PORQUE NO SIEMPRE EN LA PRÁCTICA CLÍNICA LA … · PORQUE NO SIEMPRE EN LA PRÁCTICA CLÍNICA LA...

PORQUE NO SIEMPRE EN LA PRÁCTICA CLÍNICA LA SUPERVIVENCIA GLOBAL ES UN OBJETIVO

Cuando la calidad de vida es el objetivo

Miquel Àngel Seguí Palmer


INTEGRANDO CONOCIMIENTO PARA ENCONTRAR ALTERNATIVAS

Metastatic breast cancer is an incurable illness with a median survival time of 2–4 years following diagnosis; it depends heavily on the nature of the

metastases and the tumor biology


• More drugs are now available for the treatment of patients with metastatic breast cancer than any other malignancy and for most patients, survival can now be measured in years rather than months.

• Patients face a wide range of challenges, including frequent Medical procedures, chronic side effects (e.g., occupational disability, pain, fatigue, cognitive impairment, sexual dysfunction), and practical concerns (e.g., work and family role disruption, financial strain).

• In the end, however, metastatic breast cancer is still an incurable condition, and it is therefore important to define the goals of therapy.



THE GOAL AND THE CHALLENGE

• Goal: Maintaining best possible quality of life, while keeping

the cancer under control, for as long as possible.

• Challenge: Toxicities of continuous treatment. Chronic pain and other symptoms associated with

metastatic sites. Symptomatic relapses from disease progression. Emotional stressors of living with an incurable,

progressive, and ultimately fatal disease, for patients and families.



Moreover, we should evaluate how we may better measure the effects of treatment in relation to those defined goals. Health-related quality of life, which has been measured in clinical trials for many years, provides data that is critical for determining the acceptability of treatment to patients, who must balance the consequences of toxicity in the short term with the chance for profression-free survival in the mid-long term



Patient perspectives



In a survey of patients with metastatic breast cancer conducted across several European countries, 67% of patients (or their

caregivers) believed that life-extending treatment was worthwhile, despite its potential for accompanying side effects

Harding V et al. Br J Cancer. 2013



With improved survival, QoL has become an important outcome during treatment, and thus QoL end points have become an integral part of breast cancer treatment and in clinical trials. Metastatic breast cancer impairs quality of life through its symptom-producing effects on organ-specific function (e.g., bone metastasis-related fractures and pain) and general effects on quality of life (both physical and psychologic). An important part of the physician’s role is to maintain patient quality of life and palliate cancer-related symptoms.



QoL can be defined as self-perceived aspects of wellbeing that are related to or affected by

the presence of a disease or treatment.



Health-related quality-of-life (HRQoL) is a multidimensional concept encompassing physical, social, emotional, cognitive and role-related well-being, along with the impact of disease-related symptoms, therapy-induced side effects, and even the financial impact of illness.

In women with breast cancer, HRQoL may be adversely affected by general cancer-related factors, such as fatigue, pain, and concerns about the illness, along with breast cancer-specific considerations, such as perceived attractiveness or sense of femininity



The Conceptual Model of the Four Domains That Comprise Quality of Life

Cancer-related quality of life is a complex entity, with physical, psychological, social,and sexual factors all playing a role



Uses of Quality-of-Life Information in Clinical Decision-Making

Determine whether a new therapy is preferable to the standard therapy

Compare two standard therapies with similar survival outcomes

Determine the balance between positive and negative effects of therapy

Identify the need for supportive care

Facilitate communication in clinical practice



Bezjak A et al. Quality of Life Research. 2001



Self-reported health-related quality of life is an independent predictor of chemotherapy treatment benefit and toxicity in

women with advanced breast cancer

Lee CK et al. Br J Cancer. 2010

PWB: Physical well-being



Self-reported health-related quality of life is an independent predictor of chemotherapy treatment benefit and toxicity in women with advanced breast cancer

Lee CK et al. Br J Cancer. 2010

• Women with poor QoL derived less benefit and experienced more toxicity when treated with chemotherapy than women with good QoL.

• Overall, women reporting poor QoL at baseline received 50% fewer cycles of chemotherapy, were 20–30% less likely to benefit from chemotherapy and experienced rates of non-haematological treatment toxicity 20% higher than women reporting good QL at baseline.



While measurement of toxicity is essential to examine the direct effects of chemotherapy from a clinical perspective, QoL outcomes provide the woman’s perception of how the treatment affects her life and well-being. This knowledge will enhance our ability to evaluate the impact of therapy on women’s quality of life; it will not replace toxicity-related evaluation and management.



Symptomatic Toxicities Experienced During Anticancer Treatment: Agreement Between Patient and Physician Reporting

Under-reporting was calculated as rate of cases where physicians reported grade 0 toxicity in all cycles, of cases where patients reported toxicity in one cycle.

Di Maio M et al. J Clin Oncol. 2015

Proportion of under-reporting by physicians



• One important issue that remains to be addressed, especially in the era of rapidly developing targeted therapies, is the impact of lower-grade treatment-induced toxicities.

• Clinicians and clinical trials tend to focus on grade 3 or 4 adverse events, especially in regard to myelosuppression and febrile neutropenia.

• Often less attention is paid to grade 2 adverse events; persistent moderate fatigue, nausea, or stomatitis can, however, be quite debilitating for patients, negatively affecting their quality of life and potentially limiting the ability to continue therapy without modifying the dose or schedule of treatment.

• A focus on only acute grade 3 or 4 adverse events may lead clinicians to underestimate the impact of treatment on a patient’s quality of life.



Assessing Quality of Life



One of the key elements to consider regarding quality of life is that it is best defined from the patient’s perspective and is her own report of her experience. Therefore, the definition of a “good” quality of life will differ on an individual patient basis and will be affected by the patient’s own unique situation.

Although physicians often view the QoL questionnaires as being patient-focused, it is the investigators rather than the individual patient who generate the questions that are addressed.

This approach may restrict the ability of patients to report the problems most affecting them as individuals.

Assessing Quality of Life



Although the number of cancer clinical trials that include QoL assessment is increasing, there is also evidence that analysis of QoL

presents methodological and statistical difficulties because of the type of data generated and the multidimensional nature of the instruments



Time to definitive deterioration for EORTC QLQ-C30

Burris HA et al. Cancer. 2013



Kaplan–Meier curves of time to ≥5-point reduction from baseline in TOI-PFB and time to docetaxel discontinuation

Cortes J et al. Annals of Oncology. 2013



Patient-Reported Outcomes From EMILIA

Welslau M et al. Cancer. 2014

Time to symptom worsening



Patient-Reported Outcomes From EMILIA

Welslau M et al. Cancer. 2014



Joensuu H et al. J Clin Oncol. 1998

Patients treated with single-agent E followed by single-agent M had similar survival, but less treatment-related toxicity and better

QoL as compared with those treated with CEF followed by MV



Effects on quality of life of weekly Docetaxel based chemotherapy in patients with metastatic breast cancer

Activity and efficacy by treatment arm Pattern of worst scores reported by the Daily Diary Card during the first 6 weeks of treatment

Nuzzo F et al. BMC Cancer. 2011



A concern over the value and sensitivity of QOL measures



Overall Survival Quality of life: global health status.

O’Shaughnessy J. et al. J Clin Oncol. 2002

“It is important to note that the higher incidence of gastrointestinal adverse events and hand-foot syndrome observed in patients receiving

the combination regimen did not seem to adversely affect QOL”



The selection and sequence of treatments should be made in cooperation with the patient and after consideration of her particular priorities. When comparing HRQoL between the two active regiments that both contain a cytotoxic agent, it is probably unreasonable to anticipate a demonstrable difference, since the quality-of-life picture may be dominated by the adverse effects of chemotherapy.



Patients and physicians frequently have diferent priorities regarding treatment and the effect that the illness will have on a patient's life and possible outcomes.

Employing the patients' views into the decision process would not only empower patients, but also could improve satisfaction and compliance with treatment.



A treatment’s side effects should be mitigated by the improvement it makes in the number and severity of disease-related symptoms. Therefore, when deciding among treatment options, clinicians must consider not only traditional outcomes, such as prolonging progression-free survival and reducing tumor burden, but also maintaining the patient’s quality of life.



A survey of patients with metastatic breast cancer conducted across several European countries identified

several areas in which patients desired more information

Harding V et al. Br J Cancer. 2013



Key Elements of Individualized Care for Patients With Advanced Cancer

• Patients should be well informed about their prognosis and treatment options, ensuring that they have opportunities to make their preferences and concerns regarding treatment and supportive care known.

• Anticancer therapy should be discussed and offered when evidence supports a reasonable chance of providing meaningful clinical benefit.

• Options to prioritize and enhance patients’ quality of life should be discussed at the time advanced cancer is diagnosed and throughout the course of illness along with development of a treatment plan that includes goals of therapy.



Key Elements of Individualized Care for Patients With Advanced Cancer

• Conversations about anticancer interventions should include information on likelihood of response, the nature of response, and the adverse effects and risks of any therapy. Direct costs to the patient in terms of time, toxicity, loss of alternatives, or financial impacts that can be anticipated should also be discussed to allow patients to make informed choices.

• Whenever possible, patients with advanced cancer should be given the opportunity to participate in clinical trials or other forms of research that may improve their outcomes or improve the care of future patients.

• When disease-directed options are exhausted, patients should be encouraged to transition to symptom-directed palliative care alone with the goal of minimizing physical and emotional suffering.



“….Our life was a maze filled with Dr. appointments, medical procedures, medications, and side-effects…”

“….Our hope was that if our family and friends saw what we were facing every day then maybe they would have a better understanding of the challenges in our life…..”


• Therapies most beneficial for maintaining or improving quality of life include those that can effectively reduce tumor burden and tumor-related symptoms, but have toxicity profiles that are well tolerated and easily managed.

• Overall outcomes of patients with metastatic breast cancer improve when therapy is focused not only on the disease itself, but also on the goals of minimizing disease-related and treatment-related symptoms.

Take-home Messages (1)



• No one other than the patient knows how she truly feels.

• A focus on quality of life will help patients participate fully in their lives with family and friends, remain independent for as long as possible, and manage the inherent ups and downs of their illness.

• This approach must become a central component of patient management.

Take-home Messages (2)


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