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Tumor debulking in addition to standard palliative combination chemotherapy provides no survival benefit for patients with multiorgan metastatic colorectal cancer, according to results from the phase 3 ORCHESTRA trial.
Standard treatment of metastatic colorectal cancer is systemic therapy, including chemotherapy and targeting agents, leading to a survival of approximately 30 months1. In addition, local debulking strategies are increasingly used2. However, the clinical benefit of these debulking strategies is uncertain.
The randomized, phase 3 ORCHESTRA trial (NCT01792934) aimed to evaluate the survival benefit of adding tumor debulking to standard palliative combination chemotherapy in patients with extensive multiorgan metastatic colorectal cancer. Previously, it was shown that local treatment in this population is feasible and safe and that tumor debulking results in more treatment-related toxicity but has no effect on health related quality of life3,4. At ASCO, Dr. Else Gootjes, MD, from Erasmus MC, in the Netherlands, presented overall survival results, the primary endpoint of ORCESTRA5.
A total of 382 patients who demonstrated a response on systemic therapy (3 x CAPOX [B] or FOLFOX[B]) were 1:1 randomly assigned to continue systemic therapy or local treatment (surgery, radiotherapy, and/or ablation) plus continuation of systemic therapy. Tumor debulking >80% was achieved in 72% of participants in the debulking arm. Median overall survival after a median follow-up of 32 months did not differ between treatment arms: 27.5 months and 30.0 months in the standard arm and debulking arm (HR 0.88 [95% CI 0.70-1.10]; P=0.23). In addition, no difference in median progression-free survival was observed (10.4 months vs 10.5 months). Outcomes were comparable in subgroups (number of metastatic sites, peritoneal involvement, duration of response to systemic therapy, completeness of debulking).
Based on these results, Dr. Gootjes concluded that “Tumor debulking in addition to standard palliative combination chemotherapy provides no survival benefit. Therefore, the increasing use of local therapies needs further consideration.”
Medical writing support was provided by Marten Dooper, PhD.
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