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Fabrice Barlési Thoracic Oncology Pôle Cardiovasculaire et Thoracique & EA3279 Marseille - France ERS live lecture – May 21, 2008 Quality of Life in Lung.

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Presentation on theme: "Fabrice Barlési Thoracic Oncology Pôle Cardiovasculaire et Thoracique & EA3279 Marseille - France ERS live lecture – May 21, 2008 Quality of Life in Lung."— Presentation transcript:

1 Fabrice Barlési Thoracic Oncology Pôle Cardiovasculaire et Thoracique & EA3279 Marseille - France ERS live lecture – May 21, 2008 Quality of Life in Lung Cancer

2 Thoracic Oncology & EA3279 Marseille - France Points of discussion 1.Why considering QoL in lung cancer ? 2.QoL in thoracic oncology trials 3.QoL in daily practice 4.Interpreting QoL data: impact of methodology 5.Conclusions

3 Thoracic Oncology & EA3279 Marseille - France Points of discussion 1.Why considering QoL in lung cancer ? 2.QoL in thoracic oncology trials 3.QoL in daily practice 4.Interpreting QoL data: impact of methodology 5.Conclusions

4 Thoracic Oncology & EA3279 Marseille - France Why considering QoL in lung cancer? Activity: –Response rate –Response duration Safety Profile Efficacy –Symptoms –Survival Quantitative assessment

5 However … –Under-evaluation of symptoms by MD (time-consuming, lack of standardization) –Some effects are known by the patient only (ex. pain) –Assessment of treatment by the patient itself is a unique point of view (ex. spirometry / dyspnea) Why considering QoL in lung cancer? Thoracic Oncology & EA3279 Marseille - France

6 Symptoms in lung cancer patients Why considering QoL in lung cancer? Thoracic Oncology & EA3279 Marseille - France

7 Thus, patients’ point of view regarding treatments’ outcomes is a potential indicator of efficacy … –Promoters & investigators (clinical trials) –State agencies (EMEA, FDA) –Clinicians (daily practice) Why considering QoL in lung cancer? Thoracic Oncology & EA3279 Marseille - France

8 ‘Modern’ qualitative assessment: –By the patient on its health: Quality of life –By the patient on its care: Satisfaction Why considering QoL in lung cancer? Thoracic Oncology & EA3279 Marseille - France

9 Quality of life – Concept Wilson, JAMA 1995 Thoracic Oncology & EA3279 Marseille - France

10 Thoracic Oncology & EA3279 Marseille - France Points of discussion 1.Why considering QoL in lung cancer ? 2.QoL in thoracic oncology trials 3.QoL in daily practice 4.Interpreting QoL data: impact of methodology 5.Conclusions

11 QoL in thoracic oncology trials? Clinical research: –Descriptive studies –Secondary objective (mostly) –Primary objective (sometimes) Thoracic Oncology & EA3279 Marseille - France

12 QoL in thoracic oncology trials? Descriptive studies: –EORTC C30 –N=110 Win et al, Thorax 2005 Thoracic Oncology & EA3279 Marseille - France

13 Secondary objective: –Docetaxel versus Pemetrexed –LCSS –N=571 Hanna et al, J Clin Oncol 2004 Thoracic Oncology & EA3279 Marseille - France QoL in thoracic oncology trials?

14 Primary objective: comparison of two (supposed) very different treatments CNAPC IIIB – IVR GMZ + BSC BSC Primary Obj.: QoL (SS14) at 2 months Anderson et al, Br J Cancer 2000 Thoracic Oncology & EA3279 Marseille - France QoL in thoracic oncology trials?

15 Primary objective: comparison of two (supposed) very different treatments CBNAPC IIIB, IV Eligibles Cx R GMZ + VNR CDDP + GMZ/VNR Primary Obj.: QoL (EORTC) at 2 cycles Gridelli et al, J Clin Oncol 2003 Thoracic Oncology & EA3279 Marseille - France QoL in thoracic oncology trials?

16 Primary objective: comparison of two (supposed) very similar treatment NSCLC IB, II, IIIA R0 Eligible for Cx R CDDP + GMZ x3 CDDP + TXT x3 Primary Obj.: QoL (EORTC) at the end of treatment? RT (centre) IIIAN2 Barlési et al, Rev Mal Respir 2006 Thoracic Oncology & EA3279 Marseille - France QoL in thoracic oncology trials?

17 Review phIII RCTs (2003+) –14 trials (6665 pts), 13 with validated instruments –EORTC QLQ C30 –QoL primary end-point, n=2 –9 trials of acceptable quality (>50% surviving pts being complaint at baseline + 1 at least one point) –Only one showing significant difference Tanvetyanon et al, J Thorac Oncol 2007 Thoracic Oncology & EA3279 Marseille - France QoL in thoracic oncology trials?

18 Review RCTs (<2003) –29 trials (8445 pts), 20 with validated instruments –EORTC QLQ C30 –QoL primary end-point, n=6 –Some difference in HRQOL in 15 trials (68%) –Results presented adequately in 17 cases (59%) –Management missing data in 18 trials (62%) Bottomley et al, J Clin Oncol 2003 Thoracic Oncology & EA3279 Marseille - France QoL in thoracic oncology trials?

19 Relationship with standard efficacy measures –EORTC 08975 –N=391 –EORTC C30 +LC13 Efficace et al, Ann Oncol 2006 Thoracic Oncology & EA3279 Marseille - France A new field for QoL?

20 Relationship with standard efficacy measures Thoracic Oncology & EA3279 Marseille - France De Marinis et al, J Thorac Oncol 2008 A new field for QoL?

21 Thoracic Oncology & EA3279 Marseille - France Gralla et al, J Thorac Oncol 2008 In summary, a complex interplay! If a treatment fails to control the disease, it is unlikely to improve QoL even if less toxic or more convenient … Patients who respond to treatment experience better symptom relief than those who progress, … And those with higher QoL at baseline have better survival than those with lower QoL.

22 Thoracic Oncology & EA3279 Marseille - France Points of discussion 1.Why considering QoL in lung cancer ? 2.QoL in thoracic oncology trials 3.QoL in daily practice 4.Interpreting QoL data: impact of methodology 5.Conclusions

23 QoL in daily practice? Bezjack et al, QoL Research 2001 Thoracic Oncology & EA3279 Marseille - France Agree % Disagree % QoL is a subjective concept that cannot be quantified 1486 Using published QoL information is essential to good care in pts with cancer 8218 I often do not have the time required to discuss QoL with my patients 2773 I rely on my clinical experience to assess QoL 7723

24 QoL in daily practice? 102 MD cancer network (51 responses) KnowledgesExperienceInteraction w PtsProposal 34 cited Q. QoL 12 know + 33 trials QoL 40 assess QoL 32 = help 37 = anxiety <15 Questions 6 domains Agreement to incorporate QoL assessment in daily practice Need to improve knowledges (initial and continous medical education) New tools (collect, assess, interpret QoL data) Barlési et al, 2006 Thoracic Oncology & EA3279 Marseille - France

25 Additional objectives? –Use in daily practice Gralla et al, Proc ASCO 2006 Thoracic Oncology & EA3279 Marseille - France QoL in daily practice?

26 Longitudinal follow-up Gralla et al, Proc ASCO 2006 QoL in daily practice? Thoracic Oncology & EA3279 Marseille - France

27 Improving communication –N=286 –3 groups EORTC + feedback EORTC  Velikova et al, J Clin Oncol 2004 QoL in daily practice? Thoracic Oncology & EA3279 Marseille - France

28 Gralla et al, ASCO 2006 QoL in daily practice? Thoracic Oncology & EA3279 Marseille - France Acceptance by patients

29 Gralla et al, ASCO 2006 QoL in daily practice? Thoracic Oncology & EA3279 Marseille - France Acceptance by physicians and nurses

30 Thoracic Oncology & EA3279 Marseille - France Points of discussion 1.Why considering QoL in lung cancer ? 2.QoL in thoracic oncology trials 3.QoL in daily practice 4.Interpreting QoL data: impact of methodology 5.Conclusions

31 Interpreting QoL data: impact of methodology Questionnaires: ‘illusion of the measure?’ –Additional, solid, and reproducible information –Standardized Questionnaire –Validated Questionnaire: Validity: contains, internal and external structures Fidelity (precision): internal consistency, reproducibility Sensibility to changes Applicability: acceptability, costs Thoracic Oncology & EA3279 Marseille - France

32 What instruments? –Hetero-evaluation –Auto-evaluation –Instruments Several tools Many Languages –EORTC LC13, LCSS, FACT-L www.atsqol.org Thoracic Oncology & EA3279 Marseille - France Interpreting QoL data: impact of methodology

33 Assessment: period? TRT D1D8D15D21D28 EORTC QLQ C30 LCSS FACT-L SF-36 Thoracic Oncology & EA3279 Marseille - France Interpreting QoL data: impact of methodology

34 Assessment: time? CDDP /X CDDP /VNB D1D8D15D21D28 QoL’s Questionnaire Thoracic Oncology & EA3279 Marseille - France Interpreting QoL data: impact of methodology

35 Assessment: intervals? Hollen et al, Support Care Cancer 2004 Thoracic Oncology & EA3279 Marseille - France Interpreting QoL data: impact of methodology

36 Results’ Presentation? Guidelines ! Staquet M et al, Qual Life Res 1996 Thoracic Oncology & EA3279 Marseille - France Interpreting QoL data: impact of methodology

37 Statistics: –Missing data –Multiples analyses (risk  ) –Variance analyses (non independant data) Osoba et al, Stat Med 1998 Fairclough et al, Stat Med 1998 Thoracic Oncology & EA3279 Marseille - France Interpreting QoL data: impact of methodology

38 Clinical significance? –EORTC QLQ C30: 10 points –LCSS: ? –SF-36: 7 points Osoba et al, Qual Lif Res 1994 Revicki et al, Health Qual Life Outcomes 2006 Thoracic Oncology & EA3279 Marseille - France Interpreting QoL data: impact of methodology

39 Standardization Health Qual Life Outcomes, 2006 Thoracic Oncology & EA3279 Marseille - France Interpreting QoL data: impact of methodology

40 Conclusions Assessment of treatments … –< 80’s: Clinic, biology, radiology –90’s: CT-scan –00’s: TEP-FDG, genes, … –10’s: QoL! Improve quantitative & add qualitative assessments Thoracic Oncology & EA3279 Marseille - France

41 Conclusions QoL measures should be done as rigorously as clinical, radiological, biological assessments. Standardization, standardization, standardization … Let’s discuss! Thoracic Oncology & EA3279 Marseille - France

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