Capecitabine in the routine first-line treatment of elderly patients with advanced colorectal cancer - results from a non-interventional observation study

Abstract

BackgroundThe purpose of this observational study was to evaluate feasibility, efficacy results and toxicity observations of capecitabine in routine first line treatment of patients with metastatic colorectal cancer, with particular regard of elderly patients (>75 years of age).MethodsPatients with colorectal cancer receiving capecitabine as part of their first-line treatment were recorded until detection of disease progression or up to a maximum of 12 cycles on standardized evaluation forms. Additional information on long-term outcomes, progression-free survival, and overall survival were retrieved at two follow-up time points. Obtained data were analyzed with regard to age up to 75 and >75 years of age. There were no specific requirements for patient selection and conduct of therapy, corresponding to the non-interventional nature of the study.ResultsIn total, 1249 evaluable patients were enrolled in Germany. The median age of the study population was 74 years (range: 21–99). Capecitabine-based combination was administered in 56 % of patients in the overall population. The median treatment duration was about 5 months. Severe toxicities occurred rarely without any difference regarding age groups. The most common hematological toxicity was anemia. Gastrointestinal side effects and hand-food-syndrome (HFS) were the most frequent non-hematologic toxicities. Overall response rate (ORR) was significantly higher in the patient group <=75 years compared to patients >75 years of age (38 vs. 32 %, p=0.019). Median progression free survival (PFS 9.7 vs. 8.2 months, p=0.00021) and overall survival (OS 31.0 vs. 22.6 months, p<0.0001) was decreased in elderly patients.ConclusionEfficacy and tolerability of capecitabine treatment either as single drug or in various combination regimens, as proven in randomized studies, could be confirmed in a clinical routine setting. Patients older than 75 years may derive a relevant benefit by first line capecitabine-based treatment with good tolerability.Electronic supplementary materialThe online version of this article (doi:10.1186/s12885-016-2113-8) contains supplementary material, which is available to authorized users.

Tolerability of Capecitabine Monotherapy in Metastatic Colorectal Cancer: A Real-World Study

“…The rates of adverse events reported in this study are similar to those of reported clinical trials of capecitabine monotherapy. The rate of HFS in this study (46.5% overall) is consistent with rates observed in phase III clinical trials of 30–53.5% [ 4 , 8 , 10 ] and with the rate of 42% reported in an observational study that included patients who received capecitabine as monotherapy or in combination treatment [ 14 ]. The rate of GI events in this study was 44.2%; previous studies have reported that between 11 and 50% of patients experience one GI event, including diarrhea, vomiting, nausea, or abdominal pain, while receiving capecitabine monotherapy [ 4 , 8 , 10 ].…”

“…In our analysis, the occurrence of HFS and GI events was not related to the dose of capecitabine, which may suggest that lower starting doses and dose reductions do not improve adverse event rates, nor do they prevent them from occurring. In an observational study by Stein et al, the incidence of HFS increased with duration of treatment and was higher in younger patients than in older patients (46 vs. 37%; p = 0.0014) despite similar median daily doses of capecitabine [ 14 ].…”

“…An observational study of capecitabine-based therapy in routine first-line treatment of mCRC reported that 56% of patients received capecitabine-based treatment—54% of these as combination therapy and 46% of these as monotherapy. Of patients who received monotherapy, 65% were older than 75 years of age [ 14 ]. Rates of grade 3/4 adverse events associated with capecitabine monotherapy were highest for HFS, bilirubin elevation, anemia, and neuropathy, which all occurred in 4% of patients [ 14 ].…”

“…Of patients who received monotherapy, 65% were older than 75 years of age [ 14 ]. Rates of grade 3/4 adverse events associated with capecitabine monotherapy were highest for HFS, bilirubin elevation, anemia, and neuropathy, which all occurred in 4% of patients [ 14 ].…”

Complete response to capecitabine in a frail, elderly patient with metastatic colorectal cancer: A case report

“…The overall response rate (ORR) was significantly increased in the patient group ≤75 years compared to patients >75 years of age (38 vs. 32%, p=0.019). Median progression free survival (PFS; 9.7 vs. 8.2 months, p= 0.00021) and overall survival (OS; 31.0 vs. 22.6 months, p<0.0001) was decreased in elderly patients (24). In a phase II trial of 51 patients aged >70 years with advanced CRC, capecitabine was effective and well tolerated, with an ORR of 24%, PFS of 7 months and OS of 11 months.…”