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Demetris Vomvas



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    P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.01-12 - SWItch Maintenance PEmbrolizumab in Patients with Metastatic Non Small Cell Lung Cancer (SWIPE) (ID 14151)

      16:45 - 18:00  |  Author(s): Demetris Vomvas

      • Abstract
      • Slides

      Background

      Pembrolizumab is currently indicated for first line use for patients with >50% PD-L1 overexpression and for pretreated patients with >1% PD-L1 expression with metastatic Non Small Cell Lung Cancer (NSCLC). There are currently no data for its use as maintenance treatment. SWIPE is a prospective single arm, one stage Phase II study offering Pembrolizumab as maintenance therapy to non-progressors after first line palliative chemotherapy with NSCLC. (NCT 02705820)

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Standard inclusion and exclusion criteria for checkpoint inhibitors studies apply, however also patients with WHO Performance Status (PS) 2 were allowed and there was no restriction on PD-L1 expression. Treatment consisted of Pembrolizumab 200 mg fixed dose every 3 weeks. Radiological assessement with CT scans every 9 weeks in the first year. The study employs a one stage phase II Fleming's design using Immune Related (IR) Progression Free Survival (PFS) at 1 year as primary endpoint. Using response hypotheses of H0 < 12 % and Ha> 25%, with a significance level α=0.05 and power 0.8, 48 patients are required to be entered into this study.

      4c3880bb027f159e801041b1021e88e8 Result

      Thirty-six (36) patients have been enrolled so far. 29 patients have more than 6 months follow up data, and are the subjects of this analysis. 23 males and 6 female patients. Median age 65 years (range 40-82). PS WHO 0 for 12 patients, WHO 1 for 15 patients and WHO 2 for 2 patients. Histology: adenocarcinoma in 22 patients and squamous in 7 patients. In terms of best radiological response 2 patients had a partial response and 13 patients stable disease. Median IR PFS is 6.8 months (CI 4.0-17.2). The 6 month and 1 year IR PFS rate is 60.7% and 45.8%. Median OS is 11.3 months (CI 7.4-15.2). The 6 month and 1 year OS rate is 65.5% and 48.0% (SPSS version 23). Toxicity was mainly grade 1-2; commonest being fatigue 18 patients (62%), anorexia, arthralgia and cough 10 patients (34%). One patient developed diabetes mellitus (grade 3) as auto-immune toxicity. Three (3) patients developed grade 3 dyspnoea, none of which were related to Pembrolizumab. There was one death during treatment due to sepsis, unlikely to be related to Pembrolizumab.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Maintenance Pembrolizumab is associated with a clinically meaningful disease control rate of almost 46% at 1 year with manageable toxicity.

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    P2.17 - Treatment of Locoregional Disease - NSCLC (Not CME Accredited Session) (ID 966)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.17-07 - Concurrent Chemoradiotherapy (ConCRT) using Cisplatin-Vinorelbine in Locally Advanced (LA) Non-Small Cell Lung Cancer (NSCLC)<br />   (ID 14097)

      16:45 - 18:00  |  Author(s): Demetris Vomvas

      • Abstract
      • Slides

      Background

      We adopted ConCRT with cisplatin and vinorelbine as our standard of care for patients with LA NSCLC since 2005. This is an analysis of a register of all patients consecutively assigned ConCRT since 2005 in an intent to treat analysis.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      From Feb 2005 to Dec 2015 we assigned ConCRT for 77 consecutive patients with LA NSCLC, who were deemed unresectable; this included T4/N3/ “bulky” N2 disease or locally recurrent disease after initial surgery. Patients had ECOG performance status 0-2 and were treated with Cisplatin 75mg/m2 d1 and Vinorelbine 30mg/m2 d1-8, 3-weekly during the induction chemotherapy phase (i.e. full doses for the first 1-2 cycles) whilst with the addition of radical RT, Vinorelbine was reduced to 12.5mg/m2 d1-8. After ensuring acceptable toxicity with the first 11 patients treated, subsequent patients received Vinorelbine at 15mg/m2 d1-8 during ConCRT and the number of treatment cycles was escalated to a maximum of 6. Patients received definitive CRT (59.4-64.8 Gy) unless surgery was planned, in which case restaging evaluation for potentially resectable patients was performed at 45-50.4 Gy. PET staging was only available since 2011.

      4c3880bb027f159e801041b1021e88e8 Result

      77 patients: 69 men and 8 women. Median age was 63 (43-81); PS 0-1 n=69, PS 2 n=8. Radiological stage IIIB n=40 (52%), IIIA n=30 (39%), IIB n=7 (9%). Histology, squamous n=42, adenocarcinoma n=21, other NSCLC n=14. Treatment delivered: median 4 cycles (range 1-6). 71 patients (92%) completed ConCRT. Overall response rate 70% (49 partial and 5 complete responses), stable disease n=7, progressive disease n=8; of the remaining 8 non-evaluable patients, 6 patients did not complete ConCRT, either due to toxicity/death or disease progression. 11 patients who received ConCRT underwent surgery (6 lobectomies, 5 pneumonectomies). 6 of these 11 patients had a complete pathologic response (pCR). Median progression-free survival (PFS) 14.4 months (C.I. 9.0-19.8) and median overall survival (OS) 23.8 months (C.I. 17.2-30.4). Five year OS rate was 28.2%. There were 2 toxic deaths from neutropaenic sepsis during concurrent CRT and one after surgery. The incidence of grade 3-4 oesophagitis or pneumonitis was < 10% and manageable.

      8eea62084ca7e541d918e823422bd82e Conclusion

      This regimen has produced encouraging results with a 23.8 month median OS in a patient cohort with predominantly IIIB disease and with a significant minority of poor PS=2 patients, with 92% being able to complete the treatment. Finally 8% of patients had pathological pCR, with 28% of patients treated achieving long-term survival.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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