Analysis of survival of patients treated with vemurafenib, ipilimumab and dabrafenib for advanced skin melanoma in daily clinical practice (Real-World Data): retrospective analysis of patients treated under drug/reimbursement programmes in Poland in 2013-2016.

Vemurafenib, ipilimumab and dabrafenib were registered for the treatment of advanced skin melanoma pursuant to the results of randomized phase III clinical trials. Real-world data on survival time for patients treated with those drugs in daily clinical practice are so far limited. Patients with advanced skin melanoma treated under reimbursement programmes (drug programmes), for which they were qualified pursuant to uniform inclusion criteria in force in all oncology centres in Poland. Data were obtained from the electronic databases of the national payer (NFZ) responsible for the implementation and monitoring of reimbursement (drug) programmes. The analysis included all patients included for treatment with vemurafenib (since March of 2013), ipilimumab (since March of 2014) and dabrafenib (since July of 2015) until December 2016. The end date of the observation was set to 31 December 2016. The total survival analysis was performed using the Kaplan-Meier estimator. Until 31 December 2016, 759 patients were treated with vemurafenib, 370 with ipilimumab and 181 with dabrafenib. The overall survival (OS) median was 9.8 months for patients treated with vemurafenib (95% confidence interval: 8.8-10.6) and 6.9 months for patients treated with ipilimumab (95% confidence interval: 5.7-9.2). For patients treated with dabrafenib, the OS median was not reached because of an overly short observation period. The probability of surviving 12 months in the group of patients treated with vemurafenib was 40.5%, ipilimumab was 35.1% and dabrafenib was 60.7%. The probability of surviving 24 and 36 months in the group of patients treated with vemurafenib or ipilimumab amounted to, respectively, 20.1, 15.4 and 21, 18.8%. OS of patients with advanced melanoma treated in daily clinical practice may be comparable to the ones achieved in registration trials. The use of appropriate treatment inclusion criteria may affect the obtained OS.

The assessment of overall survival (OS) after adjuvant chemotherapy for patients with malignant endometrial cancer in Poland.

OBJECTIVES: In 2013 malignant endometrial cancers have amounted to 7.3% of all cancers diagnosed among women in the report by the Polish National Cancer Registry Raw prevalence rate amounted to 28.7, whereas standardised prevalence rate 15.6 per 100 000 population. Among the causes of death, these cancers amounted to 3% and were ranked ninth on the list of the most common causes of oncologic mortality of women. In the year 2013 a total of 1243 women died of malignant endometrial cancers. A stable increase of malignant endometrial cancer incidence has been observed for 2 decades. Despite that fact, the increase of the mortality incidence is at a much lower level, which demonstrates the much higher effectiveness of the treatment of such cancers. The recording rate of the malignant endometrial cancer mortality amounts to 95%, so the presented absolute numbers are reliable. Examining the clinical stages of malignant endometrial cancers, we can establish that approx. 85% of them are diagnosed at stage I or II according to the FIGO classification. Patients with advanced stages of cancer represent less than 15%. MATERIAL AND METHODS: retrospective analysis of endometrial body cancer prevalence data for the entire population of Poland, assessment of malignant endometrial cancer prevalence in the years 2008-2015 and overall survival probability in the population of patients undergoing adjuvant chemotherapy. RESULTS: The number of patients with a diagnosed malignant endometrial cancer within the studied period in Poland remains on a stable level (2008 - 30.6 thousand patients, 2015 - 40.2 thousand patients). Among all listed patients with the indica-tion of C54 each year approx. 20% enters hospital treatment. System therapy with chemotherapy drugs was used in approx. 1-2% of patients treated in hospitals. The average age of the patients was 64.9 years, and the median age 65 years. The num-ber of observations was 2085, including 1088 censored observations. The average survival for the sample under study was 30.67 month (SD = ± 0.6); median survival time was 23.93 month. The number of censored observations was 1088 (52.16%). Probable survival of 1 year is achieved by 67.57% of patients, 2 years by 49.73%, 3 years by 40.68%, above 5 years 30.77%. CONCLUSIONS: The incidence of endometrial cancer in Poland in the years 2008-2015 continues to grow at 5% upward trend (in Europe 3.4-5.9). In Poland in 2012, crude incidence rate for cancer of the uterus was 29.8 and did not differ significantly from the results in countries such as Finland, Slovakia, Sweden, Belgium and Bulgaria. The overall survival after adjuvant chemotherapy for patients with malignant endometrial cancer in Poland shows considerable differences depending on the region of the country.