1. Effect of NACT on optimal debulking in advanced EOC-A retrospective study at a tertiary cancer centre
Investigator: Dr.Rekha.B.R
Fellow-gynec onco
Guide: Dr.Rani Akhil Bhat
HOD: Gynec oncology

2. Introduction
Ovarian cancer is known to present in advanced stage and complete cytoreduction at surgery is the most important prognostic indicator
Primary debulking surgery followd by adjuvant chemtherapy is the current guideline for primary treatment of ovarian cancer1
Majority of EOC (Epithelial ovarian cancer) present in advanced stage due to lack of symptoms and screening tools. In advanced stages, the presence of extensive peritoneal disease, upper abdominal disease and visceral involvement makes optimal cytoreduction a difficult task to achieve and involves high rates of morbidity and mortality.

3. Introduction
Over 80% of EOC are sensitive to taxanes and hence neo-adjuvant chemotherapy can reduce the disease burden and increase the probability of optimal cytoreduction that is residural disease of less than 1 cm at the end of surgery, in advanced EOC.
In a study by Shekar sharma et al it was found that the probability of optimal cytoreduction was higher in the neo-adjuvant chemotherapy (NACT) group than with primary surgery (88.6% vs 50.0%; p < )2.

4. Rationale for study
Ovarian cancer tends to present in advanced stages and complete cytoreduction is the goal of surgery
But due to extensive disease in advanced stages complete cytoreduction may not be feasible in many cases. But complete cytoreduction gives a good outcome in terms of progression free survival(PFS) and overall survival(OS).
Hence NACT is useful to decrease the disease burden and helps to achieve complete cytoreduction in most of the cases leading to better outcomes

5. Research Hypothesis
Does NACT facilitate complete cytoreduction in advanced ovarian cancers?

6. Aims
To evaluate the role of NACT followed by interval debulking, in advanced ovarian cancers, in obtaining complete cytoreduction in a higher number of cases with a favourable outcome

7. Objectives
In this study, case records of patients who underwent NACT followed by interval debulking surgery will be reviewed.
The number of cases who had complete cyto-reduction will be considered as positive outcome in support of the said hypothesis.
Statistical analysis will be done to evaluate the significance of the results obtained

8. Review of Literature
The CHORUS trial, a phase III, non-inferiority randomised controlled trial was conducted to test the hypothesis that giving primary chemotherapy with delayed surgery could result in survival similar to primary surgery, with reduced surgical morbidity.
Out of 550 women who were eligible, 276 were assigned to primary surgery and 274 to primary chemotherapy. All were included in the intention-to-treat analysis; 251 assigned to primary surgery and 253 to primary chemotherapy were included in the per-protocol analysis
Median overall survival was 22·6 months in the primary-surgery group versus 24·1 months in primary chemotherapy.
It was concluded that in women with stage III or IV ovarian cancer, survival with primary chemotherapy is non-inferior to primary surgery.
Primary chemotherapy versus primary surgery for newly diagnosed advanced ovarian cancer (CHORUS): an open-label, randomised, controlled, non-inferiority trial. Prof Sean Kehoe et al. THE LANCET vol 386, Issue 9990, July 2015, pages

9. Review of Literature
In a retrospective study involving 165 patients older than 70yr, 125 (75.8%) underwent PDS and 40 (24.2%) underwent NACT-IDS.
The NACT-IDS group was associated with less intraoperative blood loss (250 vs. 400 mL, p=0.001), a greater chance of achieving no residual disease (40% vs. 16%, p=0.005) and a shorter hospital length of stay (LOS) (5 vs. 7 days, p<0.001).
PFS (17 vs. 15 months, p=0.708) and OS (29 vs. 33 months, p=0.827) were similar between the two groups.
Readmission rates within 30 days of surgery were greater in those undergoing PDS (17.6% vs. 2.5%, p=0.016).
Does neoadjuvant chemotherapy decrease the risk of hospital readmission following debulking surgery? Worley MJ Jr1, Guseh SH, Rauh-Hain JA, Williams KA, Muto MG Feltmate CM Berkowitz RS, Horowitz NS Gynecol Oncol. 2013 Apr;129(1):

10. Review of Literature SCORPION TRIAL A phase III randomised trial
55 were assigned to PDS (arm A) and 55 to NACT-IDS (arm B).
Twenty-nine patients (52.7%) in arm A experienced early grade III-IV complications versus three patients (5.7%) in IDS (p=0.0001).
Mean QoL scores of several scales/items were shown to ameliorate over time in both arms.
Emotional functioning, cognitive functioning, nausea/vomiting, dyspnoea, insomnia and hair loss were statistically and clinically better in NACT/IDS compared to PDS arm.
CONCLUSIONS:
Perioperative moderate/severe morbidity as well as QoL scores were shown to be more favourable in NACT/IDS arm than PDS in AEOC patients with very HTL. Completion of patient enrolment and analysis of survival data will clarify whether PDS with such a high rate of severe complications is an acceptable treatment in AEOC women with HTL.
Phase III randomised clinical trial comparing primary surgery versus neoadjuvant chemotherapy in advanced epithelial ovarian cancer with high tumour load (SCORPION trial): Final analysis of peri-operative outcome. European Journal of Cancer 59 (2016) 22e33
Fagotti A, Ferrandina G, Vizzielli G, Fanfani F, Gallotta V, Chiantera V, Costantini B, Margariti PA, Gueli Alletti S, Cosentino F, Tortorella L, Scambia G.

11. Material and Methods
Records of patients with advanced ovarian cancer who underwent NACT followed by interval debulking during 2013 to July 2017 will be analysed.
Inclusion criteria:
Biopsy proven Epithelial ovarian cancer/primary peritoneal cancer stage III/IV and fit for NACT
NACT followed by interval debulking

12. Material and Methods Exclusion criteria: 1.Ovarian cancer stage I/II
2. Non-epithelial ovarian cancers
3. Primary debulking surgery

13. Statistical analysis
Descriptive analysis of the data will be done on SPSS 23.
Continuous variables will be expressed as Mean and standard deviation.
Categorical variables will be expressed as frequency and percentage
In inferential statistics, chi-square test and fisher’s exact test will be used to find out association between categorical variables.
P<0.05 will be considered as statistically significant

14. Bibliography
1. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology . Ovarian cancer including fallopian tube cancer and primary peritoneal cancer. Version Accessed October 30, 2015.
2. Neoadjuvant Chemotherapy in Advanced Epithelial Ovarian Cancer : A Retrospective Study. Shekar Sharma, D.K. Vijay Kumar, Chitrathara K, Altaf Gauhar et al. Indian Journal Of Medical & Paediatric Oncology Vol. 28 No 1, 2007.

15. THANK YOU