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

Alexander Stein,Axel Hinke,Jan Klaus Schröder,Tim Wohlfarth,Dirk Arnold,Thomas Göhler,Annette-Rosel Valdix,Julia Quidde,Silke Schirrmacher-Memmel,Barbara Tschechne,Heinz-Gert Höffkes,Andreas Engelen

doi:10.1186/s12885-016-2113-8

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.

Highlights

The 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)
In addition to new agents with a classical cytotoxic mode of action, such as irinotecan and oxaliplatin, “targeted therapies”, such as monoclonal antibodies, tyrosine kinase inhibitors or fusion proteins directed against vascular endothelial growth factors (VEGF(R)) or epidermal growth factor receptors (EGFR) have gained increasing importance [1, 2]
Capecitabine (Xeloda®) was licensed for the treatment of metastatic colorectal cancer mainly based on two large multicenter studies, both comparing the oral drug with a common 5-FU/leucovorin combination (Mayo regimen) [3, 4]

Summary

Introduction

The 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). For more than four decades, the treatment of colorectal cancer (CRC) consisted almost exclusively of the fluoropyrimidine 5-fluorouracil (5-FU) (eventually modulated by folinic acid or levamisole), the development of a plethora of new drugs since the 1990s has improved the therapeutic options in this indication. The development of capecitabine, an oral fluoropyrimidine carbamate working as 5-FU prodrug, relevantly facilitated treatment for CRC patients. Capecitabine (Xeloda®) was licensed for the treatment of metastatic colorectal cancer mainly based on two large multicenter studies, both comparing the oral drug with a common 5-FU/leucovorin combination (Mayo regimen) [3, 4]. Despite the longstanding application of capecitabine in the treatment of colorectal cancer, data in elderly patients are still limited

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Discussion

Conclusion