Abstract
ObjectiveThis phase II, single-arm, prospective study aimed to evaluate the efficacy and safety of anlotinib in Chinese patients with recurrent or metastatic cervical cancer (CC).MethodsPatients with histologically proven recurrent or metastatic advanced CC were enrolled at Fudan University Shanghai Cancer Center. Patients received 12 mg of oral anlotinib daily before breakfast for 2 weeks of each 3-week (21 days) cycle separated by a 1-week interval. Anlotinib was administered orally until disease progression, patient withdrawal, intolerant toxicity, or death. The primary endpoint was the objective response rate (ORR) according to the Response Evaluation Criteria in Solid Tumors, and the secondary endpoints included the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.ResultsBetween September 2018 and November 2019, 41 patients were recruited. The median age was 53 years old. The histological results revealed that 82.9% of the recruited patients had squamous cell carcinoma, 14.6% had adenocarcinoma, and 2.4% had other types. At the data cutoff date, six patients were still being treated, and 35 patients had discontinued treatment. Forty (40/41, 97.5%) patients were evaluated for treatment response. The median PFS and OS was 3.2 and 9.9 months, respectively, in patients who received anlotinib treatment. The ORR was 24.4%. In addition, 34.2% (14/41) of patients were confirmed to have stable disease, and 39.0% (16/41) of patients were confirmed to have progressive disease. The DCR was 58.5%. Ten patients (10/41) had a confirmed response during the follow-up period. Most adverse events (AEs) were grade 1 or 2. High-grade AEs (grade 3) included urinary leukocyte positivity (9.8%), hematuria (4.9%), and hypertension (2.4%).ConclusionThis is the first study to evaluate the efficacy and safety of anlotinib in Chinese patients with recurrent or metastatic CC. Anlotinib produced durable clinical responses with manageable safety in these patients.
Highlights
Cervical cancer (CC) is one of the most common gynecologic cancers, ranking fourth in morbidity and mortality among women worldwide [1]
The criteria for inclusion were as follows: age ≥ 18 years old; histologically confirmed metastatic, recurrent, or persistent CC; an Eastern Cooperative Oncology Group performance status (ECOG PS) [22] of 0–2; treatment with at least one line of platinum-based chemotherapy; no prior treatment with VEGF inhibitor; documented radiological progression during the last treatment administered before enrollment; there were no previous heart, liver, kidney, brain, or hematopoietic system diseases; an expected survival time of ≥3 months; and measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [23]
From September 2018 to November 2019, a total of 46 patients were screened, of which 41 patients with recurrent advanced CC were enrolled into this study
Summary
Cervical cancer (CC) is one of the most common gynecologic cancers, ranking fourth in morbidity and mortality among women worldwide [1]. It is reported that the incidence of CC ranked second only to breast cancer among Asian women [2, 3]. The recent statistical data illustrated that globally, there were 528,000 new cases of CC in 2018 and 311,000 CC deaths [1]. In China, new cases account for approximately 20% of CC cases, and the number of cases still increases annually. The guidelines of the National Comprehensive Cancer Network (NCCN) and European Society of Gynecological Oncology (ESGO) recommend palliative chemotherapy as the standard treatment for patients with recurrent and advanced CC [5, 6]. The reported response rate for second-line or later therapy is relatively low at 15%–30%, and the duration of response is short in recurrent or metastatic CC [7, 8]. Novel targeted therapies with low toxicity are anticipated for recurrent or refractory CC
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