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Jaklitsch, Michael

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Jaklitsch

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Michael

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Jaklitsch, Michael
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    Neoadjuvant irinotecan, cisplatin, and concurrent radiation therapy with celecoxib for patients with locally advanced esophageal cancer
    (BioMed Central, 2016) Cleary, James; Mamon, Harvey; Szymonifka, Jackie; Bueno, Raphael; Choi, Noah; Donahue, Dean; Fidias, Panos M.; Gaissert, Henning; Jaklitsch, Michael; Kulke, Matthew; Lynch, Thomas P.; Mentzer, Steven; Meyerhardt, Jeffrey; Swanson, Richard; Wain, John Charles; Fuchs, Charles; Enzinger, Peter
    Background: Patients with locally advanced esophageal cancer who are treated with trimodality therapy have a high recurrence rate. Preclinical evidence suggests that inhibition of cyclooxygenase 2 (COX2) increases the effectiveness of chemoradiation, and observational studies in humans suggest that COX-2 inhibition may reduce esophageal cancer risk. This trial tested the safety and efficacy of combining a COX2 inhibitor, celecoxib, with neoadjuvant irinotecan/cisplatin chemoradiation. Methods: This single arm phase 2 trial combined irinotecan, cisplatin, and celecoxib with concurrent radiation therapy. Patients with stage IIA-IVA esophageal cancer received weekly cisplatin 30 mg/m2 plus irinotecan 65 mg/m2 on weeks 1, 2, 4, and 5 concurrently with 5040 cGy of radiation therapy. Celecoxib 400 mg was taken orally twice daily during chemoradiation, up to 1 week before surgery, and for 6 months following surgery. Results: Forty patients were enrolled with stage IIa (30 %), stage IIb (20 %), stage III (22.5 %), and stage IVA (27.5 %) esophageal or gastroesophageal junction cancer (AJCC, 5th Edition). During chemoradiation, grade 3–4 treatment-related toxicity included dysphagia (20 %), anorexia (17.5 %), dehydration (17.5 %), nausea (15 %), neutropenia (12.5 %), diarrhea (10 %), fatigue (7.5 %), and febrile neutropenia (7.5 %). The pathological complete response rate was 32.5 %. The median progression free survival was 15.7 months and the median overall survival was 34.7 months. 15 % (n = 6) of patients treated on this study developed brain metastases. Conclusions: The addition of celecoxib to neoadjuvant cisplatin-irinotecan chemoradiation was tolerable; however, overall survival appeared comparable to prior studies using neoadjuvant cisplatin-irinotecan chemoradiation alone. Further studies adding celecoxib to neoadjuvant chemoradiation in esophageal cancer are not warranted. Trial registration Clinicaltrials.gov: NCT00137852, registered August 29, 2005.
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    Identification of Metastatic Nodal Disease in a Phase 1 Dose-Escalation Trial of Intraoperative Sentinel Lymph Node Mapping in Non–small Cell Lung Cancer Using Near-Infrared Imaging
    (Elsevier BV, 2013-09) Gilmore, Denis M.; Khullar, Onkar V.; Jaklitsch, Michael; Chirieac, Lucian; Frangioni, John V.; Colson, Yolonda
    Objectives Early stage non-small cell lung cancer (NSCLC) has a high recurrence rate and poor 5-yearsurvival, particularly if lymph nodes are involved. Our objective was to perform a dose escalationstudy to assess safety and feasibility of intraoperative near-infrared (NIR) fluorescence imaging toidentify the first tumor draining lymph nodes, i.e. sentinel lymph nodes (SLN) in NSCLCpatients. Methods A dose escalation Phase I clinical trial assessing real-time NIR imaging followingperitumoral injection of 3.8 – 2500 μg indocyanine green (ICG) was initiated inpatients with suspected stage I/II NSCLC. Visualization of lymphatic migration, SLN identification,and adverse events were recorded. Results Thirty eight patients underwent ICG injection and NIR imaging via thoracotomy(n=18) or thoracoscopic imaging (n=20). SLN identification increased with ICG dosewith <25% SLN detected in dose cohorts ≤600ug vs 89% success at≥1000 μg. Twenty six NIR+ SLNs were identified in fifteenpatients, with seven NIR+ SLNs (six patients) harboring metastatic disease onhistologic analysis. Metastatic nodal disease was never identified in patients with a histologicallynegative NIR+ SLN. No adverse reactions were noted. Conclusion NIR-guided SLN identification with ICG was safe and feasible in this initial doseescalation trial. ICG doses ≥ 1000ug yielded nearly 90% intrathoracic SLNvisualization, with presence or absence of metastatic disease in the SLN directly correlating withfinal nodal status of the lymphadenectomy specimen. Further studies are needed to optimize imagingparameters and confirm sensitivity and specificity of SLN mapping in NSCLC using this promisingimaging technique.