Phase II study of cabozantinib in recurrent or metastatic cervical cancer after progression on platinum-based chemotherapy (CABOCOL).

Objective

The antiangiogenic pathway is an effective target for recurrent uterine cervical carcinoma (rCC). This study evaluated the safety and efficacy of cabozantinib monotherapy for rCC. PATIENTS &

Methods

This open-label phase II study (NCT04205799) enrolled patients with rCC who previously received platinum-based chemotherapy. Patients received oral cabozantinib (60 mg daily) until progression or discontinuation from any cause. The main objective was based on joint primary endpoint of efficacy (3-month disease control rate, DCR3) and safety (proportion of patients with grade ≥ 2 (CTCAE v5.0) gastro-intestinal (GI) perforation, GI-vaginal and/or genito-urinary (GU) fistula events) according to a Bryant-and-Day design. Key secondary endpoints were progression-free survival (PFS), duration of response (DOR) and safety.

Results

Among 57 patients enrolled, 54 received cabozantinib: median age was 55.5 years, 18 patients (33.3%) had received more than two prior lines of treatment; 28 patients (51.9%) had been previously treated with bevacizumab. Median duration of follow-up was 8.9 months. DCR3 was 46.3% [95% CI, 32.8-60.3]. Fistula/perforation occurred in 5 (9.3%) patients. Objective response rate was 9.3%, with a median DOR of 2.5 months. Median PFS was 2.8 months (95% CI, 2.5-4.6). Grade ≥ 3 treatment-related adverse events occurred in 51.9% of patients, most commonly asthenia (15%), hypertension (9%) and mucositis (6%). Dose reductions and treatment interruptions were reported in 26 (48%) and 24 (44%) patients, respectively.

Conclusions

Cabozantinib demonstrates efficacy comparable to other anti-angiogenic monotherapy in rCC; however, modest benefit and toxicity do not support further monotherapy development.