Comparison Of Laparoscopic And Abdominal Radical

Hysterectomy in Early Stage Cervical Cancer Patients

without Adjuvant Treatment : Ancillary Analysis Of a
Korean Gynecologic Oncology Group Study
(KGOG 1028)

Dr. Riyan Wira Pratama

Moderator :
Dr. H. P. Agustiansyah SpOG(K), MARS

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OUTLINE
01 INTRODUCTION

02 MATERIAL AND METHOD

03 RESULT & DISCUSSION

04 CRITICAL APPRAISAL

05 CONCLUSION
Introduction
 BACKGROUND

Cervical cancer is the fourth

most frequent malignancy in
women & the seventh most
frequent malignancy in the world.
In Korea, it is one of the common
gynecologic cancers,
represents 9.8% of newly
diagnosed malignancies in A number of retrospective studies
women. showed no significant differences
in survival outcomes between
Radical hysterectomy is the surgical methods
standard treatment for stage IA–IIA
uterine cervical cancer patients. However, result of recent studies
showed different perspectives.
 Aim of This Study

To obtain additional information regarding survival outcomes of the two

surgical methods, this study assessed data from the KGOG 1028 study.
 OBJECTIVE

This study compared two groups of early stage cervical

cancer patients treated with different surgical methods
without adjuvant treatment using retrospective multicenter
data previously collected for Korean Gynecologic
Oncology Group (KGOG) study designed for developing
prognostic models.
Material
& Method
Material and Method
Study design
• A multi-institutional cohort study
• Statistical analyses were performed using R 3.3.2

Study location
All medical records were collected according to the protocol
and case report forms approved by each institutional
review board

Subject
Early stage (IB-IIA) cervical cancer patients treated with
radical hysterectomy without adjuvant treatment from
January 2000 to December 2008 from nine KGOG-
affiliated institutions
 Material and Method
Inclusion
Patients with pathologically
confirmed cervical cancer, a
clinical diagnosis of FIGO stage
(2014) IB-IIA disease, and who
had undergone radical
hysterectomy (type II or III) with
pelvic and/or para-aortic
lymphadenectomy.
Exclusion
- Patients treated with neoadjuvant
chemotherapy before surgery
- Those with previous radiation therapy
- Those with cervical cancer incidentally
found after simple hysterectomy,
- Those with rare cell types (mostly
adenosquamous carcinoma and other
types with neuroendocrine small cell
carcinoma and clear cell carcinoma)
 Statistical Analytics
P-values < 0.05 indicated statistical significance.

The Mann-Whitney test was used Student's t-test for comparing mean
for comparing median values, Content Content values was used after the Shapiro-
Wilks test to confirm normal
01 02 distributions.

Fisher's exact test or the χ2 test Analyses of survival curves

for analyzing the distributions of Content
Content were performed by the Kaplan–
characteristics according to
surgical method
03 04 Meier method

Content

05 Statistical analyses were performed using R 3.3.2

RESULT
& DISCUSSION
 Characteristics Of Early Stage Cervical Cancer Patients Who Had
Surgical Treatment Without Adjuvant Treatment
cohort 1

• 738 patients (laparoscopy 133,laparotomy 605) of early stage cervical cancer

without adjuvant treatment to surgery for analysis. After a median follow-up
period of 63.6 months, 33 patients experienced recurrences, and there were
13 deaths.

• After propensity score matching, a total of 476 patients was analyzed for
survival comparisons, with no significant differences between the two
groups for any of the matched variables, median age; 45 years, 119 patients
with laparoscopy vs. 357 patients with laparotomy.
Survival Outcomes After Propensity Score Matching
(CONT..)

IN THE LAPAROSCOPY GROUP

IN THE LAPAROTOMY GROUP
• 9 cases with pelvic recurrence
• Hematogenous recurrence was seen
• 6 hematogenous recurrences
in 7 case
• 1 lymphatic recurrence were
• Pelvic recurrence in 6 patients
observed
• Lymphatic recurrence observed in
4 patients.

6 deaths in patients treated with laparoscopy and 1 in patients treated with laparotomy.
 Cont..

A total of 248 patients were analyzed for survival comparisons, with no significant
differences between the two groups for any of the matched (cohort 2, median follow-
up period of 69.1 months, median age; 45 years, 62 patients with laparoscopy vs.
186 patients with laparotomy).
Survival Outcomes Of Low-risk Early Stage Cervical Cancer
Patients With Tumor Size < 2 Cm
Cohort 2

 A total of 248 patients were analyzed for survival comparisons, with no significant
differences between the two groups for any of the matched.
 A total of 7 recurrences was observed in low-risk patients with tumor size < 2 cm

IN THE LAPAROSCOPY GROUP

• 3 cases with pelvic recurrence
• 2 hematogenous recurrence
• 1 lymphatic recurrence were
observed.
IN THE LAPAROTOMY GROUP
• 1 pelvic recurrence was observed
• 1 death with laparotomy in this
patients group.
 Cont..

Patients treated with laparoscopy showed inferior DFS, although there was no
significant difference in OS between the two groups.
In analyses of each type of recurrence, significant differences between groups
were observed for pelvic recurrence and hematogenous recurrence but not f
or lymphatic recurrence.
 DISCUSSION
Previous studies showed
no significant differences
Before the LACC trial, 1 in DFS and OS rates
between laparoscopy and
most retrospective laparotomy
studies comparing
outcomes between
Main limitations including
laparoscopy 2 lack of information or
and laparotomy in short follow-up times

cervical cancer showed

The LACC trial has
no significant differences strengths including its
in survival design as a prospective,
3
randomized trial that
included a large number
Discussion of centers worldwide
 CONT…
We observed
a lower rate of
DFS in the Reasons may include increased tumor spillage
laparoscopy due to use of a uterine manipulator or
group, but OS 1 exposure of tumor cells by intracorporeal
colpotomy or tumor cell growth and spread by
did not differ use of insufflation gas (CO2) in laparoscopy.
significantly
between
Differences in DFS did not lead to
groups
differences in OS. The main reason may
2 be related to small number of patients for
differences in OS to be shown

There was a difference in pattern of

recurrence between surgical groups.
3 Pelvic recurrence was more frequent in
the laparoscopy group than in the
laparotomy group
 CONT…

This study hypothesize that the

inferior DFS in the laparoscopy
group compensated for OS due
to better response to salvage
therapy and better treatment
outcomes in patients with The mechanism underlying
pelvic recurrence. these observations should be
elucidated in future studies.
Critical
Appraisal
 Critical Appraisal
Population
1 Medical records of patients with early stage cervical cancer from January 2000 to
December 2008 from nine KGOG-affiliated institutions were retrospectively reviewed

Intervention
2 This research only observes the history of the research subjects using medical records of
patients with early stage cervical cancer from January 2000 to December 2008 from nine
KGOG-affiliated institutions so that no intervention is given to the research subjects.

Comparison
3 This research compared two groups of early stage cervical cancer patients treated
with different surgical methods without adjuvant treatment using retrospective
multicenter data previously collected for KGOG study designed for developing
prognostic models.
 Cont..
Outcome

• After matching, 119 patients with laparoscopic radical hysterectomy

were compared with 357 patients with abdominal radical hysterectomy
• Inferior DFS was observed in the laparoscopy group p = 0.005) with a significant
difference in pelvic p > 0.001) and hematogenous recurrence p = 0.03 but OS was not
significantly different between two groups (p = 0.624).
4 • In subgroup analysis in the patient with tumor size < 2 cm laparoscopy was associated with
lower rate of DFS p =0.003),but no significant difference in OS was observed between
groups
• Regarding OS, number of events is lacking, and inferior DFS in the laparoscopy group
may be compensated by better response to radiation therapy in pelvic recurrence.
 Cont..
5 Study Validity

Is the research question well-defined that can be answered using

this study design?
Yes, the aim of this study is to compared two groups of early stage cervical cancer patients
treated with different surgical methods without adjuvant treatment using retrospective
multicenter data previously collected for KGOG study designed for developing prognostic
models. The research is well-defined that can be answered using this study
design

Does the author use appropriate methods to answer their

questions?
Yes, because this study initially assessed data from the multi-institutional cohort with early
stage (IB-IIA) cervical cancer patients treated with radical hysterectomy without adjuvant
treatment between 2000 & 2008. Propensity score matching was performed to compare DFS
and OS of patients with laparoscopic to abdominal radical hysterectomy. Additionally, survival
comparison was performed in patients with tumor size > 2 cm.
 Cont..
5 Study Validity

Is the data collected in accordance with the purpose of research?

Yes the data collected is in accordance with the purpose of research after
obtaining approval from the local institutional review board, medical records of
patients with early stage cervical cancer from January 2000 to December 2008
from nine KGOG-affiliated institutions were retrospectively reviewed.

Does the author explain the sample selection criteria?

Yes, the authors explain the inclusion and exclusion criteria of this study.
 Cont..
6 Importance

Is this study important?

Yes, because after matching inferior DFS was observed in the laparoscopy
group with a significant difference in pelvic and hematogenous recurrence, but
OS was not significantly different between two groups. In subgroup analysis in
the patient with tumor size < 2 cm, laparoscopy was associated with lower rate
of DFS, but no significant difference in OS was observed between group .
 Cont..
7 Applicability

Can the results be applied to the local population?

Yes, because in Indonesia, cervical cancer is the second highest of all cancer
that also has high mortality rate, after breast cancer. So this study will be
needed to be a reference for future cervical treatment in Indonesia, especially in
the early stage to prevent cervical cancer become higher stage and reduce
mortality rate.

Were all important outcomes considered?

Yes, there were important information included and analyzed in this study. This
study analyzed data of low-risk early stage cervical cancer patients. Results of
adjuvant treatment to surgery could interfere with evaluation for outcomes of
surgical treatment. Using patients group only with primary surgical treatment,
outcomes of surgery could be more clearly determined.
CONCLUSION
 Conclusion

In this analysis, laparoscopic radical hysterectomy

was associated with lower rates of DFS but not
OS in early stage cervical cancer patients without
adjuvant treatment.

Further larger scale studies are needed.

This study is Valid, Important and Applicable so

this study can be used as a reference
Thank you