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A nonrandomized cohort and a randomized study of local control of large hepatocarcinoma by targeting intratumoral lactic acidosis.
Chao, M, Wu, H, Jin, K, Li, B, Wu, J, Zhang, G, Yang, G, Hu, X
eLife. 2016
Abstract
BACKGROUND Previous works suggested that neutralizing intratumoral lactic acidosis combined with glucose deprivation may deliver an effective approach to control tumor. We did a pilot clinical investigation, including a nonrandomized (57 patients with large HCC) and a randomized controlled (20 patients with large HCC) study. METHODS The patients were treated with transarterial chemoembolization (TACE) with or without bicarbonate local infusion into tumor. RESULTS In the nonrandomized controlled study, geometric mean of viable tumor residues (VTR) in TACE with bicarbonate was 6.4-fold lower than that in TACE without bicarbonate (7.1% [95% CI: 4.6%–10.9%] vs 45.6% [28.9%–72.0%]; p<0.0001). This difference was recapitulated by a subsequent randomized controlled study. TACE combined with bicarbonate yielded a 100% objective response rate (ORR), whereas the ORR treated with TACE alone was 44.4% (nonrandomized) and 63.6% (randomized). The survival data suggested that bicarbonate may bring survival benefit. CONCLUSIONS Bicarbonate markedly enhances the anticancer activity of TACE. FUNDING Funded by National Natural Science Foundation of China. CLINICAL TRIAL NUMBER ChiCTR-IOR-14005319.
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Exploring the relationship between patients' information preference style and knowledge acquisition process in a computerized patient decision aid randomized controlled trial.
Sawka, AM, Straus, S, Rodin, G, Tsang, RW, Brierley, JD, Rotstein, L, Segal, P, Gafni, A, Ezzat, S, Goldstein, DP
BMC medical informatics and decision making. 2015;:48
Abstract
BACKGROUND We have shown in a randomized controlled trial that a computerized patient decision aid (P-DA) improves medical knowledge and reduces decisional conflict, in early stage papillary thyroid cancer patients considering adjuvant radioactive iodine treatment. Our objectives were to examine the relationship between participants' baseline information preference style and the following: 1) quantity of detailed information obtained within the P-DA, and 2) medical knowledge. METHODS We randomized participants to exposure to a one-time viewing of a computerized P-DA (with usual care) or usual care alone. In pre-planned secondary analyses, we examined the relationship between information preference style (Miller Behavioural Style Scale, including respective monitoring [information seeking preference] and blunting [information avoidance preference] subscale scores) and the following: 1) the quantity of detailed information obtained from the P-DA (number of supplemental information clicks), and 2) medical knowledge. Spearman correlation values were calculated to quantify relationships, in the entire study population and respective study arms. RESULTS In the 37 P-DA users, high monitoring information preference was moderately positively correlated with higher frequency of detailed information acquisition in the P-DA (r = 0.414, p = 0.011). The monitoring subscale score weakly correlated with increased medical knowledge in the entire study population (r = 0.268, p = 0.021, N = 74), but not in the respective study arms. There were no significant associations with the blunting subscale score. CONCLUSIONS Individual variability in information preferences may affect the process of information acquisition from computerized P-DA's. More research is needed to understand how individual information preferences may impact medical knowledge acquisition and decision-making.
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Fast track for elderly patients: is it feasible for colorectal surgery?
Compagna, R, Aprea, G, De Rosa, D, Gentile, M, Cestaro, G, Vigliotti, G, Bianco, T, Massa, G, Amato, M, Massa, S, et al
International journal of surgery (London, England). 2014;:S20-S22
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Abstract
BACKGROUND Fast-track program has been applied in several surgical fields. However, currently many surgical patients are elderly over 70 years of age, and discussion about the application of such protocols for elderly patients is inadequate. MATERIALS AND METHODS The present study was designed to consider the safety and feasibility of application of a fast-track program after colorectal surgery in elderly patients. A total of 76 elderly patients with colorectal cancer who underwent laparoscopic colorectal resection were randomly assigned to receive either the fast-track care program (n = 40) or the conventional perioperative care protocol (control group, n = 36). The fast track protocol included no preoperative mechanical bowel irrigation, immediate oral alimentation and earlier postoperative ambulation exercise. The length of postoperative hospital stay, the length of time to regain bowel function and the rate of postoperative complications were compared between the two groups. RESULTS The length of time to regain bowel function, including the passage of flatus [32 (24-40) h vs 42 (32-52) h], and to start a liquid diet (13 [10-16] h v/s 43 [36-50] h) were significantly shorter in patients receiving the fast track care protocol compared with those receiving the conventional care protocol. A shorter duration of postoperative hospital stay was recorded in patients receiving the fast-track program than in those receiving conventional care [6 (5-7) days v/s 9.5 (7-12) days]. A reduced percentage of patients who developed general complications was also observed in the fast-track group (5.0% v/s 18%). CONCLUSION Fast-track after laparoscopic colorectal surgery can be safely applied in carefully selected elderly patients older than age 70 years. The fast-track recovery program resulted in a more rapid postoperative recovery, earlier discharge from hospital and fewer general complications compared with a conventional postoperative protocol.
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Randomized crossover pharmacokinetic study of solvent-based paclitaxel and nab-paclitaxel.
Gardner, ER, Dahut, WL, Scripture, CD, Jones, J, Aragon-Ching, JB, Desai, N, Hawkins, MJ, Sparreboom, A, Figg, WD
Clinical cancer research : an official journal of the American Association for Cancer Research. 2008;(13):4200-5
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Abstract
PURPOSE Abraxane (ABI-007) is a 130-nm albumin-bound (nab) particle formulation of paclitaxel, devoid of any additional excipients. We hypothesized that this change in formulation alters the systemic disposition of paclitaxel compared with conventional solvent-based formulations (sb-paclitaxel; Taxol), and leads to improved tolerability of the drug. PATIENTS AND METHODS Patients with malignant solid tumors were randomized to receive the recommended single-agent dose of nab-paclitaxel (260 mg/m(2) as a 30-minute infusion) or sb-paclitaxel (175 mg/m(2) as a 3-hour infusion). After cycle 1, patients crossed over to the alternate treatment. Pharmacokinetic studies were carried out for the first cycle of sb-paclitaxel and the first two cycles of nab-paclitaxel. RESULTS Seventeen patients were treated, with 14 receiving at least one cycle each of nab-paclitaxel and sb-paclitaxel. No change in nab-paclitaxel pharmacokinetics was found between the first and second cycles (P = 0.95), suggesting limited intrasubject variability. Total drug exposure was comparable between the two formulations (P = 0.55) despite the dose difference. However, exposure to unbound paclitaxel was significantly higher after nab-paclitaxel administration, due to the increased free fraction (0.063 +/- 0.021 versus 0.024 +/- 0.009; P < 0.001). CONCLUSION This study shows that paclitaxel disposition is subject to considerable variability depending on the formulation used. Because systemic exposure to unbound paclitaxel is likely a driving force behind tumoral uptake, these findings explain, at least in part, previous observations that the administration of nab-paclitaxel is associated with augmented antitumor efficacy compared with solvent-based paclitaxel.