Feasibility of Reducing One Cycle of Neoadjuvant Chemotherapy in Advanced Ovarian Cancer
Posted: Tuesday, June 30, 2020
Hee Seung Kim, PhD, of the Seoul National University College of Medicine, Republic of Korea, and colleagues proposed a randomized controlled trial to assess the safety and efficacy of neoadjuvant chemotherapy with a reduced number of cycles prior to interval debulking surgery for patients with advanced ovarian, fallopian, and primary peritoneal cancers. The protocol for this phase III trial was published in BMC Cancer.
“Neoadjuvant chemotherapy followed by interval debulking surgery has been introduced as an alternative [to primary debulking surgery and adjuvant chemotherapy], showing similar efficacy and decreased postoperative complications,” the authors commented. “We hypothesize that reducing one cycle of neoadjuvant chemotherapy will contribute to more resection of visible tumors despite 10% reduction of optimal cytoreduction, which could improve survival.”
The investigators plan to enroll approximately 298 patients with histologically confirmed stage IIIC to IVB epithelial ovarian, fallopian, or primary peritoneal cancer. Patients will be randomly assigned in a 1:1 ratio to receive either the control or experimental treatment. Every 3 weeks, the control group will be administered three cycles of neoadjuvant chemotherapy consisting of paclitaxel and carboplatin. Patients in the experimental group will be treated in a similar manner; however, they will receive just two cycles of chemotherapy. The investigators intend to perform interval debulking surgery approximately 3 to 6 weeks after the last chemotherapy cycle. After surgery, the control and experimental groups will undergo up to three and four cycles of adjuvant chemotherapy, respectively.
The investigators identified progression-free survival as the primary endpoint. Several effect and safety variables will be evaluated as secondary endpoints. According to the investigators, the patients will undergo follow-up CT scans and tumor marker assessments every 3 months for 2 years and then every 6 months for the next 3 years.
Disclosure: For full disclosures of the study authors, visit www.bmccancer.biomedcentral.com.