Anti-calcitonin gene-related peptide monoclonal antibodies (CGRPmAbs) are a favourable option for patients with migraine who experience distressful headache disability and fail to respond to traditional preventive treatment options. However, since CGRPmAb has been available for only 2 years in Japan, the difference between good and poor responders remains unknown. We aimed to investigate the clinical characteristics of patients with migraine in Japan who responded well to CGRPmAb based on real-world data.We analysed patients who visited Keio University Hospital, Tokyo, Japan, between the 12th of August 2021 and 31st of August 2022, and were prescribed one of three CGRPmAbs (erenumab, galcanezumab, and fremanezumab) for more than 3 months. We recorded the patients' basic migraine characteristics, such as pain quality, monthly migraine days (MMD)/monthly headache days (MHD), and the number of prior treatment failures. We defined good responders as patients whose MMDs decreased by more than 50% after 3 months of treatment and other patients as poor responders. We compared the baseline migraine characteristics between the two groups and performed logistic regression analysis based on the items that showed statistically significant differences.In total, 101 patients were considered eligible for the responder analysis (galcanezumab: 57 (56%), fremanezumab: 31 (31%), and erenumab: 13 (13%)). After 3 months of treatment, 55 (54%) patients achieved ≥ 50% reduction in MMDs. Comparisons between ≥ 50% responders and non-responders revealed that age was significantly higher (p = 0.003), and MHD and total prior treatment failures were significantly lower (p = 0.027, 0.040, respectively), in responders than in non-responders. Age was a positive predictive factor, and the total number of prior treatment failures and past medical history of immuno-rheumatologic diseases were negative predictive factors of CGRPmAb responsiveness in Japanese patients with migraine.Patients with migraine who are older, with fewer prior treatment failures and no past history of immuno-rheumatologic disease, may respond well to CGRPmAbs.
4058 Background: The recent global concern about the early onset cancer (EOC) has been rising in the field of GI cancers. Precision oncology based on comprehensive genome profile (CGP) test is anticipated to attribute the improvement of cancer treatment for EOC. This study explored the genetic alteration of EOC and association with genome matched therapy in colorectal cancer (CRC) and gastric or gastroesophageal junction cancer (G/GEJC). Methods: We retrospectively assessed Japanese nationwide, the Center for Cancer Genomics and Advanced Therapeutics (C-CAT) database. Pts meets following eligibility criteria were enrolled. 1) Pts received the reimbursed CGP tests between June 2019 and May 2023 in Japan, 2) pts registered as CRC or G/GEJC, 3) pts agreed with the utilization of their data. We defined EOC as diagnosed at less than 50 and 40 in EO-CRC and EO-G/GEJC, respectively. We investigated the genomic alterations of EOC and compared the genes with a difference in frequency of 5% or more between earlier and later onset cancer of disease. The transition rate to the subsequent matched therapy was compared between EOC and non-EOC. This study was approved by both the ethics committee of Cancer Institute Hospital of JFCR (No. 2022-GB-121) and C-CAT data utilization review board (No. AP20230309-01N). Results: Among a total of 8,180 eligible pts, 1,289 (19.9%) and 123 (7.2%) EOC were identified in CRC and G/GEJC, respectively. Tissue based assay with Foundation One (n = 6.591, 80.6%) was most frequently employed as CGP test. TP53 (84.1%), APC (77.2%) and KRAS (49.5%) mutation were most frequently occurred in EO CRC. Meanwhile, TP53 (64.2%), CDH1 (36.5%) and ARID1A (17.1%) mutation were the most prevalent in EO G/GEJC. Among the top 30th somatically mutated genes in EO CRC and EO G/GEJC, 31 (96.9%) and 29 (85.3%) genes shared with non-EO in CRC and G/GEJC, respectively. Notably, the proportion of shared genes was significantly decline to 21 (71.9%) and 18 (52.9%) in CRC and G/GEJC when they compared between pts aged <30 and ≥30 years old. The proportion of pts harboring at least one actionable mutation was 42.3% in EO CRC similar to that of non-EO CRC (43.2%) and 19.5% in EO G/GEJC and lower than that of non-EO G/GEJC (32.2%), respectively. The proportions of individuals who received targeted therapy as recommended by CGP test were all approximately 5% (EOC vs. non-EOC: 6.4% vs. 5.6% in CRC and 4.1% vs. 4.4% in G/GEJC). The treatment access rate was not improved in very young pts (aged <30). Conclusions: Genomic alterations were mostly shared between EOC and non-EOC in pts with CRC and G/GEJC. The mutation profile apparently differs between earlier onset (<30) and later onset (≥30) both in CRC and G/GEJC. Very limited proportion of EOC could access the matched therapy after CGP test in the treatment of CRC and G/GEJC as well as non-EOC.
Headache is an adverse event of coronavirus 2019 (COVID-19) vaccination. Whether patients with history of headache suffer more from vaccination-induced headaches is unknown. We aimed to uncover if headache patients develop more headaches after COVID-19 mRNA vaccination than healthy controls.We performed a questionnaire survey for nursing staff in our hospital from April to May 2021. Based on baseline characteristics, we divided the participants into migraine, non-migrainous headache, and healthy control, and examined the occurrence and features of headache after COVID-19 vaccinations.We included 171 participants (15.2% migraine and 24.6% non-migrainous headache). Headache incidence after vaccinations was significantly higher in the migraine (69.2%) and non-migrainous headache (71.4%) groups than in the healthy control (37.9%) group. The incidence of headaches was significantly higher after the second dose compared to the first (45.6% vs. 20.5%).Migraineurs and non-migrainous headache participants developed more headaches compared to the healthy controls after COVID-19 vaccination.
Abstract This meta-analysis aimed to evaluate the device performance of conventional balloon catheters (POBA), drug-coated balloons (DCB), bare-metal stents (BMS), and drug-eluting stents (DES) in below-the-knee (BTK) ischemic lesions with regard to lesion characteristics. Online searches of PubMed, Web of Science, and Cochrane databases (2010–2019) were conducted for each of the test devices. Primary patency rates (pp) and major amputation rates 1 year after the use of each device were analyzed using a random-effects meta-analysis model. Meta-regression analysis was conducted to test associations between the outcomes and lesion characteristics. The analysis included 18 studies reporting on 24 separate cohorts comprising 2,438 patients. DES demonstrated the best pp among the test devices (83.6%; 95% confidence interval = 78.4–88.8%, studies = 8; I 2 = 66%, P = 0.005). A negative coefficient between lesion length and pp ( P = 0.002) was obtained. The ratio of critical limb ischemia (CLI) patients impacted the amputation rates ( P = 0.031), whereas no statistically significant difference was found between the devices. DES showed favorable pp in BTK lesions; however, as the lesion lengths using DES were short, pp in long lesions still needs to be evaluated. Shorter lesions gained better pp. A higher ratio of CLI patients resulted in increased amputation rates.
The pain of skin graft site after surgery is compara- tively severe. We present three cases of combined of ultrasound-guided femoral nerve block and lateral fem- oral cutaneous nerve block that was effective for har- vesting skin grafts. Case 1 : a 32-year-old man had a split-thickness skin grafting of lateral upper arm harvested from outside of the thigh under general anesthesia, brachial nerve block, femoral nerve block and lateral femoral cutane- ous nerve block. Case 2 : a 39-year-old man had split-thickness skin grafting of lower thigh harvested from outside of the thigh under general anesthesia, femoral nerve block and lateral femoral cutaneous nerve block. Case 3 : a 94-year-old man had split-thickness skin grafting of acrotarsium harvested from outside of the thigh under spinal anesthesia, femoral nerve block, lat- eral femoral cutaneous nerve block and sciatic nerve block. In all cases, there was no pain just after surgery, and postoperative pain was controlled well through the hospitalization with administration of oral analgesic agents.