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X. Xu



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    MINI 05 - EGFR Mutant Lung Cancer 1 (ID 103)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      MINI05.12 - Erlotinib Combined with Chemotherapy versus Erlotinib Alone Treating Advanced Lung Adenocarcinoma with Brain Metastases (NCT01578668) (ID 620)

      17:50 - 17:55  |  Author(s): X. Xu

      • Abstract
      • Presentation
      • Slides

      Background:
      Erlotinib has a synergistic effect with pemetrexed when treating non-squamous non-small cell lung cancer. The aim of our study was to confirm the efficacy and safety of erlotinib (E) in combination with pemetrexed/cisplatin (E-P) in Chinese lung adenocarcinoma with brain metastases.

      Methods:
      This study is a prospecive, non-randomized cocurrent controlled study. Lung adenocarcinoma patients with brain metastases, who were erlotinib or pemetrexed treatment-naive and had adequate organ functions, were assigned in parallel to receive either erlotinib 150 mg/day or erlotinib on days 4-21 plus pemetrexed 500 mg/m[2] on day 1 and cisplatin 20 mg/m[2] on day 1-3 every 21 days up to 6 cycles and subsequent oral erlotinib, until progressive disease or unacceptable toxicity. The primary endpoint was intracranial overall response rate (ORRi). Previous data showed that about 56% of the patients treated with E and 78% of the patients treated with E-P, achieved an ORRi. We estimated the minimum sample size of 65 with 70% power (two-sided alpha 0.05).

      Results:
      69 lung adenocarcinoma patients with brain metastases had received E (n=35) or E-P (n=34) from Jan 2012 through Nov 2014. Demographics and patient characteristics were well balanced between two groups, including EGFR status, gender, age, smoking status, ECOG performance status, brain metastases and number of prior treatments. ORRi, in the E-P arm was superior to that in the E arm (79% vs. 48%, P=0.008) (Table S). Especially in the patients with EGFR wild type or treated as first-line treatment could achieve much better ORRi. Patients treated with E-P arm, compared with E arm as first-line treatment, were associated with better intracranial PFS (PFSi) (median PFSi, 9 months vs. 2 months, P=0.02) and systemic PFS (median PFS, 8 months vs. 2 months, P=0.006).The most frequent adverse events related with erlotinib were higher in the combination arm. No new safety signals were detected. The side effects were tolerable and no-drug related deaths. Table S The ORRi between the E-P and E arm

      group (n) ORRi (n,%）
      Total patients E (35) 17,48.6%
      E-P (34) 27, 79.4%
      P value 0.008
      EGFR mutation E (18) 10,55.6%
      E-P (14) 12,85.7%
      P value 0.124
      EGFR negative E (7) 1, 14.3%
      E-P (11) 7, 63.6%
      P value 0.066
      EGFR unknown E (10) 6,60.0%
      E-P (9) 8,88.9%
      P value 0.303
      First-line treatment E (16) 7,43.7%
      E-P (18) 14 ,77.7%
      P value 0.08


      Conclusion:
      The combination of erlotinib and pemetrexed/cisplatin is effective and improved PFS as first-line treatment in Chinese lung adenocarcinoma with brain metastases. Toxicities are tolerable and the erlotinib-related side-effects were higher.

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    P1.02 - Poster Session/ Treatment of Localized Disease – NSCLC (ID 209)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Localized Disease - NSCLC
    • Presentations: 1
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      P1.02-025 - Complete VATS Resection and Reconstruction of Carina and Trachea for Malignant or Benign Disease (ID 1218)

      09:30 - 09:30  |  Author(s): X. Xu

      • Abstract

      Background:
      General thoracic surgery involving carinal and/or tracheal reconstruction is technically demanding. The aim of this study is to discuss the feasibility of complete video assisted thoracoscopic surgery (VATS) in the surgical treatment of disease involving the carina and/or trachea.

      Methods:
      Between May 2012 and April 2015, seven cases of malignant or benign disease involving carina and/or trachea were treated via complete VATS resection and reconstruction of carina and trachea in our hospital. Among the seven patients (median age, 47 years; range, 43-60 years), two patients suffered from a malignant tracheal tumor, one from a main bronchial malignant tumor invading the carina, two from right upper lobe malignant tumor invading the carina, and two from benign bronchial stenosis due to endobronchial tuberculosis. A prospective analysis of clinical characteristics, operative data, and postoperative events was performed. Figure 1



      Results:
      There were five different types of VATS airway reconstruction in our group, including left main bronchus resection and carinal reconstruction, right main bronchus resection and carinal reconstruction, right upper lobectomy and carinal reconstruction, right upper lobectomy and half carinal reconstruction, and tracheal resection and reconstruction. Median data of surgical outcome are as follows: operative time-200 minutes (range, 50-300 minutes); time of airway reconstruction-50 minutes (range, 19-130 minutes); blood loss-100 mL (range, 30-1000 mL). One patient suffered from endobronchial tuberculosis; during the thoracic procedure we observed complete pleural adhesions which led to large volume of blood loss during pleuropneumonolysis. No conversions to thoracotomy were performed. There was no 30-day mortality. Median data of perioperative outcomes are as follows: postoperative hospital stay-12 days (range, 7-15 days); ICU stay -1 day (range, 0-6 days) and duration of thoracic drainage- 2 days (range, 1-5 days). No patient required postoperative mechanical ventilation. One patient had to be assisted with bronchoscopy as a result of insufficient sputum excretion. Median duration of follow-up was 6 months (range, 0-37 months). Minor anastomotic stenosis(less than 1/4 diameter) was found in two patients during follow-up, but no complaints of significant impact on activity were noted.

      Conclusion:
      Complete VATS for carina and trachea resection and reconstruction is a technically challenging, but feasible procedure for both benign and malignant disease and should be restricted to skilled VATS surgeons.