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Gynecol Oncol. 2019 Jul;154(1):13-21. doi: 10.1016/j.ygyno.2019.03.240. Epub 2019 Apr 30.

The addition of paclitaxel to doxorubicin and cisplatin and volume-directed radiation does not improve overall survival (OS) or long-term recurrence-free survival (RFS) in advanced endometrial cancer (EC): A randomized phase III NRG/Gynecologic Oncology Group (GOG) study.

Author information

1
Women's Cancer Center, Las Vegas, NV 89169, United States of America. Electronic address: nspirtos@wccenter.com.
2
NRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY 14263, United States of America. Electronic address: denserro@gogstats.org.
3
Gynecologic Oncology Network/Brody School of Medicine, Division of Gynecologic Oncology, Leo Jenkins Cancer Center, Greenville, NC 28734, United States of America.
4
Albany Medical Center, Dept. of Radiation Oncology, Albany, NY 12208, United States of America. Electronic address: gibbons@mail.amc.edu.
5
Northwestern University, Dept. of Medical Social Sciences, Feinberg School of Medicine, Chicago, IL 60201, United States of America. Electronic address: d-cella@northwestern.edu.
6
Wayne State University, Dept. of Gynecologic Oncology, Detroit, MI 48201, United States of America. Electronic address: rmorris@med.wayne.edu.
7
University of Iowa Hospitals and Clinics, Iowa City, IA, United States of America. Electronic address: degeest@ohsu.edu.
8
Obstetrics & Gynecology, Tacoma General Hospital, Tacoma, WA, United States of America.
9
Division of Gynecologic Oncology, UT Southwestern Medical Center at Dallas, Dallas, TX 75390-9032, United States of America. Electronic address: David.Miller@utsouthwestern.edu.

Abstract

OBJECTIVES:

To determine if the addition of paclitaxel (P) to cisplatin and doxorubicin (CD) following surgical debulking and volume-directed radiation therapy improved long-term, recurrence-free survival (RFS) and overall survival (OS) in patients with advanced-stage endometrial cancer (EC).

METHODS:

Prospective, randomized GOG trial comparing (CD) (50 mg/m2)/(45 mg/m2) +/- (P) (160 mg/m2) following volume-directed radiation and surgery in advanced EC. A Kaplan-Meier (KM) analysis characterized the relationship between treatment arms and the OS outcome, a log-rank test assessed the independence of treatment with the OS outcome, and the treatment effect on estimated OS was determined using a Cox proportional hazards (PH) model stratified by stage. The PH assumption was assessed using a test of interaction between treatment variable and the natural logarithm of survival time. Adverse events, regardless of attribution, were graded.

RESULTS:

Since initial publication, 60 deaths occurred, leaving 311 patients alive with 290 (93.8%) recurrence- free. There was no significant decrease in the risk of recurrence or death associated with the CDP treatment regimen stratified for stage (p = 0.14, one-tail). The exploratory analysis for OS and the corresponding homogeneity tests for different effects across subgroups revealed only EFRT and EFRT & GRD status to have significantly different treatment effects (p = 0.027 and p = 0.017, respectively). Second primary malignancies were identified in 17/253 (6.4%) and 19/263 (7.0%) of patients treated with CD and CDP respectively. Breast (2.4%) followed by colon (1%) were the two cancers most frequently diagnosed in this setting.

CONCLUSION:

No significant difference between treatment arms was identified. Subgroup analysis both in the initial and current reports demonstrated a trend towards improved RFS and OS in patients treated with CDP and EFRT. This long-term analysis of outcomes also identified the necessity of providing on-going cancer screening to patients enrolled in trials.

KEYWORDS:

Advanced endometrial cancer; Chemotherapy and radiation; Long-term follow-up; Optimal surgery

PMID:
31053405
DOI:
10.1016/j.ygyno.2019.03.240
[Indexed for MEDLINE]

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