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A randomized, controlled trial evaluating the efficacy and safety of BTH1677 in combination with bevacizumab, carboplatin, and paclitaxel in first-line treatment of advanced non-small cell lung cancer.
Engel-Riedel, W, Lowe, J, Mattson, P, Richard Trout, J, Huhn, RD, Gargano, M, Patchen, ML, Walsh, R, Trinh, MM, Dupuis, M, et al
Journal for immunotherapy of cancer. 2018;(1):16
Abstract
BACKGROUND BTH1677, a beta-glucan pathogen-associated molecular pattern molecule, drives an anti-cancer immune response in combination with oncology antibody therapies. This phase II study explored the efficacy, pharmacokinetics (PK), and safety of BTH1677 combined with bevacizumab/carboplatin/paclitaxel in patients with untreated advanced non-small cell lung cancer (NSCLC). METHODS Patients were randomized to the BTH1677 arm (N = 61; intravenous [IV] BTH1677, 4 mg/kg, weekly; IV bevacizumab, 15 mg/kg, once each 3-week cycle [Q3W]; IV carboplatin, 6 mg/mL/min Calvert formula area-under-the-curve, Q3W; and IV paclitaxel, 200 mg/m2, Q3W) or Control arm (N = 31; bevacizumab/carboplatin/paclitaxel as above). Carboplatin/paclitaxel was discontinued after 4-6 cycles and patients who responded or remained stable received maintenance therapy with BTH1677/bevacizumab (BTH1677 arm) or bevacizumab (Control arm). Efficacy assessments, based on blinded central radiology review, included objective response rate (ORR; primary endpoint), disease control rate, duration of objective response, and progression-free survival. Overall survival and adverse events (AEs) were also assessed. RESULTS ORR was higher in the BTH1677 vs Control arm but the difference between groups was not statistically significant (60.4% vs 43.5%; P = .2096). All other clinical endpoints also favored the BTH1677 arm but none statistically differed between arms. PK was consistent with previous studies. Although a higher incidence of Grade 3/4 AEs occurred in the BTH1677 vs Control arm (93.2% vs 66.7%), no unexpected AEs were observed. Serious AEs and discontinuations due to AEs were lower in the BTH1677 vs Control arm. CONCLUSIONS Improvements in tumor assessments and survival were observed with BTH1677/bevacizumab/carboplatin/paclitaxel compared with control treatment in patients with advanced NSCLC. TRIAL REGISTRATION ClinicalTrials.gov registration ID: NCT00874107 . Registered 2 April 2009. First participant was enrolled on 29 September 2009.
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Is preoperative protein-rich nutrition effective on postoperative outcome in non-small cell lung cancer surgery? A prospective randomized study.
Kaya, SO, Akcam, TI, Ceylan, KC, Samancılar, O, Ozturk, O, Usluer, O
Journal of cardiothoracic surgery. 2016;:14
Abstract
OBJECTIVE Protein-rich nutrition is necessary for wound healing after surgery. In this study, the benefit of preoperative nutritional support was investigated for non-small cell lung cancer patients who underwent anatomic resection. METHODS A prospective study was planned with the approval of our institutional review board. Fifty-eight patients who underwent anatomic resection in our department between January 2014 and December 2014 were randomized. Thirty-one patients were applied a preoperative nutrition program with immune modulating formulae (enriched with arginine, omega-3 fatty acids and nucleotides) for ten days. There were 27 patients in the control group who were fed with only normal diet. Patients who were malnourished, diabetic or who had undergone bronchoplastic procedures or neoadjuvant therapy were excluded from the study. Patients' baseline serum albumin levels, defined as the serum albumin level before any nutrition program, and the serum albumin levels on the postoperative third day were calculated and recorded with the other data. RESULTS Anatomic resection was performed by thoracotomy in 20 patients, and 11 patients were operated by videothoracoscopy in the nutrition program group. On the other hand 16 patients were operated by thoracotomy and 11 patients were operated by videothoracoscopy in the control group. In the control group, the patients' albumin levels decreased to 25.71 % of the baseline on the postoperative third day, but this reduction was only 14.69 % for nutrition program group patients and the difference was statistically significant (p < 0.001). Complications developed in 12 patients (44.4 %) in the control group compared to 6 patients in the nutrition group (p = 0.049). The mean chest tube drainage time was 6 (1-42) days in the control group against 4 (2-15) days for the nutrition program group (p = 0.019). CONCLUSIONS Our study showed that preoperative nutrition is beneficial in decreasing the complications and chest tube removal time in non-small cell lung cancer patients that were applied anatomic resection with a reduction of 25 % in the postoperative albumin levels of non-malnourished patients who underwent resection.
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[Effect of oleum fructus brucease injection via bronchial arterial infusion in treating advanced lung cancer].
Bai, ZP, Deng, XS
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine. 2010;(8):838-40
Abstract
OBJECTIVE To explore the clinical effects of bronchial arterial infusion (BAI) with oleum fructus bruceae (OFB) Injection and chemotherapeutic agents (CTA) in treating advanced non-small cell lung cancer (NSCLC). METHODS One hundred and three patients with advanced NSCLC were randomized into 2 groups, the 98 patients in the treatment group treated by BAI with OFB + CTA and the 50 in the control group by BAI with CTA alone. The incidence of adverse reaction, change of tumor size and patients' quality of life (QOL) in the two groups were observed and compared. RESULTS The objective effective rate (CR + PR) was 63.3% in the treatment group and 46.0% in the control group (P < 0.01); the median survival duration in them was 363 days and 305 days; the 1-year cumulative survival rate was 70.4% and 44.0%, and the QOF improving rate was 83.7% and 62.0% respectively, the difference between groups were all statistically significant (P < 0.01). In addition, the incidence of adverse reactions of digestive symptoms, bone marrow suppression and the hepato-, renal and cardiac toxicities were lower in the treatment group than those in the control group (P < 0.01). CONCLUSION BAI with OFB + CTA in treating NSCLC could enhance the objective therapeutic effect of simple chemotherapy, as well as raise the QOL and protect immune and medulla function in patients.
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Vitamin E and beta-carotene supplementation and hospital-treated pneumonia incidence in male smokers.
Hemilä, H, Virtamo, J, Albanes, D, Kaprio, J
Chest. 2004;(2):557-65
Abstract
BACKGROUND Vitamin E and beta-carotene affect various measures of immune function and accordingly might influence the predisposition of humans to infections. However, only few controlled trials have tested this hypothesis. STUDY OBJECTIVE To examine whether vitamin E or beta-carotene supplementation affects the risk of pneumonia in a controlled trial. DESIGN AND SETTING The Alpha-Tocopherol Beta-Carotene Cancer Prevention (ATBC) study, a randomized, double-blind, placebo-controlled trial that examined the effects of vitamin E, 50 mg/d, and beta-carotene, 20 mg/d, on lung cancer using a 2 x 2 factorial design. The trial was conducted in the general community in southwestern Finland in 1985 to 1993; the intervention lasted for 6.1 years (median). The hypothesis being tested in the present study was formulated after the trial was closed. PARTICIPANTS ATBC study cohort of 29,133 men aged 50 to 69 years, who smoked at least five cigarettes per day, at baseline. MAIN OUTCOME MEASURE The first occurrence of hospital-treated pneumonia was retrieved from the national hospital discharge register (898 cases). RESULTS Vitamin E supplementation had no overall effect on the incidence of pneumonia (relative risk [RR], 1.00; 95% confidence interval [CI], 0.88 to 1.14) nor had beta-carotene supplementation (RR, 0.98; 95% CI, 0.85 to 1.11). Nevertheless, the age of smoking initiation was a highly significant modifying factor. Among subjects who had initiated smoking at a later age (> or =21 years; n = 7,469 with 196 pneumonia cases), vitamin E supplementation decreased the risk of pneumonia (RR, 0.65; 95% CI, 0.49 to 0.86), whereas beta-carotene supplementation increased the risk (RR, 1.42; 95% CI, 1.07 to 1.89). CONCLUSIONS Data from this large controlled trial suggest that vitamin E and beta-carotene supplementation have no overall effect on the risk of hospital-treated pneumonia in older male smokers, but our subgroup finding that vitamin E seemed to benefit subjects who initiated smoking at a later age warrants further investigation.
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[Clinical observation of music therapy combined with anti-tumor drugs in treating 116 cases of tumor patients].
Cai, GR, Li, PW, Jiao, LP
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine. 2001;(12):891-4
Abstract
OBJECTIVE To observe the clinical effect of music therapy in treating tumor patients. METHODS Music therapy combined with anti-tumor drugs, including chemotherapy and Chinese drugs, was given to 162 tumor patients according to syndrome differentiation to observe the change of self-rating depression scale (SDS), self-rating anxiety scale (SAS), minnesota multiphasic personality inventory (MMPI), Hamilton rating scale for depression (HAMD) and T lymphocyte subsets (immuno-histochemical assay), NK cell anti-tumor activity (NAG method), etc. while 46 caces didn't receive music therapy were taken as the control group. RESULTS The scale marks of SDS and SAS of the treated group after treatment were obviously lower than that of the control group significantly (P < 0.05, P < 0.01). After treatment, the average values of MMPI on falseness (F), hypochondriasis (HS), depression (D) and psychosthenia (Pt) in the treated group were all improved (P < 0.01 or P < 0.05); but in the control group, significant difference only showed in MMPI on HS (P < 0.05). HAMD in the treated group revealed some improvement in insomnia, early awakening, daily work and interest, systemic symptoms and hypochondriasis (P < 0.05), and significant improvement in depression, difficulty in falling asleep, psychiatric anxiety and somatic anxiety (P < 0.01); while in the control group, only work interest and HS had some improvement (P < 0.05). CD8 percent was reduced in both groups after treatment (P < 0.01), but in the treated group CD3, CD4 and CD4/CD8 ratio were not significantly changed after treatment (P > 0.05); while in the control group they lowered obviously (P < 0.05). As for NK cell anti-tumor activity in the treated group before and after treatment, it was not significantly lowered (P > 0.05); while in the control group the lowering after treatment was significant (P < 0.05). CONCLUSION Music therapy could regulate the emotion of tumor patient, optimize the emotional effect, improve the somatic symptoms, enhance the immune function, motivate the active principle and raise the self-regulating power in the body.
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[Clinical study on treatment of advanced non-small cell lung cancer with Chinese herbal medicine combined with synchronous radio- and chemotherapy].
Liu, X, Wang, B, Fu, X
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine. 2000;(6):427-9
Abstract
OBJECTIVE To explore the effect of applying Chinese herbal medicine according to Syndrome Differentiation of TCM combined with synchronous radio- and chemotherapy (combination therapy) in treating advanced non-small cell lung cancer (NSCLC). METHODS The 56 patients in the group A were treated with combination therapy, and the 44 patients in the group B treated with synchronous radio- and chemotherapy, while the 34 patients in the group C treated with non-synchronous radio- and chemotherapy. The efficacy of treatment in the three groups were observed and compared. RESULTS The immediate effective rate in the A, B, C groups was 87.5%, 84.1% and 55.9% respectively, that in the group A and B was better than that in the group C (P < 0.01). The median survival time in the three groups was 16.4, 11.8 and 10.6 months respectively. The 2-year and 3-year survival rate in the group A were markedly higher than those in the group B (P < 0.05), moreover, the clinical symptoms, Karnovsky scoring and immune function were obviously improved in the group A (P < 0.05, P < 0.01). CONCLUSION Effect of the combination therapy is superior to that of synchronous radio- and chemotherapy alone in improving immune function, elevating quality of life and prolongating survival time of patients with NSCLC.