Too little, too late Real World Insights on Current Practice of Home Parenteral Nutrition in Germany

Transcription

1 Too little, too late Real World Insights on Current Practice of Home Parenteral Nutrition in Germany ESMO 2018, Munich Prof. Dr. med. Ingolf Schiefke Gastroenterology and Hepatology Klinikum St. Georg ggmbh Leipzig, Germany 1

2 Agenda Introduction parenteral nutrition Objectives Methodology Results Demography Comorbidities Clinical outcomes: Survival Drug costs utilisation Summary Conclusions 2

3 Prevalence of Malnutrition and Current Use of Nutrition Nutrition Support Volume 38 Number 2 Original Communication Adapted from Hébuterne X, et al. JPEN J Parenter Enteral Nutr. 2014;38:

4 ESPEN Guidelines on Nutrition in Cancer Patients (1) Arends J, et al. Clin Nutr. 2017;36(1):

5 ESPEN Guidelines on Nutrition in Cancer Patients (2) Arends J, et al. Clin Nutr. 2017;36(1):

6 Malnutrition Increases Chemotherapy Toxicity in Cancer Patients *Includes values of arm circumference, triceps skinfold, albumin and transferrin normal values <40 1. Andreyev HJ, et al. Eur J Cancer. 1998;34(4):503-9; 2. Arrieta O, et al. BMC Cancer. 2010;10:50; 3. Di Fiore F, et al. Am J Gastroenterol. 2007;102(11): ; 4. Seo SH, et al. BMC Cancer. 2016;16(1):900. 6

7 Sarcopenia is a prognostic marker Hazard Ratios for: Cancer-specific Survivals Progression-free Survivals Disease-free Survivals Shachar SS, et al. Eur J Cancer. 2016;57:

8 Toxicity from Taxane in Breast Cancer Patients with Sarcopenia 2,500 Skeletal Muscle Gauge (SMG) 2,000 1,500 1,000 P= No Grade 3-4 Toxicity Yes Shachar SS, et al. Clin Cancer Res. 2017;23(3):

9 Study Objectives This study 1 is set out to investigate real-world use of home parenteral nutrition (HPN) amongst cancer patients with 5 tumour types in Germany. The study quantified the number of deceased cancer patients who received HPN Data analysis described 1)patients demographic characteristics 2)patients comorbidities 3) clinical outcomes of patients who received PN Additional data analysis provided an indication of cost share between cancer treatment and parenteral nutrition across 5 tumour types. 1 ) Data on file: Versorgungsforschung zur parenteralen Ernährung in Deutschlang in Zusammenarbeit HGC GesundheitsConsult GmbH,

10 Study Content Methodology (1) ~4 million insured individuals ~70 Statutory Health Insurances 5.5% nationwide representative sample Longitudinal Patient Data Available SHI claims data Observation window is 6 years Basic data Age Gender Region Outpatient treatment Utilization (EBM Figures) Diagnoses (ICD codes) Physicians Inpatient treatment Hospital stays (DRG, OPS) Diagnoses (ICD) Length of stay Pharmaceutical data ATC, PZN DDD Prescriptions/ prescriber Treatment via medical devices medical aids, remedies Disability and sick pay Costs and resource use 10

11 Study Content Methodology (2) Validity of dataset External validity of database There is a good overall accordance of the Health Risk Institute database and the German population in terms of measures of morbidity, mortality and drug usage. Persistence of insurant with the database over time is high, indicating suitability of the data source for longitudinal epidemiological analyses 1. Validity of Methodology The analysis has been designed following the Good Practice in Secondary Data Analysis (GPS) 2 The 11 guidelines range from ethical principles and study planning through quality assurance measures and data preparation to data privacy, contractual conditions and responsible communication of analytical results. 1 Andersohn, F; Walker, J (2016), Characteristics and external validity of the German Health Risk Institute (HRI) Database 2 Swart, E et. al (2014), Gute Praxis Sekundärdatenanalyse (GPS): Leitlinien und Empfehlungen 11

12 Study Content Methodology (3) We observed deceased Stage IIIb/IV cancer patients with or without home parenteral nutrition (HPN) The study population was defined as deceased stage IIIb/ IV cancer patients Five cancer types were included ovarian, pancreas, colorectal carcinoma (CRC), gastric, head & neck (H&N); defined regarding to ICD 10 GM Coding Chapter C (confirmed outpatient or inpatient diagnoses) Observation period was defined as period between initial therapy of Stage IIIb/IV cancer until day of death Definition of initial treatment to identify Stage IIIb/IV patients (metastatic or recurrent carcinoma) Definition of home parenteral nutrition based on prescriptions (Pharmacy Registration Number) in the outpatient sector 12

13 Study Content Methodology (4) Head & Neck Cetuximab without radiation CRC Bevacizumab or Cetuximab Ovarian Carboplatin and Paclitaxel and/or Bevacizumab Pancreatic Gemcitabin, if there was no surgery 3 months before Gastric diagnosis, directly followed by prescription of parenteral or enteral nutrition Deceased cancer patients Stage IIIb/IV Index Quarter in which the initial therapy pursuant to guidelines of stage IV cancer started Individual observation period Index Day of death/ calendar quarter 13

14 Study Content Demographics (1) Age per cancer indication / age at pick up stage IIIb/IV Maximum Mean Median y 62.9 y SD:10,1 93 y 67.0 y SD:11 85 y 63.4 y SD:11,1 92 y 69.9 y SD:9,7 95 y 71.6 y SD:12,6 Minimum y 23 y 26 y 33 y 21 y 0 Head & Neck CRC Ovarian Pancreatic Gastric Gender distribution H&N CRC Ovarian Pancreas Gastric M (%) F (%) H&N CRC Ovarian Pancreas Gastric No HPN 300 1, , HPN Mean age of the patients at 1 st line cancer treatment is 67 years with a higher share of male patients 14

15 Study Content Demographics (2) Number of patients in DB *1 (cancer all stages) Indexing period: Date of death between No multiple cancer diagnoses Indexing: 1 st line patients and no previous HPN *2 Head & Neck 19,313 6,027 5, CRC Ovarian Pancreatic Gastric 53,390 19,574 17,742 1,966 8,900 3,353 2, ,143 7,633 6,784 1,406 12,480 6,783 5, Number of patients with or without HPN HPN No HPN 290 1,675 HPN No HPN HPN No HPN 209 1,197 HPN No HPN HPN No HPN The number of HPN users differs substantially in each cancer group * 1 The total database (DB) comprises data of 4 million insured individuals per year * 2 initial therapy pursuant to guideline of Stage IV cancer (metastatic or recurrent carcinoma) 15

16 Study Results Demographics (1) 100% 80% Share of patients with / without PN per cancer indication 60% 40% % 0% % 15% 19% 15% 25% 153 H&N CRC Ovarian Pancreatic Gastric Share of patients with HPN Share of patients without HPN The share of patients with HPN in overall cancer types is on average 16% The highest share of HPN patients is observed in patients with Gastric cancer at 25% (153 out of 600). The lowest share of HPN patients is observed in patients with Head & Neck cancer at 12% (43 out of 343). Caveat: Enteral nutrition therapy is not covered within this analysis 16

17 Study Results Demographics (2) Share of Gastric cancer patients with comorbidities 100% PN No PN 80% 60% 61% 71% 40% 20% 37% 38% 21% 14% 10% 11% 28% 27% 37% 16% 0% Year 1 Year 2 Year 1 Year 2 Year 1 Year 2 Cachexia Infection With at least one of defined comorbidities* Only 2 years of observation. Third follow-up year n<5. Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Patients with HPN <5 <5 <5 Patients without HPN Up to 40% of the gastric cancer patients suffering from cachexia are not treated with HPN *Defined comorbidities: Chronic wound/ Wound healing disorder, Decubitus, Pneumonia 17

18 Study Results Comorbidities (2) Share of Gastric cancer patients with Decubitus vs. no Decubitus (in year 1) without HPN with HPN 22% Dekubitus No Dekubitus 12% 78% 88% Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Patients with PN <5 <5 <5 Patients without PN The share of patients with decubitus is higher in year 2 compared to year 1, especially for patients with HPN That indicates a physical decline in patients with HPN Patients without HPN suffer less from decubitus in year 2 The higher share of patients with decubitus who did not receive HPN indicates that HPN is prescribed too late 18

19 Study Results Survival (1) Overview of average duration until death per patient in each cancer indication Head & Neck CRC Ovarian Pancreatic Gastric Mean period until death per patient without HPN in HPN - No HPN + 81 d + 29 d + 41 d + 84 d d Mean period until death per patient with HPN in The longest mean period until death per patient without HPN is observable in Ovarian cancer patients (~2 years) The biggest difference in the period until death between HPN and no HPN can be seen in Gastric patients (+118 ) The period between start HPN and death amounts is around 3 months, which is too late according to the definition of refractory cachexia H&N CRC Ovarian Pancreas Gastric No HPN 300 1, , HPN Data suggests that patients receiving HPN survive on average 70 longer than patients not receiving HPN (caveat: descriptive readout only) 19

20 Study Results Survival (2) Average period until PN initiation per patient in each cancer indication Head & Neck CRC Ovarian Pancreatic Gastric Average duration until PN initiation per patient in H&N CRC Ovarian Pancreatic Gastric The longest average period until HPN initiation per patient is observable in Ovarian cancer patients ~ 2 yrs The shortest average period until HPN initiation per patient is observable in Gastric cancer patients ~ 6 mos H&N CRC Ovarian Pancreas Gastric No HPN 300 1, , HPN The time from initiation of cancer treatment to initiation of HPN varied widely by cancer indication, with on average of 20 1 year (337 ) delay

21 Study Results Survival (3) Average period until HPN initiation and until death per patient in each cancer indication Average period until death per patient with HPN in Average duration until HPN initiation per patient in 2016 H&N 2017 CRC Ovarian 2018 Pancreatic 2019 Gastric 2020 The period between start of HPN and death amounts around 3 months, which is too late according to the definition of refractory cachexia The data indicates that the patients initiated HPN, receive it too late H&N CRC Ovarian Pancreas Gastric No HPN 300 1, , HPN The average period until initiation of HPN is approximately 337, which is similar to the average period from HPN initiation until death (380 ) 21

22 Study Results Survival (4) Correlation analysis Overall Survival of Gastric cancer patients, n=153 Days until death Tage bis zum Versterben Effekt auf Überleben/Mortalität Kohort: Magen R-Quadrat= Effect on cancer survival - Gastric R 2 = Patients without PN Mean= SD=279,51 95% CI=( ,67) Patients without Pat ohne PE PN Pat Patients ohne PE: without PN Mean= SD= % CI=( ) Days from 1 st HPN until death Tage von erster PE (Gesamt) bis zum Versterben Effekt der PE auf Mortalität Kohort: Magen R-Quadrat= Effect on cancer survival Gastric R 2 = Days from 1Tage st line von 1st-Therapie cancer bis Tx erste to PE first (Gesamt) HPN initiation Days from 1 st Tage line von cancer 1st-Therapie Tx bis erste to first PE (Gesamt) HPN initiation Average period until death: % CI: The average survival of Gastric cancer patients after first HPN treatment initiation is approximately

23 Study Results Costs Share of HPN drug costs of total drug costs per patient in (Q0-Q4) Share of HPN drug costs 16% 9% % % 39% The largest share of HPN costs of total drug treatment costs is observable in the gastric cancer patient groups Share of cancer drug costs Ovarian cancer has the lowest share of HPN costs H&N CRC Ovarian Pancreatic Gastric H&N CRC Ovarian Pancreatic Gastric The largest share of cancer drug costs can be seen in Head & Neck and CRC cancer patient groups The cost share between cancer & HPN therapies varies between 6% to 39%; in non-gi cancers the cost share of nutrition is lower than of cancer drugs 23

24 Summary Across five cancer types the share of patients who received HPN is on average 16%, with the highest share observed in gastric cancer patients (25%) and the lowest share (12%) amongst patents with Head & Neck cancer Up to 40% of patients, who were not artificially fed displayed cachexia, which suggests a significant care deficiency in cancer management. Patients who did not receive HPN also showed higher rate of infections and other co-morbidities including decubitus The study data suggested that patients who did not receive HPN survived on average 70 less, compared to those who did receive HPN and lived longer, - which highlights the potential benefit of HPN on overall survival Across five tumor types the share of costs between cancer treatment and home parenteral nutrition varies significantly; with the lowest proportion of costs spent on HPN in comparison with conventional cancer therapy was observed in patients with CRC, ovarian and Head & Neck cancers Clinical nutrition use in oncology is currently very low, and patterns of use do not allow to achieve the best possible patient outcomes 24

25 Conclusion Early screening to identify patients at risk of malnutrition, as well as best practices for targeted intervention, including supplemental parenteral nutrition, will be key to improve patients outcomes. The benefits of appropriate clinical nutrition treatment including overall survival, treatment tolerance and quality of life have to be taken into consideration in patients at risk and/or suffering from malnutrition. Further research and a clear understanding of the current practices to address benefits of clinical nutrition in oncology is warranted. Best practices needed to be delineated for early MN diagnosis and clinical nutrition treatment further research is essential 25