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No survival benefit of tumour debulking for patients with multi-organ metastatic CRC

Presented by
Dr Elske Gootjes, Radboudumc, the Netherlands
Conference
ASCO 2024
Trial
Phase 3, ORCHESTRA
Doi
https://doi.org/10.55788/92c29c12
Tumour debulking in addition to standard palliative combination chemotherapy provides no survival benefit for patients with multi-organ metastatic colorectal cancer (CRC), according to the results of the phase 3 ORCHESTRA trial.

The standard treatment for metastatic CRC is systemic therapy (chemotherapy and targeting agents), which results in a survival of approximately 30 months [1]. In addition, local debulking strategies are increasingly being used [2]. However, the clinical benefits of these debulking strategies remain uncertain.

The randomised, phase 3 ORCHESTRA trial (NCT01792934) aimed to evaluate the survival benefit of tumour debulking in addition to standard palliative combination chemotherapy in patients with extensive multi-organ metastatic CRC. Previously, local treatment in this population was shown to be feasible and safe, and that tumour debulking results in more treatment-related toxicity but has no effect on health-related quality-of-life [3,4]. At ASCO, Dr Elske Gootjes (Radboudumc, the Netherlands) presented the overall survival (OS) results, which is the primary endpoint of ORCHESTRA [5].

The 382 participants who responded to systemic therapy (3x CAPOX or 4x FOLFOX ± bevacizumab) were 1:1 randomised to continuation of systemic therapy or to local debulking treatment (surgery, radiotherapy, and/or ablation) plus continuation of systemic therapy.

Tumour debulking >80% was achieved in 72% of participants in the debulking arm. After a median follow-up of 32 months, the median OS did not differ: 27.5 versus 30.0 months in the standard arm and debulking arm, respectively (HR 0.88; 95% CI 0.70–1.10; P=0.23). In addition, the median progression-free survival was not different between the treatment arms (10.4 vs 10.5 months). Outcomes were also comparable between subgroups (i.e. stratified by number of metastatic sites, peritoneal involvement, duration of response to systemic therapy, completeness of debulking).

Based on these results, Dr Gootjes concluded that “tumour debulking in addition to standard palliative combination chemotherapy provides no survival benefit. Therefore, the increasing use of local therapies requires further consideration.”

  1. Cremolini C, et al. J Clin Oncol 2020;38:3314-3324.
  2. Caroni C, et al. Crit Rev Oncol Hematol. 2023:186:103990.
  3. Gootjes EC, et al. Oncologist 2020;25:e1195-e1201.
  4. Bakkerus L, et al. J Natl Compr Canc Netw. 2023;21:1059-1066.
  5. Gootjes EC, et al. Primary endpoint analysis of the ORCHESTRA trial. Abstract LBA3502, ASCO Annual Meeting 2024, 31 May–4 June, Chicago, IL, USA.

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