Three- versus six-month adjuvant FOLFOX or CAPOX for high-risk stage II and stage III colon cancer patients: the efficacy results of Hellenic Oncology Research Group (HORG) participation to the International Duration Evaluation of Adjuvant Chemotherapy (IDEA) project.

BACKGROUND: The International Duration Evaluation of Adjuvant Chemotherapy (IDEA) aimed to investigate whether a 3 months (3M) of oxaliplatin/fluoropyrimidine-based adjuvant chemotherapy (CT) is non-inferior to the 6-month (6M) administration in 3-year disease-free survival (3yDFS) in high-risk (HR) stage II or stage III colon cancer (CC). METHODS: Hellenic Oncology Research Group (HORG)-IDEA randomized patients between 3M and 6M of CT with FOLFOX4 or CAPOX. RESULTS: In total 1115 patients, 413 with HR stage II and 702 with stage III CC, were randomized. The median follow-up was 67.0 (38.3-126.0) months. Overall, 394 DFS events (202 in 3M arm and 192 in 6M arm) where recorded. The 3yDFS rate was 77.2% [95% confidence interval (CI) 72.1% to 82.3%] for 3M and 77.9% (72.6% to 82.5%) for 6M of treatment [hazard ratio (HR) 1.05 (95% CI 0.61-1.55); P = 0.647]. Eighty DFS events (3M N = 41; 6M N = 39) were observed in HR stage II patients for a 3yDFS rate of 82.7% and 83.4%, respectively (HR 1.05; 95% CI 0.68-1.63, P = 0.829). For stage III patients, 314 DFS events (3M N = 161 and 6M N = 153) were observed, for a 3yDFS rate of 72.9% for 3M versus 74.1% for 6M (HR 1.06; 95% CI 0.81-1.42, P = 0.622). For HR stage II patients receiving FOLFOX4, 3yDFS rate was 76.7% for 3M and 79.3% for 6M (HR 1.21; 95% CI 0.54-2.70). For HR stage II patients receiving CAPOX the 3yDFS rate was 85.4% for 3M and 83.8% for 6M (HR 0.99; 95% CI 0.59-1.67). For stage III patients receiving FOLFOX4, the 3yDFS rate was 71.5% for 3M and 77.3% for 6M (HR 1.18; 95% CI 0.74-1.86). For stage III patients receiving CAPOX, the 3yDFS rate was 74.5% for 3M and 74.7% for 6M (HR 0.99; 95% CI 0.70-1.44). CONCLUSIONS: The results of the HORG-IDEA study are in line with those of the global IDEA project, indicating that the 3yDFS is dependent on the administered adjuvant regimen and the choice and duration of regimen should be personalized. CLINICALTRIALS.GOV REGISTRATION NUMBER: NCT01308086.

The role of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in the management of recurrent advanced ovarian cancer: a prospective study.

PURPOSE: Ovarian cancer is the leading cause of death from gynecological cancer. The current treatment of this type of cancer consists of cytoreductive surgery (CRS) and systemic chemotherapy. The aim of this study was to examine if the hyperthermic intraoperative chemotherapy (HIPEC) is an alternative modality to treat this category of patients along with a second attempt of surgical resection and second or third line systemic chemotherapy. METHODS: Forty-eight patients suffering from advanced ovarian cancer (FIGO stages III and IV) who recurred after initial treatment with conservative or debulking surgery and systemic chemotherapy were included in this study. Twenty-four patients (group A) were treated with CRS followed by HIPEC and then systemic chemotherapy. Due to various reasons the remaining 24 patients (group B) were treated with CRS and systemic chemotherapy alone. RESULTS: The median survival for group A was 19.4 months vs. 11.2 months in group B (p <0.05). One-year survival was 85% in group A vs. 35% in group B (p <0.05). The 3-year survival rate was 50% in group A vs. 18%. in group B (p <0.01). The resection status was found to be a significant predictor of overall survival (p <0.05). Patients with peritoneal cancer index (PCI) score < 15 appeared also to have longer survival. CONCLUSION: The use of HIPEC along with the extent of the disease and the extent of cytoreduction play an important role in the survival of patients with a recurrence in an initially advanced ovarian cancer.

Morbidity and mortality of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in the management of peritoneal carcinomatosis.

PURPOSE: Peritoneal carcinomatosis (PC), which has been regarded as a lethal condition, may now be treated, achieving a long-term disease-free survival with cytoreductive surgery by treating macroscopic tumor seeding and hyperthermic intraperitoneal chemotherapy (HIPEC) by treating residual microscopic disease. The purpose of this study was to analyse the morbidity and mortality of this procedure. METHODS: A total of 39 consecutive patients were included in this retrospective study. After complete resection of the PC, HIPEC was performed via the coliseum technique. The chemotherapeutic agents used depended on the tumors' histology. RESULTS: Postoperative mortality and morbidity rates were 5.1%% (2/39) and 43.5% (17/39), respectively. The most frequent complications were pulmonary complications (31%), gastrointestinal fistulas (20%), hematologic toxicity (16%) and postoperative bleeding (11%). Statistical correlations were evidenced between morbidity and PC index (p<0.004), duration of surgery (p<0.001) and blood loss (p<0.001). CONCLUSION: This approach has resulted in a relatively high but acceptable percent of adverse events considering the expected advantage for survival.