Abstract
BackgroundInnovative systemic treatments and loco-regional chemotherapy by hypoxic pelvic perfusion (HPP) have been proposed for unresectable recurrent rectal cancer (URRC). Regorafenib and trifluridine-tipiracil reported significantly increased PFS 1.9-2.0 months, OS 6.4-7.1 months vs placebo, respectively. Present study evaluated safety and efficacy of mitomycin/oxaliplatin HPP associated to intravenous cetuximab, and of third line systemic therapy in clinical practice.MethodsHPP consisted of: isolation, perfusion, chemofiltration. Patients received mitomycin 25 mg/m2 and oxaliplatin 80 mg/m2 during HPP; from days 21 to 28, cetuximab 250 mg/m2/week. In case of partial response or stable disease, HPPs were repeated every 8 weeks. In control group, systemic third and further lines of therapy were defined in clinical practice according to clinical (age, comorbidities, performance status), biological parameters (KRAS, NRAS, BRAF genotype).ResultsFrom 2005 to 2018, 49 URRC patients were enrolled; 33 in HPP/target-therapy, 16 in systemic therapy control group. No HPP related complications were reported. Most common adverse events were skin, bone marrow toxicities. In HPP/target-therapy group, ORR and DCR were 36.4 and 100%; in systemic therapy control group, 18.7 and 31.25%, respectively. In HPP/target-therapy compared with systemic therapy group, respectively, DCR seemed significantly favourable (P = 0.001), as PFS 8 vs 4 months (P = 0.018), and OS 15 vs 8 months (P = 0.044).ConclusionsPresent data showed that integration of HPP/target-therapy may be effective in local control, and efficacy as third line treatment of URCC patients. This therapeutic strategy deserves further prospective randomized trials to be compared to conventional systemic treatments.
Highlights
The incidence of local recurrence in rectal cancer has decreased to approximately 8% in the last years [1]
Present data showed that integration of hypoxic pelvic perfusion (HPP)/target-therapy may be effective in local control, and efficacy as third line treatment of URCC patients
The purpose of this retrospective cohort study of unresectable recurrent rectal cancer (URRC) patients in progression after two lines of systemic chemotherapy and radiotherapy was to evaluate safety and efficacy of a cohort of patients treated with mitomycin/ oxaliplatin HPP associated to intravenous cetuximab, and a control cohort of patients treated with third and further lines of systemic therapy
Summary
The incidence of local recurrence in rectal cancer has decreased to approximately 8% in the last years [1]. For unresectable recurrent rectal cancer (URRC) patients in progression after systemic chemotherapy and radiation, several palliative therapies have been proposed [3,4,5]. In the Recourse trial [14], evaluating TAS-102, all the patients had received prior chemotherapy regimens containing fluoropyrimidine, oxaliplatin, and irinotecan, all but one patient had received bevacizumab, all but two patients with KRAS wild-type tumors had received cetuximab or panitumumab; median PFS was 2.0 vs 1.7 months, median OS was 7.1 vs 5.3 months, in the TAS-102 compared with placebo group, respectively. Innovative systemic treatments and loco-regional chemotherapy by hypoxic pelvic perfusion (HPP) have been proposed for unresectable recurrent rectal cancer (URRC). Present study evaluated safety and efficacy of mitomycin/oxaliplatin HPP associated to intravenous cetuximab, and of third line systemic therapy in clinical practice
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