Adjuvant chemotherapy versus adjuvant concurrent chemoradiotherapy after radical surgery for early-stage cervical cancer:a randomized,non-inferiority,multicenter trial

We conducted a prospective study to assess the non-inferiority of adjuvant chemotherapy alone versus adjuvant concurrent chemoradiotherapy (CCRT) as an alternative strategy for patients with early-stage (FIGO 2009 stage IB–IIA) cervical cancer having risk factors after surgery. The condition was assessed in terms of prognosis, adverse effects, and quality of life. This randomized trial involved nine centers across China. Eligible patients were randomized to receive adjuvant chemotherapy or CCRT after surgery. The primary end-point was progression-free survival (PFS). From December 2012 to December 2014, 337 patients were subjected to randomization. Final analysis included 329 patients, including 165 in the adjuvant chemotherapy group and 164 in the adjuvant CCRT group. The median follow-up was 72.1 months. The three-year PFS rates were both 91.9%, and the five-year OS was 90.6% versus 90.0% in adjuvant chemotherapy and CCRT groups, respectively. No significant differences were observed in the PFS or OS between groups. The adjusted HR for PFS was 0.854 (95% confidence interval 0.415–1.757;P = 0.667) favoring adjuvant chemotherapy, excluding the predefined non-inferiority boundary of 1.9. The chemotherapy group showed a tendency toward good quality of life. In comparison with post-operative adjuvant CCRT, adjuvant chemotherapy treatment showed non-inferior efficacy in patients with early-stage cervical cancer having pathological risk factors. Adjuvant chemotherapy alone is a favorable alternative post-operative treatment.

Chemotherapy initiation with single-course methotrexate alone or combined with dactinomycin versus multi-course methotrexate for low-risk gestational trophoblastic neoplasia: a multi-centric randomized clinical trial

We aimed to evaluate the effectiveness and safety of single-course initial regimens in patients with low-risk gestational trophoblastic neoplasia(GTN).In this trial (NCT01823315),276 patients were analyzed.Patients were allocated to three initiated regimens:single-course methotrexate(MTX),single-course MTX+dactinomycin(ACTD),and multi-course MTX(control arm).The primary endpoint was the complete remission(CR)rate by initial drug(s).The primary CR rate was 64.4%with multi-course MTX in the control arm.For the single-course MTX arm,the CR rate was 35.8%by one course;it increased to 59.3%after subsequent multi-course MTX,with non-inferiority to the control(difference-5.1%,95%confidence interval(CI)-19.4%to 9.2%,P=0.014).After further treatment with multi-course ACTD,the CR rate(93.3%)was similar to that of the control(95.2%,P=0.577).For the single-course MTX+ACTD arm,the CR rate was 46.7%by one course,which increased to 89.1%after subsequent multi-course,with non-inferiority(difference 24.7%,95%CI 12.8%-36.6%,P<0.001)to the control.It was similar to the CR rate by MTX and further ACTD in the control arm(89.1%vs.95.2%,P=0.135).Four patients experienced recurrence,with no death,during the 2-year follow-up.We demonstrated that chemotherapy initiation with single-course MTX may be an alternative regimen for patients with low-risk GTN.