Abstract 454P
Background
Colorectal cancer (CRC) in Egypt is often at an advanced stage at diagnosis. Although there has been a dramatic increase in efficacy, reduction of mortality, and improvements in survival through standard doses of chemotherapy, some CRC patients suffer from severe toxicities and disease progression. Use of chemotherapy at less than the maximum tolerated dose, with no prolonged drug-free breaks reduces the capability of tumour cells to engage in progression mechanisms, suggesting that it could be a better alternative to standard dose therapy with a better toxicity profile.
Methods
This is a randomized phase II prospective study that included 70 (35 in each arm) metastatic Egyptian CRC cancer patients diagnosed at the National Cancer Institute, Cairo University between January 2016 and June 2018. Patients were randomly treated with either classic XELOX (arm A) or with capecitabine (2000 mg daily x 8 weeks) and oxaliplatin (30 mg/m2 weekly X 8 weeks) then 2 weeks rest (arm B). Toxicities and survival analysis after two years for both regimens were recorded.
Results
The median progression-free survival (PFS) was 7.6 months for patients in arm A and 5.7 months for patients in arm B (P=0.318). The median overall survival (OS) for arms A and B were nearly equal (15.9 months and 15.8 months, respectively) (P = 0.8). Disease control rate was slightly higher in arm A (48%) compared to arm B (37%) (P=0.3). Almost all toxicities were higher in group A than group B (P-values: Anaemia 0.03, diarrhoea 0.027, hand & foot syndrome 0.002, neutropenia 0.001, oral mucositis 0.003, gastritis 0.004). The recorded grade III toxicities were higher in arm A; anaemia, hand and foot syndrome, diarrhoea, fatigue, gastritis (P-values: 0.017, <0.001,0.009, <0.001, <0.0001, respectively).
Conclusions
The metronomic protocol was associated with significantly lower rates of almost all toxicites and grade III toxicities compared to the standard protocol. The OS was almost equal for both treatment strategies, and the use of metronomic treatment did not affect PFS or response rates.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
National Cancer Institute-Cairo University.
Funding
National Cancer Institute-Cairo University.
Disclosure
All authors have declared no conflicts of interest.