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C.B. Simone



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    MINI 28 - Psychological Impact of Lung Cancer and its Treatment (ID 150)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Palliative and Supportive Care
    • Presentations: 1
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      MINI28.02 - Utilization of Survivorship Care Plans and Analysis of Patient Reported Outcomes in Multinational Lung Cancer Patients (ID 2269)

      16:50 - 16:55  |  Author(s): C.B. Simone

      • Abstract
      • Presentation
      • Slides

      Background:
      Lung cancer is the leading cause of cancer death in the United States and is also a significant source of morbidity. Patient-reported outcomes (PROs) are prognostic for survival. Herein we report our analysis of emerging patterns of longitudinal PROs collected in the development of survivorship care plans (SCPs) using an anonymous web-based program.

      Methods:
      OncoLife and the LIVESTRONG Care Plan are web-based programs that generate unique SCPs and are accessed via OncoLink (www.oncolink.org), the world’s first cancer website. We selected all consecutive patients identifying as primary lung cancer survivors creating SCPs. Patient-reported demographics, treatment and toxicity were examined. For toxicity data, questions with > 10 “yes” responses were included, and were categorized into: cardiovascular; genitourinary; neurocognitive; endocrine; speaking, breathing, swallowing (SBS); thoracic; and musculoskeletal/dermatologic symptoms. Research was conducted under an IRB-approved protocol.

      Results:
      Overall, 689 plans were created for users self-identifying as primary lung cancer survivors. Average time from diagnosis to reporting was 1.68 years (0-24). Most were Caucasian (85.9%), well-educated (67.3% > “some college”), and lived in a suburban area (45.6%) and the United States (91%). Table 1 shows treatment modalities . Neurocognitive symptoms (e.g. fatigue and cognitive changes) were most common (48.8%), followed by musculoskeletal/dermatologic (14.1%), and thoracic (13.5%). Figure 1 shows symptoms analyzed by treatment. Only 11.2% were initially offered a SCP, and of those, 54.5% were offered by their healthcare provider, most often at a non-university-based cancer center (66.2%).

      TREATMENT N (689 total) %
      Any Surgery 375 54.4
      Any Chemotherapy 522 75.8
      Any Radiation 377 54.7
      Surgery Alone 98 14.2
      Surgery + Chemotherapy 119 17.3
      Surgery + Radiation 15 2.2
      Surgery + Chemotherapy + Radiation 143 20.8
      Chemotherapy Alone 70 10.2
      Chemotherapy + Radiation 190 27.9
      Radiation Alone 29 4.2
      Not Specified 25 3.6
      Figure 1



      Conclusion:
      For lung cancer patients worldwide, it is feasible to obtain PROs and create SCPs through a web-based program. As lung cancer survivors live longer, further attention should be paid to PROs, and our data indicates that, surprisingly, the most common symptoms to address are neurocognitive. As very few patients were offered SCPs, increased effort should be made to provide SCPs, particularly in urban and university cancer center settings. This study was funded in part by the LIVESTRONG Foundation.

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    ORAL 12 - Quality of Life and Trials (ID 96)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Advocacy
    • Presentations: 1
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      ORAL12.06 - Trial Eligibility of NSCLC Patients Receiving Proton Therapy: Are Cooperative Group Trials Being Designed for the Right Patients? (ID 2759)

      11:39 - 11:50  |  Author(s): C.B. Simone

      • Abstract
      • Presentation
      • Slides

      Background:
      Participation in oncology clinical trials has historically been low compared to the number of individuals diagnosed with cancer each year. It has been reported that between 3% and 5% of adults with cancer participate in clinical trials. However, research into this statistic usually focuses on the reasons why patients choose not to participate, rather than whether or not clinical trials are designed adequately to capture a proper patient sample truly representative of the population being studied. This study explored a sample of lung cancer patients who received treatment with proton therapy and compared the group to the eligibility requirements of two lung cancer trials. We hypothesized that most patients treated with proton therapy would not be eligible to participate in the currently accruing cooperative group studies.

      Methods:
      The Proton Collaborative Group’s (PCG) prospective registry was mined for information on all lung cancer patients who received proton therapy between the years of 2010 and 2015. These patients were then evaluated to determine if they would have been eligible to participate in either of the two active cooperative group clinical trials for proton therapy currently enrolling patients with inoperable stage II-IIIB non-small cell lung cancer (NSCLC): PCG LUN005 (phase I/II trial of hypofractionated proton therapy) and RTOG 1308 (phase III trial randomizing to protons versus photons).

      Results:
      A total of 244 consecutive patients with lung cancer were available in the registry for evaluation. Patients were ineligible for LUN005 and RTOG 1308 due to exclusionary stage (n=77), histology (n=37), performance status (n=66), prior surgery for lung cancer (n=53), and/or prior radiation therapy (RT) for lung cancer (n=53). Of the remaining 55 patients, 27 were enrolled in the PCG registry prior to LUN005 or RTOG 1308 opening for accrual. This left 28 patients. Those patients were ineligible for the following reasons: prior chemotherapy (n=3), prior RT within the treatment field (n=3), prior cancer (n=6), weight loss (n=2), outdated procedures (n=2), oxygen dependence (n=1), disease progression prior to RT start (n=2), or not felt to be an upfront candidate for concurrent chemotherapy and RT (n=2). This left 7 patients who were ultimately eligible for enrollment, one of which refused trial participation and one of which the reason for not participating was unknown. Reasons for lack of enrollment of the 5 remaining patients on LUN005 were due to administrative issues (ex: protocol enrollment on hold pending interim review), whereas RTOG 1308 was unavailable for those patients at their treating center.

      Conclusion:
      The vast majority of patients treated with proton therapy for lung cancer on PCG’s prospective registry were not eligible for participation cooperative group trials. Given the high ineligibility rate among patients found in this study, pragmatic trials with more inclusive eligibility criteria are needed to better mirror the general population of patients with newly diagnosed, locally advanced NSCLC. More inclusive trials may allow for increased rates of trial participation and further advances and improvements in survival.

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    ORAL 26 - Clinical Trials 2 (ID 127)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
    • Presentations: 1
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      ORAL26.06 - Prospective Assessment of Proton Therapy for Malignant Pleural Mesothelioma (ID 3071)

      11:39 - 11:50  |  Author(s): C.B. Simone

      • Abstract
      • Presentation
      • Slides

      Background:
      Use of radiotherapy (RT) to treat malignant pleural mesothelioma (MPM) has been limited due to reported significant morbidity and risk of fatal pneumonitis when treating large pleural volumes. To date, RT for MPM has generally been limited to palliation, prophylaxis of surgical tract sites, and adjuvant therapy generally after extrapleural pnuemonectomy. Reports of RT for MPM have employed photons and electrons nearly exclusively. Proton therapy (PT) can significantly reduce irradiation to lung and other critical organs, possibly reducing treatment toxicities and enabling novel RT indications. To date, only a single case series of 4 patients has reported on PT for MPM. We report our prospective experience using PT as adjuvant or definitive therapy for MPM and hypothesized that PT will have low rates of esophagitis and pneumonitis, while providing excellent local control.

      Methods:
      All consecutive patients diagnosed with MPM from 2011-2015 and treated at the Penn Mesothelioma and Pleural Program with PT on a prospective registry study were included for this Institutional Review Board-approved analysis. Local control, defined as lack of tumor progression in the RT portal, and overall survival were measured from PT completion to last follow-up or death. Toxicities were scored using CTCAEv4.

      Results:
      Sixteen patients treated to 17 PT courses were included. Patients were predominantly male (81%) and Caucasian (100%) with epithelial histological subtype (82%) and stage III-IV disease (94%). Patients were a median of 69.8 years old at PT start, which was delivered at a median of 11.1 months (range 3.5-69.3 months) after diagnosis. All patients received pemetrexed plus cisplatin or carboplatin prior to (n=15) or concurrent with (n=1) PT. PT was administered as adjuvant therapy following lung-sparing radical pleurectomy (n=8), to sites of gross disease following progression on systemic therapy (n=8), or as initial definitive therapy with concurrent chemotherapy (n=1). Patients were treated to a median dose of 51.75Gy (CGE) in 2.0Gy daily fractions (range 50.0-75.0Gy/1.8-2.5Gy). At a median follow-up of 5 months from PT completion, all patients had durable local control throughout the study period. Five patients died at a median of 5.4 months following PT. Median overall survival for the cohort has not yet been reached, and 6- and 12-month survival rates were 35% and 24%, respectively. No patients experienced grade ≥3 acute or late toxicity. Across the 17 PT courses, acute grade 2 toxicities included radiation dermatitis (n=8), dysphagia/esophagitis (n=4), anorexia (n=3), fatigue (n=2), and cough (n=1). Late grade 2 toxicity included a single patient with radiation pneumonitis (6%). Overall, patients experienced no significant change in ECOG performance score from PT beginning to end (mean 0.82 to 0.88).

      Conclusion:
      This is the largest report of PT for MPM and demonstrated PT is well tolerated with a favorable toxicity profile compared with photon reports. As such, PT may better allow for integration of RT in multimodality therapy for MPM. This study also demonstrated the efficacy of PT, with local control achieved following all 17 treatment courses. Longer follow-up and additional patients are needed to assess late toxicities and overall survival after PT.

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