Nab-paclitaxel Versus Sb-taxanes As First-Line Treatment in Advanced Ovarian Cancer

NCT05737303RecruitingPHASE3INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Women's Hospital School Of Medicine Zhejiang University

Enrollment

538

Start Date

2023-11-27

Completion Date

2025-12-31

Study Type

INTERVENTIONAL

Official Title

Nab-paclitaxel Versus Solvent-based Taxanes As First-Line Treatment for Patients With Advanced Ovarian Cancer

Interventions

nab-paclitaxel combined with carboplatin

Conditions

Epithelial Ovarian Carcinoma Stage IIIEpithelial Ovarian Carcinoma Stage IVFallopian Tube Carcinoma Stage IIIFallopian Tube Carcinoma Stage IVPrimary Peritoneal Carcinoma Stage IIIPrimary Peritoneal Carcinoma Stage IV

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

Inclusion Criteria:

1. Epithelial ovarian cancer/tubal cancer/peritoneal cancer was diagnosed by histopathology or hydroexfoliation cytopathology of the chest and abdomen, and was classified as stage III-IV according to FIGO(International Federation of Gynecology and Obstetrics)stage
2. Physical condition Eastern Cooperative Oncology Group PS score: 0-2 points
3. Participants who had not participated in other drug clinical trials within 4 weeks prior to enrollment
4. Written informed consent
5. Expected survival ≥6 months
6. The disease met the criteria for Efficacy Evaluation of solid tumors (RECIST 1.1)
7. Be able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits during study participation.

Exclusion Criteria:

1. Patients with low malignant potential ovarian tumors;
2. Other malignant tumors within the previous 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
3. Patients who have previously received chemotherapy or radiotherapy for pelvic cavity;
4. Patients with central nervous system metastasis or peripheral neuropathy \> grade 1;
5. Patients with severe myelosuppression, severe liver dysfunction (Child's Class III), or renal dysfunction at the time of screening;
6. Severe cardiovascular disease: Grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms); According to NYHA(New York Heart Association) criteria, patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricular ejection fraction (LVEF) \< 55% indicated by color Doppler ultrasonography;
7. Uncontrolled systemic infection requiring anti-infective treatment;
8. Arteriovenous thrombosis events occurring within 6 months before randomization, such as cardiovascular and cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction, myocardial infarction), deep vein thrombosis and pulmonary embolism;
9. Patients who are allergic to the active ingredients or excipients of albumin paclitaxel and carboplatin for injection;
10. Pregnant or lactating women;
11. Those who were considered unsuitable for inclusion by the researchers.

Outcome Measures

Primary Outcomes

Progression Free Survival

Disease progression as first failure

Time frame: 20 months

Secondary Outcomes

Objective Remission Rate

The target lesion disappeared for at least 4 weeks,Tumor volume reduced by at least 30 percent.

Time frame: 12 months

Survival

Overall survival (all-cause death)

Time frame: 3 years, 5 years

Adverse events

Treatment-related symptoms

Time frame: 3 years, 5 years

Locations

Sun Yat-Sen University Cancer Hospital, Guangzhou, China

Qilu Hospital of Shandong University, Ji'nan, China

Yaxia Chen, Hangzhou, China

Sir Run Run Hospital, Hangzhou, China

The First Affiliated Hospital of Medical College of Zhejiang University, Hangzhou, China

The Second Affiliated Hospital of Medical College of Zhejiang University, Hangzhou, China

Zhejiang Cancer Hospital, Hangzhou, China

Ningbo women's and children's Hospital, Ningbo, China

The No, 1 People's Hospital of Ningbo, Ningbo, China

The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, China

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China

Linked Papers

2022-06-11

Efficacy evaluation of albumin-bound paclitaxel combined with carboplatin as neoadjuvant chemotherapy for primary epithelial ovarian cancer

AbstractObjectiveThis study aimed to compare the efficacy of albumin-bound paclitaxel combined with carboplatin (Nab-TC) with that of traditional solvent-based paclitaxel combined with carboplatin (TC) as neoadjuvant chemotherapy (NAC) regimens for primary epithelial ovarian cancer.MethodsEighty patients with advanced primary epithelial ovarian cancer admitted for treatment at the Harbin Medical University Cancer Hospital from January 2015 to January 2020 were retrospectively selected. All patients underwent surgery after 1–4 courses of NAC with Nab-TC or TC regimen. Among the patients included for study, 40 patients in each group.ResultsThe ORR in Nab-TC group was better compared to TC group (45% vs 40%), but the difference was not significant (P = 0.651). While the reduction rate of CA-125 value in the Nab-TC group was significantly better (P &lt; 0.05). The postoperative complication rate such as postoperative blood transfusion (5% vs 35%) and postoperative infusion of human albumin (25% vs 55%) were significantly lower relative to the TC group. The median progression-free survival of the Nab-TC group was significantly longer relative to the TC group (20 months vs 13 months,P = 0.012), and the patient’s quality of life was also better in the Nab-TC group (P &lt; 0.05). Our study demonstrated that Nab-TC regimen and R0 represented the independent prognostic factors.ConclusionThe efficacy of the Nab-TC regimen as NAC for advanced primary epithelial ovarian cancer was non-inferior to that of the TC regimen along with a lower incidence of adverse reactions, a longer PFS and a higher quality of life, supporting its therapeutic value in the clinic.

2020-07-18

Incidence and mortality of ovarian cancer at the global, regional, and national levels, 1990–2017

Ovarian cancer (OC) is a commonly diagnosed gynecologic cancer. Knowing the incidence and mortality rates of OC is critical to understanding the disease burden and updating prevention strategies. We retrieved the age-standardized incidence and mortality rates (ASIR and ASMR, respectively) of OC from the Global Burden of Disease study online database. Estimated average percentage change (EAPC) was used to quantify the trends of OC incidence and mortality from 1990 to 2017. Worldwide, the number of incident cases and deaths from OC increased from 152.1 and 95.5 thousand in 1990 to 286.1 and 176.0 thousand in 2017, respectively. Both the ASIR and ASMR decreased slightly during the study period (EAPC = -0.10, 95% CI, -0.16, -0.03; EAPC = -0.32, 95% CI, -0.38, -0.27). The greatest decreases of ASIR and ASMR were observed in Western Europe (EAPC = -1.22, 95% CI, -1.31, -1.14; EAPC = -1.31, 95% CI, -1.37, -1.25). A total of 137, 10, and 48 countries or territories experienced an increase, remained stable, and experienced a decrease in OC ASIR, respectively, between 1990 and 2017. For ASMR, a total of 129, 9, and 57 countries or territories experienced an increase, remained stable, and experienced a decrease, respectively, during the same period. The greatest increases in the ASIR and the ASMR were found in countries located in the Caribbean and Latin America. The incidence and mortality of OC significantly decreased in developed countries. However, remarkable increases were observed in more than two-thirds of all countries, suggesting that OC will be more frequently diagnosed in developing countries.

2020-03-26

Comparing Paclitaxel–Carboplatin with Paclitaxel–Cisplatin as the Front-Line Chemotherapy for Patients with FIGO IIIC Serous-Type Tubo-Ovarian Cancer

The use of weekly chemotherapy for the treatment of patients with advanced-stage serous-type epithelial Tubo-ovarian cancer (ETOC), and primary peritoneal serous carcinoma (PPSC) is acceptable as the front-line postoperative chemotherapy after primary cytoreductive surgery (PCS). The main component of dose-dense chemotherapy is weekly paclitaxel (80 mg/m2), but it would be interesting to know what is the difference between combination of triweekly cisplatin (20 mg/m2) or triweekly carboplatin (carboplatin area under the curve 5-7 mg/mL per min [AUC 5-7]) in the dose-dense paclitaxel regimen. Therefore, we compared the outcomes of women with Gynecology and Obstetrics (FIGO) stage IIIC ETOC and PPSC treated with PCS and a subsequent combination of dose-dense weekly paclitaxel and triweekly cisplatin (paclitaxel–cisplatin) or triweekly carboplatin using AUC 5 (paclitaxel–carboplatin). Between January 2010 and December 2016, 40 women with International Federation of Gynecology and Obstetrics (FIGO) stage IIIC EOC, FTC, or PPSC were enrolled, including 18 treated with paclitaxel–cisplatin and the remaining 22 treated with paclitaxel–carboplatin. There were no statistically significant differences in disease characteristics of patients between two groups. Outcomes in paclitaxel–cisplatin group seemed to be little better than those in paclitaxel–carboplatin (median progression-free survival [PFS] 30 versus 25 months as well as median overall survival [OS] 58.5 versus 55.0 months); however, neither reached a statistically significant difference. In terms of adverse events (AEs), patients in paclitaxel–carboplatin group had more AEs, with a higher risk of neutropenia and grade 3/4 neutropenia, and the need for a longer period to complete the front-line chemotherapy, and the latter was associated with worse outcome for patients. We found that a period between the first-time chemotherapy to the last dose (6 cycles) of chemotherapy &gt;21 weeks was associated with a worse prognosis in patients compared to that ≤21 weeks, with hazard ratio (HR) of 81.24 for PFS and 9.57 for OS. As predicted, suboptimal debulking surgery (&gt;1 cm) also contributed to a worse outcome than optimal debulking surgery (≤1 cm) with HR of 14.38 for PFS and 11.83 for OS. Based on the aforementioned findings, both regimens were feasible and effective, but maximal efforts should be made to achieve optimal debulking surgery and following the on-schedule administration of dose-dense weekly paclitaxel plus triweekly platinum compounds. Randomized trials validating the findings are warranted.

Linked Investigators

Peng-Hui Wang

Name Peng-Hui, Wang Title Professor, Director, Department of Obstetrics and Gynecology, National Yang-Ming University Address No. 201, Sec.2, Shih-Pai Road, Taipei, 112 Taiwan Email phwang@vghtpe.gov.tw pongpongwang@gmail.com Telephone 886-2-2875-7566 Education 2002-2003 Post-Dr. Pathology University of Rochester, NY, USA 2002 Ph.D. Philosophy National Yang-Ming University, Taiwan 1990 M.D. Medicine National Yang-Ming University, Taiwan. Academic appointments 2009-present Professor, Department of Obstetrics and Gynecology, National Yang-Ming University 2009-present Professor and Director, Department of Obstetrics and Gynecology, National Yang-Ming University 2009-present Professor, Department of Obstetrics and Gynecology, Taipei Veterans General Hospital 2011- present Chief, Division of Gynecology, Department of Obstetrics and Gynecology, Taipei Veterans General Hospital 2006-2009 Associate Professor, Department of Obstetrics and Gynecology, National Yang-Ming University 2002-2006 Assistant Professor, Department of Obstetrics and Gynecology, National Yang-Ming University 1998-2002 Instructor, Department of Obstetrics and Gynecology, National Yang-Ming University 1996-present More than 300 SCI peer review papers Honors 2015 Silver Award of Research Paper for Cancer in the Hsu Chien-Tien Cancer Foundation 2015 Golden Award of Research Paper in the Taiwan Association of Obstetrics and Gynecology 2014 Silver Award of Research Paper in the Taipei Veterans General Hospital, Taipei 2013 Golden Award of Research Paper in the Chinese Medical Association, Taipei 2012 Life-long Outstanding Teacher Award from the National Yang-Ming University 2008-2012 Outstanding Teacher Award from the National Yang-Ming University 2010 Yung-Kuei Soong Endoscopy and Minimally Invasive Medicine Best paper honor (6th Taiwan Association for Minimally Invasive Gynecology) in 2010 2004 The outstanding Young Persons of Republic of China (42th) in 2004 2003 Prize Paper Award-Honorable Mention- Best Clinical Research Article form a Developing Country in 2003 2003 Best Postgraduate Prize Paper third place in Global Congress of Gynecologic Endoscopy AAGL 32nd Annual Meeting in 2003 2000 Outstanding Performance Award from the Taipei Veterans General Hospital, Taiwan in 2000 1999 Outstanding Researcher Award from the National Science Council, Taiwan in 1999 Academic Members 2014-present Supervisor, The Taiwan Association of Perinatology 2014-present Director, The Taiwan Society of Gynecologic Cancer 2013-present President, The Taiwan Association of Gynecology 2013-present Supervisor, The Taiwan Association of Obstetrics and Gynecology 201- present Chief, Division of Gynecology, Department of Obstetrics and Gynecology, Taipei Veterans General Hospital Publications in Peer-Review Journal 385 SCI and peer-review articles

Nab-paclitaxel Versus Sb-taxanes As First-Line Treatment in Advanced Ovarian Cancer