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  Volume 96
Numero 3
maggio-giugno 2010 		I documenti sono in formato PDF, consultabili utilizzando Acrobat Reader
 
Clinical governance benchmarking issues in oncology: aggressiveness of cancer care and consumption of strong opioids. A single-center experience on measurement of quality of care

Petros Giovanis, Giovanni De Leonardis, Antonella Garna, Viviana Lovat, Francesca Caldart, Annarita Quarta, Laura Moretto, Fausto Tuccia, Marilisa Marcante, Mauro Giusto
1Operative Unit of Medical Oncology, and 2Department of Pharmacy, City Hospital of Belluno,
Ulss 1, Belluno, Italy

Key words: benchmarking issue, palliative care, quality of care.

abstract

Aims and background. The aggressiveness of cancer care near the end of life and the consumption of opioids are potential indicators of quality of care in palliative and end-of-life settings. The purpose of this article is to present a retrospective analysis regarding these themes and the adopted procedures to improve quality of care.
Methods. We evaluated all cancer patients treated and deceased during 2008 and considered those who died and received any antiblastic therapy within 14 and 30 days prior to death. Moreover, we evaluated the annual consumption of pure opioids during 2007 and 2008 in our inpatient clinic.
We found that 5% and 9% of all treated patients were still receiving antiblastic treatment near the end of life within respectively 14 and 30 days prior to death (respectively 29.6% and 51.5% of deceased patients). All but 2 patients died from progressive disease, one patient died from acute myocardial infarction during chemotherapy, and one of severe sepsis after chemotherapy for non-Hodgkin lymphoma. As regards the annual consumption of strong opioids, there was a 179% increase in the use of morphine-equivalent doses of oral long-acting opioids (+228% for oxycodone) after the introduction of daily pain measurement through a numerical rating scale.
Conclusions. To reduce the administration of chemotherapy near the end of life, we introduced the palliative prognostic score, to be administered to all advanced cancer patients with performance status of at least 2. To evaluate the effectiveness of analgesics and to reduce the cases of undertreatment of cancer pain, we adopted, in addition to the numerical rating scale, Cleeland’s Pain Management Index. We are convinced that attempts to improve the quality of care can be achieved by the collaboration of all health professionals, patients and care givers. Free full text available at www.tumorionline.it

Introduction
Despite advances in the management of cancer and the increase in median overall survival for many types of cancer, a large proportion of patients still die from the disease1. Therefore, the quality of medical care that incurable cancer patients receive is one of the major issues in palliative medicine and medical oncology. Nevertheless, relatively limited work has been carried out on how to identify models to evaluate the quality of care given to patients near the end of life2.
Poor-quality care is defined as “when practices of known effectiveness are being under-utilized, practices of known ineffectiveness are being over-utilized, and when services of equivocal effectiveness are being utilized in accordance with provider rather than patient preferences”3. An overly aggressive cancer treatment probably represents poor-quality care, and we can use a set of measures to assess three major areas: the overuse of chemotherapy near death; high rates of emergency room visits, hospitalization or intensive care stays for terminal patients as a result of treatment; and underuse of hospice services2.
According to the literature, the proportion of patients still receiving chemotherapy 14 days prior to death has increased, up from 9.7% in 1993 to 11.6% by 1999, even if there is evidence that the use of chemotherapy near the end of life is not related to clinical benefit2,4. Hematological diseases were more frequently associated with aggressive chemotherapy, such as simply living in an area with more teaching hospitals or receiving care in a teaching hospital2. Not surprisingly, when high-quality palliative care is available, a decrease in aggressive chemotherapy use is observed2. Furthermore, we know that there is a trend towards being less satisfied with care, as perceived by the care giver, when chemotherapy is continued near the end of life, when death occurs in an acute care setting, or when there is only a short (≤3 days) hospice stay involved2.
The European Association for Palliative Care strongly recommends the use of easy prognostic scores to identify classes of patients with different life expectancies5. The palliative prognostic score, the palliative prognostic index, the Chuang prognostic score, and the terminal cancer prognostic score are most frequently used. All of them have limitations but offer an improvement on the unadjusted clinicians’ estimate of survival6.
The adequate treatment of cancer pain is a milestone of palliative and end-of-life care7. Even if it is well known that more than 60% of patients affected by advanced stage disease or metastatic cancer will experience symptom pain, and that an effective therapy is available for 70-90% of cases, undertreatment involves more than 40% of these patients8. Regarding the treatment of cancer pain, recent reports indicate that the level of opioid use is a novel indicator of the quality of end-of-life care, measuring underuse of palliative care, both in prospective and retrospective analyses9.
In an attempt to improve the quality of care in cancer patients, as criteria of efficacy we evaluated the annual percentage of patients receiving any antiblastic treatment (chemotherapy, radiotherapy, hormone therapy or pamidronate for bone metastases) 14 and 30 days prior to death and the annual consumption of pure opioids in the Operative Unit of Medical Oncology, City Hospital of Belluno. We present a retrospective analysis of the patients who died from cancer during 2008 and a comparative analysis of data regarding the use of strong opioids in 2007 and 2008.

Materials and methods
Antiblastic treatment 14 and 30 days prior to death
To determine the patients affected by cancer, treated and deceased during 2008, we used the electronic data base of our Unit, where any information regarding diagnosis, treatment, state of the disease and eventually date of death is reported. In the case of missing data, we verified the state of the patient through the Registrar’s Office at the Municipality. We evaluated all patients who received chemotherapy and all deceased patients, analyzing the cause of death, age and performance status at the last antiblastic treatment, number of previous therapies, state of the disease, date the last treatment was begun, and date of death of the patient. We considered as active, any specific treatment (chemotherapy, radiotherapy, hormone therapy, biphosphonates for bone metastases) with the exception of radiotherapy for pain. We also excluded from the analysis patients who died from the disease and were affected by advanced cancer who never received any specific antiblastic therapy.

Annual consumption of major opioids
A retrospective analysis of the use of pure opioids in our Unit during 2007 and 2008 was carried out using the electronic data base of the Department of Pharmacy and considering the orders filled by the Unit of Oncology. Strong opioids regularly used include fentanyl transdermal patch (Durogesic), morphine chlorhydrate in vials, oral morphine prompt release (Oramorph oral solution, drops), oxycodone (Oxycontin), oral morphine chlorhydrate prolonged release (Ticinan) available since 2007, oral morphine sulphate prolonged release (Twice) available since 2007, and OROS ® hydromorphone (Jurnista) available in the hospital’s pharmacy since November 2008.

Local palliative care
In the geographic area of Belluno, according to the recommendations of the Veneto Region for palliative care, an Operative Unit of Analgesic Therapy, home-care assistance and hospice with a capacity of 8 beds are available. The structures for palliative care are coordinated by anesthesiologists and are available for patients affected by cancer with a life expectancy of less than 3 months. A terminally ill patient can also be admitted to the Operative Unit of the Medical Oncology ward (capacity 10 beds), like patients near the end of life and not receiving any antiblastic treatment but needing supportive care.

Results
Antiblastic treatment 14 and 30 days prior to death
During 2008, 364 patients received chemotherapy in the Operative Unit of Medical Oncology, City Hospital of Belluno, and 64 patients affected by advanced cancer disease and treated in the same Operative Unit died. Of the treated patients, 33 (9%) died within 30 days of chemotherapy, whereas 19 (5%) received an active treatment within 14 days prior to death. Nevertheless, evaluating the group of deceased patients (n = 64), we found that 29.6% and 51.5% of patients were still receiving chemotherapy respectively within 14 days (19 patients, median 7 days, range 2-14) and 30 days prior to death (33 patients, median 12.5 days, range 2-30). The median age of deceased patients was 64 years (range, 42-84). All of them were affected by metastatic and/or locally advanced disease and received palliative therapy. The performance status was 1 in 12 patients (36.3%) and 2 or more in 21 patients (63.7%). Most of them were affected by advanced non-small cell lung cancer (NSCLC) (11 of 33, 33.3%), followed by breast cancer (4 of 33, 12.1%), small-cell lung cancer, gastric, pancreatic and gynecological cancer (3 patients, 9.1%), unknown primary tumor (2 patients, 6.06%), and other tumors (4 of 33, 12.1%).
Fourteen patients died after a first-line treatment (42.4%), 11 after a second-line (33.3%), and 8 after a third or more lines of therapy (24.2%). Seventeen of 33 patients (51.5%) died during hospitalization, 11 (33.3%) died in hospice, and 5 died at home (15.1%). Regarding the cause of death, all but 2 died from progressive disease. One patient affected by extended small cell lung cancer died from acute myocardial infarction during chemotherapy with carboplatin and etoposide. One female patient, treated in a University hospital and affected by Hodgkin’s disease in a previous non-Hodgkin lymphoma and treated with anthracycline-based chemotherapy for relapse of the disease after high-dose chemotherapy and peripheral blood progenitor cell support, died of toxicity, with severe sepsis and pneumonia. All but 3 patients (90.9%) received chemotherapy as the last treatment. One patient affected by liver and bone metastases from NSCLC and with performance status 4, according to WHO criteria, received 90 mg pamidronate 2 days before dying, and 2 patients affected by lung, liver and brain metastases from an unknown primary tumor and locally advanced NSCLC, received respectively whole brain and thoracic radiation 8 and 3 days before death.
Details regarding characteristics of the deceased patients and schedules of chemotherapy used in the patients are reported in Tables 1 and 2, respectively. Table 3 reports the characteristics of the patients deceased during 2008 more than 30 days from their last treatment.



Table 2 - Chemotherapy schedules used in the deceased patients

Type of cancer

Line of

Chemotherapy

 

treatment –

schedule

 

No. pts

 

 

 

 

NSCLC

1st: 6

Navelbine, gemcitabine

 

2nd: 3

Pemetrexed, docetaxel

 

3rd: 1

Pemetrexed

 

> 3: 1

Erlotinib

Breast

2nd: 2

Capecitabine

 

>3: 2

Weekly paclitaxel, epirubicin

 

 

 

SCLC

1st: 3

Carboplatin-etoposide

Gastric cancer

1st: 2

Docetaxel-carboplatin-

 

 

capecitabine

 

 

(weekly schedule)

 

2nd: 1

Capecitabine

Gynecologic cancer

1st: 1

Epirubicin

 

2nd: 2

Epirubicin, carboplatin

UPT

3rd: 1

Erlotinib

 

>3: 1

Capecitabine

Hodgkin’s lymphoma

3rd: 1

Anthracyclin-based

 

 

chemotherapy

Head & neck

2nd: 1

Carboplatin-5-fluorouracil

Pancreas

1st: 2

Gemcitabine

 

2nd: 1

Capecitabine

Colon

1st: 1

Oxaliplatin-capecitabine

Ocular melanoma

1st: 1

Fotemustine

Table 3 - Patients who died from their disease more than 30 days after the last treatment

Cancer

No. of  pts

No. of days between

 

 

last treatment & death

 

 

 

NSCLC

8

Median 61.5 (range, 43-81)

Breast cancer

2

60, 115

SCLC

3

50, 60, 75

Gastric cancer

0

-

Gynecologic cancer

0

-

UPT

0

-

Hodgkin’s lymphoma

1

55

Head & neck cancer

1

150

Pancreatic cancer

3

31, 39, 120

Colorectal cancer

6

Median 59.5 (range 35-210)

Ocular melanoma

0

-

Other cancer

7

Median 60 (range 37-210)

 

 

 

Other cancer: renal, soft tissue sarcoma, brain tumor, prostatic.



Annual consumption of pure opioids
Compared to 2007, in 2008 there was an increase of 179% regarding the use of oral long-acting opiates: oxycodone, oral morphine chlorhydrate prolonged release, oral morphine sulphate prolonged release, and OROS® hydromorphone (19,000 mg in 2007 vs 53,120 mg in 2008; morphine-equivalent doses). An increase of 8% regarding morphine chlorhydrate for parenteral use was also reported (4600 mg in 2007 vs 5000 mg in 2008). According to regional recommendations for use of the fentanyl transdermal patch in selected patients with a limitation on oral intake and poor compliance, there was also a reduction of 27% in the use of this opiate (5250 µg used in 2007 vs 3825 µg in 2008). Details regarding all molecules are reported in Table 4.

Table 4 - Annual consumption of opiates

Drug

2007

2008

Difference (%)

 

 

 

 

Fentanyl transdermal patch

5250 µg

3825 µg

-1425 µg (-27)

Morphine chlorhydrate vials

4600 mg

5000 mg

+400 mg (+8.6)

Oral morphine prompt

1600 mg

800 mg

-800 mg (-50)

  release, drops

 

 

 

Oxycodone

7840 mg

25720 mg

+17880 mg (+228)

 

 

 

 

Oral morphine chlorhydrate

2200 mg

-

- 2200 mg (-100)

  prolonged release

 

 

 

Oral morphine sulfate

1120 mg

-

- 1120 mg (-100)

  prolonged release

 

 

 

OROS hydromorphone

-

336 mg

+336 (+100)




Discussion
Measuring quality is a cornerstone of oncologic work, and its rationale has been defined as “the creation of an environment of watchful concern that motivates everyone to perform better”10. Monitoring performance and providing feedback on performance measures can improve clinical outcomes and quality of care in both palliative and end-of-life settings2.
In 2008, 19 (5%) of 364 cancer and treated patients who had died from the disease received an antiblastic therapy within 14 days prior to death, and 33 (9%) patients were treated within 30 days prior to death. Most of them had a performance status of 2 or more (63.7%), were affected by NSCLC (33.3%), and received a first-line treatment (42.4%).
Our analysis, comparing data from the group of patients who died more than 30 days after receiving their last treatment, could indicate that aggressive cancer care may be offered to patients affected by locally advanced or metastatic NSCLC, with the use of single-agent chemotherapy as first-line therapy in a palliative setting. All patients and family members were motivated to opt for chemotherapy, even though it was explained that the primary purpose of therapy was palliative. We did not perform an analysis of patient and care giver’s points of view regarding cancer care near to the end of life.
Our data are similar to those reported in the literature, i.e., assessed as 8-11% of patients who received chemotherapy within 30 days prior to death2,11. Moreover, inadequate communication and symptom management could be associated with aggressive care, and many patients frequently accept more toxicity for a smaller benefit12. Interestingly, although oncologists limit prognostic information to preserve hope, there has been no evidence that disclosure of prognosis makes parents of children affected by cancer less hopeful13.
By introducing use of the palliative prognostic score in our daily clinical practice, we expect to reduce the use of chemotherapy by over 30% and increase the use of hospice and/or palliative home care programs. An annual analysis of the percentage of patients who died from the disease within 14 and 30 days of antiblastic treatment should be performed and presented to all members of the Operative Unit.
A widespread problem in the treatment of cancer pain remains the risk of undertreating. A survey of symptomatic pain is mandatory but is also necessary to control the correct use and effectiveness of analgesics according to the patient’s reported level of pain. We decided to integrate the daily use of pain measurement through the numeric rating scale and adopt Cleeland’s pain management index, evaluating the congruence between the patient’s reported level of pain and the intensity of the use of painkillers 7,8. This index is constructed on the patient’s level of worst pain on the Brief Pain Inventory, defined as 0 (no pain), 1 (1-3, mild pain), 2 (4-7, moderate pain), and 3 (8-10, severe pain). The pain level is subtracted from the most potent level of analgesic drug therapies prescribed, scored as ≥0 (no painkiller), 1 (non-opioid), 2 (weak opioid), and 3 (strong opioid). The index can range from -3 (severe pain receiving no analgesic drug) to +3 (a patient receiving strong opioids and reporting no pain). Negative scores indicate inadequate orders for painkillers, and score ≥0 is an indicator of acceptable treatment 8.
Palliative prognostic scores and evaluation of pain and pain management index are two easily applicable tools to improve the quality of care and clinical outcome for cancer patients affected by advanced disease and at end-of-life settings. We believe that any attempt to improve quality of care can be achieved by close collaboration among all health professionals and direct involvement of the patient and the caregivers in establishing and accepting the therapeutic goal in any setting of the neoplastic disease.

References
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 2. Earle CC, Landrum MB, Souza JM, Neville BA, Weeks JC, Ayanian JZ: Aggressiveness of cancer care near the end of life: is it a quality-of-care issue? J Clin Oncol, 26: 3860-3866, 2008.
 3. National Cancer Policy Board: Ensuring Quality Cancer Care. Washington, DC, National Academy Press, 1999.
 4. Emanuel EJ, Young-Xu Y, Levinsky NG, Gazelle G, Saynina O, Ash AS: Chemotherapy use among Medicare beneficiaries at the end of life. Ann Intern Med, 138: 636-643, 2003.
 5. Maltoni M, Caraceni A, Brunelli C, Broeckaert B, Christakis N, Eychmueller S, Glare P, Nabal M, Viganò A, Larkin P, De Conno F, Hanks G, Kaasa S: Prognostic factors in advanced cancer patients: evidence-based clinical recommendations – a study by the Steering Committee of the European Association for Palliative Care. J Clin Oncol, 23: 6240-6248, 2005.
 6. Stone PC, Lund S: Predicting prognosis in patients with advanced cancer. Ann Oncol, 18: 971-976, 2007.
 7. Cleeland CS, Gonin R, Hatfield AK, Edmonson JH, Blum RH, Stewart JA, Pandya KJ: Pain and its treatment in outpatients with metastatic cancer. N Engl J Med, 330: 592-596, 1994.
 8. Deandrea S, Montanari M, Moja L, Apolone G: Prevalence of undertreatment in cancer pain. A review of published literature. Ann Oncol, 19: 1985-1991, 2008.
 9. Setoguchi S, Earle CC, Glynn R, Stedman M, Polinski JM, Corcoran CP, Haas JS: Comparison of prospective and retrospective indicators of the quality of end-of-life cancer care. J Clin Oncol, 26: 5671-5678, 2008.
10. Donabedian A: The quality of care: How can it be assessed? JAMA, 260: 1743-1748, 1988.
11. O’Brein M, Borthwick A, Rigg A, Leary A, Assersohn L, Last K, Tan S, Milan S, Tait D, Smith IE: Mortality within 30 days of chemotherapy: a clinical governance benchmarking issue for clinical oncology patients. Br J Cancer, 95: 1632-1636, 2006.
12. Matsuyama R, Reddy S, Smith TJ: Why do patients choose chemotherapy near the end of life? A review of the perspective of those facing death from cancer. J Clin Oncol, 24: 3490-3496, 2006.
13. Mack JW, Wolfe J, Cook EF, Grier HE, Cleary PD, Weeks JC: Hope and prognostic disclosure. J Clin Oncol, 25: 5636-5642, 2007.



 
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