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C. Puparelli



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    P1.01 - Advanced NSCLC (ID 757)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 3
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      P1.01-019 - ALK+ Non-Small Cell Lung Cancer Treated with First Line Crizotinib: Patient Characteristics, Treatment Patterns, and Survival (ID 10137)

      09:30 - 16:00  |  Author(s): C. Puparelli

      • Abstract
      • Slides

      Background:
      This study describes the characteristics, treatment sequencing, and outcomes among locally advanced/metastatic crizotinib-treated ALK+ Non-small cell lung cancer (NSCLC) Hispanic patients.

      Method:
      From June 2014 to June 2017, a retrospective patient review was conducted among several centers from México (n=10), Costa Rica (n=4), Panamá (n=13), Colombia (n=16), Venezuela (n=10), and Argentina (n=20). Participating clinicians identified their ALK+ NSCLC patients who received crizotinib and reported their clinical characteristics, treatments, and survival using a pre-defined case report form. Kaplan-Meier analyses were used to describe overall survival (OS) and progression-free survival (PFS).

      Result:
      73 ALK+ NSCLC patients treated with crizotinib as a first line were included. Median age at diagnosis was 62 years (range, 34-77), 60.3% were female and histological distribution was adenocarcinoma in 93.2%, squamous cell carcinomas in 2.7%, NOS in 2.7% and adenosquamous in 1.4%. Sixty-five patients (89%) were never or former smokers, 52 (71.1%) had ≥2 sites of metastasis and 15 (20.5%) had brain metastasis at diagnosis. Median PFS to treatment with first line crizotinib was 12.3 months (95%CI 9.4-15.3) and overall response rate (ORR) was 52% (CR 6.8% and PR 45.2%). Of those who discontinued crizotinib, 26.1% had brain progression, 35.6% switched to chemotherapy, 14% switched to a different ALK inhibitor and 59% received no further therapy. After starting crizotinib, median OS was 32.5 months (95%CI 25.6-39.4), 42.6 months (95%CI 31.8-53.5) for those who received ceritinib or/and alectinib, and 23.8 months (95%CI 19.0-28.6) among those treated with second line platinum based chemotherapy (p=0.003).

      Conclusion:
      The ORR and PFS observed in Hispanic patients with ALK+ NSCLC treated with first-line crizotinib was similar to that previously described. Limited access to new-generation ALK inhibitors affects OS. Those patients exposed to ceritinib or alectinib demonstrated a significant improvement in OS versus those treated with second-line platinum-based chemotherapy.

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      P1.01-022 - Prediction of Central Nervous System Progression During Crizotinib Treatment in ALK+ NSCLC Among Hispanics (ID 10479)

      09:30 - 16:00  |  Author(s): C. Puparelli

      • Abstract
      • Slides

      Background:
      Crizotinib has offered patients with non-small cell lung cancer (NSCLC) positive to ALK rearrangements a powerful therapeutical option. Despite the benefit of crizotinib, most patients develop resistance and progression with special emphasis on the central nervous system. Early identification of patients that will present brain metastases could potentially lead to additional interventions preventing relapse. The objective of this study was to identify patients who would present with future CNS relapse after initiation of crizotinib.

      Method:
      A random forest tree model was constructed. Data from Hispanic patients with NSCLC harboring ALK rearrangements treated with crizotinib were collected from the CLICaP database. Clinical variables including age at diagnosis, sex, smoking status, number of metastasis and location and objective response were included. Based on these parameters, progression to central nervous system was predicted.

      Result:
      66 patients were included in the analysis. Median age for the cohort was 55 years old (r, 33-85), 33 (59%) were women, 38 (58%) were never smokers and 29 (44%) presented disease progression during crizotinib treatment while 17 had central nervous system involvement. Median overall survival (OS) was 13.9 months (95%CI 11.6-19.3) in contrast to 8.3 months (95%CI 4.47-13.13) in terms of progression free survival (PFS) after crizotinib initiation. The best predictors for central nervous system progression were age, sex, number of metastasis, objective response to crizotinib and previous CNS involvement. With an AUC of 0.99, a sensitivity of 100% and a specificity of 88%, the model reached an overall accuracy of 97%.

      Conclusion:
      Central nervous system progression after crizotinib treatment can be accurately predicted. Validation for this model in larger cohorts is warranted.

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      P1.01-058 - Real World Data with Nivolumab: Experience in Argentina (ID 8800)

      09:30 - 16:00  |  Author(s): C. Puparelli

      • Abstract
      • Slides

      Background:
      Nivolumab has improved overall survival (OS) in metastatic non-small cell lung cancer (NSCLC) patients. Analysis of the use of these drugs in real world provides more evidence about efficacy and toxicity. We describe here the experience of the use of nivolumab in NSCLC in Argentina.

      Method:
      NSCLC patients (pts) who received nivolumab between 6/2015 - 12/2016. Patients consented their respective physicians to be treated on a drug expanded access program. Data was collected retrospectively by the physician. Images and follow up were done according to physician´s discretion. Adverse events were classified according to CTC3.1. Responses were evaluated according to RECIST 1.1 criteria. DFS and OS was assessed. All pts who received at least one dose of Nivolumab were evaluated for toxicity.

      Result:
      N 109. Fup 8.83 m (IQR 3.4-12.67). 57.8% men, 29.4% current smoker, 78.0% non-squamous, 8.3% EGFR mutated. Chemotherapy lines before nivolumab 2 md (r 1-4), and 59.6% received radiotherapy. 89% received previously platinum based chemotherapy. Sites of relapse or progression before nivolumab were: lung (75.2%), lymph nodes (47.7%), bone (19.3%), liver (11.9%), central nervous system (11.0%), and adrenal gland (13.8%). PS 0 26.6%, 1 56.0%, 2 13.8% and 3 1.8%. Cycles of nivolumab 10 Md (IQR 3-18). Drug related toxicity 78.9%. Grade 2-3 28.4%. Corticoid use 33.9%. Responses were evaluated in 104 pts who had as best response CR 2/104 (2%), PR 28/104 (27. %), SD 33/104 (32%) and PD 41/104 (39.%). Time to the best response was 4.0 m (IQR 2.3-5.9). DFS 6.1 m (IQR 2.4-13.1) and OS 12.3 m (IQR 4.1-NR). Univariate analysis revealed that absence of corticoids use (p=0.034), toxicity grade 1-3 (p=0.0025), PS≤1 (p=0.049), age<=50 (p= 0.0011) were associated with longer DFS; PS≤1 (p<0.001) and toxicity grade 1-3 (p=0.001) were associated with longer OS. In multivariate cox regression analysis, toxicity grade 1-3 (HR 0.44 CI95% 0.24-0.81, p=0.008) and age<=50 (HR 0.28 CI95% 0.13-0.61, p=0.001) were associated with longer DFS while corticoids use was associated with shorter DFS (HR 2.06 CI95% 1.22-3.48, p=0.007); toxicity grade 1-3 (HR 0.28 CI95% 0.14-0.54, p<0.0001) and PS≤1 (HR 0.16 CI95% 0.08-0.31, p<0.0001) were associated with longer OS.

      Conclusion:
      The use of Nivolumab in a real world setting, in heavily pre-treated NSCLC patients was well tolerated and showed promising clinical efficacy. PS, the use of corticoids and immune-mediated toxicity seem to be conditions which could affect clinical outcomes.

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