Abstract
Aim: Systemic chemotherapy is a part of multi-modality treatment in patients with stage II-IV rectal cancer. In particular, patients not eligible for curative resection at the time of diagnosis require more efficient approaches to improve outcomes. Metabolically supported chemotherapy (MSCT) is a novel approach targeting dysregulated energy mechanism of the tumor cell. This study aimed to examine the efficacy of MSCT combined with ketogenic diet, hyperthermia and hyperbaric oxygen therapy (HBOT) in patients with stage II-IV rectal cancer not eligible for surgery at baseline. Methods: Twenty-one patients diagnosed with stage II-IV rectal carcinoma who received metabolically supported chemotherapy (MSCT) combined with ketogenic diet, hyperthermia and HBOT were included. First-line chemotherapy regimen was oxaliplatin-based, whereas second line regimen was irinotecan-based. Overall survival and progression-free survival were estimated. Results: Mean duration of follow-up was 33.3±22.0 months. Mean overall survival was 58.6 months (95% CI, 43.3 - 73.9) and corresponding figure for progression-free survival was 45.1 months (95% CI, 28.9-61.2). Mean overall survival for patients with metastatic disease was 35.7 months. Multivariate analysis identified male gender and stage IV disease as independent predictors of worse progression free survival. No other parameter effected survival outcomes. Conclusion: Findings of this study are promising for potential use of this novel combinatorial protocol targeting multiple vulnerabilities of tumor cells in patients with advanced rectal cancer, particularly for patients with metastatic disease, without additional safety concerns. However, long term results are warranted to draw firm conclusion.
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