OPTIMIZING TREATMENT FOR ADVANCED OVARIAN CANCER: PRIMARY DEBULKING SURGERY(PDS) VERSUS NEOADJUVANT CHEMOTHERAPY (NACT) Tahira Baloch January 24th ,2017

BACKGROUND: Approx. 70% of women with epithelial OC are diagnosed with advanced stage disease. high morbidity and mortality. 5-years survival 17% Goal of treatment: complete cytoreduction Debulking NACT Depending on Patients condition : In our hospital we do imaging on this basis we decide to give patients with its treatment. But in other hospital there is a set guideline like with the help of laproscopic we decide either we give which treatment.

BUT THE ISSUE IS??WHICH SHOULD BE GIVEN FIRST!!! NACT utilization has increased as an alternative to PDS in selected patients with more advanced disease NACT should show improved survival in these select patients. Controverse remains But selection bias! he effect of neoadjuvant chemotherapy (NAC) on Gastric carcinoma (GC) has been extensively studied, while its survival and surgical benefits remain controversial. NACT: use was iniated in selected patients that had more disease, tumor burden, and therefore bad candidates for surgery. Note that I told you about the goal of the treatment is to accomplish complete cytoreduction. So before taking this patients to surgery, chemotherapy reduces the tumor burden to make the chances higher to do a complete debulking.

AIM AND OBJECTIVES: Identify prognostic  Randomised Controlled Trial,Multicentered: PDS vs NACT in patients with advanced ovarian cancer Identify prognostic Primary outcome: overall survival and progression free survival. Secondary outcome: peri-operative complications, adverse effects treatment, Quality of Life (SF-36 or FACT- G)

STUDY FLOW: N=120 Randomized 1:1 NACT PDS (NEOADJUVANT CHEMOTHERAPY) Conducted : approx. 5 years Informed consent: before enrollment patient will be provided with the form. Safety Measures: Images will be taken at certain time interval Quality of life: Questionaire (SF-36) will be provided (every 3 months) to objectify Enrollment: Clinically Stage III & IV disease EXCLUDING: Patients with Co-Morbidities Having Previous chemotherapy N=120 Randomized 1:1 PDS (PRIMARY DEBULKING SURGERY) n=30 NACT (NEOADJUVANT CHEMOTHERAPY) n=30 Some patient refuse to under go surgery so they prefer to do neoadjuvant. Some times due to work on more patients we take both therapies together. After 3 cycles:imaging After surgery Again after giving 3 cycles After surgery: images will be taken. After every 3 cycles imaging will be taken Primary outcome analysis Secondary outcome analysis Primary outcome analysis Secondary outcome analysis

ANTICIPATICING RESULTS: Primary Outcomes: Is NACT better than PDS? NACT > PDS or =, OS and PFS Alternatively is there a subset of patients for whom NACT is good? Secondary Outcomes: Quality of life, adverse events To correlate to secondary outcomes: Quality of life Adverse effects Strength of this study: No selection bias based on clinical screening RCT = take away selection bias NACT group: will be more mixed ( not only the worse cases)

Where we are in CANCER therapies??