Postoperative adjuvant dose-dense chemotherapy with bevacizumab and maintenance bevacizumab after neoadjuvant chemotherapy for advanced ovarian cancer: A phase II AGOG/TGOG trial.

Authors

null

Wei-Chun Chen

Chang Gung Memorial Hospital of Linkou Main Branch, Taoyuan, Taiwan

Wei-Chun Chen , Hung-Hseuh Chou , Lan-Yan Yang , Huei-Jean Huang , Wei-Yang Chang , Hao Lin , Ren-Chin Wu , Min-Yu Chen , J. Timothy Qiu , Kuan-Gen Huang , Angel Chao , Ting-Chang Chang , Chyong-Huey Lai

Organizations

Chang Gung Memorial Hospital of Linkou Main Branch, Taoyuan, Taiwan, Gynecologic Cancer Research Center, Chang Gung Memorial Hospital, Biostatistics and Informatics Unit, Clinical Trial Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan, Department of Pathology, Chang Gung Memorial Hospital and Chang Gung University college of Medicine, Taiwan; Gynecologic Cancer Research Center, Chang Gung Memorial Hospital;, Taoyuan, Taiwan, Taipei Medical University Hospital, Taipei, Taiwan, Chang Gung Memorial Hospital, Taoyuan, Taiwan, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan, Department of OB/GYN, Chang Gung Memorial Hospital, Taoyuan, Taiwan

Research Funding

Other Government Agency
Ministry of Health and Welfare, Taiwan, Other Foundation

Background: The objective of this study is to evaluate the safety and efficacy of adding bevacizumab to dose-dense adjuvant chemotherapy with bevacizumab maintenance after neoadjuvant chemotherapy (NAC) and interval debulking surgery (IDS) for stage III/IV ovarian, tubal, and primary peritoneal cancer. Methods:This phase II clinical trial using Simon's minimax two-stage design was conducted. At the first stage, 13 subjects were enrolled, and the trial would proceed to second stage if ≤3 subjects discontinued treatment for study-defined significant adverse events (AEs). Patients with stage III/IV ovarian, tubal, and primary peritoneal cancer deemed not feasible for primary cytoreductive surgery were enrolled after 3 to 4 cycles of NAC and IDS without disease progression. NAC could be either weekly paclitaxel (80mg/m2) (dose-dense) plus 3-weekly carboplatin (AUC5-6) or 3-weekly conventional schedule. After IDS, postoperative dose-dense adjuvant chemotherapy for 3 cycles at least (best to 6 cycles), and 3-weekly bevacizumab 15mg/kg was given since postoperative cycle 2. Further 3-weekly maintenance bevacizumab 15mg/kg was given intravenously for 17 cycles. Results: Of the 22 enrolled subjects, 13 (59.1%) had no gross lesion after IDS. Of the 13 subjects enrolled on the 1st stage, one study-defined significant AE occurred, therefore the trial proceeded to the 2nd stage (n = 9). The median progression-free survival (PFS) was 22.1 months (95% confidence interval [CI], 13.7 – 30.5), and the median overall survival (OS) was 49.2 months (95% CI, 33.8 – 64.6). Peritoneal Cancer Index score at entering abdomen during IDS was significant for PFS (>12 vs ≤ 12: p = 0.003). One of the 22 subjects did not receive any study treatment. In the safety analysis (n = 21), grade 3/4 AEs included thrombocytopenia of 38.1%, neutropenia 71.4%, and anemia 28.6%. Study-defined significant AEs of bowel perforation, poor-healing wound, and hypertension were found in 1 case each, respectively. Conclusions: This phase II trial demonstrated adding bevacizumab to dose-dense adjuvant chemotherapy with bevacizumab maintenance after NAC was feasible with tolerable toxicity and comparable PFS/OS as compared to other studies using bevacizumab in the NAC phase or dose-dense scheduling throughout. Clinical trial information: NCT02022917

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Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Ovarian Cancer

Clinical Trial Registration Number

NCT02022917

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr 5540)

DOI

10.1200/JCO.2021.39.15_suppl.5540

Abstract #

5540

Poster Bd #

Online Only

Abstract Disclosures

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