoea (29 [3%] vs 13 [3%]), and metastases to central nervous system (32 [3%] vs 9 [2%]). Serious immune-related adverse events did not differ between groups.

Interpretation: We found no significant difference in overall survival with the administration of tecemotide after chemoradiotherapy compared with placebo for all patients with unresectable stage III non-small-cell lung cancer. However, tecemotide might have a role for patients who initially receive concurrent chemoradiotherapy, and further study in this population is warranted.

Funding: Merck KGaA (Darmstadt, Germany).
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http://dx.doi.org/10.1016/S1470-2045(13)70510-2DOI Listing
January 2014

[The effect of coffee on blood pressure at healthy subjects].

Pol Merkur Lekarski 2013 Sep;35(207):133-5

Students' Group in association with Department of Oncology, Medical University of Warmia and Mazury in Olsztyn, Poland.

Unlabelled: Coffee is one of the most popular beverages. Its stimulatory effects comes from the natural alkaloid- caffeine. Caffeine is the antagonist of the adenosine receptors A1 and A2. Caffeine acts chronotropic positive and increases heart action; inotropic positive and increases cardiac contraction; tronotropic positive and increases hearts muscular ton, brain's vascular stenosis, vasodilatation of coronal vessels, renal vessels, muscular vessels and skin vessels. The aim of the study was determination of coffee effect on blood pressure in healthy subjects.

Material And Methods: 17 healthy subjects (age 22-44 years; median 22 years) was included. There were two experiments. Experiment 1: examined persons drank instant coffee with or without caffeine. Experiment 2: examined persons drank natural coffee with or without caffeine. The blood pressure and pulse were examined before coffee drinking and 15 and 30 minutes after (in experiment 1) and only 30 minutes after (in experiment 2).

Results: The blood pressure was increased on 10 mmHg or more in 9-40% of examined subjects in all groups, but there were no significant difference between groups. The pulse increased (10 or more per minute) was observed only in one person and decrease was observed in three who drank natural coffee with caffeine.

Conclusions: In healthy subjects the blood pressure does not increased significantly after caffeine consumption. The consumption of caffeine in large doses may be harmful to some hypertensive or hypertension-prone subjects.
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September 2013

Concurrent chemotherapy and short course radiotherapy in patients with stage IIIA to IIIB non-small cell lung cancer not eligible for radical treatment: results of a randomized phase II study.

J Thorac Oncol 2010 Aug;5(8):1255-62

Radiation Oncology Unit, University of Warmia and Mazury, 10-228 Olsztyn, Al. Wojska Polskiego 37, Poland.

Introduction: The optimal treatment for patients with stage IIIA to IIIB non-small cell lung cancer (NSCLC) not eligible for surgery and definitive chemoradiotherapy is unknown. The aim of this study was to evaluate concurrent chemotherapy and palliative radiotherapy.

Methods: Patients with stage IIIA to IIIB NSCLC with tumor >8 cm and/or forced expiratory volume < or =40%, performance status 0 to 2, and tumor-related chest symptoms were randomly assigned to arm A: radiotherapy alone (30 Gy/10 fractions) or arm B: chemoradiotherapy (two cycles of cisplatin and vinorelbine followed by radiotherapy together with third cycle). Primary end point was response rate, the power of the study was 90%, and the significance level was p = 0.1.

Results: A total of 99 patients were eligible for response, overall survival, and progression-free survival evaluation. Median age was 66 years (45-78 years). Response rate was 27% versus 53%, p = 0.08; median overall survival was 9.0 versus 12.9 months, p = 0.0342; and median progression-free survival was 4.7 versus 7.3 months, p = 0.046, in arm A versus arm B, respectively. There were no deaths during treatment in arm A and six deaths in arm B; no hematological G3 to G4 toxicities in arm A and 14 toxicities in arm B. Symptom control was high and similar in both arms.

Conclusions: Upfront chemotherapy combined with palliative radiotherapy (30 Gy) is a promising treatment option in the subpopulation of patients with stage IIIA to IIIB NSCLC not amenable for definitive chemoradiotherapy and deserves further investigation.
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http://dx.doi.org/10.1097/JTO.0b013e3181e15d33DOI Listing
August 2010

The Polish Cancer Anemia Survey (POLCAS): a retrospective multicenter study of 999 cases.

Int J Hematol 2009 Apr 4;89(3):276-284. Epub 2009 Apr 4.

Department of Radiotherapy, Ministry of Internal Affairs and Administration Hospital and Warmia and Mazury Oncology Centre, Olsztyn, Poland.

The purpose of the retrospective study in cancer patients in Poland was to analyze the frequency of anemia and methods of its treatment. An attempt was also made to evaluate the hemoglobin (Hb) levels in relation to patient's performance status (PS) prior to and after anticancer treatment. A total of 999 patients (pts) were enrolled, who were followed for up to six chemotherapy cycles or six evaluation points within a 6-month period. The incidence of anemia at the time of enrollment into the study equaled 31%, and was observed mainly among gynecologic and colorectal cancer pts. After anticancer treatment, anemia was reported in 54% of patients, mainly in gynecologic and lung cancer pts. As many as 71% of patients were anemic at some point of time during the survey, which was most often documented among gynecologic, lung and testicular cancer patients. At the 5th visit more than 50% of patients were anemic. The difference between the mean Hb level at 1st and 6th visit was 1.04 g/dL. However, anemia was treated in only 32% of patients (red blood cell transfusions, 61%; iron supplementation, 33%; while erythropoietic, stimulating proteins in just 6%). Worse PS was observed in anemic pts with lung as well as with head and neck cancer. In Poland the occurrence of anemia in cancer patients is as high as 70%. Anemia in this group of patients is underestimated and undertreated. This calls for more attention of physicians providing medical care to cancer patients.
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http://dx.doi.org/10.1007/s12185-009-0273-xDOI Listing
April 2009

Clinical trials of active cancer immunotherapy.

Expert Opin Investig Drugs 2007 Aug;16(8):1137-41

Active immunotherapy of cancer needs its own clinical trials' methodology. The standard methodology paradigm for clinical trials in oncology was developed for cytotoxic drugs, which differ dramatically from cancer vaccines in their mode of action and toxicity profile. To minimize the risk of overlooking benefits for patients, Mackiewicz and Nawrocki invite to open discussion on vaccine trials' methodology. Our point of view is based on several Phase I and II trials with hundreds of melanoma patients treated with allogenic cellular vaccine genetically modified with cytokine genes. We feel that a simplified two-stage clinical trial design without a separate Phase I is justified. In the first stage, preliminary efficacy together with proof-of-principle and feasibility issues could be addressed. For real efficacy assessment, careful consideration of end points is necessary. Immunologic responses and objective clinical responses are not the best measures of vaccine efficacy for many patients who benefit from treatment. Randomized single institution studies with time-to-event end points are probably well suited for such combined Phase I/II studies. In the second stage trial (Phase III), the final efficacy analysis with comparator arm is needed.
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http://dx.doi.org/10.1517/13543784.16.8.1137DOI Listing
August 2007

From microarrays to new therapeutic approaches in bladder cancer.

Pharmacogenomics 2003 Mar;4(2):179-89

Eli Lilly Polska, Ul Smolenskiego 2, 01-698 Warszawa, Poland.

Bladder cancer is a model tumor progressing from superficial to locally invasive and finally metastatic disease. The likelihood of progression is determined to a large extent by the molecular profile of the tumor. From the pre-genomic era only p53 emerged as the molecular prognostic factor able to add value to existing clinical and pathological features of bladder cancer, however it was not introduced to the clinic. Microarray technologies enable us to study expression of thousands of genes in the tumor tissue. This method has already proven to add information to clinical classifiers, to find new tumor suppressor genes and to define p53 related pathways of cell-cycle regulation. In the last decade, progress in the treatment of locally invasive and metastatic bladder cancer was minimal; large Phase III trials with neo/adjuvant chemotherapy were inconclusive. The new paradigm of treatment tailored to an individual patient could be realized in bladder cancer for his chronic clinical course with opportunities to obtain tumor samples for microarray studies. Molecular profiling of two samples taken at the superficial stage and at cystectomy should enable us to study the microevolution of the tumor, to tailor existing treatment options, and to introduce new biologicals to the clinic.Introduction
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http://dx.doi.org/10.1517/phgs.4.2.179.22632DOI Listing
March 2003

Pharmacotherapy of bladder cancer--practice and prospects.

Expert Opin Pharmacother 2002 Jun;3(6):671-9

Eli Lilly Polska Sp zoo ul Smolenskiego 2, Warszawa, Poland.

In contrast to the US, the incidence and mortality rates of bladder cancer are still increasing in some European countries, despite the fact that most new cases are diagnosed as early, superficial tumours. The standard of care of superficial tumours consists of cytoscopic electroresection of the tumour followed by intravesical immunotherapy or chemotherapy. Immunotherapy with bacillus-Calmette Guerin (BCG) prevents recurrence in most treated patients and has a positive impact on survival; however, approximately 30% are BCG-refractory, progressive tumours. Pharmacogenomics will enable to distinguish those high-risk patients in clinical practice soon. New immunotherapy approaches, such as BCG combined with low-dose interferon or recombinant BCG strains, are promising approaches which need to be explored in prospective trials. The use of neoadjuvant or adjuvant chemotherapy is still controversial but the results of recent trials of neoadjuvant chemotherapy in locally-advanced bladder tumours convinced some leading centres to implement neoadjuvant chemotherapy in selected groups of patients. By far, the four-drug methotrexate-vinblastine-doxorubicin-cisplatin regimen was widely used in metastatic and locally-advanced disease. Recently, two-drug combination gemcitabine-cisplatin proved to be equally effective and less toxic. New chemotherapies tested in clinical trials include gemcitabine, taxanes and new drugs that interfere with signal transduction. Individualisation of established and investigational treatment options based on molecular tumour characteristics, such as p53 status, is probably the future of bladder cancer pharmacotherapy.
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http://dx.doi.org/10.1517/14656566.3.6.671DOI Listing
June 2002