Sequential Chemotherapy for Early-Stage, Post–Radical Hysterectomy Cervical Cancer: Are the STARS Aligned?

Mené en Chine sur 1 048 patientes atteintes d'un cancer du col de l'utérus de stade IB-IIA et ayant subi une hystérectomie radicale (âge médian : 48 ans), cet essai randomisé multicentrique de phase 3 compare l'efficacité, du point de vue de la survie sans maladie à 3 ans, de 3 traitements postopératoires (une chimioradiothérapie concomitante, une chimioradiothérapie séquentielle et une radiothérapie seule)

Résumé en anglais

Cervical cancer is a preventable disease with a relatively low incidence of 13 800 new cases annually in the United States, approximately 50% of which are localized and amenable to curative-intent surgical resection. The standard operation for these patients includes a radical hysterectomy with removal of the upper vagina and paracervical suspensory ligaments (cardinal and uterosacral), as well as dissection of the retroperitoneal pelvic lymph nodes. In 1990, the Gynecologic Oncology Group (GOG) and Delgado et al analyzed outcomes for 732 women who underwent this procedure and identified tumor size, cervical stromal invasion, lymphovascular space invasion (LVSI), and lymph node metastases as independent risk factors for disease recurrence, which, in most cases, is incurable. These newly found risk factors informed 2 pivotal postoperative adjuvant therapy trials. Sedlis et al reported a 47% improvement in recurrence-free survival with adjuvant vs no further treatment in women with 2 of 3 “intermediate” risk factors of tumor larger than 4 cm, stromal invasion greater than one-third, or +LVSI, and Peters et al examined the benefit of adding a concurrent dose of radiosensitizing cisplatin to standard radiotherapy (RT) in the high-risk group with either positive lymph nodes, resection margins, or parametria. The hazard ratios for progression-free survival (PFS) and overall survival with RT only were 2.01 (P = .003) and 1.96 (P = . 007), respectively.