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Richard J Gralla



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    MA 08 - Supportive Care and Communication (ID 669)

    • Event: WCLC 2017
    • Type: Mini Oral
    • Track: Nursing/Palliative Care/Ethics
    • Presentations: 1
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      MA 08.11 - Do Patients Treated with Chemotherapy for Advanced NSCLC Regret Having Received Treatment? A Prospective Evaluation in 164 Patients (ID 10241)

      11:00 - 12:30  |  Author(s): Richard J Gralla

      • Abstract
      • Presentation
      • Slides

      Background:
      While many thousands of patients per year receive chemotherapy for advanced NSCLC with first-line or subsequent chemotherapy, little is known about patients’ views on their decision to receive that treatment. In that median survival results generally do not exceed one year, there are many potential risks for regret. Given the highly symptomatic nature of NSCLC coupled with patient, family and oncologist desires to decide rapidly on treatment, many challenges exist affecting quality decision making for patients and their supporters facing treatment. Among 59 studies dealing with regret in a recent systematic review (Becerra Perez 2016), none analyzed patients with lung cancer (66% of studies were in oncology). A clinical profile of the extent of regret, and factors contributing to that regret is lacking in those undergoing chemotherapy for lung cancer.

      Method:
      All patients were entered into a phase III, two-arm, prospective, randomized trial in patients receiving chemotherapy for lung cancer. Patients were randomly assigned to either usual care (UC), or enhanced care (EC) using the DecisionKEYS decision aid coupled with every 3 week PRO assessment using the electronic LCSS measure. All patients were offered the Decision Regret Scale (“DRS,” O’Connor 1999), at 11 weeks (+/- 2 weeks) after starting treatment. The DRS is a categorical scale with 5-items in 5 categories (ranging from “strongly disagree” to “strongly agree”). Patients completed assessment for decisional conflict; the patients’ supporters completed similar measures.

      Result:
      164 patients were entered, 160 received chemotherapy. Characteristics: 43% women; 92% Stage IV; 73% first-line therapy. Means: age 63; KPS 81. ECOG 1 = 56%; ECOG 2 = 42%. 46% represented minority groups. 22 different chemotherapy regimens were used. First-line patients received combination regimens with the majority being platinum-based with 2 or 3 drugs. 128 patients (80%) completed the DRS. Results combined the two top categories indicating the greatest extent of regret. Only 9 patients (7%) expressed regret as the maximum of the 5 DRS questions. 94% expressed that the decision for chemotherapy was a wise one. This low degree of regret did not differ by first-line or subsequent chemo or by EC versus UC groups.

      Conclusion:
      Patients receiving chemotherapy for advanced NSCLC, at 3 months after starting treatment, rarely (7%) have regret, and 98% expressed that they made the right decision. Other factors associated with the few patients with regret, such as decisional conflict or reduced quality of life, will also be presented. Support: NIH/NCI R01 CA-157409

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    MTE 09 - Management of Difficult Symptoms (Sign Up Required) (ID 558)

    • Event: WCLC 2017
    • Type: Meet the Expert
    • Track: Nursing/Palliative Care/Ethics
    • Presentations: 1
    • Moderators:
    • Coordinates: 10/16/2017, 07:00 - 08:00, Room 503
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      MTE 09.01 - Management of Difficult Symptoms (ID 7787)

      07:00 - 08:00  |  Presenting Author(s): Richard J Gralla

      • Abstract
      • Presentation
      • Slides

      Abstract:
      Studies conducted over many years have documented the highly symptomatic nature of lung cancer. Presenting symptoms are largely due to the cancer; however, the common co-morbidities frequently seen in patients with lung cancer, complicate diagnosis, treatment, and all areas of care. Even in early stage disease, high rates of COPD and cardiovascular disease influence treatment. In advanced disease at presentation, typically over 90% of patients will have at least two major symptoms and 80% will report three or more. In addition to symptoms, side effects of treatment must be considered. Further affecting care is the fact common patient issues can be both symptoms of the lung cancer and side effects of treatment. This includes anorexia and fatigue which are reported by the majority of patients prior to treatment and are complications of radiation therapy and chemotherapy. In a recent trial, these two symptoms were more predictive of survival than respiratory symptoms or pain. New therapeutic modalities, such as checkpoint inhibitors and TKIs have offered new opportunities and challenges. When effective, both of these modalities can positively influence patient reported outcomes (PROs) fairly rapidly and make management of symptoms easier for patients. On the other hand, they can be associated with complications that previously were uncommon such as cutaneous toxicities, diarrhea, and endocrine abnormalities. While pulmonary toxicities have long been an occasional problem with radiotherapy and some chemotherapeutic agents, this complication can be especially severe with the newer modalities. Many recent trials in advanced lung cancer have focused on combinations of systemic therapy. This includes combinations of immuno-oncology agents, or combinations of immune-oncology agents with chemotherapy. Not surprisingly, these approaches are associated with increased side effects. Careful analysis will be required to examine the true survival and quality of life benefits of such combinations when the agents are given together or sequentially. Patient reported outcomes have many roles. Following patients for benefit in quality of life and symptom control is of great value. These aspects are crucial in new agent evaluation as well, and need to be better performed in future studies. There are, however, additional roles for PROs. Several new studies indicate that aspects of PROs provide a better assessment of a patient’s ‘tumor burden’ that is only partially estimated by performance status. Newer, simple PRO tumor burden assessments at baseline are highly predictive of survival (more so than performance status), and can indicate risk groups of patients likely to require hospitalization. Use of these PRO tumor burden assessments may allow better identification for additional health care resources for patients with the greatest needs, may guide better stratification for clinical trials, and may identify futility in treatment at an earlier point than imaging and standard assessments. Enhanced evaluation of patients’ symptoms and risks, may guide in appropriate treatment selection. In turn this may allow prevention of side effects with better individualized treatment choices. Precision medicine is meant to go beyond molecular assessment or the results of laboratory analysis. Challenges include identifying tumor burden assessments that are practical for clinical use and incorporating these approaches in daily care.

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    P2.01 - Advanced NSCLC (ID 618)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P2.01-050 - Predicting Risk of Hospitalization in Patients with NSCLC Receiving Chemotherapy Using the LCSS 3-Item Global Index (3-IGI) (ID 10313)

      09:00 - 16:00  |  Presenting Author(s): Richard J Gralla

      • Abstract

      Background:
      A leading factor of poor treatment outcomes and cost in cancer care is hospitalization. If hospitalization risk can be accurately predicted, preventive interventions can be effectively used and treatment regimen selection may be able to be refined. Currently, oncologists do not routinely use laboratory, molecular, PRO or imaging data to predict risk of hospitalization or its prevention. Prior research demonstrated that the 3-IGI (quality of life, activities, distress) of the LCSS at baseline, predicts survival more accurately than performance status and requires only two minutes for administration.

      Method:
      The objective was to determine if the 3-IGI measured at baseline accurately predicts cancer-related or treatment toxicity-related hospitalization risk. PROs were prospectively evaluated in 164 patients receiving chemotherapy for advanced NSCLC using the LCSS 3-IGI, with electronic assistance (“eLCSS-QL”). Patients were followed for hospitalization over three months. Hospitalizations were characterized as cancer-related, or treatment toxicity-related.

      Result:
      Characteristics: 57% men; 92% Stage IV; 73% first-line therapy; mean age 63; ECOG 1/2: 56%/42%. 77 hospitalizations occurred among 53 (33%) patients. Patients were placed into 3-IGI groups based on scores at baseline by thirds (tertiles; mean 3-IGI = 188 with 0=worst, 300=best; 33[rd] percentile <162, and 67[th] percentile > 239). Baseline 3-IGI significantly predicted risk of cancer-related hospitalizations (p<0.0001), but not treatment toxicity-related hospitalizations (27%, p=0.69). The table outlines marked differences in hospitalizations associated with baseline 3-IGI groups.

      PERCENT OF HOSPITALIZATIONS BY 3-IGI GROUP AT BASELINE (p = 0.0001)
      TIME FROM BASELINE: LEAST-RISK GROUP MEDIUM-RISK GROUP HIGHEST-RISK GROUP
      30-DAYS 0% 18% 23%
      60-DAYS 10% 20% 39%
      90-DAYS 12% 27% (HR 2.7) 41% (HR 4.6)
      Additionally, in only those in the ECOG=1 group, the 3-IGI significantly identified cancer-related hospitalization risk (p=0.025).

      Conclusion:
      The 3-IGI of the LCSS significantly identifies risk of hospitalization in patients receiving chemotherapy for NSCLC, and is more accurate than ECOG PS. Interventions (including enhanced monitoring) focused on identifiable high risk groups is warranted to reduce hospitalization. These results may also help in appropriate regimen choice to reduce hospitalization. Such interventions could improve cancer care and reduce costs. Support: NIH/NCI R01 CA-157409