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İrfan Çiçin



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    MA10 - Considerations in Immunotherapy / Real World (ID 911)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 10:30 - 12:00, Room 105
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      MA10.08 - Choice of Taxane and Outcomes in the KEYNOTE-407 Study of Pembrolizumab Plus Chemotherapy for Metastatic Squamous NSCLC (ID 14698)

      11:25 - 11:30  |  Author(s): İrfan Çiçin

      • Abstract
      • Presentation
      • Slides

      Background

      In the randomized, double-blind, phase 3 KEYNOTE-407 study (NCT02775435), pembrolizumab plus chemotherapy with carboplatin and paclitaxel or nab-paclitaxel significantly prolonged OS (HR 0.64, 95% CI 0.49-0.85, P=0.0008) and PFS (HR 0.56, 95% CI 0.45-0.70, P<0.0001) compared with placebo plus chemotherapy in patients with previously untreated, metastatic squamous NSCLC. The benefit of pembrolizumab plus chemotherapy was observed irrespective of PD-L1 TPS. Pembrolizumab plus chemotherapy also had a manageable safety profile. We performed an exploratory analysis of outcomes by investigator’s choice of paclitaxel or nab-paclitaxel, which was a randomization stratification factor.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      559 eligible patients were randomized 1:1 to pembrolizumab 200 mg or placebo Q3W for up to 35 cycles plus 4 cycles of carboplatin AUC 6 mg/mL/min Q3W and investigator’s choice of paclitaxel 200 mg/m2 Q3W or nab-paclitaxel 100 mg/m2 QW. Primary end points were OS and PFS; ORR and safety were secondary.

      4c3880bb027f159e801041b1021e88e8 Result

      Paclitaxel was the chosen taxane in 60% of patients. The addition of pembrolizumab to chemotherapy improved OS, PFS, and ORR regardless of choice of carboplatin and paclitaxel or carboplatin and nab-paclitaxel (Table). Incidence of grade 3-5 AEs in the pembrolizumab plus chemotherapy arm vs placebo plus chemotherapy arm was 63.9% vs 59.3% in paclitaxel recipients and 78.9% vs 81.4% in nab-paclitaxel recipients. AEs led to discontinuation of all treatment in 13.6% vs 8.4% of paclitaxel recipients and 12.8% vs 3.5% of nab-paclitaxel recipients and led to discontinuation of any treatment in 19.5% vs 13.2% and 29.4% vs 9.7%, respectively. Immune-mediated AEs occurred in 29.6% vs 9.6% of paclitaxel recipients and 27.5% vs 7.1% of nab-paclitaxel recipients.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Adding pembrolizumab to chemotherapy with carboplatin and a taxane improved efficacy and was generally tolerable compared with chemotherapy alone as first-line therapy in patients with metastatic squamous NSCLC regardless of whether paclitaxel or nab-paclitaxel was the chosen taxane.

      Carboplatin plus Paclitaxel Carboplatin plus Nab-Paclitaxel

      Pembrolizumab + Chemotherapy

      N = 169

      Placebo + Chemotherapy

      N = 167

      Pembrolizumab + Chemotherapy

      N = 109

      Placebo + Chemotherapy

      N = 114

      OS, median

      (95% CI), mo

      		 14.0 (12.6-16.6) 10.3 (8.2-14.8) NR (NE-NE) 12.6 (9.6-NE)
      HR (95% CI)a 0.67 (0.48-0.93) 0.59 (0.36-0.98)

      PFS, median

      (95% CI), mo

      		 6.4 (6.0-8.3) 4.4 (4.2-5.1) 6.5 (6.2-8.5) 5.9 (4.4-6.9)
      HR (95% CI)a 0.52 (0.40-0.68) 0.65 (0.45-0.94)
      ORR, % (95% CI) 57.4 (49.6-65.0) 37.7 (30.4-45.5) 58.7 (48.9-68.1) 39.5 (30.4-49.1)
      aBased on a Cox regression model with treatment as a covariate.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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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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      P1.01-45 - Crizotinib Efficacy in ALK-Positive Advanced Stage Non-Small Cell Lung Cancer Patients: A Real-World Experience from Turkey (ID 14012)

      16:45 - 18:00  |  Author(s): İrfan Çiçin

      • Abstract

      Background

      ALK mutation is observed in 4% of patients diagnosed with NSCLC. The present study aimed to evaluate the efficacy of crizotinib, an ALK inhibitor, and clinical characteristics of ALK-positive NSCLC patients.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      In this multicenter, retrospective study, data of ALK-positive advanced stage NSCLC patients who received crizotinib were retrieved from hospital records.

      4c3880bb027f159e801041b1021e88e8 Result

      Data of 353 ALK-positive metastatic NSCLC patients receiving crizotinib in any treatment line were analyzed. The mean age of the patients was 53.2±12.6 years [median, 53 years (21-85 years)] and 193 (54.7%) patients were male. Age at diagnosis was significantly higher in males than in females (54.8±11.8 years and 51.3±13.2 years, respectively; p=0.044). The rate of patients who never smoked was 50.1%. The most common histological subtype was adenocarcinoma (96%). The frequency of brain metastasis at the time of diagnosis was 23.4%. The most common initial symptoms were cough (56%) and dyspnea (53%). Initial ECOG score was 0 or 1 in 80% of the patients. Crizotinib had been used in 37% of the patients in the 1st-line treatment, in 45% of the patients in the 2nd-line treatment, and in 18% of the patients in the ≥3rd-line treatment.

      Table 1. Response rates of the patients

      Treatment line

      Overall
      N (%)

      1
      N (%)

      2
      N (%)

      3
      N (%)

      Other
      N (%)

      Complete response

      28 (7.9)

      9 (7.3)

      14 (8.9)

      4 (9.8)

      1 (5.6)

      Partial response

      217 (61.5)

      78 (62.9)

      103 (65.2)

      25 (61.0)

      10 (55.6)

      Stable disease

      50 (14.2)

      18 (14.5)

      21 (13.3)

      7 (17.1)

      4 (22.2)

      Progressive disease

      67 (13.3)

      19 (15.3)

      20 (12.7)

      5 (12.2)

      3 (16.7)

      Undefined

      11 (3.1)

      ORR

      245 (69.4)

      87 (70.2)

      117 (74.1)

      29 (70.8)

      11 (61.2)

      DCR

      295 (83.6)

      105 (84.7)

      138 (87.4)

      36 (87.1)

      7 (83.4)

      Undefined

      11 (3.1)

      ORR was 69.4% and DCR was 83.6% (Table 1). ORR and DCR in the patients received crizotinib were 70.2% and 84.7% in the 1st-line treatment, respectively and were 74.1% and 87.4% in the 2nd-line treatment, respectively. The frequency of brain metastasis was 40.2% at 12 months. Of these patients, the median PFS and OS were 11.3 and 28.0 months, respectively.

      The most common side effects were fatigue, visual disturbances, nausea, abdominal discomfort, and pretibial edema.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Clinical characteristics of ALK-positive patients and crizotinib efficacy are consistent with studies. Response rates and survival outcomes are similar regardless of treatment lines. Crizotinib is safely used in these patients.

      6f8b794f3246b0c1e1780bb4d4d5dc53