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Transcript of QLM0301 Quality of life and Care Needs in Advanced Ovarian Cancer Patients Vivian von Gruenigen MD,...
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QLM0301Quality of life and Care Needs in
Advanced Ovarian Cancer Patients
Vivian von Gruenigen MD, Lari Wenzel, PhD David Cella PhD, Nancy Fusco RN
Helen Huang MS
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QLM 0301
Objectives
To identify symptoms and needs which disrupt quality of life (QOL) in patients with platinum resistant ovarian cancer from study entry to 6 months post enrollment
• Cumulative incidence of symptoms (FOSI) which coincide with ↓ QOL (FACT-O, -F, -Abd Dis) and clinical measures (PS, disease status, weight change)
• To identify unmet needs as measured by the “NEST” instrument
• To examine the relationship between symptoms, QOL, clinical disease and treatment data.
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QLM 0301ENROLL IN STUDY
•After progressing through 1 or more second line platinum resistant chemotherapy agents
Enrollment, and 6 months
FACT-O, -F, +2 Questions = FOSI-Abd Dis, NEST,
Performance StatusWeightResponse rate or tumor status
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Needs at the End-of-Life Screening Tool (NEST)
• 13 items which assess 4 clusters of human need at the end of life: – Needs (social), – Existential, – Symptoms, – Therapeutic
• study entry – baseline measurement• 6 months
Emanuel LL et al. J Palliat Med 2001
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Primary, Neoadjuvant, and Adjuvant Chemotherapy in Elderly Women with Ovarian , Peritoneal
Primary or Tubal Cancer
Vivian von Gruenigen MD, Arti Hurria MDMerrill Egorin PhD, Mark Brady PhD, Tom Herzog MD,
Elisa Eldermire RN
OVM0502
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Background
• US population aging• The current population of elderly will more
than double within the next thirty years.• Cancer incidence rises with age
– 2/3 of solid tumors occur in patients 65+
• Cognitive disability and frailty are rapidly becoming dominant elements in old age.
» Lynn J. Sick to Death 2004» Smith BD, Hurria A. et al JClinOncol 2009
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Background
• Co-morbidity - Overall more important than chronological age– Needs to be assessed independent from
functional status
• Most elderly are living with more than one chronic condition
» Goodwin JS et al. Cancer 1993» Extermann M et al. J Clin Oncol 1998
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Background
• Accrual rates to trials for elderly ovarian cancer patients are lower compared to pancreatic, colon, lung, leukemia and breast cancers
• Practitioners’ “attitudes” should be monitored to assure that elderly patients are not inappropriately denied participation on GOG trials
» Talarico L et al ASCO 2003» Moore DH et al. Gynecol Oncol 2004
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GOG/SDC/DMCMemorandum 2003
GOG-0182• The overall death rate within the first 6 months of entering
the study – for patients ≥ 80 was 30%– For patients ≥ 70-79 was 7%
GOG-158 and ICON3• The overall death rate within the first 6 months of entering
– for patients ≥ 80 was 33%• For ICON3 it was “somewhat higher.”
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Side Effects• Elderly are less likely to receive surgery, and/or combination
chemotherapy • Have a higher proportion of post-operative complications,
reductions of chemotherapy cycles/doses and post-operative deaths.
• Bone marrow suppression, nausea and vomiting are more common and severe
• Dose-reduced regimens: T-175, Carbo-AUC 5/6 vs Taxol- 135, Carbo-AUC 4/5)– Fewer side effects including bone marrow suppression, delays,
neutropenic fever and hospitalizations– No survival differences
Wenzel L et al. J Clin Oncol 2005; Moore KN et al. Gynecol Oncol 2008, Fader A, von Gruenigen, Gynecol Oncol, 2008; Uyar D, von Gruengien, Gynecol Oncol 2005
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Questions
• What is the QOL of elderly ovarian cancer patients?• What type of impact does their “age” have on QOL and
feasibility of surgery/chemotherapy?• Why is the elderly cancer death rate so high (GOG 182,
158; ICON3)? And, what are the causes of death?• What is their trajectory of decline and what happens to QOL
and needs?• What doses should we give?• PK differences?• What about >80 years?• PFS, OS differences?
Lunney, J. R. et al. JAMA 2003von Gruenigen et al. Cancer 2008
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Geriatric Measures
• Activities of daily living (ADL)
• Instrumental activities of daily living (IADL)
• Nutritional status (BMI, % unintentional weight loss)
• Co-morbidity (Charlson Index)
• PS» Extermann M, Hurria A. J Clin Oncol 2007
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Design
• IADL to predict tolerability of chemotherapy for elderly (age > 75)
• Initially, the investigator decides between primary surgery versus primary chemotherapy
• The physician also chooses between different
chemotherapy regimens versus placing the patient on GOG 218-R.
• Treatment after the four cycles of chemotherapy is at the discretion of the treating physician.
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Interval surgery (if no primary surgery), and/or further chemotherapy at discretion of the physician
GOG 218, -R(primary surgery
only)
Carboplatin AUC 5 every 3 weeks X 4
Carboplatin AUC 5Paclitaxel 135 mg/m2
Plus G-CSFevery 3 weeks X 4Clinical Stage III-IV
confirmed and elevated CA125 > 50 at age > 75, PS 0-3. Investigator decides primary surgery vs. chemotherapy and adj chemotherapy
PROTOCOL OVM0502
PROs @baseline, prior to Cycle 3, 3-6 weeks after Cycle 4, and 6 months after completion of chemotherapy
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Objectives
• To assess % of patients who are able to complete 4 cycles (reductions/delays)
• To determine whether baseline IADL predicts
patients who are able to complete 4 cycles of chemotherapy (reductions/delays)
• To compare actual and calculated (using standard GOG Jeliffe formula) carboplatin AUC in this patient population.
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Secondary Objectives
• Assess % treated with primary surgery versus primary chemotherapy
• Treatment regimen choice• IADL at baseline predicts physician choice of
primary surgery, primary chemotherapy and/or interval surgical cytoreduction
• IADL at baseline predicts physician choice of chemotherapy regimen
• Relationship between IADL at baseline and morbidity in patients receiving primary surgery.
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Secondary Objectives• Relationship of age, geriatric measures (ADL, PS, FACT,
nutritional status, co-morbidity) correlation with completion of 4 cycles of chemotherapy
• Reasons and timing of dose reductions and delays• Toxicities, serial QOL, and relationships with geriatric measures.• Explore whether patients with CR return to their pre-treatment
scores of QOL and geriatric assessment following completion of therapy.
• Describe RR, OS, PFS on each arm of therapy
Translational Research Objective• To explore relationships between carboplatin AUC, paclitaxel, and
paclitaxel time above a plasma concentration of 0.05 mM with nadir neutrophil and platelet counts during Cycle 1 of treatment.