GTN: MTX With, Without Dactinomycin May Be Effective Option
Patients in the single-course MTX+ACTD arm had a 46.81% CR rate after initial therapy.
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Single-course methotrexate (MTX) and MTX plus dactinomycin (MTX + ACTD) are therapeutic options for patients with low-risk gestational trophoblastic neoplasia (GTN) who do not want an extended duration of chemotherapy and have low pretreatment hCG levels, according to findings presented at the 2018 Society of Gynecologic Oncology Annual Meeting on Women's Cancer in New Orleans.1
For this study, researchers randomly assigned 272 patients with low-risk (WHO risk score 0 to 6) GTN to 1 of 3 study arms: single-course MTX 0.4 mg/kg for 5 days, multi-course MTX 0.4 mg/kg daily for 5 days every 2 weeks, or single-course MTX+ACTD. Patients who failed single-course treatment underwent additional courses of the same regimen.
Of the patients assigned to the multiple-course MTX arm, 67.9% (55/81) achieved initial complete response (CR); 36.08% (35/97) assigned to the single-course MTX arm attained CR. Of the patients who failed initial therapy, 21 eventually reached CR after additional rounds of MTX. There was no significant difference in the median rounds of chemotherapy administered to both groups (P = .432).
Patients in the single-course MTX+ACTD arm had a 46.81% (44/94) CR rate after initial therapy.
Patients with a higher risk score (WHO risk score 5 or 6) had poorer outcomes, with 21.4%, 25%, and 55.56% of patients achieving CR for single-course MTX, single-course MTX+ACTD, and multiple-course MTX, respectively (P = 0.331).
There were 11 severe adverse events among patients in the multi-course MTX arm, but the other groups demonstrated a favorable safety profile.
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- Chen L, Yin R, Xi L, et al. Single-course methotrexate and single-course combined methotrexate–dactinomycin: a phase III randomized controlled clinical trial in treatment of low-risk gestational trophoblastic neoplasm. Oral presentation at: 2018 Society of Gynecologic Oncology Annual Meeting on Women's Cancer; March 24-27, 2018; New Orleans, LA.