Cancer occurs more frequently in elderly people, and the current demographic changes with an aging population in Western countries will therefore result in a rising incidence of cancer and an increasing amount of older cancer patients [
1‐
3]. For the US, it has been estimated that by 2030, approximately 70% of all cancers will be diagnosed in adults older than 65 years [
4]. In contrast to this development, older patients remain underrepresented in the clinical cancer studies that establish standard treatment regimens [
5]. There is widespread critique concerning this issue, but to date, trial results have to be extrapolated to the older population, although this approach remains questionable [
6]. Fear of increased toxicities and uncertainty concerning both clinical treatment benefit and the patient’s physical resources may cause limitation of tumor-specific therapies in older patients. Ensuring an adequate antitumor treatment while avoiding toxicity is a challenging task for geriatric oncology in daily routine.
For pancreatic adenocarcinoma, the fourth common cause of cancer-related death in the US [
7], approximately two-thirds of cases are diagnosed in patients over 65 years [
8]. The overall 5-year survival rate is about 6% and remains the poorest of all major malignancies [
9,
10]. Because the majority of tumors is irresectable or recurs after surgery, systemic palliative treatment is needed for almost every patient [
11]. Despite its limited activity, single-agent gemcitabine was the standard palliative first-line treatment for patients with advanced disease for more than a decade [
12], until therapy options improved in 2011. In the landmark PRODIGE 4 trial, the FOLFIRINOX protocol had an impressive response rate of 31.6%, and it significantly improved median overall survival (OS) from 6.8 months in the gemcitabine monotherapy arm to 11.1 months [
13]. More recently, this protocol has also been used successfully in patients with irresectable, locally advanced disease to achieve resectability and therefore offering a chance for cure [
14]. The impressive results of the FOLFIRINOX protocol are accompanied by significantly increased grade 3 and 4 toxicities, mainly myelosuppression, diarrhea and peripheral neuropathy. Concerns regarding safety in the palliative setting have been raised immediately [
15]. Likewise, the study population was criticized as heavily selected (young age, excellent performance status, mostly “non-head” tumors), not representing the average “real-life” patient. Subsequent retrospective clinical analyses confirmed the substantial toxicity profile, and modifications of the regimen are commonly recommended [
16‐
18]. In 2013, therapeutic options further increased with publication of the MPACT trial. In this study, the addition of nab-paclitaxel to gemcitabine therapy increased the median overall survival from 6.6 to 8.7 months [
19].
Thus, oncologists might be reluctant to apply FOLFIRINOX to older patients. Given the undoubted advantages in response rate and survival, older cancer patients might be at risk for therapeutic disparity and undertreatment. We conducted a retrospective analysis of patients with advanced pancreatic cancer under palliative first-line treatment with FOLFIRINOX at the National Center for Tumor Diseases, Heidelberg, to assess efficacy and toxicity in academic practice, especially focusing on older patients.