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M.J. Villanueva Silva



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    P1.07 - Poster Session/ Small Cell Lung Cancer (ID 221)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Small Cell Lung Cancer
    • Presentations: 1
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      P1.07-005 - Paclitaxel and Irinotecan in Platinum Refractory/Resistant Small Cell Lung Cancer: Final Analisis of One Galician Lung Cancer Group Experience (ID 1441)

      09:30 - 17:00  |  Author(s): M.J. Villanueva Silva

      • Abstract

      Background:
      Patients with Small Cell Lung Cancer (SCLC) whose disease progresses during or shortly after treatment with platinum, have a poor prognosis. Paclitaxel (P) and irinotecan(I) have demonstrated activity both as monotherapy as in combination regimen for this neoplasm. We have previously presented data from our experience with this agents in patients with SCLC . Here, we present a final analysis of survival and security.

      Methods:
      We included patients with measurable disease that had progressed during or within six months of first-line chemotherapy based on platinum, with an Eastern Cooperative Oncology Group (ECOG) performance status <2, adequate liver, renal and bone marrow function. They were treated with (P): 75 mg/m2 and (I): 50 mg/m2, both drugs administered on days 1 and 8 of a 21 day cycle. Treatment was maintained until disease progression and/or unacceptable toxicity.

      Results:
      We included 50 patients with a mean age of 65 years (43-77) and with metastases in two or more locations in 39 of them (78%). A median of 4 cycles of treatment was administered and eight patients (16%) received six or more cycles. The main reason for discontinuation of chemotherapy was disease progression, observed in 22 patients (44%). Partial response was documented in 18 patients (36%), stable disease in 20 (40%) and disease progression in 7 (14%). There were five patients in whom it was not possible to evaluate response. The median progression free survival was 4.09 months (CI 95%: 2.13-6.05) and the median overall survival was 5.092 months (CI 95% 4.22 – 5.96). No treatment-related deaths were described. The clinical and hematologic toxicities most frequently observed were grade 1 and 2: asthenia (n:20; 40%), diarrhea (n:14; 28%), anorexia (n:12; 24%), alopecia (n:11; 22%), neutropenia (n:5; 10%) and anemia (n:4; 8%). There was one (2%) grade 4 and four (8%) grade 3 neutropenia. There were no cases of grade 4 clinical toxicity and there were 16 (32%) grade 3 : nine of diarrhea (18%), three of asthenia (6%), one of vomiting (2%), one of hiponatremia (2%), one hepatic (2%) and one hyperglycemia (2%).

      Conclusion:
      This (P) and (I) regimen is an effective and well tolerated option for this subgroup of very poor prognosis patients with SCLC.Future explorations using this therapeutic regimen are warranted.

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    P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P3.01-055 - Carboplatin-Pemetrexed Combination in Elderly Patients with Advanced Non-Squamous Non Small Cell Lung Cancer (NS-NSCLC) (ID 1595)

      09:30 - 17:00  |  Author(s): M.J. Villanueva Silva

      • Abstract

      Background:
      The standard treatment for elderly patients in advanced NS-NSCLC is not defined. The aim of this study was to evaluate the efficacy and safety profile of the combination of carboplatin and pemetrexed in this population.

      Methods:
      Elegibility criteria included, histologically or citologically confirmed NS-NSCLC clinical stage IIIB vs IV, evaluable disease, no prior cytotoxic chemotherapy, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, an adequate organ function and ³ 70 years old. Patients received carboplatin at an area under the concentration time curve (AUC) of 5 and pemetrexed 500 mg/m2 for four cycles on day 1 every 3 weeks. In non-progressing patients, maintenance therapy with pemetrexed every 3 weeks was optional to continue at the discretion of the investigator, until either disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). The secundary endpoints were the response rate (RR), disease control rate (DCR), overall survival (OS) and the rates of adverse events.

      Results:
      A total of thirty-six patients were included in a phase II clinical trial from 6 different centers. The patients demographics were: median age 76 years (range 70-82), 8 female and 28 male; 33 patients adenocarcinoma and 3 large-cell lung carcinoma; tumor EGFR status wild type in all patients. 51% went to manteinance. Among 32 patients evaluated, the RR was 31,3%, disease stabilization 31,3%, disease progression 28,1% and non-evaluable 9,3%. The DCR was 62.5%. In non-manteinance group the PFS was 4.1 months and OS 8.6 months. In the manteinance group instead, the PFS was 9.5 months and OS 11.9 months. Most common attributable adverse events were fatigue and anemia. Each of the toxicities were controllable and there were no treatment-related deaths.

      Conclusion:
      These data provided that Carboplatin and pemetrexed combination is effective and well tolerated in elderly patients with advanced NS-NSCLC