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K.A. Mooney

Moderator of

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    O07 - Supportive and Surgical Care (ID 136)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Surgery
    • Presentations: 8
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      O07.01 - Randomized phase III trial of aprepitant compared with dexamethasone for emesis induced by carboplatin (ID 1261)

      10:30 - 12:00  |  Author(s): K. Takeda, H. Daga, H. Okada, A. Tsuya, S. Tokubaga, K. Taira, U. Katsushima, M. Tsuda, S. Kimbara, Y. Shibata, T. Yoshida, M. Nakao

      • Abstract
      • Presentation
      • Slides

      Background
      Carboplatin (CBDCA) is used widely against various tumors,including non-small cell lung cancer, small cell lung cancer, which is classified a moderate emetic risk. 5-HT~3~ antagonist and corticosteroid had a great efficacy in patients (pts) treated with CBDCA containing chemotherapy. This randomized trial was conducted to evaluate the efficacy and safety of aprepitant (APR) compared with corticosteroid, based on granisetron (GRA) plus corticosteroid at the first day, in pts treated with CBDCA containing chemotherapy.

      Methods
      Pts treated with CBDCA (AUC 5 or 6) containing chemotherapy were entered on this trial. Major eligible criteria included more than 20 years old, and ECOG PS 0-2. Patients were randomized either A group (GRA 3 mg, iv, day 1, dexamethasone [DEX] 3.3 mg, iv, day 1, APR 125 mg , po, day 1, and APR 80 mg, po, days 2,3) or D group (GRA 3 mg, iv, day 1, D EX 6.6 mg, iv, day 1, and DEX 8 mg, po, days 2, 3). Randomization was stratified by gender and CBDCA AUC 5 or 6. Study period was 120 hours from administration of CBDCA. During this period, pts recorded the time and date of emetic episodes and severity of nausea by themselves in a survey form. Primary endpoint was complete response rate (CRR), defined as no emetic episodes and no rescue medications during the overall study period. Secondary endpoints included CRR during the acute (0-24 h) and the delayed (24-120 h) phases, no nausea rate, severity of nausea and safety. The planned sample size of 128 provided 80% power to detect a 20% improvement in the CRR at overall period with two-sided α of 0.1. This study was approved by the institutional review board in our institution. All pts provided written informed consent prior to enrollment.

      Results
      From October 2010 to August 2012, 128 pts were entered in this phase III trial. Three quarters of entered pts were male, and 63% were received CBDCA AUC 6. Baseline factors, such as age, gender, AUC of CBDCA, chemotherapy regimen, and PS, were well balanced between the two groups. The CRR during overall study period were 61.3% and 68.8% in A and D group, respectively (p=0.3799). There was no difference of CRR during both the acute phase (98.4% vs 98.4%) and the delayed (61.3% vs 68.8%). There was no adverse event due to the antiemetic therapy in both groups during the overall study period.

      Conclusion
      This randomized phase III trial failed to demonstrate that APR was superior to DEX for emesis induced by CBDCA containing chemotherapy which was classified a moderate emetic risk. Combination APR with DEX on days 2 and 3, or more was likely to increase an antiemetic efficacy during delayed phase. Further study was warranted.

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      O07.02 - The preferred and actual levels of involvement in decision-making among patients considering adjuvant chemotherapy (ACT) for non-small-cell lung cancer (NSCLC). (ID 2038)

      10:30 - 12:00  |  Author(s): P. Blinman, S. McLachlan, A. Veillard, N. Muljadi, M. Hudson, M. Stockler

      • Abstract
      • Presentation
      • Slides

      Background
      Patients with cancer have varying preferences for involvement in decision-making between active, collaborative and passive roles. Previous studies suggest that many patients prefer a more active role than they experienced, and a more active role over time[MSA(1] . We sought the preferred and actual level of involvement in decision-making among patients considering ACT after resection of early NSCLC.

      Methods
      98 patients completed a self-administered questionnaire at baseline (before ACT, if they were having it) and at 6 months (after ACT, if they had it). Preferred and actual level of involvement in decision-making were assessed by the Control Preferences Scale (CPS) and trichotomised into active, collaborative, and passive roles. Health-related quality of life (HRQL) data were assessed by the Patient DATA Form. Differences on the original CPS scale between preferred and actual roles and between preferred roles over time were assessed with the Wilcoxon signed-rank test. Determinants of preference for an active role were assessed with chi-square tests of association in 2x2 tables, summarising by odds ratios (ORs). Wilcoxon rank-sum (WRS) tests were used to assess differences in survival benefits required to make ACT worthwhile between patients preferring active and less active roles.

      Results
      Most patients were male (55%) with a median age of 64 years (range, 43-79 years), married (74%) and previous smokers (82%). The majority had had a lobectomy (85%), adenocarcinoma histology (63%), and half (46%) had stage II disease. 83 patients decided to have ACT (85%), 15 declined ACT (15%). ACT was most commonly 4 cycles (71%) of cisplatin/ vinorelbine (73%). Preferred role in decision-making at baseline (n=98) was active in 26 (27%), collaborative in 46 (47%), and passive in 26 (27%); and at 6 months (n=73) was active in 15 (21%), collaborative in 37 (51%) and passive in 21 (29%). Preferred decision-making roles were stable over time (p=0.5). Actual decision-making roles at baseline (n=98) were active in 24 (24%), collaborative in 47 (48%), and passive in 27 (28%). There was concordance between preferred and actual decision-making roles at baseline (p=0.4). Preferring a more active role was associated with university education (p=0.02, OR 2.9) and worse HRQL during ACT: physical well-being (p=0.05, OR 4.4), overall well-being (p=0.02, OR 5.5), sleep (p=0.03, OR 8.4) and shortness of breath (p=0.01, OR 7.6). Patients who preferred an active decision-making role judged larger survival benefits to make ACT worthwhile than patients who preferred a passive role (eg extra survival time of 1 year v 6 months, WRS p=0.03; extra survival rate of 17.5% v 2.5%, WRS p <0.01).

      Conclusion
      Patients with recently resected NSCLC varied in their preferred roles in decision-making about ACT with most patients preferring a collaborative role. Their preferences were stable over time, and were concordant with their perceived actual role in decision-making at baseline. Preferences for an active role in decision-making were associated with judging larger survival benefits necessary to make ACT worthwhile. Clinicians should elicit and consider patients’ preferences for involvement in decision-making when discussing ACT for NSCLC.

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      O07.03 - Quantifying the humanistic burden of caregiving for patients with lung cancer in Europe (ID 1981)

      10:30 - 12:00  |  Author(s): J. Jassem, I. Gilloteau, J.R. Penrod, A. Goren

      • Abstract
      • Presentation
      • Slides

      Background
      Lung cancer, the leading cause of cancer-related death, is associated with poor survival, painful, life-threatening disease attributes, and greater associated economic burden compared with other cancers. The disease also presents multiple challenges for the caregivers of patients with lung cancer, including increased distress, significant impact on social and health-related quality of life (HRQoL), and costs associated with loss of income and time spent on patient care. Little information exists on the extent of this caregiver burden. The current study aims to investigate the HRQoL and the comorbidity burden of caregivers of patients with lung cancer in several European (EU) countries.

      Methods
      Data were provided from the 2010 and 2011 EU National Health and Wellness Survey (NHWS), an annual, stratified, random, cross-sectional, self-administered Internet-based survey of healthcare attitudes and behaviors among adults in France, Germany, Italy, Spain, and the United Kingdom (n=114,962). Respondents who reported providing care for a patient with lung cancer ("caregivers") were compared with respondents not providing care ("non-caregivers") on measures of HRQoL and self-reports of diagnosis with conditions known to be caused or exacerbated by psychological stress. HRQoL was assessed using the 12-Item Short Form Survey (SF)-12v2, which included Mental (MCS) and Physical (PCS) Component Summary scores; mental and physical functioning subscales; and SF-6D health state utilities (with higher scores indicating better health status and minimally important differences [MIDs] of 3 points in PCS/MCS scores, and 0.03 points in health utilities).The self-reported diagnoses of interest included depression, anxiety, insomnia, headache, migraine, and gastrointestinal (GI) illnesses (ie, gastroesophageal reflux disease, heartburn, and/or irritable bowel syndrome). Regression models were used to predict health outcomes as a function of caregiving vs non-caregiving, controlling for demographics (age, gender, education, income, marital status, employment, body mass index category), health risk behaviors (exercise, smoking), and the Charlson Comorbidity Index (reflecting mortality risk).

      Results
      No significant differences between caregivers (n=107) and non-caregivers (n=103,868) on sociodemographic and health characteristics were observed. Caregivers and non-caregivers were on average 44.1 and 46.3 years old, respectively, and employed (55.1% and 57.4%, respectively), suggesting care given by children rather than by spouse/partner. Adjusting for covariates, caregivers reported significantly worse HRQoL than non-caregivers, including PCS (-1.91 points, P=.017), MCS (-3.52 points, P <.001, exceeding MID), health utilities (-0.049 points, P <.001, exceeding MID), and all subscales, except vitality (-1.83 to -4.87, all P <.03). In addition, caregivers had about twice the odds of non-caregivers of diagnosis with depression (OR=1.885, P =.018), insomnia (OR=2.190, P =.002), headache (OR=1.997, P =.008), and GI problems (OR=1.970, P =.002).

      Conclusion
      Adjusting for confounders, caregivers for patients with lung cancer reported significantly lower mental and physical health status, lower health utilities, and higher depression, insomnia, headache, and GI problems than non-caregivers. In addition to confirming and extending knowledge of the caregiver burden of lung cancer in EU, this study highlights a need for increased personalized support for caregivers. Research on other aspects of caregiver burden, such as healthcare resource utilization and work productivity, will help refine estimation of the financial impact of lung cancer on society.

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      O07.04 - DISCUSSANT (ID 4004)

      10:30 - 12:00  |  Author(s): M. Stockler

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      O07.05 - Guidelines to Prepare and Support Patients Undergoing a Lung Resection (ID 101)

      10:30 - 12:00  |  Author(s): J. White, S. Dixon, V. Beattie

      • Abstract
      • Presentation
      • Slides

      Background
      Lung cancer affects nearly 40,000 patients per year in the UK of which 5000 (12%) will undergo major lung resection for primary lung cancer. Approximately 15% of patients will have complications post operatively. Once the patient develops a post surgical pulmonary complication mortality increases from 0.5% to 12%, ITU admission rate increases from 1.5% to 26% and the length of stay increases from 5 to 14 days. A Lack of preparedness prevents patients immediately engaging in post operative activities successfully and can result in an increase in patient’s anxiety, post operative complications and length of stay in hospital. The United Kingdom National Lung Cancer Forum for Nurses Thoracic Surgical Group (TSG) has produced this Guideline to aid health care professionals in the preparation and support of patients undergoing a lung resection with an aim to promote patient self management.

      Methods
      Following a literature review and discussion amongst this specialist group the Guideline was developed focusing on key topic areas and interventions which included: poor nutrition, before and during the healing process is associated with poor wound healing risks of hospital death and pulmonary complications after lung cancer resection are increased by smoking patients who receive a multi-disciplinary rehabilitation and early mobilisation achieve earlier discharge from hospital and significantly reduce in hospital morbidities and complication rates patient’s satisfaction regarding pain management significantly correlates to the preoperative information they have received good quality patient information is vital in reducing patient’s anxiety and improving the overall patient experience

      Results
      The Guideline was developed to support any health professional involved in the provision of care for patients who are undergoing thoracic surgery. The Guideline includes information for health professionals providing examples of current best practice and information for patients. The aim of the Guideline is to support self management, support patients through the surgical pathway, and improve patient outcomes and patient experience. The full guideline can be found at http://www.nlcfn.org.uk/editorimages/Guidelines%20to%20Prepare%20etc.pdf

      Conclusion
      The Guideline is relevant to all patients who are undergoing a lung resection. The Guideline includes a series of broad statements and where necessary local procedures should be developed to complement the guidelines in each clinical area. The Guideline compliments the Surgical Follow Up Guideline also produced by the NLCFN Thoracic Surgical Group.

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      O07.06 - Early Post-Operative Ambulation is Feasible and Safe (ID 2893)

      10:30 - 12:00  |  Author(s): S.J. Khandhar, D.L. Fortes, C. Schatz, S. Schermer, P.D. Kiernan

      • Abstract
      • Presentation
      • Slides

      Background
      The goal of any intervention in medicine is to return the patient to the “pre-clinical state”. Thoracic surgical intervention remains the most effective way to manage early stage lung cancer. Minimally invasive techniques have substantially reduced the morbidity associated with traditional open procedures and have returned patients to health faster. This has been achieved without compromising the oncologic validity of the operation and when done appropriately, has even proved superior. Our health system instituted a minimally invasive thoracic surgical program 5 years ago to realize these benefits. This was accomplished through the recruitment of minimally invasive trained, dedicated thoracic surgeons; service line focused team development; rigorous training of the team; systematic community awareness; and investment in technology and equipment. Seeing tremendous success in volumetric growth with our minimally invasive program, we began to focus on strategies to return patients to their pre-operative functional state more swiftly. We believed inherently that early post-operative ambulation had several clear benefits: 1) clearance of pulmonary secretions and reduction of atelectasis thereby preventing pneumonia, 2) avoidance of deep venous thromboses and subsequent pulmonary emboli, 3) reduced third space fluid shifts therefore reducing the risk of atrial fibrillation and myocardial infarction, 4) better pain control without narcotics, and 5) a general sense of well being. Therefore, we hypothesized that prompt initiation of ambulation should reduce morbidity and return patients to the pre-operative state expeditiously and with greater predictability.

      Methods
      Our limitations were pain, nursing motivation and culture. Pain is substantially reduced in minimally invasive approaches. Ambulation inherently reduces pain as the upright position takes tension off the intercostal spaces. Nursing motivation and culture proved to be a bigger challenge given limitations in the time available for “bedside nursing”. However, perhaps more relevant was the skepticism related to the safety of this endeavor. Given these realities, we created an environment to test our hypothesis seeking first to demonstrate safety and feasibility of an endeavor that we believed to be so pivotal. In July of 2010, with the support of nursing leadership, administration and our thoracic oncology team, we began a program of aggressive post-operative ambulation with one simple mandate: every patient must walk 250 feet within 1 hour of extubation.

      Results
      For this analysis we included all patients recovered in our dedicated unit after VATS, thoracotomy, robotic or laparoscopic interventions. We excluded patients undergoing bronchoscopy or mediastinoscopy as they were routinely discharged within two hours of extubation. From July 2010 through May 2013, a total of 720 patients were recovered in our unit. 553 (77%) were able to walk 250 feet or more. Of these, 328 (59%) were successful within 1 hour of extubation. 74 patients (10%) were unable to ambulate largely due to weakness and hypotension. There have been no adverse events since implementation (0% complication rate).

      Conclusion
      We conclude that early post-operative ambulation is feasible and safe. We have observed favorable responses from patients and families and have enjoyed a considerable decrement in our overall post-operative length of stay. Further investigation will be necessary to quantify these endpoints.

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      O07.07 - Lung Cancer Clinical Trials and the Involvement of The Lung Cancer Nurse Specialist (ID 2245)

      10:30 - 12:00  |  Author(s): J. McPhelim, S. Hughes

      • Abstract
      • Presentation
      • Slides

      Background
      Clinical trials (CT) are fundamental to improving outcomes in lung cancer. Recruitment to CT in the UK is poor. The National Cancer Research Interest Group, Clinical Studies Group (UK), identified that Lung Cancer Nurse Specialist (LCNS) may have a role in improving recruitment to CT. The National Lung Cancer Audit (England) 2010-2012 identified that patients who access a LCNS are more likely to recieve anti cancer treatment. Therefore could this correlation be applicable to the CT setting? A survey was conducted to understand the role of LCNS in relation to CT, and to investigate the views of LCNS regarding CT involvement of advanced stage patients.

      Methods
      A questionnaire was emailed to all registered members of the National Lung Cancer Nurses Forum NLCFN(UK) with an explanatory letter,during the month of April 2013. An e-survey was chosen, to facilitate a convenient route for response and to minimise costs. A custom excel database was built for the purposes of data collection and analysis. The audit was pilot tested by 10 LCNS prior to distribution.

      Results
      138 (50%) responses received. Results support that LCNS have a good understanding of CT availability (92%). Research nurses were regarded as key team members by all respondents, and 81% were dedicated to lung cancer CT. 85% of LCNS discussed CT in the course of treatment option consultations. The vast majority of technical aspects of CT recruitment, was deferred to the Research nurses. Benefits of CT participation identified by the LCNS's included: access to new drugs, closer follow up,benefit for future patients, additional support from Research nurses, a level of decision making regarding treatment. Disadvantages included: excessive time commitment, additional requirement for hospital appointments, travel distance to trial centre, patients deriving false hope, delays commencing therapy due to protocol requirements, increased number of invasive procedures, feeling they will let the doctor down by non-participation, psychological harm if they don’t responsed to therapy. 17% of respondents suggested that CT participation may be unethical. On further analysis concerns were information, selection and appropriate support levels. Responses confirmed that there is uncertainty in relation to the LCNS role in CT management generally. Little reference was made regarding non drug CT, such as radiotherapy or supportive care.

      Conclusion
      The LCNS community understand and supports the value of CT. This include patients in the advanced stages of the disease. The role of the LCNS is not clearly defined in relation to CT. Most LCNS are comfortable speaking to patients regarding CT and have a good working knowledge of CT availability. The finer detail in terms of recruitment and clinical trial management is seen as the remit of the research nurse. No expressions of serious concern in relation to trial participation or ethical concerns where derived from responses. LCNS’s have reported understanding of CT philosophy in the UK, and the requirement for CT to continue in this patient group, while at the same time demonstrating a strong advocacy role. LCNS’s in the UK support clinical trial recruitment in patients with lung cancer and regard them as ethical.

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      O07.08 - DISCUSSANT (ID 4005)

      10:30 - 12:00  |  Author(s): H. Date

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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