P H Cashin1, H Mahteme2, N Spång3, I Syk4, J E Frödin5, M Torkzad6, B Glimelius7, W Graf3. 1. Department of Surgical Sciences, Section of Surgery, Uppsala University, Akademiska Sjukhuset, 75185 Uppsala, Sweden. Electronic address: Peter.cashin@gmail.com. 2. Department of Surgical Sciences, Section of Surgery, Uppsala University, Akademiska Sjukhuset, 75185 Uppsala, Sweden; Uppsala Cancer Clinic, Uppsala, Sweden. 3. Department of Surgical Sciences, Section of Surgery, Uppsala University, Akademiska Sjukhuset, 75185 Uppsala, Sweden. 4. Department of Surgery, Skåne University Hospital, 21428 Malmö, Sweden. 5. Department of Oncology and Pathology, Karolinska Institutet, 171 76 Stockholm, Sweden. 6. Department of Surgical Sciences, Section of Radiology, Uppsala University, Akademiska Sjukhuset, 75185 Uppsala, Sweden. 7. Department of Oncology and Pathology, Karolinska Institutet, 171 76 Stockholm, Sweden; Department of Immunology, Genetics and Pathology, Section of Oncology, Uppsala University, Akademiska Sjukhuset, 75185 Uppsala, Sweden.
Abstract
BACKGROUND: First-line treatment of isolated resectable colorectal peritoneal metastases remains unclear. This study (the Swedish peritoneal study) compares cytoreductive surgery and intraperitoneal chemotherapy (surgery arm) with systemic chemotherapy (chemotherapy arm). METHODS: Patients deemed resectable preoperatively were randomised to surgery and intraperitoneal 5-fluorouracil 550 mg/m(2)/d for 6 d with repeated courses every month or to systemic oxaliplatin and 5-fluorouracil regimen every second week. Both treatments continued for 6 months. Primary end-point was overall survival (OS) and secondary end-points were progression-free survival (PFS), and morbidity. RESULTS: The study terminated prematurely when 48 eligible patients (24/arm) were included due to recruitment difficulties. Two-year OS was 54% in the surgery arm and 38% in the chemotherapy arm (p = 0.04). After 5 years, 8 versus 1 patient were alive, respectively (p = 0.02). Median OS was 25 months versus 18 months, respectively, hazard ratio 0.51 (95% confidence interval: 0.27-0.96, p = 0.04). PFS in the surgery arm was 12 months versus 11 months in the chemotherapy arm (p = 0.16) with 17% versus 0% 5-year PFS. Grade III-IV morbidity was seen in 42% and 50% of the patients, respectively. No mortalities. CONCLUSIONS:Cytoreductive surgery with intraperitoneal chemotherapy may be superior to systemic oxaliplatin-based treatment of colorectal cancer with resectable isolated peritoneal metastases.(ClinicalTrials.gov nr:NCT01524094).
RCT Entities:
BACKGROUND: First-line treatment of isolated resectable colorectal peritoneal metastases remains unclear. This study (the Swedish peritoneal study) compares cytoreductive surgery and intraperitoneal chemotherapy (surgery arm) with systemic chemotherapy (chemotherapy arm). METHODS:Patients deemed resectable preoperatively were randomised to surgery and intraperitoneal 5-fluorouracil 550 mg/m(2)/d for 6 d with repeated courses every month or to systemic oxaliplatin and 5-fluorouracil regimen every second week. Both treatments continued for 6 months. Primary end-point was overall survival (OS) and secondary end-points were progression-free survival (PFS), and morbidity. RESULTS: The study terminated prematurely when 48 eligible patients (24/arm) were included due to recruitment difficulties. Two-year OS was 54% in the surgery arm and 38% in the chemotherapy arm (p = 0.04). After 5 years, 8 versus 1 patient were alive, respectively (p = 0.02). Median OS was 25 months versus 18 months, respectively, hazard ratio 0.51 (95% confidence interval: 0.27-0.96, p = 0.04). PFS in the surgery arm was 12 months versus 11 months in the chemotherapy arm (p = 0.16) with 17% versus 0% 5-year PFS. Grade III-IV morbidity was seen in 42% and 50% of the patients, respectively. No mortalities. CONCLUSIONS: Cytoreductive surgery with intraperitoneal chemotherapy may be superior to systemic oxaliplatin-based treatment of colorectal cancer with resectable isolated peritoneal metastases.(ClinicalTrials.gov nr:NCT01524094).
Authors: Joel M Baumgartner; Victoria M Raymond; Richard B Lanman; Lisa Tran; Kaitlyn J Kelly; Andrew M Lowy; Razelle Kurzrock Journal: Ann Surg Oncol Date: 2018-06-14 Impact factor: 5.344