Neo-adjuvant Chemotherapy in Advanced Epithelial Ovarian Cancer (EOC): A Prospective, Randomized Study

Abstract

Purpose: To determine the impact of neo‐adjuvant chemotherapy on surgical debulking rate, perioperative morbidity, overall & progression free survival and quality of life in patients with advanced epithelial ovarian carcinoma. Materials and Methods: Between October 2001 and December 2008, previously untreated patients of advanced epithelial ovarian carcinoma were randomized to (i) primary debulking surgery (PDS) followed by 6 cycles of paclitaxel and carboplatin (AUC 6) chemotherapy of (ii) neoadjuvant chemotherapy (NACT) group ‐ wherein patients received 3 cycles of paclitaxel and carboplatin chemotherapy followed by debulking surgery followed by 3 more cycles of chemotherapy. Eligibility criteria included ‐ age 16 to 65 years, biopsy/cytological proven EOC, adequate hematological, renal, liver & cardiac functions, normal upper & lower GI endoscopy &CEA levels. Both groups were compared for debulking rate, duration of surgery, blood loss, intra & postoperative morbidity & mortality, overall response to treatment and quality of life (QOL) using Functional Assessment of Cancer Therapy‐Ovarian (FACT‐O) questionnaire. Results: One hundred and thirty three patients have completed the treated till December 2008; 128 patients are evaluable ‐ 62 in PDS group and 66 in NACT group. Fifty patients were detected to have histopathology other than EOC (Germ Cell tumour‐1, mixed mullerian tumour 2, dual primary ‐1and krukenburg‐1). Patient in NACT group had higher optimum debulking rate ( 86.2% vs 22.6 % p<0.0001), decreased blood loss during surgery ( mean vol 413 vs 600 ml, p>0.0001), reduced postoperative infections (1.54% vs 14.5%, p<0.025), reduced operative time (89.2 vs 75.4 minutes, p<0.001) and shorter hospital stay (7.6 Vs 11.5 days, p<0.001). There was no significant difference in the chemotherapy toxicity in the 2 groups. At the median followup up of 42 months, estimated median overall survival is 42 and 41 months in PDS and NACT group, respectively (p=0.57, HR 1.1 95% CI:0.71‐1.86). QOL was significantly better in NACT group at the end of treatment. (95 vs 113, p<001). Conclusions: Neoadjuvant chemotherapy in advanced epithelial ovarian cancer is associated with higher optimum debulking rate with reduced postoperative morbidity and improved quality of life.