Background. Treatment options for refractory metastatic colorectal cancer (mCRC) were limited. Anlotinib is a novel multitarget tyrosine kinase inhibitor. ALTER0703 study was conducted to assess efficacy and safety of anlotinib for refractory mCRC patients.
The present study investigated the association between the Janus kinase/signal transducer and activator of transcription (JAK/STAT) signaling pathway with tumor progression and prognosis of colon cancer. A total of 62 patients with colon cancer were selected as the colon cancer group, and 40 patients with colon lesions were selected as the benign colon lesion group. Immunohistochemistry was used to detect the expression levels of JAK-1 and STAT-3 proteins in colon tissues. The association of JAK-1 and STAT-3 proteins with the pathological parameters and prognosis of colon cancer were analyzed. The total positive rates of JAK-1 and STAT-3 proteins in lesions of patients in the colon cancer group were significantly higher compared with those in the benign colon lesion group (P<0.05). The positive expression of JAK-1 and STAT-3 proteins in patients with colon cancer were not significantly associated with sex, age, tumor differentiation degree and neurovascular invasion (P>0.05), but significantly associated with the clinical stage of colon cancer, tumor infiltration depth and lymph node metastasis (P<0.05). The survival time of patients with colon cancer with positively-expressed JAK-1 and STAT-3 proteins was significantly shorter compared with that of patients with negatively-expressed JAK-1 and STAT-3 proteins (P<0.05). tumor-node-metastasis (TNM) stage, lymph node metastasis and the expression of JAK-1 and STAT-3 proteins in the tumor were associated with the prognosis of patients with colon cancer (P<0.05). TNM stage and the expression levels of JAK-1 and STAT-3 proteins were independent risk factors influencing the prognosis of colon cancer (P<0.05). The JAK/STAT signal may be used as a novel tumor marker and prognostic factor for the diagnosis, assessment and prognosis of colon cancer.
Background: Opioid titration is necessary to achieve rapid, safe pain relief. Medication can be administered via patient-controlled analgesia (PCA) or by a healthcare provider (non-PCA). We evaluated the efficacy of intravenous PCA versus non-PCA hydromorphone titration for severe cancer pain (≥7 at rest on the 11-point numeric rating scale [NRS]). Patients and Methods: Patients with severe cancer pain were randomized 1:1 to PCA or non-PCA titration, stratified by opioid-tolerant or opioid-naïve status. The PCA pump was set to no continuous dose, with a hydromorphone bolus dose 10% to 20% of the total previous 24-hour equianalgesic (for opioid-tolerant patients) or 0.5 mg (for opioid-naïve patients). For the non-PCA group, the initial hydromorphone bolus dose was identical to that in the PCA group, with the subsequent dose increased by 50% to 100% (for NRS unchanged or increased) or repeated at the current dose (for NRS 4–6). Hydromorphone delivery was initiated every 15 minutes (for NRS ≥4) or as needed (for NRS ≤3). The primary endpoint was time to successful titration (TST; time from first hydromorphone dose to first occurrence of NRS ≤3 in 2 consecutive 15-minute intervals). Results: Among 214 patients (PCA, n=106; non-PCA, n=108), median TSTs (95% CI) were 0.50 hours (0.25–0.50) and 0.79 hours (0.50–1.42) for the PCA and non-PCA groups, respectively (hazard ratio [HR], 1.64; 95% CI, 1.23–2.17; P=.001). TSTs in opioid-tolerant patients were 0.50 hours (0.25–0.75) and 1.00 hours (0.50–2.00) for the PCA and non-PCA groups, respectively (HR, 1.92; 95% CI, 1.32–2.78; P=.003); in opioid-naive patients, TST was not significantly different for the PCA versus non-PCA groups (HR, 1.35; 95% CI, 0.88–2.04; P=.162). Pain score (median NRS; interquartile range) over 24 hours was significantly lower in the PCA group (2.80; 2.15–3.22) than in the non-PCA group (3.00; 2.47–3.53; P=.020). PCA administration produces significantly higher patient satisfaction with pain control than non-PCA administration (P<.001). Conclusions: Intravenous hydromorphone titration for severe cancer pain was achieved more effectively with PCA than with non-PCA administration.
Background: Apatinib combined with chemotherapy might be effective and safe for the management of advanced gastric cancer, but the available data are limited. To investigate the efficacy and safety of apatinib in combination with paclitaxel (PTX) alone or POF (PTX, oxaliplatin, and 5-fluorouracil) in patients with taxane-resistant advanced gastric cancer.Methods: Patients with taxane-resistant advanced gastric cancer were enrolled in the single-center, openlabeled, single-arm, exploratory study (ClinicalTrials.gov #NCT02697838). Apatinib was administered at 850 mg po in combination with weekly PTX or the POF regimen. The primary endpoint was the objective response rate (ORR). The secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), the time to tumor progression (TTP), and safety.Results: Twenty participants were recruited from 08/2016 to 01/2018. The duration of the study treatment was 2.07 (0.03-16.2) months. The median follow-up was 24.8 (0.3-26.0) months. The reasons for termination of treatment were disease progression (n=6), adverse events (AEs) (n=5), and patients' will (n=9). The ORR was 11.1% (95% CI: 1.4-34.7%) and the DCR was 77.8% (95% CI: 52.4-93.6%). The median PFS was 3.5 (95% CI: 1.9-5.1) months, the median OS was 4.7 (95% CI: 2.0-7.3) months, and the median TTP was 4.2 (95% CI: 0.562-7.838) months. All 20 (100%) patients had AEs, 17 (85%) had apatinib treatment-emergent AEs (TEAEs), and 18 (90%) had chemotherapy TEAEs. The main grade 3-4 TEAEs were neutropenia, leukopenia, hypertension, and anemia.Conclusions: This preliminary study suggests that apatinib combined with PTX or POF might be effective and tolerable in patients with chemotherapy-refractory gastric cancer. Studies are necessary to confirm the results.Trial registration: ClinicalTrials.gov #NCT02697838.
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