Effectiveness and safety of nab-paclitaxel/gemcitabine in locally advanced or metastatic pancreatic adenocarcinoma.

BACKGROUND: Treatment based on nab-paclitaxel plus gemcitabine is one of the standard treatments for locally advanced or metastatic pancreatic adenocarcinoma. Not much information is available about its use in clinical practice. Looking for prognostic markers may aid in improving treatment plans for patients. OBJECTIVE: To describe the effectiveness and safety profile of nab-paclitaxel/gemcitabine in locally advanced or metastatic pancreatic adenocarcinoma. We also tried to evaluate prognostic markers of response to treatment. SETTING: Retrospective descriptive study carried out in a tertiary hospital of Spain. METHOD: Patients with locally advanced or metastatic pancreatic adenocarcinoma treated with nab-paclitaxel/gemcitabina between January 2014 and December 2017 were included in the analyses. MAIN OUTCOME MEASURE: Effectiveness was measured in terms of overall survival, progression-free survival and response rate. To evaluate the safety profile, every adverse event from the start of the treatment and up to 10 days after its completion was registered. RESULTS: Fifty patients were included. Thirty-three (66%) had metastatic disease. Median overall survival was 8.8 months (95%CI: 5.1-12.5) and the median progression-free survival was 5.6 months (95%CI: 4.3-6.9). Relevance of carbohydrate antigen 19-9 baseline levels as prognostic response marker was confirmed, while neutrophil-to-lymphocyte ratio did not show conclusive results for overall survival. Safety profile was similar to that observed in clinical trials, with a single case of treatment discontinuation due to grade 3 neuropathy. CONCLUSION: The studied schedule for locally advanced or metastatic pancreatic adenocarcinoma seems to be an effective therapeutic option, with an easy to manage toxicity profile, similar to other schedules used in pancreatic adenocarcinoma.

Effectiveness and security of chronic hepatitis C treatment in coinfected patients in real-world.

Background HIV-HCV coinfection produces high morbi-mortality. Direct-acting antivirals (DAAs) have shown high efficacy, although special attention should be paid to the risk of drug interactions. However, due to the lack of representativeness of coinfected patients in clinical trials, it is important to know real-world results. Objective To evaluate DAA treatment effectiveness in coinfected patients. We also analyse safety profile of DAA treatment and drug interactions between HCV and HIV therapy. Setting Descriptive study carried in a tertiary hospital of Spain Method HIV-HCV coinfected patients treated with DAAs between November 2014 and June 2016 were included. Main outcome measure Efficacy was measured in terms of sustained virologic response at week 12 after the end of therapy. Adverse events that led to treatment discontinuation were registered to evaluate the safety profile, and also drug interactions between DAAs and antiretroviral treatment were evaluated. Results Main HCV genotypes were 1a (34.9%) and 4 (24.5%). 51.9% were HCV previously treated, 54.7% had grade 4 liver fibrosis. SVR12 was reported in 90.6%. HCV treatment was well tolerated and there were no discontinuations because of adverse events. 30.2% of HIV treatments had to be modified before DAA treatment was started due to interactions, HIV suppression was not compromised. Conclusion DAA treatment in coinfected patients seems to be highly effective and secure. Evaluation of drug interactions must be a priority in order to maximize effectiveness and avoid toxicity.

Trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel in the neoadjuvant setting of HER-2 positive breast cancer.

BACKGROUD: Neoadjuvant treatment based on the combination of trastuzumab plus chemotherapy is the standard of care in patients with HER2-positive early or locally advanced breast cancer. The concurrent use of trastuzumab, anthracyclines and taxanes is frequently used in this setting despite the potential cardiotoxicity of both anthracyclines and trastuzumab. However, not much information is available about this chemotherapy scheme. OBJECTIVE: We wanted to evaluate the efficacy and safety profile of the combination of trastuzumab, liposome-encapsulated doxorubicin and paclitaxel as neoadjuvant scheme. We also tried to establish predictive factors of pathologic complete response. SETTING: The study was carried out in a tertiary University Hospital of Spain. METHOD: This is a descriptive study of the clinical practice performed in our hospital. MAIN OUTCOME MEASURE: Efficacy was measured in terms of pathologic complete response, which was defined as the absence of invasive cancer cells in the breast and the axilla after neoadjuvant treatment. RESULTS: Thirty patients were included, the median age was 48. Seventeen (56.7 %) were hormonal receptor (HR) positive, 14 (46.6 %) had IIIa-b clinical stage and one of them had inflammatory breast cancer. 12 patients (40 %) achieved pCR. Patients with HR-negative BC achieved a higher pCR rate than those ones with HR-positive BC (61.5 % and 23.5 %, respectively; p value = 0.035). 21 patients (70 %) underwent breast conservative surgery. The treatment was in general well tolerated, most frequent grade 3-4 adverse events were neutropenia (20 %), asthenia and liver enzyme alteration (10 %) and febrile neutropenia (6.7 %). No patient developed heart failure, but one (3.3 %) presented a 10 % asymptomatic absolute reduction in left ventricular fraction ejection. CONCLUSIONS: The studied treatment for the neoadjuvant setting of HER2 positive breast cancer seems to be an effective therapeutic option. Despite the expected high rate of cardiotoxicity of this regimen, the study results shows that this treatment regimen appears to be safe. The combination of trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel should be considered for the treatment of HER2-overexpressing breast cancer.