Anamorelin hydrochloride (ANAM), used to treat cancer cachexia, is often discontinued early in clinical practice. Herein, we explored the clinical factors associated with the early discontinuation (Ed) of ANAM and examined its effect on treatment outcomes. Clinical data of patients with gastrointestinal cancers who were administered ANAM between April and November 2021 from 16 institutions were retrospectively collected. Ed was defined as ANAM discontinuation within 4 weeks of initiation. ANAM efficacy was compared between the continuation (Co) and Ed groups. Of the 123 patients, 50 had an Ed of ANAM. The most common reasons were cancer progression (36
Purpose Placental abruption has a high recurrence risk, but the timing of recurrence relative to the previous episode remains unclear. This study evaluated recurrence timing and compared recurrent and first-time placental abruption in multiparous women. Methods This retrospective multicenter cohort study included 239 women with placental abruption managed at nine perinatal centers in northern Japan between 2003 and 2024. Clinical characteristics and pregnancy outcomes were compared between multiparous women with recurrent placental abruption (n = 10) and multiparous women with first-time placental abruption and no previous history of placental abruption (n = 134). To assess recurrence timing, we also examined the gestational age at placental abruption in the previous and current pregnancies among women with recurrent placental abruption. Results Among the 239 women with placental abruption, 10 (4.2%) had recurrent placental abruption. Maternal age was significantly higher in the recurrent group, whereas BMI, smoking status, conception by assisted reproductive technology, and hypertensive disorders of pregnancy were similar between groups. Most clinical features and maternal and neonatal outcomes did not differ significantly, although birth weight was significantly higher in the recurrent group. Among the 10 women with recurrent placental abruption, 11 recurrent events were identified; 6 (54.5%) occurred within ± 1 week and 8 (72.7%) within ± 2 weeks of the gestational age at the previous episode. Pathology reports in the recurrent group suggested maternal vascular malperfusion in 7 of 10 cases. Conclusion Recurrent placental abruption tended to occur near the gestational age of the previous episode. The gestational age at the previous abruption may serve as a practical anchor for surveillance planning in subsequent pregnancies, although management should remain individualized. These findings should be interpreted cautiously because of the small number of recurrent cases.
Background/Objectives: Placental abruption has a high risk of recurrence, but the timing of recurrence relative to the previous episode remains unclear. This study described the gestational-age distribution of recurrent placental abruption and compared recurrent with first-time placental abruption in multiparous women. Methods: This retrospective multicenter descriptive study included 239 hospital-managed cases of placental abruption at nine perinatal centers in northern Japan from 2003 to 2024. Clinical characteristics and outcomes were compared between multiparous women with recurrent placental abruption (n = 10) and those with first-time placental abruption and no prior history of placental abruption (n = 134). Recurrence timing was assessed descriptively by comparing gestational age at onset between previous and current episodes. Results: Among 239 cases, 10 women had recurrent placental abruption. Maternal age was higher in the recurrent group, whereas BMI, smoking, assisted reproductive technology, and hypertensive disorders of pregnancy were similar between groups. Most clinical features and maternal and neonatal outcomes did not differ significantly, although birth weight was higher in the recurrent group. Among 11 recurrent events, 6 occurred within ±1 week (54.5%; exact 95% CI, 23.4-83.3%) and 8 within ±2 weeks (72.7%; exact 95% CI, 39.0-94.0%) of the previous gestational age. Available placental pathology in recurrent cases was reviewed descriptively only and was not interpreted as evidence of an association between maternal vascular malperfusion and recurrence. Conclusions: In this small exploratory cohort, recurrent placental abruption tended to occur within approximately ±1 to ±2 weeks of the gestational age of the previous episode, with 6 of 11 recurrent events occurring within ±1 week and 8 of 11 occurring within ±2 weeks. These exploratory findings may assist clinicians when individualizing surveillance strategies but should not be interpreted as supporting a specific surveillance protocol; confirmation in larger datasets is required.
In metastatic colorectal cancer (mCRC), human epidermal growth factor receptor 2 (HER2)-positive disease is a molecular subtype for targeted therapy; however, real-world data remain limited. A multicenter retrospective study of patients with HER2-positive mCRC diagnosed between 2010 and 2023 at 14 institutions in Japan was conducted. In patients with RAS wild-type tumors, outcomes were compared based on the molecular targeted agent (anti-epidermal growth factor receptor [EGFR] antibody or bevacizumab) combined with first-line chemotherapy. In patients treated with trastuzumab plus pertuzumab (Tmab+Per), outcomes and safety, with infusion-related reactions (IRRs) assessed. Forty-five patients were included. In patients with RAS wild-type tumors, outcomes were comparable between the anti-EGFR antibody (n = 17) and bevacizumab (n = 9) groups (progression-free survival: 15.6 vs. 12.0 months; hazard ratio: 0.94, 95
147 Background: The HGCSG1801 trial evaluated the treatment outcomes of aflibercept (AFL) plus FOLFIRI for patients(pts) with metastatic colorectal cancer (mCRC) refractory to an oxaliplatin-based regimen combined with an anti-EGFR agent. Here we report results of the updated efficacy, safety, and a biomarker analysis. Methods: This was a prospective open-label phase II trial. AFL (4 mg/kg iv) followed by FOLFIRI (irinotecan 180 mg/m 2 , leucovorin 200 mg/m 2 iv, bolus 5-fluorouracil [5-FU] 400 mg/m 2 , and infusional 5-FU 2400 mg/m 2 /46 h) was given every 2 weeks until progression or unacceptable toxicities. The primary endpoint was 6-month progression-free survival (PFS) rate, and the secondary endpoints included overall survival (OS), PFS, overall response rate (ORR), disease control rate (DCR), and adverse events. Angiogenic factors were analyzed in plasma sample using a Luminex multiplex assay using the Cox proportional hazards model. This study was sponsored by the Non-Profit Organization Hokkaido Gastrointestinal Cancer Study Group and supported by a grant from Sanofi. Results: Forty-three pts were enrolled between November 2019 and October 2022. The data cut-off date was April 30, 2024. The 6-month PFS rate was 59.0% (90% confidence interval [CI], 45.8–72.1%). Median PFS and OS were 7.3 months (95% CI, 5.5–11.0 months) and 18.8 months (95% CI, 12.9–26.6 months), respectively. The ORR was 20.9% (95% CI, 10.0–36.0%) and DCR was 88.4% (95% CI, 74.9–96.1%). No deaths and no new safety signals with a causal relation to the study treatment were observed. A biomarker analysis using pretreatment plasma samples showed a trend toward better PFS in pts with low VEGF-A (hazard ratio [HR] 0.40 [95% CI, 0.18-0.91]), TSP-2 (HR 0.40 [95% CI, 0.18-0.88]) or IL-8 levels (HR 0.43 [95% CI, 0.20-0.93]). There was also a trend toward better OS in pts with low levels of TSP-2 (HR 0.30 [95% CI, 0.11-0.81]) or TIMP-1 (HR 0.20 [95% CI, 0.06-0.69]). Conclusions: These updated data further support the activity and manageable safety profile of AFL plus FOLFIRI for pts with mCRC who failed an oxaliplatin-based regimen combined with an anti-EGFR agent. It was suggested the association between some angiogenic factors in plasma samples and the activity of AFL plus FOLFIRI in mCRC. Clinical trial information: jRCTs011190006 .
