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A. Abernethy
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MTE 30 - Cachexia (Ticketed Session) (ID 82)
- Event: WCLC 2015
- Type: Meet the Expert (Ticketed Session)
- Track: Palliative and Supportive Care
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 07:00 - 08:00, 702+704+706
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MTE30.01 - Cachexia (ID 2018)
07:00 - 08:00 | Author(s): A. Abernethy
- Abstract
- Presentation
Abstract:
The cancer anorexia-cachexia syndrome (CACS) is a significant clinical problem, affecting upwards of half of all patients with cancer, and causing at least 20% of deaths in the general cancer population. An international expert consensus grouprecently defined cancer anorexia-cachexia as “a multifactorial syndrome characterized by an ongoing loss of skeletal mass (with or without loss of fat mass) that cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment” [1]. Its impact is particularly significant in lung cancers, where it is present in 60% of patients at diagnosis; in all stages of NSCLCa patients, 5 kg of weight loss reduced survival rates by more than 40%. Systemic inflammation, reduced food intake and altered metabolism contribute to loss of muscle mass and body weight reduction [2,3]. CACS is associated with fatigue and a reduction in physical functioning, quality of life (QoL), tolerance and response to anticancer therapy, and survival [1,4,5,6]. The condition is further compounded by its under-recognition, with CACS often present even in the absence of weight loss and at times obscured by obesity [5]. CACS may be preceded by muscle loss and may be exacerbated by anticancer therapies. It is the final common pathway in people with advanced cancer leading to death unless some other process supervenes. The most prominent feature of CACS is its nonresponsiveness to existing treatment approaches, which have included unsuccessful use of nutritional supplements, appetite stimulants, 5-hydroxytryptamine-3 (5-HT3) antagonists and cyclooxygenase-2 (COX-2) inhibitors [2]. American guidelines are aimed at the delivery of optimal nutrition management [7], with those of organizations such as the National Comprehensive Cancer Network lacking specific guidance on pharmacologic treatments [8]. The European Palliative Care Research Collaborative (EPCRC) offers clinical guidance on drug treatments for cancer cachexia [9], but is limited in available advice due to the lack of widely effective and safe agents. There is a vast unmet medical need for this debilitating syndrome. While CACS continues to be an issue that impacts many cancer patients, headway is being made in the development of drugs that can significantly improve quality of life. Some investigational agents have shown potential in completed Phase II or III studies of patients with CACS. During this session we will review recent clinical trial evidence for these agents. Other developmental headway is being made in rapid identification of people at risk for CACS and/or requiring treatment, and point of care clinical decision support to optimize treatment approach. The use of aggregating clinical, biological and patient-reported data and development of specific predictive models are leading to personalized symptom control. In totality, the industry is making progress in the treatment of CACS, and there continues to be vast opportunity to further improve in the future. 1 Fearon K, Strasser F, Anker SD et al.Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 12(5), 489–495 (2011). 2 Suzuki H, Asakawa A, Amitani H, Fujitsuka N, Nakamura N, Inui A. Cancer cachexia pathophysiology and translational aspect of herbal medicine. Jpn. J. Clin. Oncol. 43(7), 695–705 (2013). 3 Dodson S, Baracos VE, Jatoi A et al. Muscle wasting in cancer cachexia: clinical implications, diagnosis, and emerging treatment strategies. Annu. Rev. Med. 62, 265–279 (2011). 4 Kumar NB, Kazi A, Smith T et al. Cancer cachexia: traditional therapies and novel molecular mechanism-based approaches to treatment. Curr. Treat. Options Oncol. 11(3–4), 107–117 (2010). 5 Fearon K, Arends J, Baracos V.Understanding the mechanisms and treatment options in cancer cachexia. Nat. Rev. Clin. Oncol. 10(2), 90–99 (2013). 6 Ross PJ, Ashley S, Norton A et al. Do patients with weight loss have a worse outcome when undergoing chemotherapy for lung cancers? Br. J. Cancer. 90(10), 1905–1911 (2004). 7 August DA, Huhmann MB; American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. A.S.P.E.N. clinical guidelines: nutrition support therapy during adult anticancer treatment and in hematopoietic cell transplantation. J.P.E.N. J. Parenter. Enteral. Nutr. 33(5), 472–500 (2009). 8 National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Palliative Care 2013. www.nccn.org/professionals/physician_gls/pdf/palliative.pdf (Accessed 14 November 2013). 9 European Palliative Care Research Collaborative. European Clinical Guidelines: Clinical practice guidelines on cancer cachexia in advanced cancer patients with a focus on refractory cachexia 2010.
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ORAL 29 - MASCC-IASLC Joint Session: Palliative and Supportive Care (ID 136)
- Event: WCLC 2015
- Type: Oral Session
- Track: Palliative and Supportive Care
- Presentations: 1
- Moderators:A. Molasiotis, P. Van Houtte
- Coordinates: 9/08/2015, 16:45 - 18:15, 708+710+712
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ORAL29.01 - Results From Phase III Trials of Anamorelin in Advanced Non-Small Cell Lung Cancer Patients with Cachexia: ROMANA 1 and 2 (ID 1359)
16:45 - 18:15 | Author(s): A. Abernethy
- Abstract
- Presentation
Background:
Cachexia is a debilitating condition often observed in patients with advanced non-small cell lung cancer (NSCLC). A decrease in body weight (BW), in particular loss of lean body mass (LBM), is a primary characteristic, and is associated with worsening functional status, quality of life, and survival. Despite the high prevalence and substantial clinical impact of cachexia in patients with advanced cancer, limited therapeutic options exist. Anamorelin is a novel, orally active, selective ghrelin receptor agonist that mimics the appetite-enhancing and anabolic effects of ghrelin. ROMANA 1 and 2 are two randomized, double-blind, Phase III trials evaluating the efficacy and safety of anamorelin in patients with advanced NSCLC and cachexia.
Methods:
In ROMANA 1 (NCT01387269; N=484) and ROMANA 2 (NCT01387282; N=495), patients with unresectable stage III/IV NSCLC and cachexia (≥5% weight loss during prior 6 months or body mass index <20kg/m[2]) were randomized (2:1) to anamorelin 100 mg daily or placebo, for 12 weeks. Co-primary endpoints were change in LBM and handgrip strength (HGS) over 12 weeks. Secondary endpoints included change in BW and in the anorexia/cachexia domain of the Functional Assessment of Anorexia/Cachexia Therapy questionnaire over 12 weeks, and pooled 1-year overall survival (OS) from both studies. Exploratory endpoints included summarizing the incidence of patients who maintained/gained LBM from baseline during 12 weeks by treatment group. Post-hoc analysis compared OS data in patients who had decrease in LBM during 12 weeks versus those who maintained/gained LBM. Safety and tolerability of anamorelin were also evaluated.
Results:
Over 12 weeks, anamorelin significantly increased median LBM versus placebo in ROMANA 1 (1.10 vs –0.44 kg; p<0.001) and ROMANA 2 (0.75 vs –0.96 kg; p<0.001); in both studies there was no difference in HGS changes between treatment arms. A significantly greater proportion of patients in the anamorelin arm versus the placebo arm maintained/gained LBM in both ROMANA 1 (58.1% vs 36.9%; p<0.001) and ROMANA 2 (51.5% vs 26.5%; p<0.001). Post-hoc analysis showed that OS was improved for patients who maintained/gained LBM versus patients who lost LBM (HR, 0.53 [95% CI, 0.42, 0.68]; p<0.001). Anamorelin-treated patients also significantly gained BW (2.20 vs 0.14 kg; p<0.001, and 0.95 vs –0.57 kg; p<0.001), and had significantly improved anorexia-cachexia symptoms and concerns (4.12 vs 1.92; <0.001, and 3.48 vs 1.34; p=0.002), compared with placebo-treated patients, in ROMANA 1 and 2, respectively. The most frequent drug-related adverse event (AE) in the anamorelin arm in both ROMANA 1 and 2 was hyperglycemia (5.3% and 4.2%); there were few drug-related grade ≥3 AEs in the anamorelin arm versus the placebo arm (0.9% vs 1.2% and 2.7% vs 2.5%).
Conclusion:
Anamorelin significantly increased LBM and BW, and improved anorexia-cachexia symptoms and concerns, compared with placebo, in patients with advanced NSCLC and cachexia. Change from baseline in HGS was similar in both treatment arms. A significantly greater proportion of patients maintained/gained LBM in the anamorelin arm versus the placebo arm. When LBM was stable or increased, OS was significantly improved. Anamorelin treatment over 12 weeks was also well tolerated.
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P1.12 - Poster Session/ Community Practice (ID 232)
- Event: WCLC 2015
- Type: Poster
- Track: Community Practice
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.12-011 - Treatment Patterns and Overall Survival for Advanced NSCLC Following Platinum-Based Chemotherapy in US Community Oncology Clinical Practice (ID 3284)
09:30 - 17:00 | Author(s): A. Abernethy
- Abstract
Background:
While clinical guidelines provide clinical decision support for selection of agent, combination, and order of administration, there are few studies that provide a comprehensive description of contemporary advanced NSCLC treatment patterns in patients following platinum therapy over time; there are limited recent US data on practice patterns and outcomes for advanced NSCLC patients following chemotherapy. The purpose of this study is (1) to describe patient flow from advanced NSCLC diagnosis to anti-cancer treatment following completion of a platinum regimen, and if EGFR mutation or ALK translocation positive, an appropriate TKI; (2) to describe the characteristics of advanced NSCLC patients treated with anti-cancer therapy following platinum therapy and, if EGFR mutation or ALK translocation positive, an appropriate TKI; to describe anti-cancer treatment patterns following completion of platinum therapy and, if EGFR mutation or ALK translocation positive, an appropriate TKI.
Methods:
Retrospective EMR database cohort study using data from a cloud-based Oncology Electronic Medical Record (EMR) system with 220 cancer clinics, 700 community-based cancer treatment clinics, 1750 clinicians, and 725,000 active cancer patients, representing 17% of incident cases in the United States. The data represents lab values and physician notes from both structured and unstructured data. Variables of interest include demographic, disease-related, biomarker testing-related, anti-cancer treatment. Treatment patterns include regimens by line of therapy, agents and number of doses administered or prescribed, and distribution of dosage strengths. Analyses will be conducted by histology and EGFR/ALK status (among non-squamous cell carcinoma patients). Data will be analyzed descriptively. Overall survival, if data are available, will be estimated using a series of Kaplan Meier curves, with median OS (95% confidence interval) reported.
Results:
Approximately 1598 patients with advanced NSCLC initiating a line of therapy after completing a platinum regimen and, if EGFR mutation or ALK translocation positive, an appropriate TKI between January 1, 2013 and October 31, 2014 will be followed until April 30, 2015. Preliminary results identified 6536 patients with advanced NSCLC; of these, 5048 (77.2%) received any 1L treatment after advanced NSCLC diagnosis with 3786 (57.9%) receiving platinum-based chemotherapy as 1L treatment. Among the final cohort of patients (n=1598), the majority were men (54.0%) initially diagnosed with stage IV disease (68.5%) at age 66. The distribution of histological subtypes in the sample included non-squamous (74.4%), squamous (21.0%), and NOS (4.6%). Treatment patterns will be described according to histology and biomarker status at index date. Patient characteristics and overall survival will be reported by histology, biomarker status at index date, and regimen type.
Conclusion:
Results from this study will describe treatment patterns in the second-line setting, prior to the introduction of newer therapies, such as anti-PD1/PD-L1 inhibitors and angiogenesis inhibitors. Additionally, it will advance current understanding of the specific patterns of 2L care for patients being treated with anti-cancer therapy in the real world of community settings.
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PRC 02 - Press Conference 2 (ID 197)
- Event: WCLC 2015
- Type: Press Conference
- Track: Other
- Presentations: 1
- Moderators:J.R. Jett
- Coordinates: 9/07/2015, 09:45 - 10:45, 108+110+112
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PRC02.04 - Abstract – Results From Phase III Trials of Anamorelin in Advanced Non-Small Cell Lung Cancer Patients with Cachexia: ROMANA 1 and 2 - Dr. Amy Abernethy, Director, Center for Learning Health Care, Duke Clinical Research Institute, North Carolina (ID 3622)
09:45 - 10:45 | Author(s): A. Abernethy
- Abstract
- Presentation
Abstract not provided
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