Quality-of-life and performance status results from the phase III RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma.

BACKGROUND: The phase III RAINBOW trial demonstrated that the addition of ramucirumab to paclitaxel improved overall survival, progression-free survival, and tumor response rate in fluoropyrimidine-platinum previously treated patients with advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma. Here, we present results from quality-of-life (QoL) and performance status (PS) analyses. PATIENTS AND METHODS: Patients with Eastern Cooperative Oncology Group PS of 0/1 were randomized to receive ramucirumab (8 mg/kg i.v.) or placebo on days 1 and 15 of a 4-week cycle, with both arms receiving paclitaxel (80 mg/m(2)) on days 1, 8, and 15. Patient-reported outcomes were assessed with the QoL/health status questionnaires EORTC QLQ-C30 and EQ-5D at baseline and 6-week intervals. PS was assessed at baseline and day 1 of every cycle. Time to deterioration (TtD) in each QLQ-C30 scale was defined as randomization to first worsening of ≥10 points (on 100-point scale) and TtD in PS was defined as first worsening to ≥2. Hazard ratios (HRs) for treatment effect were estimated using stratified Cox proportional hazards models. RESULTS: Of the 665 patients randomized, 650 (98%) provided baseline QLQ-C30 and EQ-5D data, and 560 (84%) also provided data from ≥1 postbaseline time point. Baseline scores for both instruments were similar between arms. Of the 15 QLQ-C30 scales, 14 had HR < 1, indicating similar or longer TtD in QoL for ramucirumab + paclitaxel. Treatment with ramucirumab + paclitaxel was also associated with a delay in TtD in PS to ≥2 (HR = 0.798, P = 0.0941). Alternate definitions of PS deterioration yielded similar results: PS ≥ 3 (HR = 0.656, P = 0.0508), deterioration by ≥1 PS level (HR = 0.802, P = 0.0444), and deterioration by ≥2 PS levels (HR = 0.608, P = 0.0063). EQ-5D scores were comparable between treatment arms, stable during treatment, and worsened at discontinuation. CONCLUSION: In patients with previously treated advanced gastric/GEJ adenocarcinoma, addition of ramucirumab to paclitaxel prolonged overall survival while maintaining patient QoL with delayed symptom worsening and functional status deterioration. CLINICALTRIALSGOV: NCT01170663.

[Morphological peculiarities of the adipose tissue and their significance for the ultrasound lipodestruction].

Using the autopsy material obtained from 20 human corpses, the samples of subcutaneous adipose tissue of the gluteal, abdominal, inguino-ileal and axillar areas, as well as the samples of mesenterial, retroperitoneal, mediastinal, pararectal and paranephral adipose tissue was studied histologically. The average sizes of the lobes and of adipocytes were measured, and the degree of the development of connective tissue elements was determined. Adipose tissue was found to have a similar general structural plan in all the areas studied, however the differences were noted in the thickness of the interlobular connective tissue septae and in tissue vascularization. The gluteal, inguino-ileal and anterior abdominal wall adipose tissue had the highest density. The lobules of this adipose tissue possessed the minimal numbers of adipocytes that had the smallest size. The mediastinal, retroperitoneal and paranephral adipose tissue was classified as a relatively loose one. The velocity of lipodestruction depended the degree of the development of connective tissue septae: this process proceed most rapidly in the mediastinal adipose tissue and most slowly--in the gluteal adipose tissue. In all the other areas studied, the duration of lipodestruction was the intermediate one.

[Liposonodestruction in spleen-saving operations in abdominal oncology].

Based on an analysis of morphological investigations the authors have shown distinctions of the adipose tissue in different topographic-anatomical areas of man. It was found that destruction of fat with an apparatus of sonolipodestruction takes different time. This technology was most efficient when used in operations on organs of the abdominal cavity, in mobilization of the spleen. In combined operations for gastric cancer the technology with sonolipodestruction allows mobilization of the spleen and 10, 11 groups of lymph nodes in obese patients with minimal complications. The technology described improves results of surgical operations in gastric cancer.

[High-intensity ultrasonic destruction of fatty tissue in the course of lymphatic dissection in oncological patients].

The paper discusses experimental findings in support of ultrasound destruction of fat tissue at different sites. Rate of destruction was designed to match that of development of the connective-tissue stroma of adipose tissue and size of adipose cells. Parameters of adipose tissue framework at different sites may be taken into account during extended lymph node dissection using ultrasound liposuction in oncological practice.