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P. Van Houtte
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ED 01 - Update in Radiation Oncology (ID 1)
- Event: WCLC 2015
- Type: Education Session
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 4
- Moderators:W.J. Curran, P. Van Houtte
- Coordinates: 9/07/2015, 14:15 - 15:45, 205+207
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ED01.01 - Current Status of Proton and Heavy Particle Therapy (ID 1770)
14:15 - 15:45 | Author(s): H. Choy
- Abstract
- Presentation
Abstract:
Proton therapy, in particular, and ion therapy, just beginning, are becoming an increasing focus of attention in clinical radiation oncology. Proton therapy is a type of radiation treatment that uses protons rather than x-rays to treat cancer. Protons, however, can target the tumor with lower radiation doses to surrounding normal tissues. Proton therapy is particularly useful for treating cancer in children because it lessens the chance of harming healthy, developing tissue. In addition, proton therapy may be used to treat Lung cancer. Compared with standard radiation treatment, proton therapy has several benefits. It reduces the risk of radiation damage to healthy tissues; may allow a higher radiation dose to be directed at some types of tumors, which may keep the tumor from growing or spreading; and may result in fewer and less severe side effects (such as low blood counts, fatigue, and nausea) during and after treatment. However, there are some drawbacks such as higher cost and lack of convincing evidence from randomized trials proving their efficacy, justifying the higher costs involved in these therapies. Carbon ion therapy is another type of radiotherapies that can deliver high-dose radiation to a tumor while minimizing the dose delivered to the organs at risk; this profile differs from that of photon radiotherapy. Moreover, carbon ions are classified as high-linear energy transfer radiation and are expected to be effective for even photon-resistant tumors. There are several centers in Asia and Europe using carbon beam to treat lung cancer patients. In this session, we will provide an overview of the current status of clinical trials in proton therapy, including recent developments in ion therapy for lung cancer. We will also attempt to highlight some of the challenges that surround clinical trials in particle therapy.
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ED01.02 - Optimal Dose and Fractionation (ID 1771)
14:15 - 15:45 | Author(s): J. Urbanic
- Abstract
- Presentation
Abstract not provided
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ED01.03 - Post-Operative Radiotherapy for Stage III Disease (ID 1772)
14:15 - 15:45 | Author(s): F. Mornex
- Abstract
- Presentation
Abstract:
Despite advances in treatment, lung cancer remains the leading cause of cancer mortality in most countries. About one third of patients with non-small cell lung cancer (NSCLC) presents with locally advanced non-metastatic disease (stages IIIA and B). Although 5-year overall survival (OS) ranges from 60 to 73% for completely resected pathologic stage I disease, OS decreases to less than 25% for pathological stage III disease. Patients with potentially resectable stage IIIA-N2 can be treated with induction chemotherapy followed by radical surgery. Prospective studies report 5-year OS rates from 20% to 30%, with about 30% of the patients reporting local recurrence (LR). When surgery is performed first, for patients presenting with node-positive disease at the time of resection, meta-analysis data demonstrate that adjuvant platinum-based chemotherapy has been shown to decrease distant metastases and locoregional recurrence (LRR), resulting in an approximately 5% OS advantage, and is now considered standard of care for patients with resected node-positive NSCLC. However, these patients have a 20% to 40% risk of LRR, and LRR correlates independently with worse OS. Thus, postoperative radiotherapy (PORT) holds great appeal as a means to reduce LRR and improve OS. Several phase III trials investigated the role of PORT after surgical resection in NSCLC. In 1998, the PORT Meta-analysis Trialists Group undertook an individual participant data (IPD) meta-analysis (of both published and unpublished trial data) of PORT versus surgery alone in NSCLC [1]. The original meta-analysis, based on 9 randomised controlled trials and 2128 patients, concluded that PORT was detrimental with a 7% absolute reduction in 2-year OS and a 4% reduction in recurrence-free survival. Subgroup analyses suggested that PORT was increasingly detrimental with decreasing stage (p = 0.0003) and lower nodal status (p = 0.016). The updated results for OS, and for local, distant and overall recurrence-free survival are unchanged, continuing to show a detrimental effect of PORT(2) : For the whole patient group, PORT decreased the OS at two years by 6% (52% vs. 58%). This deleterious effect was detected in patients with pN0–1 disease. No effect was detected in patients with pN2 disease. The PORT meta-analysis raised a lot of criticism for the following reasons: significant heterogeneity between trials, inclusion of trials with old radiotherapy techniques (notably, most of these trials, conducted principally in the 1960s to 1970s, included outmoded RT techniques and doses). The deleterious effect of PORT has been attributed to an excess of intercurrent deaths, with a high incidence of cardiac and respiratory complications due to poor radiotherapy techniques. In support of this hypothesis, several more recent trials with contemporary radiation techniques did not report an increase of death from intercurrent disease. Kepka et al. did not detect a difference in QoL scores, cardiopulmonary morbidity or non-cancer related deaths between patients receiving PORT and those treated with surgery alone (3). Two Surveillance, Epidemiology, and End Results (SEER) analyses and a secondary analysis of data from the Adjuvant Navelbine International Trialist Association (ANITA) trial suggest that PORT may be safely delivered in a modern cohort of patients with a potential OS benefit for stage IIIA (N2) disease (4, 5). In addition, being now established that the use of adjuvant chemotherapy in stage III disease prolongs OS, it is then hypothesised that with the reduction of distant metastases with chemotherapy, the survival benefit by improved local control after three-dimensional conformal (3D-CRT) PORT will occur. Then, recently, the National Cancer Data Base (NCDB), joint program of the Commission on Cancer of the American College of Surgeons and the American Cancer Society, has been queried to study the impact of modern PORT in the setting of standard-of-care adjuvant chemotherapy for pathologic stage IIIA (N2) NSCLC (6). Data of 1850 patients who received PORT between 1998 and 2010 were obtained. Use of PORT, compared with no PORT, was associated with a significant increase in median OS (45.2 v 40.7 months, respectively), 3-year OS (59.3% v 55.2% , respectively), and 5-year OS (39.3% v 34.8%, respectively; P=.014. This analysis of the NCDB for patients with pathologic N2 disease, receiving adjuvant chemotherapy, shows that PORT seems to confer an additional improvement in OS. In conclusion, modern radiotherapy techniques should be evaluated in stage III patients, as already stated in the initial individual-patient-data meta-analysis. This new evaluation is justified for several reasons: (a) the N2 population has changed because of a better selection with pre-treatment PET-CT scan and brain imaging; (b) adjuvant chemotherapy has become a standard of care in these patients; (c) technical advances of radiotherapy may enhance the ability of PORT to improve local relapse-free survival and possibly overall survival. Thus, based on the previous studies, the underlying hypotheses remain to be proven, with sufficiently powered new randomised trials. A prospective randomized phase III trial, LungART (Lung Adjuvant Radiotherapy Trial), designed with the primary aim of investigating the benefits of conformal radiotherapy in completely resected pN2 NSCLC, together with adjuvant chemotherapy, is currently ongoing in Europe, and should help answering definitely this question, investigators are strongly encouraged to enroll patients on this randomized trial. 1 : PORT Meta-analysis Trialists Group. Postoperative radiotherapy in non-small-cell lung cancer: systematic review and meta-analysis of individual patient data from nine randomised controlled trials. PORT Meta-analysis Trialists Group. Lancet 1998; 352:257-63. 2 : PORT Meta-analysis Trialists Group: Postoperative radiotherapy for non-small cell lung cancer. Cochrane Database Syst Rev 2:CD002142, 2005 3 : Kepka L, Bujko K, Orlowski TM, et al. Cardiopulmonary morbidity and quality of life in non-small cell lung cancer patients treated with or without postoperative radiotherapy. Radiother Oncol 2011;98:238–43. 4 : Lally BE, Zelterman D, Colasanto JM, et al. Postoperative radiotherapy for stage II or III non-small-cell lung cancer using the surveillance, epidemiology, and end results database. J Clin Oncol 2006; 24:2998-3006. 5 : Douillard JY, Rosell R, De Lena M, et al. Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer. Adjuvant Navelbine International Trialist Association ANITA: a randomised controlled trial. Lancet Oncol 2006;7: 719-27. 6 : Robinson CG, Patel AP, Bradley JD et al. Postoperative radiotherapy for pathologic N2 Non small Cell lung cancer treated with adjuvant chemotherapy : A review of the National Cancer Data Base. J Clin Oncol 2015 ; 33 :870-77
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ED01.04 - Evolving Role of Radiation for Oligometastases (ID 1773)
14:15 - 15:45 | Author(s): B. Movsas
- Abstract
- Presentation
Abstract:
Evolving Role of Radiation for Oligometastases The key objectives of this presentation are to review the fundamental biology underlying metastatic disease, understand the definition and clinical evidence for oligo- (or limited) metastatic disease, analyze key clinical trials showing the potential role of stereotactic body radiation therapy (SBRT) for oligometastases and address challenges regarding this “high-tech” strategy. In the early 1900s, Halsted suggested that breast cancer spread via the local regional lymphatic vessels in a stepwise manner. Thus, once there are metastases, local therapy had no clear role. Later in the 20[th] century, an opposing theory (the “Fisher” theory) suggested that cancer is a systemic disease that, if it will ever metastasize, will already have done so early in the disease course. Local therapies are therefore less important than systemic therapies. A counterpoint to these approaches was proposed by Hellman and Weichselbaum, postulating that cancer is a spectrum from localized to wide-spread disease at the time of diagnosis, with many intermediate states (Hellman S, Weichselbaum RR. Oligometastases. J Clin Oncol. 1995 Jan;13(1):8-10). “Oligometastases” are essentially early metastases which are limited in number and location and based on a state of limited metastatic capacity. The hypothesis based on this approach is that there may be a subset of patients with oligometastatic disease for whom aggressive local treatment (such as surgery or SBRT) could change their outcome. Clinical evidence for oligometastasis includes the surgical experience for lung or liver metastases showing long-term survivals of approximately 20%. Studies are now emerging suggesting similar results utilizing SBRT. In an individual patient data meta-analysis of outcomes after surgery or SBRT, Ashworth et al. reported a 5-year survival rate of approximately 30% in patients with oligometastatic non-small cell lung cancer (Ashworth AB, et al. An individual patient data metaanalysis of outcomes and prognostic factors after treatment of oligometastatic non-small-cell lung cancer. Clin Lung Cancer. 2014 Sep;15(5):346-55). They developed a risk classification schema showing a better prognosis for metachronous vs. synchronous oligometastases (of which node-negative was favorable to node-positive). Other studies have shown that, among patients treated with SBRT for 1-5 oligometastases, those with ≤3 metastases had better outcomes compared to those with 4-5 metastases. The size of the metastases also appears to be important, as well as the biological equivalent dose (BED) of the SBRT. Studies have begun to explore the role of SBRT for oligometastases involving the lung, liver, adrenal, and other sites. It is likely that host-related factors (for example, immune mediated anti-cancer activity) and tumor related factors (such as genomics and proteomics) also affect the spectrum of disease aggressiveness. Challenges to this new “high-tech” approach will also be addressed, including issues related to patient selection, the level of evidence, and the cost effectiveness of this approach. Other approaches for improving the outcome for patients with metastatic disease will also be discussed, including the role of early palliative interventions. In summary, emerging (albeit non-randomized) data suggests that SBRT appears to be a promising strategy in selected patients with oligometastases. The patients most likely to benefit from SBRT have metachronous (vs. synchronous) metastases, N0 (vs. N+) disease, 1-3 metastases (vs. more), small metastases, and the ability to receive a higher radiation dose (BED >100Gy). Randomized trials are needed to establish whether SBRT improves progression free and/or over survival in this setting.
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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: 8
- Moderators:A. Molasiotis, P. Van Houtte
- Coordinates: 9/08/2015, 16:45 - 18:15, 708+710+712
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- 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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ORAL29.02 - ONO-7643/Anamorelin for the Treatment of Cancer Cachexia in Advanced NSCLC Patients: Results From the Phase 2 Study in Japan (ID 1375)
16:45 - 18:15 | Author(s): N. Katakami, T. Yokoyama, S. Atagi, K. Yoshimori, H. Kagamu, Y. Takeda, K. Takase, H. Saito, K. Eguchi
- Abstract
- Presentation
Background:
Cancer cachexia is characterized by decreased body weight (BW), mainly lean body mass (LBM) and negatively impacts quality of life (QOL) and prognosis. ONO-7643/anamorelin (ANAM) is a novel selective ghrelin receptor agonist with appetite-enhancing and anabolic activity.
Methods:
ONO-7643-03 was a double-blind, exploratory Phase 2 trial assessing ANAM efficacy and safety in Japanese non-small cell lung cancer (NSCLC) patients with unresectable stage III/IV NSCLC, ECOG performance status (ECOG PS) 1-2 and cachexia (main criteria: ≥5% weight loss within prior 6 months). Patients were randomized to ANAM at 100 or 50 mg, or placebo, given daily orally for 12 weeks. Co-primary endpoints were change from baseline over 12 weeks in LBM (measured by DXA) and handgrip strength (HGS). Secondary endpoints included change in BW, ECOG PS, Karnofsky performance scale (KPS) and QOL assessment (QOL-ACD).
Results:
Demographics were balanced (N=180); median age=66 yr, male (68.9%), ECOG PS=1 (77.5%) and stage IV (76.1%). Treatment effects: the change in LBM over 12 weeks was 0.55 kg in the placebo arm and 1.15 kg in the ANAM 100 mg arm, and the change in LBM at both Weeks 8 and 12 showed significant differences between ANAM 100 mg and placebo (p<0.05). However, the change in HGS was similar between arms at both time points. The change in BW to Weeks 12 was -0.93 kg in the placebo arm vs +0.54 kg in the 50 mg arm and +1.77 kg in the 100 mg arm, and was significantly different between the 100 or 50 mg arms and the placebo arm at all time points (p<0.05). The cumulative rate of deterioration of ECOG PS was lowest in the 100 mg arm, and ANAM 100mg significantly improved KPS and QOL-ACD compared to placebo at Weeks 4 and 12 (p<0.05). Regarding safety, ANAM treatment for 12 weeks was well tolerated. While median survival time (MST) was not significantly different between active treatment arms and placebo, MST of patients with BW loss was significantly shorter than those without (215 vs 327 days; p=0.0055).
Conclusion:
This phase 2 study demonstrated that ANAM has promising potential in improving body composition, performance status and QOL in patients with cancer cachexia.
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ORAL29.03 - Efficacy of the Antiemetic Combination Agent, NEPA, in Patients with Lung Cancer Receiving Platinum Chemotherapy (ID 1275)
16:45 - 18:15 | Author(s): P.J. Hesketh, M. Palmas, E.M. Carreras
- Abstract
- Presentation
Background:
Lung cancer is the most common cancer worldwide with first-line chemotherapy treatments consisting predominantly of emetogenic platinum agents. Chemotherapy-induced nausea and vomiting (CINV) can be prevented in most patients with appropriate combination antiemetic regimens. The antiemetic standard-of-care for patients receiving cisplatin consists of a combination of a NK~1~ receptor antagonist (NK~1~RA), a 5-HT~3~ RA, and dexamethasone (DEX). Adherence to antiemetic guidelines is unacceptably low with patients frequently not receiving recommended antiemetic combinations. NEPA has been developed as the first oral antiemetic combination; it delivers guideline-consistent prophylaxis with its combination of a highly selective NK~1~ RA (netupitant [NETU] 300 mg) and the pharmacologically/clinically distinct 5-HT~3~ RA, palonosetron (PALO 0.50 mg). NEPA has demonstrated superior prevention of CINV compared with oral PALO. The intent of this retrospective analysis was to evaluate the efficacy of NEPA in a subset of lung cancer patients from two of the pivotal trials.
Methods:
Patients in two randomized, double-blind trials received a single dose of NEPA on Day 1 prior to cisplatin- or carboplatin-based chemotherapy. Three dose groups (NETU 100/200/300 mg + PALO 0.50 mg) showing similar efficacy were pooled in Study 1, while all patients in Study 2 received NETU 300mg/PALO 0.50 mg. All patients also received oral DEX on Day 1 (carboplatin) or Days 1-4 (cisplatin). Study 1 was single cycle, while Study 2 included evaluation over multiple chemotherapy cycles. The focus of this analysis was on the efficacy of NEPA only, as a PALO comparator group was included in only one of these studies. Endpoints were complete response (CR: no emesis, no rescue) and no significant nausea (max <25 mm on 100 mm visual analog scale) during the acute (0-24h), delayed (25-120h), and overall (0-120h) phases.
Results:
231 patients (78% males, 22% females) with lung cancer received NEPA; 152 patients received cisplatin and 79 received carboplatin as initial chemotherapy. CR rates in Cycle 1 exceeded 90% in Study 1 and 80% in Study 2 (Table). As expected, overall nausea rates were somewhat lower than CR rates (87% Study 1, 80% Study 2). Overall CR rates were maintained over subsequent cycles in Study 2 (87%, 95% and 94% in Cycles 2-4, respectively). Figure 1
Conclusion:
As a combination antiemetic agent targeting two critical pathways associated with emesis, NEPA offers a convenient and highly effective option for prevention of CINV in lung cancer patients receiving platinum-based emetogenic chemotherapy.
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ORAL29.04 - The Impact of Perioperative Immunonutrition on Tissue Healing and Infection Related Morbidity in Patients Undergoing Lung Resection for NSCLC (ID 1462)
16:45 - 18:15 | Author(s): G. Olgaç, T. Cosgun, M. Vayvada, S. Bayram, G. Yanikkaya Demirel, F.T. Akdeniz, Ö. Albayrak, G. Terzioglu, C.A. Kutlu
- Abstract
- Presentation
Background:
Despite several improvements in surgical techniques and postoperative management, tissue healing and infection related complications comprise substantial amount of morbidity associated with major lung resections. Perioperative use of immunomodulating diets in order to decrease the risk of acquired infections and wound complications remains controversial. This study aims to investigate the impact of perioperative immunonutrition over a standard regimen in decreasing tissue healing and infection related morbidity and if any, its relation to immune cell function in patients undergoing major lung resection for NSCLC.
Methods:
Seventy-eight patients undergoing a major lung resection for NSCLC were randomized into two groups to receive either study formula enriched with L-arginine, nucleotides and ω-3 polyunsaturated long-chain fatty acids (Group S; n=39) or isocaloric and isonitrogenous standard formula (Group C; n=39) starting at least 4 days prior to scheduled operation and discontinued on the 8th postoperative days at the earliest. At least half of the required daily calorie intake of each patient was supplied with their assigned nutrition formula. Primary outcome of the study was incidence of tissue healing and infection related morbidity, including prolonged air leak, bronchopleural fistula, wound infection, empyema, pneumonia and sepsis leading to prolonged hospital stay and/or both ICU and hospital readmissions. Leukocyte (WBC) and Lymphocyte counts, CRP, and ratio of CD4/CD8 were also obtained as secondary outcomes at 4 different time points (t1=Randomization; t2= 1st postoperative day; t3= Prior to discharge or 7th postoperative day; t4= 1st outpatient visit following discharge).
Results:
Demographic and preoperative clinical characteristics were comparable between the groups. All patients achieved targeted nutritional support during the study period. Incidence of tissue healing and infection related morbidity was significantly higher in Group C than in Group S [20 (51%) vs. 9 (23%); p=0.02)]. Cumulative rate of both ICU and hospital readmissions were also higher in Group C than in Group S [12 (31%) vs. 4 (10%), respectively; p=0.049], although this difference was not reflected to the median length of hospital stay [5 (4-7) vs. 5.5 (4-9) days, respectively; p=0.12]. Compared to randomization, WBC was significantly higher in Group C than in Group S throughout the postoperative period (8.0x10[3] vs. 8.1x10[3], 14.0x10[3] vs. 12.1x10[3], 12.2x10[3] vs. 10.4x10[3] and 11.8x10[3] vs. 9.8x10[3] for t1, t2, t3 and t4, respectively; p=0.01). Lymphocyte counts as percentages of total WBC declined considerably during the postoperative period in both groups; however this drop was significantly more evident in Group C than in Group S (22.7% vs. 23.5%, 10.2% vs. 16.7%, 14.8% vs. 18.9% and 16.8% vs. 18.7% for t1, t2, t3 and t4, respectively; p=0.01). Confirming the favorable effect on immunity, CD4/CD8 ratio was significantly higher in Group S during postoperative period, reaching its maximum value at t3 (1.6 vs. 1.5, 1.8 vs. 1.3, 2.2 vs. 1.5 and 2.0 vs. 1.4 for t1, t2, t3 and t4, respectively; p=0.02).
Conclusion:
This study suggests that supplementary immunonutrition enriched with L-arginine, nucleotides and ω-3 polyunsaturated long-chain fatty acids may help reducing the incidence of tissue healing and infection related complications in patients undergoing lung resection for NSCLC.
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ORAL29.05 - Discussant for ORAL29.01, ORAL29.02, ORAL29.03, ORAL29.04 (ID 3543)
16:45 - 18:15 | Author(s): R.J. Gralla
- Abstract
- Presentation
Abstract not provided
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ORAL29.06 - Skeletal Muscle and Lean Body Mass Loss Are Associated with Poorer Prognosis in Patients with NSCLC Treated with Afatinib (ID 3053)
16:45 - 18:15 | Author(s): M. De La Torre-Vallejo, J. Turcott, J. Luvián, O. Arrieta Rodriguez
- Abstract
- Presentation
Background:
Irreversible tyrosine kinase inhibitors of the epidermal growth factor receptor (EGFR) such as afatinib have shown clinical benefits and prolonged survival in patients with NSCLC. Weight loss and sarcopenia are common in NSCLC patients and have been recognized as important prognostic factors of toxicity and survival. The aim of this study was to assess the impact of muscle and
Methods:
Patients diagnosed with NSCLC, who progressed to prior chemotherapy, received 40 mg of afatinib. Skeletal muscle (SM) was quantified by computed tomography scan analysis using pre-established Hounsfield (HU) unit threshold and lean body mass (LBM) was calculated with the following formula: LBM (kg)=(0.30 × (skeletal muscle area at L3 using CT (cm[2]))+6.06). These variables were estimated at baseline (T0) and after four months of treatment with afatinib (T1).
Results:
Eighty-four patients were assessed at baseline. 70.2% were female, mean age was 59.3±1.6 years, 94% had adenocarcinoma, 53.6% received afatinib as 2nd line of treatment, and 91.7% had a good performance status (ECOG 0-1). Patients included were both EGFR+ (23.8%) and EGFR- (76%). Body composition evaluation was obtained at T0 and T1 in 46 patients, median differences (∆) between T0 and T1 for SM, LBM and weight were -1.4(-56.8, +27.9 cm[2]), -0.42(-17,-8 kg) and -0.1(-12,+6), respectively, and were not statistically significant. Median OS and PFS were 23.8(17.9-29.7) months and 8.9(5.5-12.4) months, respectively (including EGFR+ and EGFR-). Weight loss was not statistically associated with poorer OS or PFS. However, SM and LBM loss greater that the median had a negative impact on PFS and OS. Figure 1(Figure1).
Conclusion:
SM and LBM changes throughout treatment with EGFR TKIs should be evaluated. Nutritional interventions should be focused on the maintenance of SM and LBM. Further clinical trials should focus on interventions improving these body composition variables since they are associated with better OS and PFS in patients with NSCLC treated with afatinib.
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- Abstract
- Presentation
Background:
The systemic immunonutritional status has been postulated as related to the long-term prognosis in various cancer types. However, no studies have assessed the prognostic role of prognostic nutritional index (PNI) on the survival of patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR)-activating mutations and receiving tyrosine kinase inhibitors (TKIs).
Methods:
Advanced NSCLC patients with sensitive EGFR mutations (19 deletion or L858R in exon 21) were retrospectively screened. The PNI was calculated as 10 x serum albumin value (g/dl) + 0.005 x peripheral lymphocyte count (per mm3). Univariate and multivariate analysis were performed to assess the prognostic value of relevant parameters.
Results:
144 cases were included for analysis after eligibility review. The optimal cut-off value of PNI for OS stratification was determined as 48.78 according to a R software-engineered, web-based system. Low PNI was significantly associated with elevated CRP level (p<0.0001) and non-response to TKIs (p=0.002). High PNI (high vs low, 35.10 vs 25.67 months; HR, 0.44; 95 % CI, 0.25–0.77; p = 0.004) correlated to superior OS. Survival analysis identified PNI as an independent prognostic factor(p=0.012). Subgroup analysis revealed that PNI was generally a significant prognostic factor in different clinical situations.
Conclusion:
Low PNI correlates with worse survival in patients with advanced NSCLC harboring EGFR sensitive mutations and treated with EGFR-TKIs. The assessment of PNI could assist the identification of patients following EGFR-TKIs treatment with poor prognosis and has implications for the routine monitoring and treatment.
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ORAL29.08 - Discussant for ORAL29.06, ORAL29.07 (ID 3568)
16:45 - 18:15 | Author(s): R. Catane
- Abstract
- Presentation
Abstract not provided
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MINI 18 - Radiation Topics in Localized NSCLC (ID 139)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Localized Disease - NSCLC
- Presentations: 1
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MINI18.04 - Tumor Volume Variations and Related Dosimetric Impact During Stereotactic Body Radiation Therapy for Lung Cancer (ID 958)
16:45 - 18:15 | Author(s): P. Van Houtte
- Abstract
Background:
This study aimed to evaluate the importance of interfraction variations in gross tumor volume (GTV) during stereotactic body radiotherapy (SBRT) for early lung cancer patients and assess its impact on dosimetric GTV coverage
Methods:
Forty-seven consecutive patients undergoing SBRT were treated with 48 Gy in 4 fractions (group 1: n=35) or 60 Gy in 8 fractions (group 2: n=12). For each patient, Cone-Beam Computed Tomography (CBCT) imaging obtained at each fraction and initial planning 4DC (CT) were analyzed. GTVs were delineated on all CBCTs, and individual treatment planning was recalculated on each CBCT. Statistical analyses were performed to compare differences between independent samples: the Mann-Whitney U test was used for non-normal continuous variables analyses between groups and the χ2 test for proportions within each SBRT group. Wilcoxon signed rank test was also used to assess changes in volume, dosimetric parameters, and tumor localization. All significance tests were two-tailed and p<0.05 was considered significant
Results:
A total of 236 CBCTs were processed and analyzed. Median total treatment times were 8 days for group 1 and 19.5 days for group 2. There was a significant tumor volume change between the initial CT and the 1st CBCT (p=0.003) in group 1. This was not found in group 2 (p=0.67). GTV was significantly larger at the 2nd CBCT (p=0.003 for group 1 and p=0.049 for group 2) compared to the 1st CBCT. Volume changes were not significantly different at the 3rd fraction compared to 1st CBCT. In group 1, GTV volume significantly decreases at the 4th fraction compared to the 2nd (p=0.047). In group 2, the significant decrease in volume occurs at the 6th fraction (p=0.026). There was no association between the overall treatment time and tumor volume variations. Taken individually (n=47) 83% of tumors have at least one occurrence of a greater than 15% volume change during SBRT compared to the 1[st] CBCT. Variations of more than 20%, 30% and even 40% were observed in ~60%, 40%, and 17% of treatments, respectively. No factor that would predict a significant volume change during SBRT for the patients analyzed could be identified. In group 1, tumor coverage factor (>95%) for any given fraction deviated no more than 5% from optimised coverage obtained in the initial treatment plan. Although sample size is smaller, there was a trend towards lower tumor coverage factors in group 2 compared to group 1. Conformity index for all tumors still ranged from 3.41 to 13.35 in group 1, and 0.95 to 10.48 in group2, without any association with tumor volume variations or treatment time
Conclusion:
There was considerable variation in tumor volumes and more frequent than initially expected for patients undergoing lung SBRT. However, these volume changes did not significantly impact dosimetric parameters. Whether these results affect treatment and/or patient outcome remains to be investigated in prospective clinical trials
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ORAL 36 - Translational Science/Radiation (ID 151)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 1
- Moderators:E. Vokes, B. Kavanagh
- Coordinates: 9/09/2015, 16:45 - 18:15, Mile High Ballroom 2c-3c
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ORAL36.08 - Discussant for ORAL36.04, ORAL36.05, ORAL36.06, ORAL36.07 (ID 3567)
16:45 - 18:15 | Author(s): P. Van Houtte
- Abstract
- Presentation
Abstract not provided
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