Dataset Information

The role of neoadjuvant chemotherapy followed by interval debulking surgery in advanced ovarian cancer: a systematic review and meta-analysis of randomized controlled trials and observational studies.

ABSTRACT:

Objective

We aimed to performed a meta-analysis and systematic review on the role of neoadjuvant chemotherapy followed by interval debulking surgery (NACT-IDS) in advanced ovarian cancer (AOC) patients.

Materials and methods

We searched PubMed, EMBASE, and the Cochrane Library for relevant articles. All statistical analyses were performed in Review Manager 5.3.5.

Results

In two randomized controlled trials (RCTs), there was no significant difference in overall survival (OS) (HR = 0.93, 95% CI: 0.81-1.06) or progression-free survival (PFS) (HR = 0.97, 95% CI: 0.86-1.09). Few adverse events (HR = 0.37, 95% CI: 0.19-0.72) and a high optimal debulking surgery rate (HR = 1.69, 95% CI: 1.50-1.91) were observed with NACT. In 22 observational studies, primary debulking surgery (PDS) yielded better OS (HR = 1.38, 95% CI: 1.19-1.60) but not progression-free survival (PFS) (HR = 1.03, 95% CI: 0.86-1.23). An increased optimal cytoreduction rate (HR = 1.17, 95% CI: 1.12-1.22) was observed with NACT. Irrespective of the degree of residual disease, OS was longer in the PDS group than that in the NACT group. Patients with FIGO stage III (HR = 1.43, 95% CI: 1.05-1.95) and IV (HR = 1.14, 95% CI: 1.06-1.23) disease had better survival with PDS.

Conclusions

Treatment with NACT-IDS improves perioperative outcomes and optimal cytoreduction rates, but it may not improve OS. NACT-IDS is not inferior to PDS-CT in terms of survival outcomes in selected AOC patients. Future studies should focus on candidate selection for NACT.

SUBMITTER: Qin M

PROVIDER: S-EPMC5823572 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BACKGROUND:Two randomized phase III trials (EORTC55971 and CHORUS) showed similar progression-free and overall survival in primary or interval debulking surgery in ovarian cancer, however both studies had limitations with lower rate of complete resection and lack of surgical qualifications for participating centers. There is no consensus on whether neoadjuvant chemotherapy followed by interval debulking surgery (NACT-IDS) could be a preferred approach in the management of advanced epithelial ovarian cancer (EOC) in the clinical practice. METHODS:The Asian SUNNY study is an open-label, multicenter, randomized controlled, phase III trial to compare the effect of primary debulking surgery (PDS) to NACT-IDS in stages IIIC and IV EOC, fallopian tube cancer (FTC) or primary peritoneal carcinoma (PPC). The hypothesis is that PDS enhances the survivorship when compared with NACT-IDS in advanced ovarian cancer. The primary objective is to clarify the role of PDS and NACT-IDS in the treatment of advanced ovarian cancer. Surgical quality assures include at least 50% of no gross residual (NGR) in PDS group in all centers and participating centers should be national cancer centers or designed ovarian cancer section or those with the experience participating surgical trials of ovarian cancer. Any participating center should be monitored evaluating the proportions of NGR by a training set. The aim of the surgery in both arms is maximal cytoreduction. Tumor burden of the disease is evaluated by diagnostic laparoscopy or positron emission tomography/computed tomography scan. Patients assigned to PDS group will undergo upfront maximal cytoreductive surgery within 3 weeks after biopsy, followed by 6 cycles of standard adjuvant chemotherapy. Patients assigned to NACT group will undergo 3 cycles of NACT-IDS, and subsequently 3 cycles of adjuvant chemotherapy. The maximal time interval between IDS and the initiation of adjuvant chemotherapy is 8 weeks. Major inclusion criteria are pathologic confirmed stage IIIC and IV EOC, FTC or PPC; ECOG performance status of 0 to 2; ASA score of 1 to 2. Major exclusion criteria are non-epithelial tumors as well as borderline tumors; low-grade carcinoma; mucinous ovarian cancer. The sample size is 456 subjects. Primary endpoint is overall survival. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02859038.