Y. Li

Efficacy and safety of biweekly single-dose actinomycin D versus multiday methotrexate in low-risk gestational trophoblastic neoplasia: a prospective multicenter randomized trial

Cure rates for low-risk gestational trophoblastic neoplasia (GTN) are high, but there is no consensus on optimal first-line chemotherapy. Here we evaluated the efficacy and safety of biweekly single-dose actinomycin D (Act-D) versus an 8-day methotrexate (MTX)-folinic acid regimen as first-line single-agent chemotherapy for low-risk GTN. This multicenter, randomized, controlled trial enrolled patients with International Federation of Gynecology and Obstetrics (FIGO) stage I-III, low-risk GTN (FIGO 2000 prognostic scores 0-4) across eight centers in China (ClinicalTrials.gov identifier: NCT04562558). Patients were randomized (1 : 1) to Act-D (1.25 mg/m Between 27 September 2020, and 18 June 2024, 228 patients were randomized to MTX or Act-D. Act-D achieved significantly higher single-agent CR rates than MTX (72.8% versus 54.4%, P = 0.0038) with shorter median remission time (7.86 versus 9.43 weeks, P = 0.0296). Overall CR rates were 100% in both groups following combination chemotherapy for resistant cases. Most adverse events were grade 1-2, but grade ≥2 nausea and vomiting and hair loss were more frequent with Act-D, and alanine aminotransferase was more frequently elevated in the MTX group. Anti-Müllerian hormone reductions were transient in both groups. After a 28.5-month median follow-up, recurrence rates remained low and comparable (MTX 0.88% versus Act-D 0.88%; P > 0.05). Fertility outcomes were favorable in both groups. Biweekly Act-D demonstrated superior efficacy and faster remission than the 8-day MTX regimen as first-line single-agent chemotherapy for low-risk GTN, offering a well-tolerated option despite a higher incidence of nausea, vomiting, and hair loss.

Comparing the KangDuo Surgical Robot-01 and da Vinci Xi system for endometrial cancer surgery: a multi-center, randomized, parallel-controlled, noninferiority trial

Background: The outcomes of patients who undergo surgical staging for endometrial cancer using the KangDuo Surgical Robot-01 (KD-SR-01) have not been compared with those of patients who undergo this procedure using the da Vinci Xi system. The aim of this study is to evaluate the efficacy and safety of the KD-SR-01 system for surgical staging of endometrial cancer by comparing short-term outcomes to those of counterparts who underwent surgery using the da Vinci Xi system. Materials and methods: This multi-center, randomized, noninferiority trial was conducted at four hospitals. Overall, 99 patients aged 18–80 years with endometrial cancer were enrolled between May 2022 and June 2023. Participants were randomized to receive surgical staging using either the KD-SR-01 (KD group) or da Vinci Xi system (DV group). The primary endpoint was the surgical success rate. The secondary endpoints were the number of harvested lymph nodes and surgical satisfaction. Safety evaluation included the docking time, console time, intraoperative blood loss, and complications. The follow-up period was 6 weeks. Results: All surgeries were completed without converting to open or other laparoscopic procedures. No significant difference was noted in the number of dissected lymph nodes between the KD and DV groups (13.29 vs. 16.92, P = 0.10). Per the National Aeronautics and Space Administration task load index, significant differences were found between the groups only in performance and frustration (P < 0.05) but not in the other categories. Compared to patients in the DV group, no significant differences were observed in console time, intraoperative blood loss, or complications in the KD group (P > 0.05). Only the docking time was longer in the latter (5.39 vs. 4.34 minutes, P = 0.01). Conclusion: The clinical application of the KD-SR-01 system for endometrial cancer staging surgery is safe and effective, with short-term results comparable to those achieved with the da Vinci Xi system after sufficient training.

Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia

The investigators conducted a randomized trial to study how well multi-day methotrexate protocol works compared to biweekly single-dose actinomycin D protocol in treating patients with low-risk gestational trophoblastic neoplasia. It is not yet known whether multi-day methotrexate protocol is as effective as biweekly single-dose actinomycin D protocol in treating patients with gestational trophoblastic neoplasia.