Early Palliative Care

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Temel JS, et al. "Early Palliative Care for Patients with Metastatic Non-Small-Cell Lung Cancer". The New England Journal of Medicine. 2010. 363(8):733-742.
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Clinical Question

In patients with metastatic NSCLC, how does early introduction of palliative care affect quality of life?

Bottom Line

Early integration of palliative care improved quality of life, reduced aggressive care at the end of life, and improved survival among patients with metastatic NSCLC.

Major Points

Patients with stage I, II, or III NSCLC are generally treated with curative intent using surgery, chemotherapy, and/or radiation therapy. In contrast, patients with stage IV metastatic NSCLC may benefit from palliative systemic therapy. However, early integration of palliative care into standard oncologic care is not the standard of care.

This trial randomly assigned 151 patients with newly diagnosed metastatic NSCLC to early palliative care or standard management and demonstrated that early integration of palliative care services improved outcomes associated with mood and quality of life. Despite receiving less chemotherapy at the end of life, median survival was improved among patients in the early palliative care arm compared with patients in the standard care arm (11.6 vs. 8.9 months).

The palliative care protocol involved more frequent outpatient visits, emphasis on symptom management, goals of care, decision-making and individual care coordination. However, it is not clear how this protocol specifically resulted in mortality benefit. Nonetheless, this trial established palliative care as an essential part of management among patients with advanced NSCLC.

Guidelines

NCCN Non-Small-Cell Lung Cancer (2015, adapted)[1]

  • Palliative care should be integrated early on in the course of treatment for patients. (Category 2A)

Design

  • Prospective, non-blinded, parallel-group, randomized, controlled trial
  • N=151 patients with metastatic NSCLC
    • Early palliative care (n=77)
    • Standard care (n=74)
  • Setting: Single academic center in Boston
  • Enrollment: 2006-2009
  • Analysis: Per-protocol, intention-to-treat
  • Primary outcome: change in TOI score from baseline to 12 wks

Population

Inclusion Criteria

  • Ambulatory patients with pathologic diagnosis of metastatic NSCLC in prior 8 weeks
  • ECOG performance status 0-2

Exclusion Criteria

  • English illiterate
  • Those already receiving palliative care services

Baseline Characteristics

  • Age: 65 years
  • Female: 52%
  • White: 100%
  • ECOG grade: 0 (38%), 1 (54%), 2 (9%)
  • Smoked ≤10 packs/year: 23%
  • Brain metastases: 31%
  • EGFR mutations: 11%
  • Initial therapy:
    • Platinum-based combination: 46%
    • Single agent: 8%
    • Oral EGFR tyrosine kinase inhibitor: 8%
    • Radiotherapy: 35%
    • As part of a clinical trial: 24%
  • Quality of life scores:
    • FACT-L: 92.7
    • FACT-L Lung cancer subscale: 19.4
    • TOI: 55.8
  • Mood scores:
    • HADS-A: 35%
    • HADS-D: 24%
    • PHQ-9: 15%

Interventions

  • Randomized to early palliative care integrated with standard oncologic care vs. standard oncologic care alone within 8 wks of diagnosis
  • Early pallitive care arm met with palliative care team within 3 wks of enrollment followed by monthly outpatient visits until death; guidelines per National Consensus Project for Quality Palliative Care emphasized assessment of physical and psychosocial symptoms, establishing goals of care, assisting with decision making regarding treatment, and coordinating individual care
  • Standard care arm met with palliative care only if requested by patient, family, or oncologist; those who were subsequently referred to palliative care did not cross over to other arm or follow specified palliative care protocol
  • Health-related quality of life assessed at baseline and at 12 wks
    • Functional Assessment of Cancer Therapy-Lung scale (FACT-L) [range 0-136]: higher scores indicate better quality of life
    • Lung Cancer Subscale (LCS) of FACT-L [0-28]: higher scores indicate fewer symptoms
    • Trial Outcome Index (TOI) [0-84]: sum of LCS scores and well-being subscales of FACT-L, higher scores indicate better quality of life
  • Mood assessed at baseline and at 12 wks
    • Hospital Anxiety and Depression Scale (HADS-A and HADS-D) [0-21]: higher scores indicate higher stress; scores ≥7 clinically significant
    • Patient Health Questionare 9 (PHQ-9): ≥5 symptoms diagnosed MDD according to DSM-IV, with 1/5 symptoms being either anhedonia or depressed mood
  • Aggressive end-of-life care, defined as:
    1. Chemotherapy within 14 days of death
    2. No hospice care
    3. Admission to hospice 3 days or less before death

Outcomes

Comparisons are early palliative care vs. standard care. Per-protocol analysis unless otherwise stated.

Primary Outcomes

Mean change in TOI score from baseline to 12 wks
2.3 vs. -2.3 (difference between groups 4.6; 95% CI 0.2-8.9; P=0.04)

Secondary Outcomes

Mean change in FACT-L score from baseline to 12 wks
FACT-L score: 4.2 vs. -0.4 (between-group difference 4.6; 95% CI -0.8-9.9; P=0.09)
Mean change in LCS score from baseline to 12 wks
LCS score: 0.8 vs. 0.3 (between-group difference 0.5; 95% CI -1.0 vs. 2.0; P=0.50)
Quality-of-life outcomes from baseline to 12 weeks
FACT-L: 98.0 vs. 91.5 (P=0.03)
LCS score: 21.0 vs. 19.3 (P=0.04)
TOI score: 59.0 vs. 53.0 (P=0.009)
Mood symptoms at 12 weeks
HADS-D: 16% vs. 38% (P=0.01)
HADS-A: 25% vs. 30% (P=0.66)
PHQ-9: 4% vs. 17% (P=0.04)
Duration of hospice care
11 vs. 4 days (P=0.09)
Aggressive end-of-life care
33% vs. 54% (P=0.05)
Documentation of resuscitation preferences
53% vs. 28% (P=0.05)
Median survival
11.6 vs. 8.9 months (HR 1.70; 95% CI 1.14-2.54; P=0.02 after adjustment for age, sex, baseline ECOG, group assigment; intention-to-treat)

Criticisms

  • Single center study
  • Non-blinded
  • Homogeneous patient population

Funding

Supported by American Society of Clinical Oncology Career Development Award and philanthropic gifts from Joanne Hill Monahan Cancer Fund and Golf Fights Cancer. Multiple disclosures.

Further Reading

  1. NCCN Clinical Practice Guidelines for Non-Small Cell Lung Cancer, version 1.2016