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Nanoparticle Albumin-bound Paclitaxel Plus Carboplatin Induction Followed by Nanoparticle Albumin-bound Paclitaxel Maintenance in Squamous Non-Small-cell Lung Cancer (ABOUND.sqm): A Phase III Randomized Clinical Trial
Spigel DR, Jotte RM, Aix SP, Gressot L, Morgensztern D, McCleod M, Socinski MA, Daniel D, Juan-Vidal O, Mileham KF, et al
Clinical lung cancer. 2020
Abstract
BACKGROUND We evaluated maintenance nanoparticle albumin-bound (nab) paclitaxel in the treatment of advanced squamous non-small-cell lung cancer. PATIENTS AND METHODS Patients with treatment-naive squamous non-small-cell lung cancer received four 21-day cycles of nab-paclitaxel 100 mg/m(2) on days 1, 8, 15 plus carboplatin area under the curve 6 on day 1 as induction therapy. Patients without disease progression after induction were randomized 2:1 to maintenance nab-paclitaxel 100 mg/m(2) (days 1 and 8 every 21 days) plus best supportive care (BSC) or BSC alone. The primary endpoint was progression-free survival (PFS). Secondary endpoints included safety and overall survival (OS). RESULTS Overall, 420 patients had received induction therapy; 202 (nab-paclitaxel plus BSC, 136; BSC, 66) had received maintenance therapy. Enrollment was discontinued after a preplanned interim futility analysis (patients could remain in the study at the investigator's discretion). The median PFS was 3.12 months for nab-paclitaxel plus BSC and 2.60 months for BSC; the difference was not statistically significant (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.61-1.19; P = .36). The median OS (median follow-up, 24.2 months) was 17.18 months for nab-paclitaxel plus BSC and 12.16 months for BSC (HR, 0.70; 95% CI, 0.48-1.02; nominal P = .07). An updated analysis (median follow-up, 28.4 months) revealed a median OS of 17.61 months for nab-paclitaxel plus BSC and 12.16 months for BSC (HR, 0.68; 95% CI, 0.47-0.98; nominal P = .037). The most frequent grade 3 and 4 treatment-emergent adverse events for the entire study were neutropenia (53.1% [nab-paclitaxel plus BSC] vs. 50.0% [BSC]) and anemia (33.1% [nab-paclitaxel plus BSC] vs. 32.3% [BSC]). Only peripheral neuropathy had occurred in ≥ 5% of patients during maintenance therapy (13.1%; nab-paclitaxel plus BSC). CONCLUSIONS The results of the ABOUND.sqm did not meet the primary endpoint of PFS. An updated OS analysis revealed a trend favoring nab-paclitaxel plus BSC.
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Study on the Effect of Nano Albumin Paclitaxel Combined with Carboplatin in the Treatment of Lung Squamous Cell Carcinoma
Wang H, Mou S, Tu M
J Nanosci Nanotechnol. 2020;20(12):7439-7443
Abstract
This study aims to compare the efficacy and side effects of albumin-binding paclitaxel plus carboplatin (NAB PC) and paclitaxel plus carboplatin (PC) in the first-line treatment of advanced non-small cell lung cancer (NSCLC). A total of 60 patients with advanced NSCLC diagnosed by histopathology or cytology were randomly divided into nab PC group (albumin-binding paclitaxel 130 mg/mL, D1, D; carboplatin AUC = 6, D1) and PC group (paclitaxel 175 mg/mL, D1; carboplatin AUC = 6, D1), one cycle every three weeks. RECIST 1.1 standard was used to evaluate the short-term objective efficacy, and who acute and subacute toxicity classification standard was used to evaluate the toxicity. The total effective rate (RR) and disease control rate (DCR) of NAB PC group were 40.0% and 80.0%, respectively, which were higher than 23.3% and 60.0% of the PC group, respectively. This difference was statistically significant (p < 0.05). In squamous cell carcinoma, the RR of NAB PC group and PC group were 57.1% (8/14) and 23.1% (3/13) respectively, with a statistically significant difference (p < 0.05); in non-squamous cell carcinoma, the RR of the two groups were 25.0% (4/16) and 23.3% (4/17) without statistical significance (p > 0.05). The median progression free survival time of the NAB PC group and PC group was 6.5 and 5.9 months, respectively, with no significant difference (p>0.05). No significant difference arose in the incidence of grade III-IV toxicity between the two groups (p > 0.05). The incidence of neutropenia in the NAB PC group was higher than that in the PC group (p < 0.05). The therapeutic effect of paclitaxel combined with carboplatin in the treatment of advanced NSCLC is better, the effect of paclitaxel combined with carboplatin is better, and the side effects can be tolerated, which is worthy of clinical application. Patients are more satisfied with their care.
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Alternatives to albumin administration in hepatocellular carcinoma patients undergoing hepatectomy: an open, randomized clinical trial of efficacy and safety
Yang J, Wang WT, Yan LN, Xu MQ, Yang JY
Chinese Medical Journal. 2011;124((10):):1458-64.
Abstract
BACKGROUND The value of artificial colloids in treating patients with liver disease is controversial. The effects of intravascular volume replacement regimens on liver function secondary to alteration of the postoperative inflammatory response are not known. In this study, we evaluated the effects of different volume replacement regimens in hepatocellular carcinoma patients undergoing hepatectomy to clarify whether albumin administration can be replaced by other volume replacement products. METHODS Ninety consecutive hepatocellular carcinoma patients scheduled for hepatectomy were prospectively randomized to receive 20% human albumin (HA), 6% hydroxyethyl starch (HES) or lactated Ringer's solution (LR) for postoperative volume replacement. Hemodynamic, liver function and inflammatory response parameters were recorded on postoperative days one, three, and five throughout the investigation period. RESULTS Significantly less volume was required in the HA and the HES groups. Although patients in all groups had similar baseline values, the plasma osmolality was significantly higher in the HA and HES groups. Total bilirubin (TB), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) increased from baseline in all groups, and did not differ significantly between groups. C-reactive protein (CRP) was significantly lower in the HES group compared with the other groups. CONCLUSIONS In hepatocellular carcinoma patients undergoing hepatectomy, HA can be replaced by HES or LR in well selected patients. Hemodynamic stability, liver function, and postoperative clinical outcomes could be equivalently achieved in the HES group; also, HES may exert more favorable effects on the acute phase response.
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Effect of hydroxyethyl starch HES 450/0.7 and 5% human albumin on the colloid osmotic pressure and hemodynamic parameters in hypovolemic patients after major abdominal procedures . German
Gahr R, Bock PR
Infusionstherapie und Klinische Ernahrung. 1981;8((3):):147-52.
Abstract
In a randomized study 20 patients with hypovolemia following abdominal surgery for malignoma were treated with 500 ml HES 450/0.7 or human albumin 5% during the first 24 h after operation. COP and various blood- and hemodynamic parameters were measured immediately before and after infusion as well as 2, 4 and 6 h after infusion. After HES-infusion COP increased from 20.2 to about 22 mmHg and remained at a significantly higher level (p less than 0.01) for 6 h. After albumin-infusion COP increased from 19.7 to 20.7 mmHg, but already returned to starting level within 2 h. CVP in the HES-group increased from 2.8 to 6.3 cmH2O after infusion, and then gradually dropped to 4 cmH2O during 6 h. In the albumin-group CVP increased from the same starting level only to 4.2 cmH2O, and then dropped back to 3.2 cmH2O after 6 h (no significant difference to the starting level). The other blood- and hemodynamic parameters measured showed no significant differences between the two groups. The results show that a quick and reliable improvement of hypovolemia can be obtained in both groups immediately after infusion, but that the COP- and volume-stabilizing effects of HES-infusion are more distinct and remained for a significantly longer period of time than the effects of albumin 5%-infusion.
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Is albumin therapy worthwhile in surgery for colorectal cancer?
Nilsson E, Lamke LO, Liljedahl SO, Elfstrom K
Acta Chirurgica Scandinavica. 1980;146((8):):619-22.
Abstract
Patients with colorectal cancer undergoing elective surgery with resection of the tumour and primary anastomosis were randomly allocated into two groups. 29 patients received a total of 60-75 g of albumin postoperatively, 30 patients received no albumin and served as controls. The two groups were comparable with respect to age and sex of the patients and stage of growth of the tumour. The patients who received albumin had a significantly lower preoperative serum albumin concentration. On day 4 after the operation the serum albumin concentrations of the control patients and the patients who received albumin were 20% and 5% lower, respectively, than the preoperative value. Eight patients of the albumin group and 5 of the control group developed postoperative complications. There was no significant difference in the postoperative clinical course between the two groups. Preoperative serum albumin levels did not differ between patients who developed postoperative complications and those who had an uneventful postoperative course whether or not they received albumin postoperatively. The present study does not confirm earlier results indicating that serum albumin alone is of prognostic value for the postoperative course following colorectal surgery. Furthermore, the postoperative course is not improved by addition of albumin postoperatively and hence albumin should be given in this situation only when its specific oncotic effect is required.