Abstract

BackgroundThird line innovative systemic treatments and loco-regional chemotherapy by hypoxic pelvic perfusion (HPP) have both been proposed for the treatment of unresectable not responsive recurrent rectal cancer (URRC). In the present study, we have compared the safety and efficacy of HPP/target therapy, using drug regimens selected by liquid biopsy precision oncotherapy, to third-line systemic therapy based on tissue specimens precision oncotherapy.MethodsHPP/target therapy regimens were selected based on precision oncotherapy, including assays for chemosensitivity and viability, and qRT-PCR for tumor-related gene expression. In the control group, systemic third-line and further lines of therapy were defined according to clinical and biological parameters.ResultsFrom 2007 to 2019, 62 URRC patients were enrolled, comprised of 43 patients in the HPP/target-therapy group and 19 patients in the systemic therapy control group. No HPP related complications were reported and the most common adverse events were skin and bone marrow toxicity. In the HPP/target-therapy group, the ORR was 41.8% whereas in the systemic therapy control group was 15.8%. DCR of the HPP/target-therapy group was significantly improved over the systemic therapy group (P = 0.001), associated with a PFS of 8 vs 4 months (P = 0.009), and OS of 20 vs 8 months (P = 0.046).ConclusionsThe present data indicate that in URCC patients, the integration of HPP/target-therapy and precision oncotherapy based upon liquid biopsy is as effective and efficacious as third-line treatment in local disease control and, therefore, deserves to be further assessed and compared to conventional systemic treatments in future prospective randomized trials.

Highlights

  • Local rectal cancer recurrences have reduced over the last 20 years but the results of treatment remain unsatisfactory (Lee et al 2017)

  • We present a retrospective study of unresectable not responsive recurrent rectal cancer (URRC), in progression after two lines of systemic chemotherapy and radiotherapy, that evaluates and compares safety and efficacy in URCC patients subjected to hypoxic pelvic perfusion (HPP) and target therapy, using different drug regimens based on precision oncotherapy, to a URRC patient control group treated with third and subsequent line systemic therapy selected by tissue specimens precision oncotherapy

  • The HPP/target therapy group was comprised of 43 patients treated with different drug regimens selected by liquid biopsy precision oncotherapy and a control group of 19 patients treated with conventional systemic therapy, according to fitness, age, performance status (PS), and comorbidity status

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Summary

Introduction

Local rectal cancer recurrences have reduced over the last 20 years but the results of treatment remain unsatisfactory (Lee et al 2017). Approximately 50% of locally recurrent rectal cancers are considered eligible for multidisciplinary treatments including extensive “ultra-radical resection”, intraoperative and/or external irradiation, peri-operative systemic chemotherapy and targeted-therapy but population-based studies indicate that only 35% of patients undergo tumor resection (Lee et al 2017; Westberg et al 2019). We present a retrospective study of URRC, in progression after two lines of systemic chemotherapy and radiotherapy, that evaluates and compares safety and efficacy in URCC patients subjected to HPP and target therapy, using different drug regimens based on precision oncotherapy, to a URRC patient control group treated with third and subsequent line systemic therapy selected by tissue specimens precision oncotherapy

Methods
Part A
Results
Part B: procedure-related toxicities
Discussion
Part B: survival
Compliance with ethical standards
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