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Carpette is an oral chemotherapy drug widely used in the treatment of metastasis breast cancer that maintains treatment at potentially low doses to prevent cancer recurrence.
previous clinical trials that included high doses of carpedabin into standard breast cancer-assisted chemotherapy programs, the results were always less than satisfactory.
, the Yuan Zhongyu team at Sun Yat-sen University's affiliated Oncology Hospital published in JAMA the title "Effect of Capecitabine Maintenance Therapy Using Lower Dosage and Frequency vs Observation on Disease-Free Survival Patient With Early-Stage" Triple-Negative Breast Cancer Who Had Received Standard Treatment: The SYSUCC-001 Randomized Clinical Trial" article looked at the effects of low-dose, high-frequency carpentry maintenance therapy on disease-free survival rates in patients with early triple-negative breast cancer receiving standard treatment.
DOI: 10.1001/jama.2020.23370 From April 2010 to December 2016, the research team conducted a randomized clinical trial at 13 academic centers and clinical institutions in China, recruiting 443 patients with early tristasal breast cancer who had completed standard assisted chemotherapy and followed them up, with a follow-up date of April 30, 2020.
main endpoint is a 5-year disease-free life, i.e. from random grouping to the time when the following events first occur: local recurrence, distant metastasis, side-by-side breast cancer, or death for any cause.
end points include long-distance disease-free survival, total survival time, local recurrence time and adverse events.
the researchers randomly assigned the patients to the Caperthabin maintenance group and the observation group by 1:1.
capabin maintenance group is required to take capedabin 650 mg/m2 ornational, 2 times a day, for one year in a row, the researchers will assess the dose and adverse events of capedabin on a monthly basis.
and regularly undergo physical examinations, assess menomenograms, breast ultrasounds, and abdominal ultrasounds.
the trial flowchart, 434 women took part in the full analysis, i.e. 98.0% of the participants completed the experiment.
61 months after the mid-level follow-up, the team observed a total of 94 events, of which 38 were in the Capentabin group, including 37 relapses and 32 deaths, and 56 in the observation group, including 56 relapses and 40 deaths.
two groups of patients with primary and secondary outcome indicators compared the estimated five-year disease-free survival rate of the Capentabin group at 82.8%, higher than the observation group's data of 73.0%, with a risk ratio of 0.64 for recurrence or death.
The estimated five-year non-distant transfer survival rate in the
Capethabin group and the observation group was 85.8% and 75.8%, respectively, with significant differences, while the estimated five-year total survival rate was 85.5% and 81.3%, respectively, and the estimated five-year partial recurrence rate was 85.0% and 80.8%, respectively.
most common adverse events associated with Carpestabin were hand-foot syndrome (45.2%), in which 7.7% of patients experienced level 3 events.
A subgroup analysis of disease-specific mortality rates in 434 patients with triple-negative breast cancer The results showed that for women with early triple-negative breast cancer who received standard complementary treatment, the use of low-dose carpentry maintenance for 1 year was effective in improving the disease-free survival rate for 5 years compared with regular observation.