780P - Safety and efficacy of endostar combined with platinum-based chemotherapy in the first-line treatment of recurrence and metastatic cervical cancer: A single-arm, prospective phase II study

Background

Endostar (a recombinant human endostatin), as a anti-angiogenesis agent, combined with chemotherapy is well-tolerated in patients with metastatic colorectal cancer, gastric cancer and advanced non-small cell lung cancer, but fewer reports are on cervical cancer. Safety and efficacy of endostar combined with platinum-based regimens in the first-line treatment of recurrence and metastatic cervical cancer remains unknown.

Methods

This study was a non-randomized, single-arm, phase II trial for the treatment of recurrent and metastatic cervical cancer. All patients were treated with platinum-based chemotherapy for 4-6 cycles and intravenous infusions of endostar (30mg/m² per day, days 1-7; 21 days per cycle) until Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1–defined progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was progression-free survival (PFS). The secondary endpoints were safety, overall survival, objective response rate (ORR), disease control rate (DCR). The study was registered at Chinese Clinical Trial Registry (ChiCTR1800018585).

Results

Between July 2018 and December 2020, this study has enrolled 16 patients, of whom 14 can be evaluated. At data cut-off (April 14, 2021), all 14 patients had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 1 at baseline. Among the 14 patients, 1 patient reached complete response (CR), 6 patients reached partial response (PR) and 3 had stable disease (SD). The median PFS (mPFS) was 12 months (95%CI, 8.33-15.67), and the 12-month PFS rate was 50.0% (95%CI, 34.0%-100%). The ORR and the DCR were 50.0% and 71.4%, respectively. The most common grade 1-2 adverse events (AEs) included myelosuppression (9 of 14, 64.29%), fatigue (5 of 14, 35.71%) and vomiting (2 of 14, 14.28%). Grade 3-4 toxicities included thrombocytopenia in 1 patient, and leukopenia in 5 patients.

Conclusions

The combination of endostar and platinum-based chemotherapy in the first-line treatment of recurrent and metastatic cervical cancer appeared to show significant efficacy and favorable safety profile.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

J. Zhou.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.