Abstract 391P
Background
Adjuvant chemotherapy completion rate for colon cancer is 50%-60% in real-world setting, while lower treatment intensity was associated with poorer disease-free survival outcomes. In China,Traditional Chinese Medicine (TCM) herbs Jianpi-Bushen formula (JPBS) was utilized to help patients reduce chemo-induced side effects and improve chemo completion, but there is still lack of evidence.
Methods
We conducted a randomized placebo-controlled clinical trial between October 2018 and November 2021 among 12 clinical centers in China. The inclusion criteria were stage II and III colon cancer patients who received radical surgery within 6 weeks and planned to receive CAPOX(capetabin and oxaplatin, q21d/cycle) chemo regimen. 400 patients were 1:1 randomized assigned into JPBS(orally taken twice per day during the whole period of chemo) or placebo group. Primary outcome was completion rate of planned chemo cycles (decided by treating physician). Secondary outcomes were incidences of chemo-related side effects such as nausea and vomiting(CINV). The study had been approved by the Medical Ethical Committee of Xiyuan Hospital (No.2018XLA048-2). All patients were paper consented before enrollment.
Results
The final per-protocol set (PPS) included 376 patients (189 in JPBS and 187 in placebo group).There were 119(63.0%) and 89 (47.6%) patients in JPBS group and placebo group respectively who completed all planned chemotherapy cycles and the difference was statistically significant(p=0.003). Subgroup analysis showed that the differences of completion rate were more significant among patients under 65 years old between groups (JPBS vs. placebo: 66.9%vs.48.8%, p=0.004) than those older than 65(p=0.25). Patients in JPBS group experienced less dose reduction of capetabin than placebo group (59.3% vs. 73.1%, p=0.004). JPBS group had less incidence of severe CINV events (NCI grade II to IV) than placebo group(3.8% vs. 6.4%, p=0.007).
Conclusions
JPBS formula could enhance completion rate and prevent dose reduction of adjuvant chemotherapy for CRC patients, which might be related with its efficacy on alleviating chemo induced side effects.
Clinical trial identification
NCT03716518.
Editorial acknowledgement
Legal entity responsible for the study
Y. Yang.
Funding
Supported by the National Key Research and Development Program of China (No.2017YFC1700604).
Disclosure
All authors have declared no conflicts of interest.