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N. Viñolas



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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): N. Viñolas

      • 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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    P1.19 - Poster Session 1 - Imaging (ID 179)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Imaging, Staging & Screening
    • Presentations: 1
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      P1.19-002 - An open-label, single arm trial to evaluate the predictive value of perfusion CT and early radiologic response to cisplatin (C) gemcitabine (G) and bevacizumab (B) in patients (pts) with advanced or metastatic non-squamous non-small cell lung cancer (nsNSCLC). (ID 723)

      09:30 - 16:30  |  Author(s): N. Viñolas

      • Abstract

      Background
      Classically the evaluation of response in oncology has been based in comparing pre and post treatment tumour volume by means of studying changes in the diameter lesions. The introduction of new targeted drugs creates the need of a different evaluation of tumours and their response to treatment. Functional imaging techniques that are able to study in vivo physiological processes of tissues and tumours have lately acquired more importance. The dynamic techniques may be more appropriate for assessing response to antiangiogenic drug, such as B, whose mechanism of action appears to focus on the normalization of the tumor vasculature. Preliminary studies have demonstrated significant and very early changes in flow, blood volume and tumor perfusion with therapy. These techniques could be useful to select patients those that are going to respond to drugs with an early evaluation of response by means of functional imaging

      Methods
      IMPACT is an open-label, single arm phase II study to evaluate the predictive value and early radiologic response or perfusion CT in pts diagnosed with unresectable advanced, metastatic or recurrent nsNSCLC treated with C, G and B. Pts receive B (7.5 mg/kg IV on d1), C (80 mg/m2 on d1) and G (1250 mg/m2 on d1 and 8) up to 6 cycles of 21 d. Pts with no evidence of progression of disease continue to receive single-agent B 7.5 mg/Kg on d1 every 21 d until progression or unacceptable toxicity. Primary endpoint is to assess basal results and early tumour response (at day +7) in terms of blood flow (BF), blood volume (BV), time to enhancement peak (TTEP) and permeability (P) as compared to Objective Response Rate (ORR) in terms of RECIST at d42. Secondary objectives include to assess tumour response (at d42) in terms of BF, BV, TTEP and P as compared to ORR at d42, to assess basal results in terms BF, BV, TTEP and P as compared to PFS and OS, to assess tumour response (at d7 and d42) in terms of BF, BV, TTEP and P to PFS and OS, to describe the safety profile using NCI-CTC AE and efficacy in the subgroup of adenocarcinoma. Planned sample size is 20 pts.

      Results
      not applicable

      Conclusion
      not applicable

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    P2.09 - Poster Session 2 - Combined Modality (ID 213)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Combined Modality
    • Presentations: 1
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      P2.09-004 - Phase II study of sequential versus concurrent chemotherapy and radiotherapy in poor risk patients with inoperable stage III non-small cell lung cancer (NSCLC): final results of the Spanish Lung Cancer Group 00-05 study (ID 1102)

      09:30 - 16:30  |  Author(s): N. Viñolas

      • Abstract

      Background
      Inoperable stage III NSCLC is increasingly diagnosed in poor-risk patients for whom there is not yet a standard treatment. We conducted a randomized two-stage phase II study to assess whether sequential or concurrent chemoradiation was feasible, tolerable and showed efficacy.

      Methods
      Patients with inoperable stage IIIA and B NSCLC and at least one of the following conditions: age ≤ 75 years, ECOG PS=2, weight loss > 5%, creatinine clearance < 60 ml/min, a comorbid condition precluding the patient from being treated in a protocol for fit patients,were randomized to receive either carboplatin AUC 2.5 and vinorelbine 15 mg /m[2] both on days 1,8,22, and 29, and thoracic radiotherapy (TRT) total dose 60 Gy starting day 1 (CT arm) or, carboplatin AUC 5, days 1 and 22 and vinorelbine 25 mg/m[2] days 1, 8, 22, and 29, followed by TRT 60 Gy starting day 43 to 50 (ST arm). The primary end-point was response rate.

      Results
      From June 2001 to June 2006, 70 patients from 8 centers were included : 47 in CT arm and 23 in ST arm. Forty-eight of these patients were randomized during the first stage of the trial. By September 2004, due to a decrease in treatment compliance and an increase in early deaths in the ST arm, accrual was continued in the second stage of the trial only in the CT arm. Patient characteristics: median age 74 (49-84), Male 96%, Stage IIIB 65%; ECOG =2, 28%; Weight loss >5%, 29%; Creatinine clearence <60, 26%; Comorbidity, 70%. More than one poor risk inclusion criteria: 59 %. Fifty-eight patients completed treatment 93 % in CT arm, and 73% in ST arm. There were 2 CR and 25 PR (RR 60%) in CT arm, and 10 PR (RR 45.5%) in ST arm. Grade 3- 4 hematological toxicity was absent in CT arm and was 14% (neutropenia) in ST arm. Grade 3 and 4 non-hematological toxicities experienced by more than 5% of patients were asthenia (7%) and dyspnea (9%) in CT arm and anorexia (9%), asthenia(14%), and dyspnea (14%) in ST arm. Only one patient developed grade 3 esophagitis (CT arm) There were five deaths during treatment: two in CT arm and three in ST arm. Median PFS and overall survival rate were 6.7 (95% CI:4.9-8.5) and 16.8 months (95% CI 9.5-24), and 7.9 (95% CI:3.9-16.2) and 5.6 months (95% CI:2.7-8.9 ), for the CT arm and ST arm, respectively.

      Conclusion
      In poor-risk patients with inoperable stage III NSCLC, concurrent chemoradiotherapy outperformed sequential chemotherapy and radiotherapy, and was feasible, very well tolerated, and provided efficacy. The survival outcome with concurrent chemoradiotherapy was notably longer than anticipated.

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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): N. Viñolas

      • 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.