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/m 2 )/(45 mg/m 2 ) +/− (P) (160 mg/m 2 ) 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.
| Original language | English (US) |
|---|---|
| Journal | Gynecologic Oncology |
| DOIs | |
| State | Published - Jan 1 2019 |
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Keywords
- Advanced endometrial cancer
- Chemotherapy and radiation
- Long-term follow-up
- Optimal surgery
ASJC Scopus subject areas
- Oncology
- Obstetrics and Gynecology
Cite this
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. / Spirtos, Nick M.; Enserro, Danielle; Homesley, Howard D.; Gibbons, Susan K.; Cella, David; Morris, Robert T.; DeGeest, Koen; Lee, Roger B.; Miller, David S.
In: Gynecologic Oncology, 01.01.2019.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - 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)
T2 - A randomized phase III NRG/Gynecologic Oncology Group (GOG) study
AU - Spirtos, Nick M.
AU - Enserro, Danielle
AU - Homesley, Howard D.
AU - Gibbons, Susan K.
AU - Cella, David
AU - Morris, Robert T.
AU - DeGeest, Koen
AU - Lee, Roger B.
AU - Miller, David S
PY - 2019/1/1
Y1 - 2019/1/1
N2 - 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/m 2 )/(45 mg/m 2 ) +/− (P) (160 mg/m 2 ) 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.
AB - 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/m 2 )/(45 mg/m 2 ) +/− (P) (160 mg/m 2 ) 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.
KW - Advanced endometrial cancer
KW - Chemotherapy and radiation
KW - Long-term follow-up
KW - Optimal surgery
UR - http://www.scopus.com/inward/record.url?scp=85064938672&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85064938672&partnerID=8YFLogxK
U2 - 10.1016/j.ygyno.2019.03.240
DO - 10.1016/j.ygyno.2019.03.240
M3 - Article
C2 - 31053405
AN - SCOPUS:85064938672
JO - Gynecologic Oncology
JF - Gynecologic Oncology
SN - 0090-8258
ER -