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Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy versus R0 resection for resectable colorectal cancer with peritoneal metastases and low peritoneal cancer index scores: A collaborative observational study from Korea and Japan.

ABSTRACT:

Background

The benefits of hyperthermic intraperitoneal chemotherapy (HIPEC) after cytoreductive surgery (CRS) for colorectal cancer with peritoneal metastasis (CPM) remain controversial. R0 resection without peritoneal stripping might be as effective as CRS plus HIPEC. We aimed to compare the long-term oncological outcomes of patients with CPM and peritoneal cancer index (PCI) scores ≤6 who underwent R0 resection in Japan with those who underwent CRS plus HIPEC in Korea.

Materials and methods

This international, retrospective cohort study was conducted in Korea and Japan using a prospectively collected clinical database. Patients who underwent surgery from July 2014 to December 2021 for CPM with a PCI score of ≤6 and completeness of the cytoreduction score-0 were included. The primary outcome was relapse-free survival (RFS), and the secondary outcomes were overall survival (OS), peritoneal RFS (PRFS), and postoperative outcomes.

Results

The 3-year RFS was significantly longer in the CRS+HIPEC group than in the R0 resection group: 35.9% versus 6.9% (P<0.001); 31.0% versus 6.7% (P=0.040) after propensity score matching. The median PRFS was significantly longer in the CRS+HIPEC group than in the R0 resection group: 24.5 months versus 17.2 months (P=0.017). The 3-year OS and postoperative complications did not significantly differ between the two groups.

Conclusions

RFS and PRFS rates were significantly prolonged after CRS plus HIPEC, whereas postoperative complications and length of hospital stay were not increased. Therefore, curative CRS plus HIPEC may be considered a treatment strategy for selected patients with resectable CPM and low PCI scores.

SUBMITTER: Kitaguchi D

PROVIDER: S-EPMC10793799 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature

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Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy versus R0 resection for resectable colorectal cancer with peritoneal metastases and low peritoneal cancer index scores: a collaborative observational study from Korea and Japan.

Kitaguchi Daichi D Park Eun Jung EJ Baik Seung Hyuk SH Sasaki Shoma S Tsukada Yuichiro Y Ito Masaaki M

International journal of surgery (London, England) 20240101 1

<h4>Background</h4>The benefits of hyperthermic intraperitoneal chemotherapy (HIPEC) after cytoreductive surgery (CRS) for colorectal cancer with peritoneal metastasis (CPM) remain controversial. R0 resection without peritoneal stripping might be as effective as CRS plus HIPEC. The authors aimed to compare the long-term oncological outcomes of patients with CPM and peritoneal cancer index (PCI) scores less than or equal to 6 who underwent R0 resection in Japan with those who underwent CRS plus H ...[more]

PMID: 37800569

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Project description:ImportanceTo date, no randomized clinical trials have investigated perioperative systemic therapy relative to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) alone for resectable colorectal peritoneal metastases (CPM).ObjectiveTo assess the feasibility and safety of perioperative systemic therapy in patients with resectable CPM and the response of CPM to neoadjuvant treatment.Design, setting, and participantsAn open-label, parallel-group phase 2 randomized clinical trial in all 9 Dutch tertiary centers for the surgical treatment of CPM enrolled participants between June 15, 2017, and January 9, 2019. Participants were patients with pathologically proven isolated resectable CPM who did not receive systemic therapy within 6 months before enrollment.InterventionsRandomization to perioperative systemic therapy or CRS-HIPEC alone. Perioperative systemic therapy comprised either four 3-week neoadjuvant and adjuvant cycles of CAPOX (capecitabine and oxaliplatin), six 2-week neoadjuvant and adjuvant cycles of FOLFOX (fluorouracil, leucovorin, and oxaliplatin), or six 2-week neoadjuvant cycles of FOLFIRI (fluorouracil, leucovorin, and irinotecan) and either four 3-week adjuvant cycles of capecitabine or six 2-week adjuvant cycles of fluorouracil with leucovorin. Bevacizumab was added to the first 3 (CAPOX) or 4 (FOLFOX/FOLFIRI) neoadjuvant cycles.Main outcomes and measuresProportions of macroscopic complete CRS-HIPEC and Clavien-Dindo grade 3 or higher postoperative morbidity. Key secondary outcomes were centrally assessed rates of objective radiologic and major pathologic response of CPM to neoadjuvant treatment. Analyses were done modified intention-to-treat in patients starting neoadjuvant treatment (experimental arm) or undergoing upfront surgery (control arm).ResultsIn 79 patients included in the analysis (43 [54%] men; mean [SD] age, 62 [10] years), experimental (n = 37) and control (n = 42) arms did not differ significantly regarding the proportions of macroscopic complete CRS-HIPEC (33 of 37 [89%] vs 36 of 42 [86%] patients; risk ratio, 1.04; 95% CI, 0.88-1.23; P = .74) and Clavien-Dindo grade 3 or higher postoperative morbidity (8 of 37 [22%] vs 14 of 42 [33%] patients; risk ratio, 0.65; 95% CI, 0.31-1.37; P = .25). No treatment-related deaths occurred. Objective radiologic and major pathologic response rates of CPM to neoadjuvant treatment were 28% (9 of 32 evaluable patients) and 38% (13 of 34 evaluable patients), respectively.Conclusions and relevanceIn this randomized phase 2 trial in patients diagnosed with resectable CPM, perioperative systemic therapy seemed feasible, safe, and able to induce response of CPM, justifying a phase 3 trial.Trial registrationClinicalTrials.gov Identifier: NCT02758951.

Project description:Colorectal cancer peritoneal metastasis (CPM) confers an exceptionally poor prognosis, and traditional treatment involving systemic chemotherapy (SC) is largely ineffective. Cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) is increasingly advocated for selected patients with CPM; however, opinions are divided because of the perceived lack of evidence, high morbidity, mortality, and associated costs for this approach. As there is no clear consensus, the aim of this study was to compare outcomes following CRS+HIPEC vs SC alone for CPM using meta-analytical methodology, focusing on survival outcomes. Secondary outcomes assessed included morbidity, mortality, quality of life (QOL), and health economics (HE).An electronic literature search was conducted to identify studies comparing survival following CRS+HIPEC vs SC for CPM. The odds ratio (OR) was calculated using the Mantel-Haenszel method with corresponding 95% confidence intervals (CI) and P-values. Heterogeneity was examined using the Q-statistic and quantified with I(2). The fixed-effect model (FEM) was used in the absence of significant heterogeneity. For included studies, 2- and 5-year survival was compared for CRS+HIPEC vs SC alone.Four studies (three case-control, one RCT) provided comparative survival data for patients undergoing CRS+HIPEC (n=187) vs SC (n=155) for CPM. Pooled analysis demonstrated superior 2-year (OR 2.78; 95% CI 1.72-4.51; P=0.001) and 5-year (OR 4.07; 95% CI 2.17-7.64; P=0.001) survival with CRS+HIPEC compared with SC. Mortality ranged from 0 to 8%. No data were available for the assessment of QOL or HE.Although limited by between-study heterogeneity, the data support the assertion that in carefully selected patients, multimodal treatment of CPM with CRS+HIPEC has a highly positive prognostic impact on medium- and long-term survival compared with SC alone. There is a paucity of comparative data available on morbidity, QOL, and HE.