Title: Olaparib for maintenance treatment of recurrent, platinum-sensitive ovarian, fallopian tube and peritoneal cancer that has responded to platinum-based chemotherapy (including a review of technology appraisal no. 381) [ID1296]
Funder: Department of Health and Social Care

Abstract: To appraise the clinical and cost effectiveness of olaparib within its marketing authorisation for maintenance treatment of recurrent, platinum-sensitive ovarian, fallopian tube and peritoneal cancer that has responded to platinum-based chemotherapy.

Lay abstract: Ovarian cancer is a cancerous growth that occurs in the ovary or fallopian tubes. The most common type of ovarian cancer, high-grade serous type, is thought to arise from the peritoneum or fallopian tube and presents after it has spread to the ovary. Ovarian cancer is classified from stage I to stage IV. Advanced ovarian cancer falls within stages II and IV; in stage II the disease has grown outside the ovaries but is still within the pelvic area, stage III denotes disease that is locally advanced and has spread outside the pelvis into the abdominal cavity, and stage IV denotes that distant metastasis to other body organs such as the liver and the pleura (two thin layers of tissue that protect and cushion the lungs) has occurred. Most people are diagnosed with advanced stage disease. Some people have gene mutations that may increase the risk of ovarian cancer. Mutated inherited genes that increase the risk of ovarian cancer include BRCA 1 and 2. The incidence of ovarian cancer increases with age and average age at diagnosis is 63 years1. In 2016, 6,430 people were diagnosed with ovarian cancer in England and there were 3,693 deaths from ovarian cancer in 20162,3. The 5-year survival for women diagnosed with ovarian cancer between 2011 and 2015 and followed up to 2016, in England was 42.9%4. Ovarian cancer may be categorised according to the response to initial platinum chemotherapy as follows: platinum-sensitive (disease responds to platinum-based therapy but relapses after 6 months or more, which can be subdivided into fully [disease responds to platinum-based therapy but relapses after 12 months or more] and partially platinum-sensitive disease [disease responds to platinum-based therapy but relapses between 6 and 12 months]); platinum-resistant (disease which relapses within 6 months of completion of platinum-based chemotherapy) and platinum-refractory, that is, does not respond to initial platinum-based chemotherapy. Although a significant percentage of people have disease that responds to initial chemotherapy, between 55% and 75% of people whose tumours respond to initial therapy relapse within 2 years of completing treatment. In people whose disease relapses following initial therapy, NICE technology appraisal guidance 389 recommends paclitaxel as monotherapy or in combination with platinum, and pegylated liposomal doxorubicin hydrochloride as monotherapy or in combination with platinum, for treating recurrent ovarian cancer. In addition, NICE technology appraisal 381 recommends olaparib as an option for maintenance treatment of relapsed, platinum sensitive ovarian, fallopian tube or peritoneal cancer in adults who have BRCA1 or BRCA2 mutations and whose disease has responded to platinum based chemotherapy, if they have had 3 or more courses of platinum based chemotherapy. NICE technology appraisal 381 stated that guidance on olaparib would be considered for review when data from the SOLO-2 study became available or after 2 years.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: CANCER AND NEOPLASMS