OBJECTIVES:The ENABLE study, an investigator-initiated, multicenter, randomized controlled trial, demonstrated comparable survival benefits between enzalutamide (ENZ) and abiraterone plus prednisolone (ABI) for castration-resistant prostate cancer (CRPC). Because randomized controlled trials typically exclude patients with a history of other cancers (HOCs), we evaluated the efficacy of these agents in this population. METHODS:This sub-analysis was conducted as a post hoc analysis using data from the ENABLE study. Endpoints included time to PSA progression, radiographic progression-free survival, overall survival (OS), prostate cancer-specific survival, and safety. Outcomes were compared between patients with and without a HOC+ versus HOC- and between treatment arms within each group. RESULTS:The HOC+ group included 35 patients (13 ENZ, 22 ABI), whereas the HOC- group included 149 patients (79 ENZ, 70 ABI). The most frequent malignancy was gastric cancer (n = 10, 29%). HOC+ patients had significantly worse OS than HOC- patients (median 24.7 vs. 37.4 months; HR 1.96; 95% CI 1.02-3.77; p = 0.0426), while other survival endpoints did not differ between the groups. Within the HOC+ group, OS was significantly worse with ENZ than with ABI (median 16.0 vs. 30.5 months; HR 3.27; 95% CI 1.08-9.89; p = 0.0354), whereas no significant differences were observed between the arms in the HOC- group. CONCLUSIONS:Although OS was poorer in HOC+ patients, other outcomes were similar, supporting the feasibility of ENZ and ABI regardless of cancer history. The longer OS with ABI in HOC+ patients represents a hypothesis-generating observation and should be interpreted with particular caution.
BACKGROUND:This study aimed to clarify whether variations in the lowest prostate‑specific antigen (PSA) level prior to the development of castration‑resistant prostate cancer (CRPC) influence the efficacy of subsequent enzalutamide (ENZ) or abiraterone plus prednisolone (ABI) therapy in metastatic CRPC. METHODS:Using data from the ENABLE study, an investigator‑initiated, multicenter, randomized controlled trial, patients were retrospectively categorized into two groups based on the lowest PSA level prior to metastatic CRPC development: ≤ 0.05 ng/mL (low group) and > 0.05 ng/mL (high group). Endpoints included time to PSA progression (TTPP), radiographic progression‑free survival (rPFS), docetaxel‑free survival (DFS), and overall survival (OS) in the overall study population and within the ABI and ENZ treatment arms. RESULTS:A total of 39 and 94 patients were classified into the low and high groups, respectively. In the overall population, survival outcomes did not differ significantly between the groups except for DFS (median 29.0 vs. 15.2 months, p = 0.0209). In the ABI arm (low group, n = 15; high group, n = 45), median TTPP, rPFS, DFS, and OS were undefined versus 4.7 months, 39.5 versus 9.8 months, 29.0 versus 14.0 months, and undefined versus 33.3 months in the low and high groups, respectively (p = 0.0443, p = 0.0243 p = 0.0106, and p = 0.0319). In contrast, in the ENZ arm (low group, n = 24; high group, n = 49), no significant differences were observed in any endpoint between the two groups. CONCLUSIONS:The findings of this study indicate that the lowest PSA level prior to CRPC onset may have a potential association with outcomes following subsequent ABI therapy, whereas no such trend was observed for ENZ in metastatic CRPC.
We report a case of chylopericardium with cardiac tamponade after lung cancer surgery. A 47-yearold female underwent right lower lobectomy with mediastinal lymph node dissection and postoperative adjuvant therapy for lung cancer with mediastinal lymph node metastases. Three months postoperatively, chylothorax developed, and pleurodesis was performed. One month after receiving treatment for chylothorax, the patient returned to the hospital with complaints of chest tightness and dyspnea on exertion. The patient developed hypotension, and echocardiography revealed a massive pericardial effusion consistent with cardiac tamponade. A drainage tube was immediately inserted into the pericardial space, releasing a chylous effusion, which confirmed the diagnosis of chylopericardium. Because conservative treatment was unsuccessful, thoracic duct ligation was performed. This resolved the chylous pericardial effusion;however, a serous effusion subsequently accumulated in the pericardial cavity, leading to recurrent cardiac tamponade. An additional pericardial fenestration was then performed, after which the pericardial effusion resolved. Chylopericardium is a rare complication following intrathoracic surgery;however, the possibility of its occurrence should be considered.
Purpose Cancer-associated malnutrition during chemotherapy may impair treatment tolerance and quality of life (QoL). Ninjin'yoeito (NYT), a Japanese Kampo medicine, is used to treat anorexia, fatigue, and general malaise. We evaluated NYT during first-line chemotherapy for metastatic colorectal cancer (mCRC). Methods This exploratory, open-label, multicenter, randomized phase II trial compared NYT plus CAPOX and bevacizumab with CAPOX and bevacizumab alone in patients with unresectable mCRC. Co-primary endpoints were longitudinal changes in Controlling Nutritional Status (CONUT) scores and grade ≥ 3 nonhematological adverse events. Secondary endpoints included body mass index (BMI), QoL, and progression-free survival (PFS). Results Enrollment was terminated early because of slow accrual. Of 78 randomized patients, 74 were included in the full analysis set (NYT, n = 39; non-NYT, n = 35). Neither co-primary endpoint differed significantly between groups: CONUT score changes (least-squares mean difference [LSMD], − 0.05; 95% confidence interval [CI], − 0.53 to 0.42; P = 0.822) and grade ≥ 3 nonhematological adverse events (25.6% vs 20.0%; P = 0.593). Exploratory analysis showed better BMI maintenance with NYT (LSMD, 0.66 kg/m²; 95% CI, 0.19–1.13; P = 0.007). Appetite loss was lower with NYT and remained significant in sensitivity analysis, whereas insomnia scores were higher. PFS did not differ significantly between groups (HR, 1.21; 95% CI, 0.44–3.33; log-rank P = 0.713). Conclusions NYT did not significantly affect either co-primary endpoint. Exploratory findings suggested better BMI maintenance and reduced appetite loss, whereas insomnia scores were higher. These findings are hypothesis-generating and require confirmation in adequately powered trials. Clinical trial registration This trial was registered in the Japan Registry of Clinical Trials (ID jRCTs041190071) on October 2, 2019.
