C. 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.

Toripalimab combined with bevacizumab plus chemotherapy as first-line treatment for refractory recurrent or metastatic cervical cancer: a single-arm, open-label, phase II study (JS001-ISS-CO214)

To evaluate the efficacy and safety of adding toripalimab to bevacizumab and platinum-based chemotherapy as first-line treatment for refractory recurrent or metastatic (R/M) cervical cancer (CC). Patients were administered toripalimab (240 mg) + bevacizumab (7.5 mg/kg) combined with platinum-based chemotherapy once every three weeks for six cycles, followed by the maintenance therapy involving toripalimab + bevacizumab once every 3 weeks for 12 months or when disease progression or intolerable toxicity occurred. The primary endpoint was the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1. The secondary endpoints were safety profiles, disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Twenty-four patients were enrolled in this study and in the final analysis. The median follow-up duration was 18.6 (range, 3.3-28.5) months. The ORR was 83.3% (95% confidence interval [CI]=62.6-95.3) and the DCR was 95.8% (95% CI=78.9-99.9); 9 (37.5%) patients achieved complete response, 11 (45.8%) achieved partial response, and 3 (12.5%) had stable disease. The median PFS was 22.6 (95% CI=10.4-34.7) months and the median OS was not reached. The most common grade 3 treatment-related adverse events (AEs) were neutropenia (41.7%) and leukopenia (16.7%). The most common immune-related AEs (irAEs) were thyroid dysfunction (37.5%) and increased adrenocorticotropic hormone (37.5%) and serum cortisol levels (33.3%). No grade ≥3 irAEs were observed. Toripalimab combined with bevacizumab and platinum-based chemotherapy show promising clinical efficacy and favorable safety profile, providing an alternative first-line treatment option for patients with R/M CC. ClinicalTrials.gov Identifier: NCT04973904.

Toripalimab Combined With Chemotherapy and Bevacizumab as First-Line Treatment in Patients With Advanced Cervical Cancer

This is a single-arm, multicenter, phase II study to investigate efficacy and safety of Toripalimab combined with chemotherapy (paclitaxel and cisplatin) and Bevacizumab as first-line treatment in patients with recurrent, refractory and metastatic cervical cancer

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.