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P. Garrido



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    MO13 - SCLC I (ID 118)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO13.09 - Small cell lung cancer in daily practice; SCOT registry (Small cell lung Cancer treatment and OuTcome) (ID 2300)

      10:30 - 12:00  |  Author(s): P. Garrido

      • Abstract
      • Presentation

      Background
      The SCOT registry is an international, multicenter, observational registry of newly diagnosed patients with SCLC. The treatment plan remained the responsibility of the patient’s physician and data collected in this registry reflect a "real world" approach for the diagnosis and treatment of patients with SCLC.

      Methods
      56 centers included 507 evaluable patients between 10[th] of November 2009 to 18[th] of August 2010. Participating countries are from Western Europe, Eastern Europe and Korea. Data has been entered into an electronic CRF via the internet.

      Results
      Mean age was 65.4 years, 73% of the patients were male, mean BMI was 25.5 Kg/m2. Smoking status showed 50% were current and 46% former smokers. The most common symptoms at presentation (>25%) were cough, dyspnea, weight loss and fatigue. Patients presented with an ECOG status of 0 (24%; 33% for limited disease (LD) and 19% for extensive disease (ED)), ECOG 1 (52%), ECOG 2 (19%) and ECOG 3 (5%). Histology was small cell carcinoma in 98% of patients and 66% presented with extensive disease. Chemotherapy alone was given to 59% of patients in the first 6 months of treatment. 58% of patients had one line of therapy, 26% had 2 lines, 11% had 3 lines of therapy and 4% had 4 lines or more. The agents most commonly used in each line of therapy are below: Table 1: Chemotherapy agents by line of therapy in SCOT (% within the treatments of the line)

      AGENT/LINE FIRST SECOND THIRD > 3
      Platinum/Etoposide 90.7 26.8 14.5 10.5
      Topotecan 0.2 25.7 20.2 2.3
      Taxanes 2.1 9.3 21.7 26.3
      Cyclophosphamide 3.9 10.9 11.6 15.8
      Cyclo/Vincristine 3.9 12.0 11.6 15.8
      Vinorelbine 0.2 1.1 2.9 2.3
      Gemcitabine 0.0 2.2 0.0 6.8
      67 % of patients with LD received chemo + thoracic radiotherapy. PCI in the first 6 months was given in 26% of patients (LD 34% ED 22%). Best overall response at 6 months in patients with combined chemoradiotherapy was PR=51%, CR=22%, SD=16%, PD=11%. Median overall survival (OS) was 10.6 months [95%CI 9.6, 12.1] with 17.8mo for limited disease and 8.7mo for extended disease. Western Europe and Korea showed OS of 11.5mo and 11.3mo respectively whereas in Eastern European median OS was 9.1 months.

      Conclusion
      This observational study captured real world data of the current treatment paradigm of SCLC. Patients are commonly treated with etoposide/platinum or chemoradiotherapy as first line. The combination of platinum and etoposide remains by far the first choice of chemotherapy in 1[st] line and often at relapse, followed by topotecan starting from second line and beyond. Details on patterns of disease, treatment and efficacy by region and smoking status plus medical resource utilisation will be available at the meeting.

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    MO25 - NSCLC - Combined Modality Therapy II (ID 112)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Mesothelioma
    • Presentations: 1
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      MO25.03 - Safety data from a Phase II study of pemetrexed (PEM) and cisplatin (CIS) with concurrent thoracic radiation after PEM+CIS induction in patients with unresectable locally advanced (LA) Non Squamous Non-Small Cell Lung Cancer (NS-NSCLC) (ID 226)

      10:30 - 12:00  |  Author(s): P. Garrido

      • Abstract
      • Presentation
      • Slides

      Background
      This single-arm multicenter Phase II study investigated the efficacy and safety of PEM+CIS induction chemotherapy (CT) followed by full-dose PEM+CIS with concurrent radiotherapy (RT) in patients with LA NS-NSCLC. The 1-year progression-free survival (PFS) rate (primary endpoint) was 51.3% (ESMO 2013). Here, we report the safety data for induction CT and concurrent CT+RT.

      Methods
      Patients with unresectable Stage IIIA/IIIB NS-NSCLC (AJCC Version 6), ECOG-PS 0-1 and forced expiratory volume (FEV) >50% of predicted normal FEV received 2 cycles of PEM 500mg/m[2] + CIS 75mg/m[2] on Day 1, every 21 days. Patients who did not progress, with no residual neurological toxicity >Grade (G)2, ECOG-PS 0-1 and lung V20<35% were candidates to receive 2 cycles of the same full-dose PEM+CIS regimen with concurrent thoracic RT of 2Gy/fraction, 5d/week for 7wks (66Gy total). All patients received vitamin supplementation/dexamethasone prophylaxis as per PEM-label.

      Results
      90 patients were enrolled in 4 European countries, 75 (83.3%) completed induction CT and started concurrent CT+RT. Characteristics of 90/75 patients starting induction/concurrent therapy: median age 61/62yrs, male 57%/53%, ECOG-PS 0 66%/65%, mean(SD) FEV 2.3(0.62)/2.3(0.59)L, adenocarcinoma 90%/92%, Stage IIIA 36%/37%. 63 of 75 patients starting concurrent CT+RT (84.0%) received all 4 CT cycles and full dose RT. Median PEM+CIS dose intensities were 90-92% during induction and >97% during concurrent CT+RT, median RT dose was 66Gy (only 6 patients <60Gy). One patient died from study-drug-related toxicity (enteritis) during Cycle 4. Four patients discontinued due to non-fatal drug- or radiation-related adverse events (AEs), 1 on induction CT (renal failure), 3 on concurrent CT+RT (hypoacusis, 2 patients with radiation esophagitis). During induction/concurrent therapy, 8 of 90 patients (8.9%)/12 of 75 patients (16.0%) had ≥1 CT dose delay due to AEs, mainly neutropenia (n=5/6). 2/6 patients (2.2%/8.0%) required CT dose reductions. 13 of 75 patients (17.3%) experienced AEs requiring interruption of radiation, mainly radiation esophagitis (9.3%). Common G1-4 toxicities are presented in the table. 41.3% of patients reported ≥1 G3/4 toxicity during concurrent CT+RT, mainly esophagitis (12.0%), neutropenia (10.7%) and leukopenia (9.3%). G3 mucositis, G3 dysphagia and G3 acute pneumonitis were each reported by 1 patient (1.3%); 6 patients (8.0%) required blood-cell transfusions. Figure 1

      Conclusion
      PEM+CIS induction CT followed by full-dose PEM+CIS with concurrent thoracic RT was well tolerated in this study. Incidences of both G3/4 and low-grade toxicities were low, not only during PEM+CIS induction CT, but also during the subsequent 2 cycles of full-dose PEM+CIS CT with concurrent thoracic RT.

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    P1.06 - Poster Session 1 - Prognostic and Predictive Biomarkers (ID 161)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Biology
    • Presentations: 1
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      P1.06-031 - Is there any role for monitoring circulating tumor cells (CTC) in stage III non-small-cell lung cancer (NSCLC) patients? (ID 2368)

      09:30 - 16:30  |  Author(s): P. Garrido

      • Abstract

      Background
      The value of CTC has not been fully examined in patients (p) with NSCLC, in particular in those with locally advanced disease

      Methods
      A prospective study to evaluate CTC in NSCLC p is been conducting. Peripheral blood samples have been collected for CTC analysis basally in all stages and after finishing chemotherapy and radiotherapy in stage III. CTC analysis is performed using CellSearch (Veridex).

      Results
      One hundred and twenty nine patients were enrolled between January 2009 and May 2013. CTC was positive (CTC ≥1) in 21% (27/129 p). The number of CTC varied between 1 and 136 (7 p had only 1 basal CTC, 4 p had 2, 4 p 3 , 2 p 4, 2 p 5 , 2 p 6 and 1 p 7, 8 11,14, 37 and 136 CTC respectively). Basal positive CTC according to the stage were: 4% stage I and II p (1/26), 13% stage III p (6/45) and 35% stage IV p (20/58). In p with positive basal CTC, no differences were found in terms of histology (adenocarcinoma 22% p (18/81), squamous 20% p (7/34), others 14% p (2/14)), smoking status (current smoker 16% (10/61 p), non-smoker 21% (3/14 p), former smoker 26% (14/54 p)), EGFR status (EGFR + 17% (2/12 p), EGFR wt 25% (25/117 p), but a statistically significant difference was found in terms of ECOG (17% ECOG 0-1 (16/97 p) versus 34% ECOG 2 (11/32 p); p: 0.044). In 58 p with stage IV no differences were found related to location of metastasis (mts): M1a 32% (5/16 p), M1b 33% (8/24 p) although none of p with brain mts showed basal CTC. With a median follow-up using inverse Kaplan-Meier of 315 days, no differences were found in terms of survival based on basaline CTC status. Data of dynamic changes are still pending

      Conclusion
      Although this study is still ongoing, the role of basal CTC in stage III NSCLC is still unclear with only 13% of p positive at diagnosis. The value as predictive factor will depend on the data of dynamic changes that will be presented at the meeting

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    P1.11 - Poster Session 1 - NSCLC Novel Therapies (ID 208)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.11-046 - Women with lung cancer harboring epidermal growth factor (EGFR) mutations: prevalence, clinical characteristics and EGFR tyrosine kinase (TKI) treatment-related outcomes. Results from the Spanish WORLD07 database (ID 3078)

      09:30 - 16:30  |  Author(s): P. Garrido

      • Abstract

      Background
      EGFR mutations define a distinct molecular subset of non-small-cell lung cancer patients (p). Prevalence, baseline clinical characteristics and outcomes for women with lung cancer harboring EGFR mutations would be of interest.

      Methods
      We analyzed the clinical characteristics of women with lung cancer harboring EGFR mutations included in the WORLD07, a Spanish prospective, multicenter, epidemiologic female-specific e-database.

      Results
      A total of 2081 newly-diagnosed women with lung cancer from 38 Spanish centers were included in the WORLD07 e-database from October/2007 to October/2012. Overall 915 p were evaluated for EGFR mutation status, and 342 of them were found to have EGFR mutation (16% of all p in the e-database, 37% of p tested). EGFR-mutated p characteristics: median age 64.6 years; 86% had offspring; 8.2% had used oral contraceptives; smoking habit: 72% never smokers, 14% current smokers, 13% former smokers; for those never smokers, second-hand smokers 35%; histology: 91% adenocarcinoma, 1.5% squamous cell carcinoma, 2% large-cell carcinoma, 5% other; EGFR mutation type: 60% deletions in exon 19, 32.5% L858R mutations, 8% exon 20 mutations, 1% exon 18 mutations, 14% unknown. Sixty-nine percent of p had stage IV disease. A total of 184 EGFR mutated p received an oral EGFRTKI as 1[st] line (ECOG PS: 0 in 24%, 1 in 53%, 2 in 13%, 4 in 4%, unknown in 5%) achieving a 59% response rate (RR), 20% stable disease (SD), 10% progression (PD) and 11% not evaluable (NE); with a median follow-up of 12 months, median overall survival for these p was 21 months. A total of 72 p received an EGFRTKI as 2[nd] line with 37% RR, 34% SD, 19% PD and 10% NE. Only 16 p received an EGFRTKI as 3[rd] line, achieving a 38% RR, 19% SD, 31% PD and 12.5% NE. For those EGFR mutated women receiving an EGFRTKI as 1[st] line, RR to an EGFRTKI was 70% in those women harboring deletion in exon 19, and 45% in those with L858R mutation; median overall survival was 24 months in those with deletion in exon 19, and 17 months in those with L858R mutation. Response rate to an EGFRTKI as 1[st] line treatment was 59% in never-smoker p and 53% in current-smoker/former-smoker p with a median overall survival of 23 months and 21 months, respectively.

      Conclusion
      According to our prospective e-database of women with lung cancer, not selected for clinical trials and including all histologies, a high proportion harbor an EGFR mutation (16% of non-selected women, 37% of those tested). The vast majority of women with lung cancer harboring EGFR mutation are never smokers, have adenocarcinoma histology and outcomes similar to those previously reported in the literature. Additional epidemiologic and treatment data will be presented at the meeting.

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    P2.22 - Poster Session 2 - Epidemiology, Etiology (ID 167)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Prevention & Epidemiology
    • Presentations: 1
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      P2.22-008 - Analysis of family history of cancer in women with lung cancer (WLC) from the Spanish WORLD07 database (ID 2430)

      09:30 - 16:30  |  Author(s): P. Garrido

      • Abstract

      Background
      Gender differences in lung cancer (LC) have been reported, but with many unresolved issues . Family history of cancer might play an important role in lung cancer, especially in never-smoker patients. The aim of this study was to analyze potential clinical, molecular and epidemiological differences between WLC with or without family history of cancer.

      Methods
      WORLD07 is a Spanish prospective, multicenter, epidemiologic female-specific LC database sponsored by ICAPEM, a professional association committed with WLC research. Clinicopathologic data, tumor genotype, family and personal history of cancer were collected and analyzed in order to detect differences between both groups.

      Results
      From October/2007 to November/2012, 2081 WLC were included in an e-database from 32 centers. Family history of cancer was common (49.4%, in first-degree was 77%), family history of lung cancer was present in 33%, of breast cancer in 25% and of colorectal cancer in 17%. No differences in median age of diagnosis of LC, previous hormonal therapy, number of children, menstrual status, tumor histology or stage at diagnosis were observed between WLC with or without family history of cancer. WLC with family history of cancer were ever smokers in a higher percentage (63% vs 56%, p=0.006), with no differences in passive smokers. The presence of EGFR mutations was similar in WLC with family history of cancer versus WLC without family history (38% vs 37%), although WLC patients with family history of cancer had a higher rate of exon 21 mutation (36% vs 28%), both in smokers WLC (32% vs 16%, p=0.220) and in never smokers WLC (43% vs 32%, p=0.094). The median overall survival was 25 months (CI95% 21.0-29.0) for WLC with family history of cancer and 22.0 months (CI95% 19.4-24.5) for patients without family history of cancer (p=0.027). Of note, the median overall survival was 34.8 months (CI95% 22.9-46.6) for WLC with family history of LC and 22.5 months (CI95% 20.5-24.5) for patients without family history of LC (p< 0.001).

      Conclusion
      The presence of familiar history of cancer in WLC patients included in the WORLD07 database was high (49.4%), being lung cancer the most common, followed by breast cancer. No clinical or pathologic characteristic differences were observed between patients with or without family history of cancer. The presence of EGFR mutations was similar, although WLC patients with family history of cancer had a higher rate of exon 21 mutation. The median overall survival was significantly higher in WLC patients with family history of cancer and LC. Family history of cancer, especially of LC, might have a role in LC development and deserves further studies focused in inherited genetic alterations related with an increased susceptibility to LC.

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    P2.24 - Poster Session 2 - Supportive Care (ID 157)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Supportive Care
    • Presentations: 1
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      P2.24-021 - Adjuvant or Induction chemotherapy for Non Small Cell Lung Cancer treated with chemoradiotherapy: An invidual data metaanalysis of phase II trials (ID 1421)

      09:30 - 16:30  |  Author(s): P. Garrido

      • Abstract

      Background
      it is well known that combining chemotherapy and radiation therapy is beneficial to patients with locally advanced non small cell lung cancer compared to radiation alone or compared to a sequential approach using chemotherapy and radiation therapy. However, it is not obvious what is the best schedule. A few randomized trials assessed chemotherapy as induction before chemoradiotherapy (CT -> CTRT) versus chemotherapy as consolidation, after chemoradiotherapy (CTRT -> CT). Most of those trials are phase II trials with moderate sample sizes and were not designed to demonstrate treatment effect in terms of overall survival.

      Methods
      the study coordinators of those trials (T. Berghmans, H. Choy, P. Fournel, P. Garrido, J. Van Meerbeeck) agreed on a protocol for carrying out a meta-analysis of individual patients data and for sharing the individual patients data that were sent to the coordinating institution. Overall survival was the primary outcome, progression-free survival and toxic death occurrence were among the secondary outcomes. The treatment effect was assessed through the estimation of the hazard ratio of the survival distributions using CTRT -> CT as reference. Combined hazard ratio was obtained through Cox regression models (fixed effects) with a stratification by trial. Preplanned interactions between baseline covariates (age, sex, performance status, stage, histology) and treatment effect were assessed. Toxic death rates were analyzed per trial and odds ratios have been estimated to assess the treatment effect. Combined odds ratio was obtained by the Peto method.

      Results
      the data bases of the 5 eligible identified trials (3 with cisplatin based chemotherapy regimens, 2 with carboplatin based regimens) were shared for a total of 534 patients (CT -> CTRT 271, CTRT -> CT 263). Median ages were 60 and 61 years, stage IIIB represented 69%/70% of the patients and EOCG PS > 1 was rare (3%/2%). Median follow-up ranged from 12 months up to 66 months and rates of events from 44% to 88%. No significant difference was detected either for overall survival with an estimated HR of 0.96 (95% CI : 0.79-1.17) without heterogeneity between the 5 trials (I[2]=0) or for progression-free survival (analysis restricted to 4 out of the 5 trials), HR=0.91 (95% CI : 0.75-1.11) and absence of heterogeneity (I[2]=2%). For both outcomes, no interaction between the above specified covariates and treatment effect was found. Toxic deaths occurred overall in 3% of the patients, no detectable impact of treatment arm was found with a combined odds ratio of 0.40 and a 95 % CI overlapping 1 (0.15-1.06).

      Conclusion
      our results suggest that there is no argument in favour of one of the two therapeutic schedules when looking at overall survival or at progression free survival; however, in the absence of benefit in terms of prognosis, a more detailed evaluation of toxicity is warranted and is ongoing.