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Colorectal cancer (CRC) is one of the leading fatal cancers.
, most of the patients are already phase IV, the tumor can not be surgically removed, can only carry out palliative care.
But for patients with both asymptomatic primary tumors and metastatic lesions that cannot be removed, the initial treatment option is still controversial, mainly about whether removing primary tumors (PTRs) before chemotherapy can improve the survival rate of such patients.
The randomized Phase III study looked at the advantages of PTR combined chemotherapy over chemotherapy alone for asymptomatic CRC in stage IV that cannot be removed and in patients with ≤3 non-removable metastatic lesions (OS) limited to the liver, lungs, distant lymph nodes, or peritina.
chemotherapy program is mFOLFOX6 plus beva monoantigen or CapeOX plus beval monoantigen.
end point is OS, which is analyzed through intentional therapy.
June 2012-September 2019, a total of 165 patients were randomly assigned to two groups: 84 for chemotherapy alone and 81 for PTR plus chemotherapy.
conducted its first interim analysis in September 2019: as of June 5, 2019, 50 percent of expected events (114/227) had been observed in 160 patients, and the Data and Safety Monitoring Board recommended that the trial be terminated early.
followed up for 22.0 months, the mid-OS in the PTR-chemotherapy group was 25.9 months (95% CI, 19.9 to 31.5), and the medium OS in the chemotherapy group alone was 26.5 7 months (95% CI, 21.9 to 32.5) (risk ratio 1.10; 95% CI, 0.76 to 1.59; one-sided p-0.69).
3 postoperative deaths in the PTR-plus chemotherapy group.
, compared with chemotherapy alone, PTR combined chemotherapy does not improve the survival rate of patients, so PTR should no longer be considered as a standard treatment for patients with asymptomatic primary tumors and colorectal cancer who cannot be removed at the same time as metastasis.