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S. Peters
Moderator of
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MO24 - NSCLC - Chemotherapy III (ID 110)
- Event: WCLC 2013
- Type: Mini Oral Abstract Session
- Track: Medical Oncology
- Presentations: 14
- Moderators:R. Feld, S. Peters
- Coordinates: 10/30/2013, 10:30 - 12:00, Parkside Ballroom A, Level 1
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MO24.01 - Treatment of elderly (70 years or older) with lung cancer. A four-year material in clinical practice from Karolinska University Hospital - Sweden. (ID 2562)
10:30 - 10:35 | Author(s): H. Koyi, E. Brandén, G. Hillerdal
- Abstract
- Presentation
Background
Sixty percent of all neoplasms and two-thirds of all deaths due to cancer occur in persons older than 65 years. More than 50% of patients with lung cancer are older than 65 years and 30% older than 70 years. With more persons surviving to older age treatment of the elderly with lung cancer has become an important issue.Methods
All patients 70 years or older with non small cell lung cancer (NSCLC) seen at the Department of Respiratory Medicine and Allergy, Karolinska Hospital from 2003 to 2006 were retrospective reviewed. In all 659 patients were analyzed.Results
The mean age was 78 years, 55.5 (%) were men. 93,2% of the males and 82.1% of the females were smokers or former smokers. There was a significant differences between smoking habbits among the genderas (P<0.0001). 77.2 (%) had PS 0-2. 38.4% adenocarcinoma, 9.8% with small cell lung cancer, 20.6% squamous cell carcinoma, 15.6% had clinical lung cancer and the others broncheoalveolar cell carcinoma or low differentiated carcinoma were 15.3%. 10.7% underwent radical surgery, 24% received chemotherapy only, 17.8% radiotherapy against the tumour (there of stereotactic 4.4%), and 3.7% concomitant chemo-radiotherapy. 7.4% received radiotherapy against metastases, and 32.1% had no therapy. Only 10% were given second-line chemotherapy. Median survival for patients 70-75, 76-80 and >80 years was 231, 250 resp 213. Median survival for patients with PS=0 was 810 days, those with PS=3 only 109 days. Median survival was 610 days for patients given second line chemotherapy. Survival among those who received only first line chemotherapy was 285 days.Conclusion
Significant survival among patients given second line chemotherapy (p<0.003). Significant survival among patients between 70-80 versus > 80 years old (P<0.001). Treatment of elderly patients with lung cancer is feasible if they have a good PS and seems to result in prolonged survival.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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MO24.02 - Treatment decisions for elderly patients with advanced non-small cell lung cancer (NSCLC) in Italian clinical practice: results from the RIGHT-3 project by Italian Association of Medical Oncology (ID 3115)
10:35 - 10:40 | Author(s): E. Maiello, S. Barni, A. Ardizzoni, F. Cappuzzo, R. Chiari, E. Maranzano, S. Novello, C. Bennati, M. Di Maio, A. Ori, S. Rizzoli, L. Crino
- Abstract
- Presentation
Background
In 2004, the Italian Association of Medical Oncology (AIOM) created the RIGHT (Research for the identification of the most effective and highly accepted clinical guidelines for cancer treatment) program. The third step of the program, RIGHT3, aimed to evaluate the concordance between AIOM lung cancer guidelines and clinical practice in Italy. Description of treatment decisions for elderly patients with advanced non-small-cell lung cancer (NSCLC) was among the indicators. According to 2009 AIOM guidelines, single-agent chemotherapy with a third-generation agent was a reasonable choice for elderly patients with advanced NSCLC, whilst evidence about use of platinum-based treatment in the elderly population was judged potentially affected by selection bias and not conclusive.Methods
RIGHT3 was a retrospective observational study conducted in a sample of 53 Italian lung cancer centers, representative of 230 AIOM centers. Patients with NSCLC diagnosis who had their first visit at the oncology center during 2010 and followed-up for at least 6 months were included. Proportion of elderly patients with stage IV disease receiving chemotherapy was among the 14 indicators evaluated.Results
Overall, 306 pts with stage IV NSLSC were enrolled, and 299 were evaluable. Of these, 91 (30.4%) were older than 70. In the elderly subgroup, 81 pts (89%) were treated with first-line chemotherapy. In detail, a single-agent treatment was administered in 28 (34.6%) of cases, and a combination chemotherapy in the other 53 cases (65.4%). Among pts receiving platinum-containing doublets, carboplatin was more frequently used than cisplatin: carbo-gemcitabine (16 pts), carbo-pemetrexed (12 pts), cisplatin-pemetrexed (8 pts), cisplatin-gemcitabine (7 pts), carbo-vinorelbine (4 pts) were the 5 most frequently used regimens.Thirty pts (33%) received a second-line chemotherapy: single-agent in 23 cases, combination chemotherapy in 7 cases.Conclusion
First-line platinum-based combination chemotherapy was commonly used in elderly patients with advanced NSCLC in 2010 by the Italian Lung cancer centers involved. First-line single-agent treatment, recommended by AIOM 2009 guidelines as the treatment choice with highest level of evidence, was used only in a minority of patients.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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MO24.03 - Treatment of elderly patients ( > 70 years ) with non-small cell lung cancer given chemotherapy. A four-year material in clinical practice from Karolinska University Hospital - Sweden. (ID 3257)
10:40 - 10:45 | Author(s): H. Koyi, G. Hillerdal, E. Brandén
- Abstract
- Presentation
Background
Sixty percent of all neoplasms and two-thirds of all deaths due to cancer occur in persons older than 65 years. More than 50% of patients with lung cancer are older than 65 years and 30% older than 70 years. With more persons surviving to older age treatment of the elderly with lung cancer has become an important issue.Methods
All patients 70 years or older with non small cell lung cancer (NSCLC) given chemotherapy at the Department of Respiratory Medicine and Allergy, Karolinska Hospital from 2003 to 2006 were retrospective reviewed. In all 149 patients were analyzed.Results
The mean age was 75,5 years and median 74 years. 54.4 % were male. 96,3% of the males and 88.2% of the females were smokers or former smokers. There was a significant differences between smoking habitts among the genderas (P<0.05). 16.1% , 50.3% and 27.5% had PS 0 resp 1 resp 2. 57.7% and 30.9% with stage IV resp III . 32.9% adenocarcinoma, 24.8% squamous cell carcinoma, and the others broncheoalveolar cell carcinoma or low differentiated carcinoma were 24.2%. 18.1% of the patients had no histopathological diagnosis – clinical diagnosis. Almost all the patients were given carboplatin/gemcitabin as first line chemotherapy regardless of histology. Four cycles was given to almost all the patients. Only 27.5% were given second-line chemotherapy. Median overall survival was 285 days. Longer overall survival among 70-80 vs > 80 years old patients.Conclusion
Significant survival among patients between 70-80 versus > 80 years old.. Treatment of elderly patients with lung cancer is feasible if they have a good PS and seems to result in prolonged survival.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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MO24.04 - Assessment of health care patterns for elderly lung cancer patients in Ontario, Canada (ID 1463)
10:45 - 10:50 | Author(s): D.E. Dawe, G.R. Pond, P.M. Ellis
- Abstract
- Presentation
Background
The number of seniors in Canada is expected to double by 2036 and 40% of new cancers are diagnosed in those ≥70 years. New data over the last decade suggests an increasing role for systemic treatment options for elderly lung cancer patients. However, age-related changes in organ function, co-morbid health problems, and a greater risk of death from other causes may impact on toxicity and expected survival gains. Historically, many oncologists excluded older patients from receiving chemotherapy. This study investigated trends in the treatment of NSCLC patients over the last decade contrasting patients ≥70 years to those <70 years old.Methods
We conducted a retrospective cohort study of NSCLC patients (ICD-9 codes 162.2-162.9) residing in Ontario and diagnosed between January 1, 2000-December 31, 2010. Data including demographic, staging, treatment and outcome information were extracted by the Institute for Clinical Evaluative Sciences and de-identified before release. The primary outcomes were the proportion of elderly v non-elderly patients referred to an oncologist and receipt of chemotherapy. Standard statistical methods were used.Results
Of 61,646 patients, 32,131 (52.1%) were ≥70 years. There was an increase in the number and proportion of cases diagnosed in the elderly over the time period. Fewer adenocarcinomas were diagnosed in the elderly (29.8 v 44%) and more elderly patients lacked microscopic confirmation of malignancy (20.1 v 6.2%). Charlson co-morbidity scores and the need for homecare services prior to diagnosis (12.6 v 4.7%) were higher in the elderly. Staging information was inconsistent prior to 2007. In 53.6% of patients, stage was unknown. Stage distribution in remaining patients was: I (18%), II (6%), III (28%), IV (48%). Referral to any lung cancer specialist (defined as medical oncologist, radiation oncologist, or thoracic surgeon) was significantly lower in the elderly population (80.6 vs 93.9%). This was true for each sub-specialty. Only 59.5% of elderly lung cancer patients were referred to a medical oncologist, compared to 78.5% of younger patients. The elderly were less likely to receive chemotherapy (18.3 v 46.7%), even after referral to medical oncology. Elderly patients had a shorter overall (5.8 v 9.6 months) and lung cancer specific survival (9.5 v 13.9 months). Among patients receiving chemotherapy, there was less difference in overall (13.6 v 14.9 months) and lung cancer specific survival (18.6 v 19.9 months). Receipt of chemotherapy increased only marginally among elderly patients between 2000 and 2010. P-values for all comparisons (p<0.001).Conclusion
There is evidence of disparity in treatment of elderly lung cancer patients. Fewer patients ≥70 years old are referred to a lung cancer specialist and receive treatment. This trend is particularly evident for referral to medical oncology and receipt of chemotherapy. In those elderly patients who receive chemotherapy, their survival approximates that seen in younger patients. Published evidence supporting the use of chemotherapy in the elderly does not appear to have been implemented into practice.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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MO24.05 - DISCUSSANT (ID 3942)
10:50 - 11:00 | Author(s): C.J. Langer
- Abstract
- Presentation
Abstract not provided
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MO24.06 - Randomized Phase II study of Pemetrexed plus Carboplatin followed by Pemetrexed versus Paclitaxel plus Carboplatin followed by Pemetrexed in Advanced Non-squamous, Non-small Cell Lung Cancer (LOGIK 0904). (ID 2235)
11:00 - 11:05 | Author(s): Y. Shiraishi, K. Inoue, M. Takeshita, T. Harada, N. Tashiro, T. Seto, T. Imanaga, N. Fujimoto, N. Nakagaki, M. Kawasaki, J. Kishimoto, K. Takayama, Y. Ichinose
- Abstract
- Presentation
Background
PARAMOUNT study confirmed the improvement of overall survival with continuation maintenance chemotherapy with pemetrexed (PEM) compared with placebo after 4 cycles of cisplatin plus PEM induction chemotherapy recently. JMEN study also showed the usefulness of switch maintenance with PEM after 4 cycles of platinum doublet without PEM. In this study, we conducted the randomized phase II study comparing switch or continuation maintenance chemotherapy with PEM after standard doublet regimen.Methods
Histologically/cytologically confirmed stage IIIb or IV non-squamous NSCLC patients with mesurable disease, ECOG PS 0-1, age over 20 years and adequate organ function were eligible for the study. Randomization was stratified by gender and stage of disease. Patients received 3 cycles of PEM 500mg/m2 plus CB AUC6 (Arm 1) or PAC 200mg/m2 plus CB AUC6 (Arm 2). All patients with non-PD after induction chemotherapy continued PEM 500mg/m2 until PD. Primary endopoint is progression free survival (PFS).Results
140 pts were enrolled and assigned to Arm1 or Arm2 randomly. The clinical data of 132 pts were used as full analysis set (median age 64.5 yrs (42-83), 85 male, 120 stage IV, 58 PS0, 127 adenocarcinoma, 46 never smoker). 42 pts had prior treatment including 9 sugery, 1 adjuvant chemotherapy, 24 radiotherapy and 8 others. In both arms, 50% of pts entered into the maintenance treatment with PEM after completion of 3 cycles induction chemotherapy. The median PFS was 113 days in Arm 1 and 143 days in Arm 2, respectively. Cox-proportinal Hazard ratio was1.047, and 95% HR confidential interval was 0.707-1.549. Stratified Log-Rank test showed no significant difference in both arms.Conclusion
There was no significant difference for PFS in Arm 1(PEM plus CB followed by PEM) and Arm 2 (PAC plus CB followed by PEM).Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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MO24.07 - nab-Paclitaxel plus carboplatin in patients (pts) with squamous cell (SCC) non-small cell lung cancer (NSCLC): analysis of pts treated beyond 4 cycles in a pivotal phase 3 trial (ID 3438)
11:05 - 11:10 | Author(s): M.A. Socinski, D. Spigel, A. Ko, M.F. Renschler
- Abstract
- Presentation
Background
Continuous maintenance is defined as continuation of ≥ 1 first-line agents after 4-6 cycles of induction therapy in pts who have not progressed. In a pivotal phase 3 trial, first-line treatment to progression with nab-paclitaxel (nab-P, 130-nm albumin-bound paclitaxel particles) + carboplatin (C) vs solvent-based paclitaxel (sb-P) + C resulted in a 68% improvement in response rate (41% vs 24%; P < .001) and a trend toward improved survival (median, 10.7 vs 9.5 months; P = .808) in the subset of pts with SCC. This unplanned exploratory analysis examined outcomes in pts with SCC receiving > 4 cycles of nab-P/C to assess the feasibility of the nab-P/C regimen in the maintenance setting in SCC.Methods
Pts with untreated stage IIIB/IV NSCLC were randomized 1:1 to nab-P 100 mg/m[2] on days 1, 8, 15 or sb-P 200 mg/m[2] on day 1 every 21 days; both arms received C AUC 6 on day 1. Overall response rate and progression-free survival (PFS) were determined by blinded centralized review. To allow comparison of the results of this analysis with maintenance studies, PFS is expressed from day 1 of cycle 5 (C5D1).Results
229 pts with SCC received nab-P/C and 221 received sb-P/C in this study. In the nab-P/C arm, 60% (n = 138) of pts with SCC were progression-free at the end of cycle 4 and entered cycle 5 (the study population). In these pts, the median PFS was 3.4 months (range 2.8 – 4.2) from C5D1. The median OS from randomization in these pts was 13.8 months (range 12.4 – 16.8). Survival at 1year was 59% (51% – 67%). The median number of treatment cycles was 7 (range 5 – 31). A total of 125 (91%), 64 (46%) and 35 (25%) pts were treated for up to 6, 8 and 10 cycles, respectively, with a median weekly dose of 75 mg/m[2 ]for nab-paclitaxel in each group, and carboplatin AUC of 6, 4.75, and 4.5, respectively. Preliminary safety findings in this population revealed that the most common grade 3/4 treatment-related adverse events were neutropenia (49%), anemia (31%), and thrombocytopenia (27%). The overall rate of grade 3 peripheral neuropathy in the nab-P/C arm was 4% (with no grade 4); 1%, 3%, and 0% of pts had grade 3 peripheral neuropathy at cycle 6, 8, and 10, respectively.Conclusion
Continued treatment with nab-P/C to progression was feasible, well tolerated, and effective in pts with advanced SCC who had not progressed after 4 cycles of first-line therapy. Future randomized, prospective studies are warranted to further evaluate the activity of nab-P/C as maintenance therapy in SCC pts.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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MO24.08 - Survival outcomes among NSCLC patients in Europe receiving platinum-based therapies as first-line treatment: results from the FRAME observational study (ID 1944)
11:10 - 11:15 | Author(s): P. Schnabel, E. Smit, J.D. Castro Carpeño, K. Lesniewski-Kmak, J. Aerts, R. Villatoro, K. Kraaij, C. Visseren-Grul, K. Nacerddine, Y. D'Yachkova, K. Taipale, A. Girvan, D. Moro-Sibilot
- Abstract
- Presentation
Background
FRAME was a European non-interventional prospective observational study of patients with advanced or metastatic non-small cell lung cancer (NSCLC) initiating platinum-based therapies as first-line treatment (FLT).Methods
Patients were enrolled between April 2009 and February 2011. Consenting adult NSCLC (Stage III/IV) patients initiating FLT with a platinum-based doublet chemotherapy, with or without an additional targeted agent, were eligible for the study. The choice of FLT was left to physician discretion, as per routine clinical practice. The primary objective of FRAME was to evaluate overall survival (OS) among different platinum-based treatment cohorts in patients with and without additional targeted therapy. Secondary objectives included the evaluation of OS in patients with different histological subtypes of NSCLC. Survival outcomes were assessed using Kaplan-Meier analysis, and unadjusted estimates are presented.Results
A total of 1564 eligible patients from 11 EU countries were observed. Patient cohorts were: pemetrexed + platinum, gemcitabine + platinum, vinorelbine + platinum, taxanes + platinum and other therapy + platinum. Table 1 shows a subset of baseline patient characteristics, which varied across several parameters in the treatment cohorts, including age, performance status (PS), stage and histology. The median OS across the 4 main treatment cohorts was 10.3 months (95% CI: 9.5-11.2). A subset of overall survival estimates in the different treatment cohorts is shown in Table 1.Table 1. Select baseline patient characteristics and overall survival
[a]A fifth cohort, the ‘other’ + platinum cohort contained a small number of subjects (n=40) and it was not included in the analyses presented here [b]Cisplatin is the platinum agent in the EMA approved prescription drug labelBaseline Patient Characteristics Overall Survival Estimates (unadjusted) Treatment Cohort[a] Age ≥70 Years (%) ECOG PS of 2/3 (%) Stage IV (%) Non-squamous Histology (%) All patients Median OS in Months (95% CI) Non-squamous Median OS in Months (95% CI) Non-squamous Cisplatin[b] Median OS in Months (95% CI) Pemetrexed + Platinum[b ](n=569) 23 18 86 97 10.7 (9.4-12.3) [n=569] 10.6 (9.4-12.0) [n=553] 11.6 (9.9-13.8) [n=374] Gemcitabine + Platinum[b] (n=360) 35 11 74 56 10.0 (8.4-11.8) [n=360] 8.4 (7.0-10.6) [n=201] 8.4 (6.7-10.8) [n=107] Taxanes + Platinum[b ](n=295) 36 23 75 64 9.1 (8.0-11.3) [n=295] 8.1 (7.4-10.1) [n=189] 9.6 (7.1-14.1) [n=44] Vinorelbine + Platinum[b] (n=300) 28 15 67 53 10.7 (8.9-12.8) [n=300] 10.1 (8.0-13.1) [n=160] 9.9 (7.2-13.4) [n=91] Conclusion
This observational study of first-line treatment for advanced NSCLC provides data describing patients and their survival outcomes in a real-world European practice setting between 2009 and 2012.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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MO24.09 - DISCUSSANT (ID 3943)
11:15 - 11:25 | Author(s): E. Felip
- Abstract
- Presentation
Abstract not provided
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- Abstract
- Presentation
Background
Despite the introduction of antiemetic treatments including corticosteroids, serotonin (5-HT3) receptor antagonists and neurokinin-1 receptor antagonist, chemotherapy-induced nausea and vomiting (CINV) remains major adverse toxicity of cancer chemotherapy deteriorating patient’s quality of life. It is recommended that these antiemetic treatments should be adopted according to the emetic risk classification of clinical practice guideline, however, the treatments are not so effective in delayed CINV comparing to acute CINV. The mechanism of delayed CINV is not clear so that effective antiemetic drug have not been developed yet. Iron poisoning in cases of blood transfusion or oversupply of iron supplement have various symptoms such as nausea, vomiting, gastroenteritis and liver injury caused by free radical iron, so-called Fenton reaction. We hypothesized that these symptoms are very similar to the adverse effects of cancer chemotherapy and that CINV may be related to the iron level of the patients receiving chemotherapy.Methods
The patients with lung cancer received cytotoxic chemotherapy were included to this study if the serum level of iron, unsaturated iron binding capacity (UIBC ) and ferritin before the chemotherapy, on day 2, and day 8 were available. All chemotherapeutic regimens were administered as standard practice indicated by Japan governmental insurance. The treatment regimens were classified to highly emetogenic chemotherapy (HEC), moderately emetogenic chemotherapy (MEC) and low emetogenic chemotherapy (LEC) according to the clinical practice guideline of the American Society of Clinical Oncology to investigate the relationship between the change of serum iron level and CINV.Results
A total of 37 patients (male26/femal11) were included. The number of patients of each classification were 18 in HEC (cisplatin+etoposide), 14 in MEC(caboplatin+gemcitabine, calboplatin+paclitaxel, calboplatin+etoposide, carboplatin+pemetrexed,irinotecan and amrubicin), 5 in LEC(pemetrexed). Serum iron level (μg/dl) of patients received HEC were 64.6±42.0 before treatment, 233.5±50.0 on day 2, and 235.5±41.3 on day 8. Those of MEC were 62.8±17.0 before treatment, 224.3±33.0 on day 2, and 175.7±87.6 on day 8. Those of LEC were 54.6±17.3 before treatment, 116.4±36.6 on day 2, and 40.7±33.5 on day 8. The serum iron levels of all patients markedly increased on day 2 and there were significant difference between LEC and the other two groups (p=0.01). The iron levels of LEC decreased to normal, on the contrary, those of other two groups remained abnormally high on day 8. With the increase of iron, the significant decrease of UIBC was observed implying that free radical iron appeared after the chemotherapyConclusion
Serum iron levels were closely correlated to CINV. This phenomenon may be a clue to new approach for antiemetic treatments.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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MO24.11 - A prospective multicenter observational study of chemotherapy induced nausea and vomiting in lung cancer patients (ID 862)
11:30 - 11:35 | Author(s): K. Takayama, M. Fujita, A. Ono, K. Takeda, T. Ohira, H. Isobe, N. Ebi, K. Tateishi, N. Yamamoto, Y. Nakanishi, K. Tamura
- Abstract
- Presentation
Background
Chemotherapy-induced nausea and vomiting (CINV) is one of the major causes to deteriorate patient’s quality of life. Therefore, it is important to assess the current status of CINV nationwide for the appropriate treatment method to manage CINV. For this purpose, prospective multi-center observational study was performed in Japan.Methods
Between 2011/Apr and 2012/Dec, 458 lung cancer patients who underwent systemic chemotherapy with high (HEC) or moderate emetogenic agents (MEC) were registered and the data in 429 patients were analyzed. CINV status was assessed in acute phase (within 24 hours from chemotherapy start) and late phase (after 24 hours) separately. Multivariate analysis was performed to clear the predictive factors in patient background for CINV.Results
Patient background was as follows; median age 65, 318 male and 111 female patients, 190 patients treated with HEC and 239 with MEC. In acute phase, nausea and vomiting were observed in 5.6% (HEC 6.8%, MEC 4.6%) and 1.2 % (HEC 0.5%, MEC 1.7%) of all patients, respectively. In late phase, nausea and vomiting were observed in 40.1% (HEC 46.3%, MEC 35.2%) and 9.6 % (HEC 7.9%, MEC 10.9%) of all patients, respectively. The frequency of nausea in late phase is significantly higher in HEC than that in MEC. The predictive factors for nausea were a younger age in female patients, and younger age, no drinking history, decreased hemoglobin in male patients. The prediction of CINV by physician was relatively poor in late phase vomiting.Conclusion
In this study, the current status of CINV and antiemetic therapy in lung cancer patients in Japan were elucidated. CINV was frequently observed in late phase and the appropriate management for late emesis is needed according to the guideline.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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- Abstract
- Presentation
Background
POLI is one of the Y-family polymerases, which are considered as error-prone replicases with low fidelity and involved in translesion synthesis (TLS) pathway. Polymorphisms on POLI genes may affect efficiency of DNA damage tolerant repair, therefore affect the platinum-based chemotherapy tolerance in tumor tissue and maintain routine function of normal organs. Our study aimed to investigate the association of five SNPs of POLI at codon 731, 5’-upstream and 3’UTR with prognosis and severe toxicity in advanced NSCLC patients in eastern developed regions in China.Methods
663 stage III-IV aNSCLC patients treated with first-line platinum-based chemotherapy were genotyped with MassARRY platform on the five polymorphisms.Results
p.731Ala (G of rs8305) indicated protective tendency from severe grade III-IV gastrointestinal toxicity in a dominant genetic model (adjusted odds ratio for Ala/Ala+Ala/Thr: 0.51, 95% confidence internal, 0.28-0.93； P for trend = 0.028). Stratified analysis revealed that the protective effect was rather for cisplatin- than carbonplatin-based regiments (adjusted OR for Ala/Ala+Ala/Thr: 0.38, 95% CI, 0.18-0.81； P for trend = 0.012). As linked loci of rs8305, rs3730668 on 5’-upstream and rs513543 on 3’-UTR of POLI performed similar protective tendency to gastrointestinal toxicity. No significant association was discovered for these five SNPs with other hematological toxicity, progress-free survival and overall survival. Both haplotype and diplotype analysis revealed consistent result as single polymorphism analysis. Haplotype “AAA” (in the order of rs3730668-rs8305-rs513543) indicated a significant susceptibility to gastrointestinal toxicity (adjusted OR: 1.92; 95% CI, 1.19-3.10; P = 0.007).Conclusion
For the first time, our study indicated error-prone replicase POLI was associated with gastrointestinal toxicity in aNSCLC patients accepting first-line platinum-base chemotherapy, especially for cisplatin-based regiments.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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- Abstract
- Presentation
Background
To determine whether volumetric assessment has potential as a predictive biomarker and to assess relationship between longitudinal tumor data during treatment and prognosis in lung adenocarcinoma patients with sensitizing EGFR mutations treated with EGFR tyrosine kinase inhibitor (TKIs).Methods
We retrospectively assessed patients with EGFR-mutant stage IV lung adenocarcinoma, who underwent EGFR TKIs as second-line therapy and this treatment was repeated every three weeks until disease progression. All 106 patients with at least one measurable lung lesions were quantitatively analyzed in terms of tumor size and volume based on the whole tumor volume, on baseline contrast-enhanced CT scans and on follow-up CT scans of every two treatment cycle. A quantify for tumor response was evaluated with growth tumor kinetics, followed by determining correlation with early tumor parameters including change of size, volume, and response rate. Cox-proportional hazard model and Log-rank test were also applied to predict the overall survival. Figure 1Results
Percent of volume change after two cycles of TKI treatment had a strong correlation with progression rate based on growth tumor kinetics (P < 0.001). Responders based on percent of volume change after two cycles of TKI treatment had a higher overall survival rate than non-responders (P = 0.001). The velocity of progression was also a good potential parameter to predict overall survival (P < 0.001). Figure 1Conclusion
Early radiologic parameters of the tumor helped predict treatment response and overall survival in EGFR mutant lung adenocarcinoma patients treated with TKIs. Longitudinal tumor data also showed potential as a predictive factor.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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MO24.14 - DISCUSSANT (ID 3944)
11:45 - 11:55 | Author(s): K. O'Byrne
- Abstract
- Presentation
Abstract not provided
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Author of
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MO06 - NSCLC - Chemotherapy I (ID 108)
- Event: WCLC 2013
- Type: Mini Oral Abstract Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:R. Perez-Soler, P.M. Ellis
- Coordinates: 10/28/2013, 16:15 - 17:45, Parkside Ballroom A, Level 1
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MO06.03 - Bevacizumab and erlotinib or bevacizumab, cisplatin and pemetrexed in patients with metastatic non-small cell lung cancer: EGFR mutation based treatment allocation and repeat biopsy at progression in the SAKK19/09 (BIOPRO) trial (ID 1862)
16:25 - 16:30 | Author(s): S. Peters
- Abstract
- Presentation
Background
Treatment allocation by EGFR mutation and maintenance therapy are two new standards for patients (pts) with metastatic non-small cell lung cancer (NSCLC). This multicenter phase II trial (NCT01116219) for the first time prospectively tested pemetrexed and bevacizumab maintenance therapy in pts with EGFR wild type NSCLC, and included repeat biopsy at progression to study molecular mechanisms of drug resistance. Pts with EGFR mutation were treated with erlotinib and bevacizumab, based on the results of the previous SAKK19/05 trial.Methods
100 pts were enrolled with metastatic nonsquamous NSCLC, sufficient material for mutation analysis and translational research, and consent to repeat biopsy at progression. Pts with EGFR wild type received 4 cycles of bevacizumab 7.5mg/kg, cisplatin 75mg/m2 (or carboplatin AUC5) and pemetrexed 500mg/m2 every 3 weeks, followed by maintenance therapy with bevacizumab and pemetrexed until progression. Pts with EGFR mutation received bevacizumab 7.5 mg/kg every 3 weeks and erlotinib 150 mg daily until progression. Pts were followed by CT-scan every 6 weeks and repeat biopsy was performed at progression. The primary endpoint was progression free survival (PFS) at 6 months. For an unpromising PFS at 6 months rate of ≤20% and a promising rate of ≥35%, 77 patients with EGFR wild type were needed to reach a power of 90% and an alpha level of 5%. Secondary endpoints were median PFS, overall survival (OS), best response rate of CR+PR (RECIST), and further biomarkers including KRAS, thymidylate synthase (TS), and multigene expression.Results
Seventy-seven pts with EGFR wild type and 20 pts with EGFR mutation were evaluable, 3 pts were not evaluable. Pts on bevacizumab and chemotherapy received on average 9 cycles (range 1-25). No unexpected toxicities were observed. PFS at 6 months was 45.5% (CI: 34.1%, 57.2%), median PFS was 6.9 (CI: 4.6, 8.3) months, OS was 12.1 (CI: 8.7, 14.7) months, and best response rate of CR+PR was 62%. Sixteen pts remain on treatment. Repeat biopsy at progression was successful in 31 of 39 (79%) of patients on trial treatment, and except for one transient pneumothorax, no relevant complications occurred. KRAS mutation was associated with poor overall survival (HR 2.0, CI: 1.05, 3.88; P=0.03), but not with PFS or best response. Pts on bevacizumab and erlotinib received on average 16 cycles (range 6-37). PFS at 6 months was 70.0% (CI: 45.7%, 88.1%), median PFS was 14.0 (CI: 8.8, NA) months, median OS is not yet reached, best response rate of CR+PR was 70%, 11 pts remain on treatment. Further analysis of serial serum and tumor samples is ongoing.Conclusion
Compared with the previous POINTBREAK trial of pemetrexed and bevacizumab maintenance in genetically unselected pts, this trial demonstrates almost identical survival rates in pts with EGFR wild type. KRAS mutation was prognostic, repeat biopsy at progression was feasible, and laboratory analysis is ongoing to validate TS and to develop a predictive gene signature. Firstline therapy with erlotinib and bevacizumab is promising in pts with EGFR mutation, and this combination is further tested in the ongoing ETOP 2-11 BELIEF trial.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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MO10 - Molecular Pathology II (ID 127)
- Event: WCLC 2013
- Type: Mini Oral Abstract Session
- Track: Pathology
- Presentations: 1
- Moderators:W.A. Franklin, A. Mahar
- Coordinates: 10/28/2013, 16:15 - 17:45, Bayside 104, Level 1
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MO10.07 - ALK immunohistochemistry and fluorescence in-situ hybridization in Lung adenocarcinomas from the ETOP Lungscape tumour cohort (ID 2267)
16:50 - 16:55 | Author(s): S. Peters
- Abstract
- Presentation
Background
The European Thoracic Oncology Platform LungScape database contains 2614 cases of primary resected lung carcinoma from 16 centres with patient demographics, pathological tumour data and detailed clinical follow-up. A total of 1281 cases of adenocarcinoma with >2 years clinical follow-up were selected for analysis of ALK status by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). Test positive cases were matched, in order of importance at ratio 1:2, by stage, gender, smoking status, study centre, year of surgery and age with test negative cases -both for IHC and for FISH testing.Methods
Testing was performed in all centres using the same protocol (IHC: Novocastra 5A4 clone antibody at 1:10 dilution, Novolink detection system. FISH: Abbott Vysis ALK break-apart probe). Each centre passed an external QA test using unknown cases in a tissue microarray before conducting the LungScape tumour testing. IHC was scored according to three intensity scores (1+, 2+, 3+) using ‘objective’ methodology previously described [1]. Maximum staining intensity was recorded. Any IHC staining was defined as IHC positive result. FISH preparations were assessed according to the Vysis protocol on all 82 IHCpositive cases plus their 164 IHCnegative matches.Results
FISH sensitivity was 87% for IHC 3+. IHCpositive/FISHnegative cases (n=54) were mostly IHC 1+ (75.9%), sometimes IHC 2+ (18.5%) and rarely IHC 3+ (5.5%). The frequency of never smokers was higher in the ALK IHCpositive group (29.3%) versus IHCnegative group (18.3%) {p=0.011}. Age, gender and tumour stage did not differ between IHC groups. The hazard of an event for IHCpositive cases decreases by 32% in relapse-free survival {RFS; p=0.03} and by 38% in either time-to-relapse {TTR; p=0.02} or overall survival {OS; p=0.016}. Multivariate models -adjusted for patient and tumour characteristics- indicated that IHC-ALK was a significant predictor for all three time-to-event outcomes (RFS, TTR, OS). In stratified Cox analysis, significantly higher OS was retained in the IHCpositive (HR=0.59, p=0.04) and FISHpositive (HR=0.34, p=0.03) cases in the matched cohorts, while conditional logistic regression yielded non-significant associations with 3-year survival status.IHC cases, n=1281 FISH positive(264 tested) IHC negative 1199 (93.6%) 0 (0.0% of 164 controls) FISH specificity: 100% IHC 1+ 43 (3.35%) 2 (4.6% of IHC 1+) IHC 2+ 16 (1.25%) 6 (37.5% of IHC 2+) IHC 3+ 23 (1.8%) 20 (87% of IHC 3+) IHC any positive 82 (6.4%) 28 (34.1% of IHC+) FISH sensitivity: 34.1% Conclusion
In this large cohort of surgically resected primary lung adenocarcinoma: ALK IHC positivity was 6.4%. IHC 3+ staining (prevalence 1.8%) showed 87% probability of ALK FISH positivity ALK IHC positivity was higher in never smokers and related to better clinical outcome ALK testing can be reliably implemented across multiple laboratories {1} Ruschoff et al. Virchows Arch. 2010;457(299-307).Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
