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M. Culligan

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 - 10:40  |  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)

      10:40 - 10:50  |  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)

      10:50 - 11:00  |  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)

      11:00 - 11:15  |  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)

      11:15 - 11:25  |  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)

      11:25 - 11:35  |  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)

      11:35 - 11:45  |  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)

      11:45 - 12:00  |  Author(s): H. Date

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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Author of

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    GR02 - Is There a Role for the Thoracic Oncology Nurse in Ensuring Patients with an Advanced Lung Cancer have Access to Early Phase Clinical Trials? (ID 17)

    • Event: WCLC 2013
    • Type: Grand Round Session
    • Track: Nurses
    • Presentations: 2
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      GR02.0 - N/A - Chair Intro (ID 450)

      10:30 - 10:35  |  Author(s): M. Culligan

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      GR02.3 - Negative (ID 453)

      11:05 - 11:20  |  Author(s): M. Culligan

      • Abstract
      • Presentation
      • Slides

      Abstract
      Cancer is the leading cause of death in the world, accounting for approximately 7.6 million deaths in 2008. Lung cancer accounted for 1.37 million of those deaths.Identification of molecular markers in lung cancer has lead to the development of targeted therapies resulting in improved survival in selected groups of lung cancer patients. Despite the advancements in treatments, the survival for patients with lung cancer, particularly in the metastatic or locally advanced patients (stage IIIb/IV), is generally poor with a 5-year survival of only 6%. The current poor prognosis and latest advances made in the field of lung cancer highlight the importance of clinical trial development, participation and analysis. Participation in clinical trials for the general cancer patient’s is low, between 5-9%. This low percentage is similar to those seen for lung cancer patients. Early stage clinical trials have a smaller number of participants by design and are aimed at establishing a maximum tolerated dose of a drug or treatment, not establishing efficacy.These clinical trials are not designed with curative intent but rather are designed to evaluate drug absorption, distribution, metabolism, excretion and mechanism of action. Only a small number of cancer patients and even a smaller number of advanced stage lung cancer patients enroll into phase I clinical trials. The number of international clinical trials has seen a rapid increase over the past decade. Recently the Office of Inspector General (OIG) reported that as of 2008, 80% of marketing applications for drugs and biologics approved by the US Food and Drug Administration (FDA) contained data from US clinical trials conducted outside of the USA. Despite the importance and availability of clinical trials for lung cancer, participation in early stage clinical trials by advanced stage lung cancer patients remains very low. There are multiple barriers that contribute to these low numbers of participants, some of which include: (1) fear of unknown benefit from the investigational treatment, (2) negative family and family physician influence, (3) logistical and attitudinal constraints – too cumbersome to participate and not willing to be the subject of “experiments”, (4) lack of knowledge, understanding and fear of the complexities of the clinical trial, (5) risk of inability to tolerate related investigational drug / treatment toxicity due to more weaken condition and (7) financial and insurance barriers.Identifying and overcoming the barriers that exist for each patient early in their diagnosis has the potential to improve both the quality and quantity of their lives and potentially help others with the same barriers in the future. Another significant barrier is the real and perceived conflict that exists between the need for palliative and/or Hospice levels of care for advanced stage lung cancer patients. The need for Hospice benefits and palliative care can and does have a significant impact on the decision to participate in early stage clinical trials to the point that participation may not even be an option. Funding and other system related issues act as barriers to participation in early stage clinical trials as well as the philosophical basis of the hospice/palliative care approach to treatment/care. Over the past decade the availability of symptom management and palliative care clinical trials has increased the awareness of this barrier and in many respects further clouded the issue for patients, their families and their healthcare providers. The primary ethical concern is does enrollment into clinical trials interfere with the spirit of hospice care or does it offer hope to a dying patient? Identifying issues that exist globally may help to increase enrollment by advance stage patients while at the same time moving early phase clinical trials forward and onto the phase II/III stage of study. Phase I trials are not designed with curative intent and phase I agents are not likely to prolong life or change the course of a disease. The life expectancy of phase I cancer patients’ averages between 5-6.5 months. Hospice providers and research investigators are in agreement that phase I clinical trials should be open and available to advanced stage lung cancer patients who are concurrently enrolled in hospice care. Overcoming the barriers and obstacles for advanced stage lung cancer patients to participate in early stage clinical trials can only happen in the setting of a committed multidisciplinary research team.Methods to utilize in an effort to move toward that goal include: (1) recognizing the importance of patient and family education, (2) recognizing the importance of healthcare provider education and awareness, (3) careful review and reinforcement of the informed consent process, (4) identifying and recognizing the potential benefit of phase I clinical trial enrollment for advanced stage lung cancer patients – clinical and altruistic, (5) recognizing and assisting patients and families with individual barriers and obstacles to participation and (6) employing effective marketing, recruiting and screening methods that are multidisciplinary in approach. Thoracic Oncology Nurses are well suited to serve as educators, advocates, resources, facilitators, and intermediaries. Nurses traditionally spend a greater amount of time in direct patient care and family interaction. Expanding and clarifying clinical information patients receive from their treating physicians is a vital role nurses play in ensuring patients are well informed and compliant with their plan of care. This is a model that can and has been extended into the realm of clinical trial work.Studies have shown that nurses play an important role in educating and recruiting cancer patients in clinical trials.A randomized clinical trial compared nurses with surgeons recruitment of patients into a clinical trial for prostate cancer and the results indicated that surgeons and nurses were equally as effective in their recruiting and educating abilities and effectiveness. With the proper education about early stage clinical trials, the conduct of clinical research, knowledge of the disease process of advance stage lung cancer and a high degree of self-motivation, thoracic oncology nurses are well suited to improve access and enrollment of advanced stage lung cancer patients into early phase clinical trials.

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    MO09 - Mesothelioma I (ID 120)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track:
    • Presentations: 3
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      MO09.03 - A pilot and feasibility trial evaluating two different chemotherapy regimens in combination with intrapleural adenoviral-mediated interferon-alpha (SCH 721015, Ad.hIFN-alpha2b) gene transfer for malignant pleural mesothelioma (ID 3374)

      16:25 - 16:30  |  Author(s): M. Culligan

      • Abstract
      • Presentation
      • Slides

      Background
      Malignant pleural mesothelioma is an incurable thoracic neoplasm for which combination chemotherapy offers limited improvement in survival. Novel agents that offer synergy with standard systemic cytotoxic therapy are under investigation. Among these agents are a variety of immunotherapeutics which can be administered either locally or in a systemic fashion.

      Methods
      We conducted a Phase I/II “in situ vaccination” clinical trial commencing in March2011 involving repeated intrapleural administration of a replication-defective recombinant adenoviral vector containing the human interferon-alpha (hIFN-α2b) gene at a dose of 3x10[11 ]viral particles concomitant with a 14-day course of high-dose cyclo-oxygenase-2 (COX-2) inhibitor (Celecoxib). This was followed by standard first-line or second-line chemotherapy agents. Primary outcome measures were safety, overall best response rate, and survival.

      Results
      We completed accrual (n=25) in the first-line chemotherapy arm, in which all patients received pemetrexed-based chemotherapy regimens. This group included patients who previously received pemetrexed chemotherapy but did not subsequently receive this agent for >6 months. In the second-line chemotherapy arm, 13of a planned 15 subjects have enrolled (with 12 evaluable), all of whom received gemcitabine-based chemotherapy (Table 1). In both arms, the combination of intrapleural Ad.IFN-α2b vector, high-dose celecoxib, and systemic chemotherapy proved safe. Adverse events during the chemotherapy portion of the study were comparable to historical controls.Most patients experienced expected mild toxicities from vector (cytokine release syndrome, interferon production), including nausea, fatigue, anemia, lymphopenia (grade 3-4) and hypoalbuminemia. Serious adverse events included: pleural catheter infection (n=2); hypoxia (n=2); supraventricular tachycardia (n=1); and esophagitis (n=1), none directly attributable to the vector or vector administration. Serial chest CT and PET/CT scans demonstrated an overall response rate of 31% by Modified RECIST criteria and disease control rate (DCR) of 78% (partial and complete responses plus stable disease) at initial follow-up scan after the first two cycles of chemotherapy. Partial responses were seen in 9/25 evaluable patients with pemetrexed-based chemotherapy and 1/12 with gemcitabine. Patients who received first-line pemetrexed-based chemotherapy (n=14) had a median survival of 10.5 months, 95% ci=(5.5,inf), whereas second-line patients (n=21; 12 gemcitabine)had a median survival of 15.0 months, 95% ci=(9.0,inf).

      Pem/Platin (N=25) Gemcitabine (N=13)
      Male % 64% (16/25) 84.6% (11/13)
      Median Age 67 (51-86) 65 (43-81)
      Histologic Subtype % Epithelioid - 17 (68%) Biphasic - 4 (17%) Sarcomatoid - 4 (17%) Epithelioid - 11 (84.6%) Biphasic - 2 (15.4%) Sarcomatoid - 0
      Stage I - 2 (8%) II - 6 (24%) III - 13 (52%) IV - 4 (16%) III - 4 (30%) IV - 9 (70%)
      Prior Treatment Chemotherapy - 4 (16%) RP/PDT - 4 (16%) XRT - 5 (20%) Chemotherapy - 13 (100%) RP/PDT - 7 (53%) XRT - 2 (15%)
      Platin Agent Cisplatin - 12 Carboplatin - 10 Cis-Carbo - 1 None - 2 Cisplatin - 0 Carboplatin - 2 None - 8
      Median Cycles of Chemo 6 (1-6) 3 (0-6)
      TABLE 1

      Conclusion
      The combination of intrapleural Ad.IFN-α2b vector, Celecoxib, and systemic chemotherapy proved safe. Disease control rates observed in this study compare favorably with historical data andthe especially encouraging OS in the second-line chemotherapy group argue strongly for proceeding with a multi-center randomized clinical trial of chemo-immunogene therapy versus chemotherapy alone.

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      MO09.12 - Posterior intercostal lymph nodes - First report of a new independent prognostic factor for malignant pleural mesothelioma (ID 1684)

      17:20 - 17:25  |  Author(s): M. Culligan

      • Abstract
      • Presentation
      • Slides

      Background
      Little is known about the significance of metastases to the posterior intercostal lymph nodes, located within the intercostal spaces at the level of the rib heads, in patients with malignant pleural mesothelioma. These nodes are not part of any staging system. This report is an initial attempt to determine the significance of these lymph nodes.

      Methods
      We sampled posterior intercostal lymph nodes from 48 patients undergoing radical pleurectomy for malignant pleural mesothelioma. Statistical analyses were then performed correlating metastases to these lymph nodes with progression free and overall survival.

      Results
      26/48 (54%) patients had positive posterior intercostal lymph nodes. Standard staging revealed: 6/48 (13%) N0, 3/48 (6%) N1, 39/48 (81%) N2, 9/49 (19%) stage III and 39/48 (81%) stage IV. Presence of positive posterior intercostal lymph nodes was not associated with stage (Fisher exact P=0.48), but was associated with N status. N1 and N2 were associated with higher rates of positive posterior intercostal lymph nodes (Fisher exact P=0.011). At a median follow-up of 9.6 months, progression-free survival was 0.83 years, 95% CI: (0.74, 1.30) years; median overall survival was 1.89 years, 95% CI: (1.29, ND) years. Patients with negative posterior intercostal lymph nodes had a median progression-free survival of 1.25 years, 95% CI: (0.95, 1.95) years, while that for patients with positive posterior intercostal lymph nodes was 0.73 years, 95% CI: (0.61, 1.40) years (p=.017 by log-rank test). Patients with negative posterior intercostal lymph nodes had a median overall survival of 3.43 years, 95% CI: (1.89, ND) years, while that for patients with positive ICLNs was 1.01 years, 95% CI: (0.61, 1.40) years (p=.007 by log-rank). In a Cox regression model that adjusted for stage, positive posterior intercostal lymph nodes were associated with an increased risk of failure (HR=2.71, 95% CI=1.15.6.39, P=.048) and death, (HR=3.3, 95% CI: 1.3, 8.1, P=0.0098. Figure 1

      Conclusion
      Bearing in mind the limitations of this retrospective study with short-term follow-up, these results suggest that the posterior intercostal lymph nodes may have independent prognostic significance. This data has served as a trigger for us to now routinely include the posterior intercostal lymph nodes in our thoracic lymphadenectomies in patients undergoing surgery for malignant pleural mesothelioma. Further investigation of this nodal station is indicated and it is likely that these nodes should be included in any future staging system for malignant pleural mesothelioma.

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      MO09.13 - Comparison of Three Radiographic Tumor Volume Estimation Techniques for Malignant Pleural Mesothelioma: Their Correlation with Each Other, Actual Measured Intraoperative Tumor Volumes, and Survival (ID 1689)

      17:25 - 17:30  |  Author(s): M. Culligan

      • Abstract
      • Presentation
      • Slides

      Background
      Studies have assessed correlation between radiographically estimated tumor volume (TV) and outcomes for malignant pleural mesothelioma, no standard radiographic model exists for estimating TV. Although radical pleurectomy yields a surgical specimen essentially all cancer, thereby allowing accurate determination of TV, empirically-derived intraoperative TVs have never been reported. We compare multiple radiographic estimates of TV with TVs determined at resection to determine which radiographic approach most accurately predicts intraoperative TV, and we correlate TV with survival.

      Methods
      Actual TVs were measured for 41 consecutive radical pleurectomy specimens by volume displacement. Radiographic TV estimates were performed by radiologists/radiation oncologists blinded to intraoperative TVs. Radiographic estimates were obtained with: Live Wire algorithm (automated tumor delineation after manual algorithm training), radiology TeraRecon (tumor automatically circumscribed with subsequent manual tracing corrections), and radiation oncology Eclipse (non-automated tumor delineation).

      Results
      Median age was 63yrs, with 80% male and 83% having epithelial histology. Stage distribution was: 3-Stage I (7%), 4-Stage II (10%), 29-Stage III (71%), and 5-Stage IV (12%). Median (interquartile range) intraoperative TV was 600(400,800)cm[3]. Median TV of 800(575,1100)cm[3] among nonepithelial compared to 500(350,838)cm[3] for epithelial was not significantly difference (p=0.099). TVs were largest for stage III (p=0.01). Median TVs for Live Wire, TerraRecon, and Eclipse were 260(147-452), 293(161-465), and 447(247-559)cm[3], respectively. Pearson correlation coefficients were 0.60, 0.75, and 0.78, with all models underestimating intraoperative TVs (Figure 1A). Among 34 epithelial patients (mean/median follow-up 9.8/8.0mo), median survival was not reached (only 9 recurrences). Epithelial patients with large (>500cm[3]) intraoperative TVs had numerically worse progression-free (p=0.148) and overall (p=0.161) survival than patients with TVs ≤500cm[3](Figure 1B), but limited events precluded statistical significance. Larger radiologic TVs similarly correlated with shorter survivals. Figure 1

      Conclusion
      This is the first study to compare radiographic estimates of TV to actual TV determined by volume displacement of radical pleurectomy specimens, arguably the TV measurement gold standard. This study is also the first to compare estimated TVs using multiple established and previously reported radiographic techniques. Our results demonstrate a clear trend toward greater overall and progression-free survival for actual TVs <500cm[3]. All radiographic techniques underestimated actual TV, with estimates progressively closer to the actual volume with each technique as they became less automated and more manual. Further analysis is ongoing to determine if any radiographic method can serve as an accurate surrogate for actual TV and if models correlate as closely with outcomes as actual TVs.

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    MO14 - Mesothelioma II - Surgery and Multimodality (ID 121)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Mesothelioma
    • Presentations: 2
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      MO14.01 - The impact of macroscopic complete resection radical pleurectomy for mesothelioma on pulmonary function (ID 1692)

      10:30 - 10:35  |  Author(s): M. Culligan

      • Abstract
      • Presentation
      • Slides

      Background
      Radical pleurectomy is our standard approach for achieving a macroscopic complete resection in patients with malignant pleural mesothelioma undergoing surgery-based treatment. This procedure, not pneumonectomy, is performed even in the setting of advanced stage disease, bulky tumors and/or extensive involvement of the pulmonary fissures. Although the majority of patients subjectively rate their breathing as “good” after this operation we recently started measuring postoperative pulmonary function, reported herein.

      Methods
      We examined pre and postoperative FEV~1~ levels among 27 patients undergoing radical pleurectomy: 2 stage I, 3 stage II, 17 stage III, 5 stage IV.

      Results
      The figure shows pre/postoperative FEV-1. Median preoperative levels did not differ significantly between stages (P=0.25): 2.47 (Stage I/II) 2.19 (Stage III) and 1.68 (Stage IV) liters/second. Post-operative median values were 2.16 (Stage I/II), 1.97 (Stage III) and 1.05 (Stage IV) liters/second. The median (interquartile range) decrease in FEV-1 was 0.28 (0.12, 0.51) liters/second, which corresponds to a median (interquartile range) decrease in percent predicted FEV-1 of 7% (4.5%, 16.0%), neither change being statistically significant between stages. Figure 1

      Conclusion
      These operations were conducted in an advanced stage cohort of patients, 81% stage III or IV. The nominal decrease in FEV1 corresponds with the subjective impression of the patients regarding their pulmonary function. While lung parenchyma is preserved with radical pleurectomy, we conjecture the decrease in FEV1 is likely related to compromise in breathing mechanics. Further studies are ongoing to better quantify and characterize the decrease in pulmonary function observed with this operation and to more rigorously integrate this information with formal quality of life assessments.

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      MO14.02 - 16 Year Experience of Routine Laparoscopy and Selective Contralateral Thoracoscopic Staging for Malignant Pleural Mesothelioma (ID 1651)

      10:35 - 10:40  |  Author(s): M. Culligan

      • Abstract
      • Presentation
      • Slides

      Background
      Surgery for malignant pleural mesothelioma (MPM) is typically restricted to patients without intraperitoneal or contralateral pleural spread. Imaging studies are accompanied by both false positive and false negative errors for both types of spread. To avoid these errors our group has routinely performed laparoscopy and selective contralateral video-assisted thoracoscopy (VATS) since 1997.

      Methods
      168 patients with MPM were evaluated for surgery as part of a multimodal treatment protocol. Radiographic staging studies included CT Chest with contrast for all 168 patients, PET Scan (112 patients) and MRI Abdomen (17 patients) for concerning findings on CT and/or PET. 150 patients underwent laparoscopy (two 5mm ports) with both peritoneal biopsy and lavage for cytology. 130/150 laparoscopies were performed in virgin abdomens with the remainder being reoperative procedures. 18 patients also underwent contralateral VATS, based upon any suspicious radiographic findings by either the interpreting radiologist or as reviewed by a multidisciplinary panel of treating physicians. All VATS were performed through a single 1 cm incision. Laparoscopies were performed as outpatient procedures. Patients undergoing combination VATS/laparoscopy were scheduled as same day admissions.

      Results
      There were no operative complications for either procedure. 5/132 (4%) laparoscopy patients scheduled as outpatients required overnight hospitalization – the most common reason being urinary retention. Laparoscopy revealed inaccuracies in radiographic staging in 13/150 (9%) patients- 6 false positive studies (1 interpretation of diaphragm transgression that was not through the diaphragm and 5 metastases that were not present) and 7 false negative studies (3 detected by lavage and 4 by biopsy). All of the false positive and all of the false negative studies occurred in patients who had PET scans. 2/18 (11%) patients who underwent VATS were positive for mesothelioma in the contralateral pleura, only one of whom had a positive PET scan finding.

      Conclusion
      Routine laparoscopy was performed safely and revealed inaccuracy in radiographic staging in 9% of the patients, all of whom had both CT and PET scans. Selective contralateral VATS was performed safely and revealed cancer in 11% of patients with suspicious findings, as determined by the interpreting radiologists and/or the treating clinicians and with PET only being accurate in one of the two positive findings. We conclude that prior to offering patients surgery-based treatment for MPM routine laparoscopy and VATS, based upon any suspicion, are indicated.

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    P1.14 - Poster Session 1 - Mesothelioma (ID 194)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Mesothelioma
    • Presentations: 1
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      P1.14-004 - Extended Survival Following Recurrence for Patients with Malignant Pleural Mesothelioma Treated with Radical Pleurectomy, Photodynamic Therapy and Chemotherapy: The potential role of STAT3. (ID 1686)

      09:30 - 09:30  |  Author(s): M. Culligan

      • Abstract

      Background
      Survival after recurrence following surgical management with curative intent for malignant pleural mesothelioma is typically measured in months. In this study, we compare survival after recurrence in patients progression free less than or greater than one year after radical pleurectomy.

      Methods
      67 consecutive patients with malignant pleural mesothelioma, epithelial subtype, who underwent radical pleurectomy and intraoperative photodynamic therapy were assessed in this IRB-approved study. Four patients who experienced perioperative mortality were excluded from this analysis. Local recurrence was defined as recurrent disease in the ipsilateral hemithorax. Early vs. late recurrence was defined as recurrence before versus after the median recurrence time, respectively. STAT3 expression was quantified in tissue microarrays using computer-based quantification of immunohistochemical staining.

      Results
      Among the 63 evaluable patients, 78% (n=49) were male, the median age of patients was 64 years, and the overwhelming majority (87.5%) had locally advanced (AJCC stage3/4) disease. 49 patients (78%) had lymph node metastases (N1/N2). 60 patients (95%) received neoadjuvant or adjuvant pemetrexed-based chemotherapy. With a median follow-up of 31 months, 42 patients demonstrated disease recurrence. Of these recurrences, 18 were isolated local recurrences and 24 were combined local + distant. The median time to recurrence was 11.6 months and patients who experienced an early recurrence (<11.6 mo) demonstrated significantly decreased survival as compared to patients experiencing a late recurrence (p < 0.0001, Figure 1). The median survival after recurrence was significantly decreased for patients who experienced an early vs late recurrence (54.7 mo [46.0-63.4 mo 95% CI] vs 10.8 mo [8.5-22.7 mo 95 % CI], respectively). We and others have previously shown that STAT3 expression can make mesothelioma more resistant to cytotoxic agents such as chemotherapy or photodynamic therapy. Preliminary analysis of TMA staining indicates that patients who experience an early disease recurrence in our series exhibit significantly higher STAT3 expression. Figure 1

      Conclusion
      This study is among the largest to describe the survival after initial recurrence for malignant pleural mesothelioma in patients undergoing definitive surgical management. Patients recurring prior to the median of 11.6 months experienced an aggressive tumor recurrence phenotype with a median 10.3 months from recurrence to death. Patients recurring after the median of 11.6 months experienced a relatively indolent disease course with a median survival of 37 months after recurrence. Further evaluation and additional studies are necessary to confirm if elevated STAT3 expression could be a poor prognostic factor for patients undergoing radical pleurectomy, photodynamic therapy and chemotherapy.

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    P2.07 - Poster Session 2 - Surgery (ID 190)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Surgery
    • Presentations: 1
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      P2.07-047 - A New Minimally Invasive Surgical Technique to Access a Fused Pleural Space for Biopsy, Gene Therapy or Other Novel Intrapleural Therapeutics - A Report of 34 Patients (ID 3323)

      09:30 - 09:30  |  Author(s): M. Culligan

      • Abstract

      Background
      Gene therapy has shown promise as a novel treatment for pleural mesothelioma. This treatment requires intrapleural placement of a catheter, a routine procedure if a patient has an effusion. After surgery or pleurodesis, however, the pleural space will be fused and access can be difficult. Previously these patients were excluded from gene therapy. The objective of this study was to develop a minimally invasive technique that would allow placement of a catheter into a fused pleural space.

      Methods
      Over the past 50 months 34 patients with fused chest cavities were enrolled in a gene therapy clinical trial. Utilizing a videoscopic saphenous vein-harvesting device, a new surgical technique was developed to safely create a space in the chest cavity for biopsy of tumor, creation of space to accommodate vector instillation and placement of a tunneled catheter. Often the procedure required tunneling directly between the lung and the chest wall, where there was no visible disease, in order to access a pleural nodule that was detectable on CT scan. In every case this procedure was performed through a single 15 mm incision (fig 1). Figure 1 Figure 1 a) The videoscopic saphenous vein tunneling device b) The device in use – not transillumination in the chest approximately 10cm distal to the incision c) Closure of the single video port with the catheter emerging from a proximally tunneled site

      Results
      All 34 patients had successful catheter placement, with 27 as outpatients. The only surgical complication was a transient air leak in 1 patient requiring overnight admission. 5 patients were admitted for urinary retention and 1 for resumption of anticoagulation. One patient had a local wound infection at the catheter site requiring readmission and 2 more were treated as outpatients, all clearing with antibiotics. All patients received gene therapy.

      Conclusion
      This technique represents a safe, effective and minimally invasive way to access a fused pleural space. This technique has proven useful in extending eligibility for pleural mesothelioma gene therapy, but could be used to safely access a fused pleural space for any purpose. This would include obtaining a biopsy in a patient who had undergone pleurodesis without an established diagnosis or placement of a catheter for any type of intrapleural therapeutic.

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    P3.07 - Poster Session 3 - Surgery (ID 193)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Surgery
    • Presentations: 1
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      P3.07-046 - A Novel Technique For Palliating Recurrent Pleural Effusions With a Port-Accessed Tunneled Catheter (ID 3330)

      09:30 - 09:30  |  Author(s): M. Culligan

      • Abstract

      Background
      The cuffed tunneled catheter has revolutionized outpatient management of recurrent pleural effusions. Some patients, however, refuse these tubes on the basis of prohibition of swimming/tub bathing or cosmetic considerations. The objective of this study was to develop a technique to serve such patients.

      Methods
      Four patients with recurrent effusions refused tunneled catheter placement and were not candidates or refused pleuro-peritoneal shunts. All required multiple thoracenteses, one weekly for over a year. One patient had a chronic benign symptomatic transudative effusion after successful nonoperative treatment of NSCLC. The second patient had recurrent chylothoraces secondary to Yellow Nail Syndrome. Two patients had malignant pleural effusions. In all cases, after assuring their effusions could be drawn through a 19 gauge needle, they were taken to the operating room where a tunneled catheter was placed, leaving the fibrous polyester cuff in place for tissue ingrowth, but trimming the valve and connecting that end of the catheter to a standard implantable single lumen infusion port (Figure 1). Figure 1 Figure 1 A) The configuration of the cuffed catheter connected to a single lumen infusion port B) The port-accessed catheter being tested after implantation of the catheter and prior to implantation of the port C) Accessing the catheter as it is done at home

      Results
      All procedures were performed uneventfully and without complications. The catheters continue to work well and are accessed by the patients at home.

      Conclusion
      This novel technique offers a safe palliative option for any effusion that can be aspirated through a 19 gauge needle, benign or malignant. The patients have been able to maintain their normal life style without the risk and inconvenience of serial outpatient thoracenteses or the limitations imposed by the presence of an exterior tube. Specifically, the proven benefits are that it enhances quality of life for those patients who wish to maintain the activities of swimming or tub bathing or have compelling concerns about the appearance of an external tube. There is also the theoretical benefit that this port-accessed drainage system may be less prone to infectious complications.