No abstract

Chemotherapy agents such as docetaxel are still used after failure of first or second-line immunotherapy. In order to establish the ideal choice of treatment, it is necessary to compare the efficacy and safety in the real-world setting between the available schemes. We performed a retrospective, observational study in a referral hospital including patients treated with docetaxel for non-small cell lung cancer between January 2013 and June 2017. Effectiveness variables included overall survival (OS) and progression free survival (PFS). The safety variable was the incidence of adverse events (AE). 91 patients were enrolled (84.6% men) with a mean age of 63.6 years. 21 patients were treated with a combination of docetaxel + nintedanib, and the rest with monotherapy. 79.1% of patients presented AEs of any grade and treatment had to be delayed or discontinued in 10%. The median PFS was 2.8 months (95% CI 2.3-3.3) and for OS, 6.9 months (95% CI 4.9-8.8). In adenocarcinoma patients no difference in OS was observed between monotherapy with docetaxel vs. docetaxel + nintedanib. Overall results are similar to clinical trials, but not when nintedanib is added to the therapy. RezumatAgenții chimioterapici, cum ar fi docetaxelul, sunt încă utilizați după eșecul imunoterapiei de primă sau a doua linie. Pentru a stabili alegerea ideală a tratamentului, este necesar să se compare eficacitatea și siguranța în mediul real între schemele disponibile. A fost efectuat un studiu observațional retrospectiv într-un spital de referință, incluzând pacienți tratați cu docetaxel pentru cancer pulmonar cu celule non-mici în perioada ianuarie 2013 -iunie 2017. Variabilele de eficacitate au inclus supraviețuirea globală (OS) și supraviețuirea fără progresie (PFS). Variabila siguranță a reprezentat incidența evenimentelor adverse (AE). Au fost înrolați 91 de pacienți (84,6% bărbați) cu o vârstă medie de 63,6 ani. 21 de pacienți au fost tratați cu o combinație de docetaxel + nintedanib, iar restul cu monoterapie. 79,1% dintre pacienți au prezentat AE de orice grad și tratamentul a trebuit să fie întârziat sau întrerupt în 10% din cazuri. PFS mediană a fost de 2,8 luni (IC 95% 2,3-3,3), iar pentru OS, 6,9 luni (IC 95% 4,9-8,8). La pacienții cu adenocarcinom nu s-a observat nici o diferență în OS între monoterapie cu docetaxel față de docetaxel + nintedanib. Rezultatele generale sunt similare studiilor clinice, dar nu și atunci când se adaugă nintedanib la terapie.

closure integrity, impurities, charge variants, oxidation, endotoxin, particulates and biological activity. Results A total of 132 syringes underwent three freeze-thaw cycles, exposing each syringe for a total of 144 hours to 30°C and 144 hours to À5°C. Following exposure, 66 syringes were used for the analysis and 66 were retained. The effects of this thermal cycling on the critical quality attributes of SB5 from baseline is shown in table 1. Conclusion and relevance SB5 was stable in the immediate pack when exposed to multiple freeze-thaw cycles. These results may help hospital pharmacists assess the impact of temperature excursions during shipment or storage on product quality of SB5.

No abstract

e21729 Background: A neutrophil/lymphocyte ratio (NLR)> 5 or its derivative (dNLR)> 3 have been proposed as a prognostic factor for non-effectiveness of nivolumab in non-small-cell lung cancer (NSCLC). Filgrastim (GSGF) increases the absolute counts of neutrophils in patients (pts) with neutropenia. The aim of this study is to determine whether the use of GSGF, during the first line therapy of nSCLC, influences the effectiveness of the anti-PD1/PDL1 inhibitors (aPD1-i) used in subsequent line. Methods: We designed a single center, observational and retrospective study. We included NSCLC pts treated with Nivolumab (NIV), Pembrolizumab (PEM) or Atezolizumab (ATE) between January-16 and November-19 after primary platinum-based chemotherapy at one hospital from south Spain. The primary endpoints were overall survival (OS) and progression-free survival (PFS). Results were assessed using Kaplan-Meier method for GSGF-use stratified by NLR, dNLR, or aPD1-i. Results: 79 pts were enrolled (91% men), mean age was 66.7 years, 78.8% of pts had ECOG = 0-1. NIV was used at 55.7%, ATE 25.3% and PEM 19.0% of pts. 50.6 % of tumors were squamous histology. GSGF was used at 19 pts (24.1%). The mean WBC at the start of therapy with aPD1-I was 9300 cell/µL (sd=3900), range 3600-25800 cell/µL. NLR was less than 5 in 46 pts (58.2%) and dNLR was less than 3 in 51 pts (64.6%). The mean time from the start of line previously to start the treatment with aPD1-i was 9.7 months (sd=8.6). The median for treatment duration was 4.1 months [IC 95%; 2.3-5.8].OS was 7.3 months [IC 95%:3.4-11.3] and PFS was 4.4 months [IC95%:2.3-6.5]. We found statistically significant difference in OS between patients with dNLR <3, median 13.9 months [IC95%; 5.4-22.4] vs patients with dNLR> 3, median 3.6 months [IC95%; 2.4-4.7], p=0.037. The median OS was higher in pts GSGF-treated (6.1 months) vs pts no GSGF-treated (3.3 months), p=0.347, no reaching statistical significance. No difference was found in OS by NLR. The analysis for OS by GSGF use stratified by dNLR is shown in the table. Conclusions: The effectiveness of aPD1-i in nSCLC patients previously treated and with dNLR>3, a priori poor prognosis, is greater in the group of patients treated with GSGF, reaching OS like pts with dNLR <3. [Table: see text]