Implementation of early palliative care in an oncologic outpatient clinic - an observational study of the first year.

BACKGROUND: As earlier studies found that early onset specialized palliative care (ESPC) results in better quality of life (QoL), less hospitalization and chemotherapy toward end-of life, we implemented ESPC in our oncology outpatient clinic. The aim of this study was to describe reasons for referral, interventions performed and the satisfaction among the oncologic staff. MATERIAL AND METHODS: The outpatient ESPC clinic was established in the department of oncology. Prespecified selected data was obtained from the patients records. All patients were asked to fill in a questionnaire concerning their symptoms and QOL. A survey among the oncologic personnel concerning their perception of the clinic was conducted. All data were consecutively collected in a share point database. RESULTS: We included 134 patients. The primary referral symptoms were pain (69%) or psychological/existential challenges (23%). 55% of patients filled in an EORTC questionnaire and rated a median (QoL) of 3.4. Interventions initiated were on based on the following symptoms: pain (70%), constipation (53%), nausea (15%), dyspnea (10%) and depression (7%). Median waiting time was 13 days. Of the 134 patients referred to the ESPC clinic 101 was admitted. Symptoms and problems were resolved in the ESPC clinic for 81 of the 101 admitted patients (80%), i.e., after one consultation for 25 patients and after a follow up course in the clinic for 56 patients. A survey among the staff at the Department of Oncology demonstrated a high degree of satisfaction with the ESPC clinic. CONCLUSIONS: We report experiences from implementation of ESPC in our outpatient oncologic clinic, where 81 (80%) of the admitted patients could be finished after one or a few follow up contacts, as their symptoms had been resolved. There was a high degree of satisfaction with the clinic among the oncologic staff.

S-1 (Teysuno) and gemcitabine in Caucasian patients with unresectable pancreatic adenocarcinoma.

PURPOSE: Gemcitabine has been standard of care in advanced pancreatic adenocarcinomas (PC) for almost two decades. Randomized, primarily Japanese, studies have shown promising efficacy when combined with S-1 (GemS-1); however, no data are published in Caucasian patients. We report the first study with a combination of GemS-1 in an unselected cohort of Caucasian PC patients. METHODS: In this observational cohort study, we analyzed efficacy and toxicity prospectively. RESULTS: From July 2012 to July 2014, 64 patients received at least one cycle of GemS-1. 16 patients started therapy with gemcitabine and capecitabine (GemCap) but switched to GemS-1 after median 3 cycles of GemCap due to toxicity (hand-foot syndrome). 48 patients received GemS-1 as initial therapy. For the complete cohort, median age was 68 years (range 44-80); 22 patients (34%) had locally advanced PC; 42 patients (66%) had metastatic disease. Five patients had received prior adjuvant therapy with gemcitabine and 9 pts had received prior first-line therapy. The most common adverse event was fatigue (86%), however, only grade 3 in 3%. Five patients (8%) developed febrile neutropenia. Median PFS was 8.1 (95% CI 6.9-9.0) months and median OS was 11.7 (95% CI 10.7-13.1) months in the whole GemS-1 population. In the 48 patients starting with GemS-1, median PFS was 7.7 (95% CI 6.7-8.9) months and median OS was 11.5 (95% CI 9.7-12.3) months. CONCLUSIONS: The combination of gemcitabine and S-1 is safe and associated with promising efficacy in a Caucasian population; however, this needs to be confirmed in prospective clinical trials.

Trends in upper gastro-intestinal cancer among the elderly in Denmark, 1980-2012.

BACKGROUND: Upper gastro-intestinal cancer (UGIC) includes malignancies in esophagus, stomach and small intestine, and represents some of the most frequent malignancies worldwide. The aim of the present analysis was to describe incidence, mortality and survival in UGIC patients in Denmark from 1980 to 2012 according to differences in age and time periods. MATERIAL AND METHODS: UGIC was defined as ICD-10 codes C15-C17. Data derived from the NORDCAN database with comparable data on cancer incidence mortality, prevalence and relative survival in the Nordic countries, where the Danish data were delivered from the Danish Cancer Registry and the Danish Cause of Death Registry with follow-up for death or emigration until the end of 2013. RESULTS: The proportion of male patients over the age of 70 years diagnosed with esophageal cancer was constant over time (around 42%) but increased in females to 49% in 2012. Incidence rates increased with time and continued to rise in all ages. Mortality rates were clearly separated by age groups with increasing mortality rates by increasing age group for both sexes. Relative survival increased slowly over time in all age groups. The proportion of older male and female patients with stomach cancer increased to 50% and 54%, respectively, in 2012. Incidence rates decreased steadily with time, especially from 1980 to 1990 but continued to decrease in all age groups. Mortality rates decreased considerably from 1980 to 90 and have been almost constant during the last decade for both women and men. Relative survival increased modest over time in both genders and all age groups. In 2012, only 1471 persons were alive after a diagnosis of stomach cancer. CONCLUSION: There is a need for clinical trials focusing on patients over the age of 70 years with co-existing comorbidity.

A nationwide retrospective study of perioperative chemotherapy for gastroesophageal adenocarcinoma: tolerability, outcome, and prognostic factors.

BACKGROUND: Recent clinical trials have demonstrated the benefit and feasibility of perioperative chemotherapy for treatment of gastroesophageal adenocarcinoma (GEA). Despite convincing results, patients entering such trials usually represent only a fraction of those who are candidates for treatment. Confirmation of trial-reported effects and tolerability in unselected cohorts is therefore required. The aims of this study were to confirm the safety and efficacy of perioperative chemotherapy for resectable GEA and to delineate risks of treatment failure. METHODS: We conducted a national retrospective cohort analysis of patients admitted for perioperative chemotherapy for resectable GEA. Regimens were epirubicin and capecitabine combined with oxaliplatin or cisplatin. RESULTS: The intention-to-treat analysis included 271 patients. Eighty-seven percent of patients completed preoperative chemotherapy, and 63 % received radical resection. Age >70 years (odds ratio 2.58) and hypoalbuminemia (odds ratio 4.10) were independent predictors of not undergoing scheduled surgery (P = 0.033). Grade 3 or higher febrile neutropenia, fatigue, and diarrhea were common in the oxaliplatin group (n = 128), but hypomagnesaemia and tinnitus/hearing loss were more common in the cisplatin group (n = 135). The median overall survival was 26.4 months, and the 1- and 2-year survival rates were 76 and 53 %, respectively. Performance status >0 (hazard ratio 1.64) and elevated serum lactate dehydrogenase (hazard ratio 3.03) were independent predictors of poor prognosis (P ≤ 0.05). CONCLUSIONS: Perioperative chemotherapy is feasible and well tolerated in patients with good performance status and low incidence of comorbidities.

Characteristics, therapy and outcome in an unselected and prospectively registered cohort of patients with gastro-oesophageal cancer.

PURPOSE: The purpose was to examine characteristics, treatment and outcome in an unselected, prospectively registered complete population of patients with gastro-oesophageal adenocarcinoma cancer (GEA). METHODS: All cases diagnosed with GEA between 2008 and 2009 in the Region of Southern Denmark (pop: 1,200,000) were registered. Patient characteristics, including performance status, stage and therapy, were retrieved from patient charts and used to compare sub-groups of patients. RESULTS: Three hundred and thirty patients were registered as having GEA. Patients were divided into three clinical subgroups based on initial treatment option: group 1: patients with resectable GEA (n = 113); group 2: patients receiving first-line therapy (n = 107); group 3: patients receiving no tumour-directed therapy (n = 110). Median overall survival (95% CI) in the three groups was 36 months (25-not reached), 7.1 months (7-9) and 2.4 months (2-3), respectively. Seven percent of patients participated in clinical trials. CONCLUSION: Among patients not amendable to resection, around 30% are candidates for three-drug combination chemotherapy. Age > 65 years was found not to be a poor prognostic factor for survival, giving the possibility of treating elderly patients in the future. Many patients (approx. 30%), however, never received cancer-directed therapy. In order to improve survival in the entire population, it is important that future trials also focus on this group of patients.

Phase I study of docetaxel, oxaliplatin and capecitabine (TEX) as first line therapy to patients with advanced gastro-oesophageal cancer.

BACKGROUND: ECF (epirubicin, cisplatin, 5-FU) has been a standard first-line regimen in patients with advanced gastro-esophageal cancer (GEC). If cisplatin is substituted by oxaliplatin (Eloxatin®) - E) and 5-FU by capecitabine (X - Xeloda®) this regimen is easily administered with at least comparable efficacy and lower toxicity. Recent studies indicate that efficacy can be improved by adding docetaxel (Taxotere® - T) to CF. We initiated a phase I trial of T, short-time infusion of E and continuously X (TEX) as first-line therapy in GEC to establish the recommended dose (RD) for further therapy. MATERIALS AND METHODS: Patients were enrolled in cohorts of three at five dose levels. Patients had histologically confirmed GEC adenocarcinoma. Therapy was administered day 1 with escalating doses of docetaxel (60 mg/m² to 75 mg/m² iv as a 60 minutes infusion), oxaliplatin (85 to 130 mg/m² iv as a 30 minutes infusion) and oral capecitabine (1 000 to 1 250 mg/m²/day). TEX was repeated every third week for a maximum of eight cycles. Toxicity was evaluated according to CTCAE v3.0 and dose limiting toxicity (DLT) was evaluated after the first course of TEX. RESULTS: From June 2007 to April 2009, 23 consecutive patients received TEX. At dose level V, two of four patients experienced DLT and therefore we included additional seven patients at dose level IV. Only one of seven experienced DLT but dose-intensity was reduced to 75% in four of seven patients after three courses of TEX. Therefore we defined dose level III as RD. Efficacy was promising with response rate 38%, PFS 9.4 months and OS 12.5 months. CONCLUSION: The recommended dose of TEX (docetaxel 60 mg/m² iv day 1, oxaliplatin 115 mg/m² iv day 1 and oral capecitabine 1250 mg/m²/day continuously) every three weeks is easily administered in an out-patient setting. Efficacy is promising and will be evaluated in a phase II study.

Long-term results of concurrent radiotherapy and UFT in patients with locally advanced pancreatic cancer.

BACKGROUND: Definition and treatment options for locally advanced non-resectable pancreatic cancer (LAPC) vary. Treatment options range from palliative chemotherapy to chemoradiotherapy (CRT). Several studies have shown that a number of patients become resectable after complementary treatment prior to surgery. METHODS: From 2001 to 2005, 63 consecutive patients with unresectable LAPC received CRT. CRT was given at a dose of 50 Gy/27 fractions, combined with UFT (300 mg/m(2)/day) and folinic acid. Re-evaluation of resectability was planned 4-6 weeks after completion of CRT. RESULTS: Fifty-eight patients completed all 27 treatment fractions. Toxicity was generally mild, with 18 patients experiencing CTCAE grade 3 or worse acute reactions. One patient died following a treatment-related infection. Two patients developed grade 4 upper GI bleeding. Median survival was 10.6 (8-13) months. Eleven patients underwent resection, leading to a resection rate of 17%, and a median survival of 46 (23-nr) months. All 11 patients had a R0 resection. Median survival for the patients not resected was 8.8 (8-12) months. CONCLUSION: CRT with 50 Gy combined with UFT, is a well-tolerated and effective treatment for patients with LAPC. R0 resection was possible in 17% leading to a long median survival of 46 months in resected patients.