Background: To evaluate the tolerability and efficacy of nolatrexed in patients with advanced hepatocellular carcinoma.
Patients And Methods: Forty-eight patients were entered onto this study. Nolatrexed was administered every 3 weeks as a 24-h continuous intravenous infusion of 725 mg/m(2)/day for 5 days. Doses were adjusted to maintain a dose level that produced > or = grade 2 toxicity. Response was assessed after every two cycles. Plasma pharmacokinetic samples were assayed using a validated high performance liquid chromatography ultraviolet method.
Results: Thirty-nine (81%) patients were evaluable for response. The mean number of cycles received was 2.8 (range 1-12). The mean dose intensity was 700 mg/m(2)/day (SD of 71). One patient had a partial response (2.6%) for 7 months. Eighteen (46%) patients had SD, 20 (51%) patients had progressive disease. The median duration of SD was 93 days. The median overall survival was 32 weeks [95% CI (22-37)]. The most frequent Grade 3 or 4 adverse events were stomatitis (25%), dehydration (23%) and asthenia (21%). There was no evidence of cumulative toxicity. The overall median plasma concentration (C (max)) was 14.20 microg/mL (range 1.41 to 119 microg /mL) with no accumulation observed between cycles 1-6.
Conclusion: This phase II study of nolatrexed in advanced HCC patients, demonstrated minimal activity and significant stomatitis. Hence, it does not warrant further study as a single agent for this disease.
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http://dx.doi.org/10.1007/s10637-006-9003-x | DOI Listing |
Palliat Support Care
January 2025
Department of Obstetrics and Gynecology, Inova Fairfax Hospital, Falls Church, VA, USA.
Objectives: To incorporate a longitudinal palliative care curriculum into obstetrics and gynecology (Ob-Gyn) residency that could become standardized to ensure competencies in providing end of life (EOL) care.
Methods: This was a prospective cohort study conducted among 23 Ob-Gyn residents at a tertiary training hospital from 2021 to 2022. A curriculum intervention was provided via lecture and simulation.
Arch Ital Urol Androl
January 2025
Department of Urology, School of Medicine, Shiraz University of Medical Sciences, Shiraz.
Objectives: This research aimed to compare the prostate cancer (PCa) features, survival rate, and functional outcomes after open suprapubic Radical Prostatectomy (RP) between younger men (≤ 55 years) and older men (> 55 years).
Methods: In this retrospective cohort study, we studied 134 patients with clinically localized PCa who underwent RP at our centers between 2011 and 2019, with 26 (19.40%) patients aged ≤ 55.
JHEP Rep
February 2025
Department of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Instituto Ramon y Cajal de Investigación Sanitaria (IRYCIS), Universidad de Alcalá, Madrid, Spain.
Background & Aims: Systemic inflammation is a driver of decompensation in cirrhosis with unclear relevance in the compensated stage. We evaluated inflammation and bacterial translocation markers in compensated cirrhosis and their dynamics in relation to the first decompensation.
Methods: This study is nested within the PREDESCI trial, which investigated non-selective beta-blockers for preventing decompensation in compensated cirrhosis and clinically significant portal hypertension (CSPH: hepatic venous pressure gradient ≥10 mmHg).
World J Gastrointest Endosc
January 2025
Department of Pediatric Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry 605006, India.
The scope of management of malignant gastric outlet obstruction is ever-expanding. The therapeutic use of endoscopy is gaining popularity not just owing to its technical advancement and satisfactory patient outcomes. With technical success rates close to 96%, stent placement for palliating gastric obstruction has ensured a median survival of about 2 months post-deployment of gastro-duodenal stents.
View Article and Find Full Text PDFFront Immunol
January 2025
Department of Nephrology, Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.
Rationale: Acute kidney injury (AKI) is a clinical syndrome associated with a multitude of conditions. Although renal replacement therapy (RRT) remains the cornerstone of treatment for advanced AKI, its implementation can potentially pose risks and may not be readily accessible across all healthcare settings and regions. Elevated lactate levels are implicated in sepsis-induced AKI; however, it remains unclear whether increased lactate directly induces AKI or elucidates the underlying mechanisms.
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