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Lukman Tijani



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    P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 2
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.01-100 - Risk of Gastrointestinal and Hepatic Toxicities in Patients with Advanced Non-Small-Cell Lung Cancer Treated with Osimertinib (ID 11755)

      12:00 - 13:30  |  Author(s): Lukman Tijani

      • Abstract
      • Slides

      Background

      Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are the standard first-line therapy in patients with advanced non-small-cell lung cancer (NSCLC) who harbors EGFR mutation. The presence of T790M point mutation, later, mediates the resistance to first-generation and second-generation EGFR-TKIs. Osimertinib, an oral third-generation EGFR-TKI, targets both EGFR-TKI sensitizing and EGFR T790M resistance mutations. We undertook a systematic review and combined analysis of two phase III randomized controlled trials (RCT) to determine the risk of gastrointestinal and hepatic toxicities among patients with advanced NSCLC treated with osimertinib.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We conducted a comprehensive literature search using MEDLINE, EMBASE databases and meeting abstracts from inception through March 2018. Phase III RCTs that mention diarrhea, nausea, vomiting, stomatitis and elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) as adverse effects were incorporated in the analysis. Mantel-Haenszel (MH) method was used to calculate the estimated pooled risk ratio (RR) with 95% confidence interval (CI). Fixed effects model was applied.

      4c3880bb027f159e801041b1021e88e8 Result

      Two phase III RCTs with a total of 971 patients with advanced NSCLC were included in the analysis. Studies compared osimertinib vs carboplatin/cisplatin + pemetrexed and osimertinib vs gefitinib/erlotinib. The randomization ratio was 1:1 in the FLAURA study and 2:1 in the AURA3 study. Osimertinib was utilized in T790M-positive advanced NSCLC after prior first-line EGFR-TKIs in the AURA3 study (n= 556) and as first-line treatment in the FLAURA study (n= 415). The RR of all-grade side effects were as follows: diarrhea, 1.305 (95% CI: 1.128 – 1.509, p < 0.0001); nausea, 0.480 (95% CI: 0.378–0.611; p < 0.0001); vomiting, 0.783 (95% CI: 0.561–1.092; p = 0.149); stomatitis, 1.262 (95% CI: 0.980 – 1.626, p = 0.071); elevated AST, 0.397 (95% CI: 0.277–0.569; p < 0.0001); and elevated ALT, 0.312 (95% CI: 0.212–0.458; p < 0.0001). The RR of high-grade side effects were as follows: diarrhea, 0.912 (95% CI: 0.354 – 2.347, p = 0.849); vomiting, 0.135 (95% CI: 0.022 – 0.831; p = 0.031); stomatitis, 0.532 (95% CI: 0.124 – 2.293, p = 0.397); elevated AST, 0.296 (95% CI: 0.096 – 0.907; p = 0.033); and elevated ALT, 0.112 (95% CI: 0.034 – 0.372; p < 0.0001).

      8eea62084ca7e541d918e823422bd82e Conclusion

      Patients on osimertinib noted a significant increase in the risk of all-grade diarrhea. Nevertheless, the risk of developing any-grade nausea, all grades of elevated AST/ALT and high-grade vomiting, was significantly reduced in osimertinib arm, favoring osimertinib.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      P3.01-93 - Osimertinib-Related Hematological and Pulmonary Toxicities in Advanced NSCLC Patients: Combined Analysis of Phase III Trials (ID 12137)

      12:00 - 13:30  |  Author(s): Lukman Tijani

      • Abstract
      • Slides

      Background

      In both epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) sensitizing and EGFR T790M resistance mutations in patients with advanced non-small-cell lung cancer (NSCLC), osimertinib, a third-generation and irreversible oral EGFR-TKI, has been shown to improve survival in studies. We performed a systematic review and meta-analysis of phase III randomized controlled trials (RCT) to determine the risk of hematological and pulmonary toxicities among patients with advanced NSCLC treated with osimertinib.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We undertook a comprehensive literature search using MEDLINE, EMBASE databases and meeting abstracts from inception through March 2018. Phase III RCTs that mention hematological and pulmonary toxicities as adverse effects were incorporated in the analysis. The primary meta- analytic approach was a fixed effects model using the Mantel-Haenszel (MH) method. It was used to calculate the estimated pooled risk ratio (RR) with 95% confidence interval (CI).

      4c3880bb027f159e801041b1021e88e8 Result

      A total of 971 patients with advanced NSCLC from two phase III studies were eligible for analysis. The study arm used osimertinib while the control arm utilized either chemotherapy (carboplatin/cisplatin+ pemetrexed) or standard EGFR-TKIs (gefitinib or erlotinib). The randomization ratio was 1:1 in the FLAURA study and 2:1 in the AURA3 study. Osimertinib was utilized in T790M-positive advanced NSCLC after prior first-line EGFR-TKIs in the AURA3 study (n= 556) and as first-line treatment in the FLAURA study (n= 415). The RR of all-grade side effects were as follows: anemia, 0.594 (95% CI: 0.433 – 0.814, p = 0.001); cough, 1.122 (95% CI: 0.829 – 1.520, p = 0.455); dyspnea, 1.143 (95% CI: 0.784 – 1.666; p = 0.487); and ILD, 2.378 (95% CI: 0.984 – 5.744; p = 0.054). The RR of high-grade adverse effects were as follows: anemia, 0.175 (95% CI: 0.072 – 0.425, p < 0.001); neutropenia, 0.293 (95% CI: 0.138 – 0.623; p = 0.001); thrombocytopenia, 0.183 (95% CI: 0.060 – 0.564, p = 0.003); pneumonia, 1.237 (95% CI: 0.442 – 3.459; p = 0.685); dyspnea, 0.895 (95% CI: 1.192 – 4.175; p = 0.888); and ILD, 1.238 (95% CI: 0.404 – 3.789; p = 0.708).

      8eea62084ca7e541d918e823422bd82e Conclusion

      Our meta-analysis demonstrated that patients on osimertinib experienced a significant decrease in the risk of hematological toxicities, compared to control arm. Moreover, no increase in the risk of pulmonary toxicities was noted in the osimertinib group.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P3.CR - Case Reports (Not CME Accredited Session) (ID 984)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
    • +

      P3.CR-03 - Pulmonary Spindle Cell Neoplasm - Neoadjuvant Treatment and Response (ID 11756)

      12:00 - 13:30  |  Author(s): Lukman Tijani

      • Abstract
      • Slides

      Background

      Sarcomatoid carcinoma (SC) of the lung comprises a small subset of non-small cell lung cancer (NSCLC) accounting for no more than 3% of all lung tumors.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Section not applicable

      4c3880bb027f159e801041b1021e88e8 Result

      A 66-year-old Caucasian man was seen in the ED for the complaints of shortness of breath, productive cough, and fever. He had a 70 pounds unintentional weight loss over 5 months and generalized weakness. His medical history included COPD, HTN, HLD, and tobacco abuse (108 pack years of smoking). He denied alcohol or illicit drug use. He was treated with antibiotics for COPD exacerbation with symptomatic improvement; However, he had a chest X-ray finding notable for an 8 cm right upper lung mass.

      Chest CT showed 6.3 x 7.9 x 8 cm RUL pleural-based mass with areas of low density changes and irregular opacity measuring 3.7 x 6.5 x 7.5 cm abutting the pleura in the right lower lobe. A right hilar node was also seen measuring up to 2.3 x 2.9 cm in size. Abdomen/pelvis CT and MRI brain showed no gross evidence of metastatic disease. The bone scan was negative for blastic or lytic bone disease. He had a CT guided biopsy which identified a spindle cell neoplasm. Histopathology confirmed spindle cells with markedly atypical nuclei amid a hyalinized background, with areas of necrosis. Immunoperoxidase stains were positive for CKAE1/AE3 and vimentin with diffuse staining. CK7 was focally positive in very few cells, as were Ber-EP4 and calretinin. PAX8 was negative.

      Transthoracic echocardiogram showed grade I diastolic dysfunction with preserved ejection fraction. Pulmonary function testing showed severe obstructive pattern consistent with severe COPD, making him a poor surgical candidate. The final decision was made to start the patient on concurrent chemoradiation.

      Initial chemotherapy regimen was Ifosfamide 1200 mg/m2 along with Mesna 240 mg/m2 to be given for a total of 15 doses. He was also planned to have Intensity-modulated radiation therapy of 3000 Centigray over 15 fractions to the lung. He finished 6 cycles of chemotherapy. He tolerated his regimen well with only mild neutropenia.

      Repeat CT chest showed interval decrease of the right upper lobe mass (now 4.5 x 1.7 cm instead of 7.9 x 4.7 cm) and a hilar lymph node that measured 1.3 x 1.3 cm (previously measuring 2.3 x 2.9 cm).

      8eea62084ca7e541d918e823422bd82e Conclusion

      We present a patient that received concurrent chemoradiotherapy with initial response on CT imaging. This can provide an acceptable alternative to patients presenting with non-resectable tumors.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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