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Giorgio Vittorio Scagliotti



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    P01 - Antibody Drug Conjugates, Novel Therapeutics and Cytotoxics (ID 227)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Antibody Drug Conjugates, Novel Therapeutics and Cytotoxics
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P01.21 - ANSELMA: Antiangiogenic Second Line Lung Cancer Meta-Analysis on Individual Patient Data in Non-Small Cell Lung Cancer, Again Relevant in ICI Era (ID 721)

      00:00 - 00:00  |  Author(s): Giorgio Vittorio Scagliotti

      • Abstract
      • Slides

      Introduction

      There is renewed interest in the efficacy of 2nd line treatments (2LT) with anti-angiogenics (AA), now that immunotherapy plus chemotherapy (CT) is one of the standard options in 1st line treatment of advanced non-small cell lung cancer (NSCLC). Antibodies (mAb) against VEGF, VEGFR2, or AA tyrosine kinase inhibitors (TKI) have inconsistently shown benefit in combination with CT or erlotinib (E). We performed an individual patient data (IPD) meta-analysis to validate efficacy of these combinations as 2LT.

      Methods

      Randomized trials of AA plus standard 2LT (CT or TKI) compared to 2LT alone that ended accrual before 2015 were identified from publication databases, abstract proceedings and trial registers. Fixed-effect models were used to compute pooled hazard ratios (HRs) for overall survival (OS, primary endpoint), progression-free survival (PFS) and subgroup analyses. Peto method was used to estimate survival benefit.

      Results

      IPD were available for 15 out of 17 eligible trials (only via remote access for 9 trials). Out of 8,502 patients (pts) enrolled, 35% were female and 64% had adenocarcinoma. At 3 years, 10.5% were alive. Addition of AA significantly prolonged OS (HR=0.93 [95% confidence interval (CI): 0.89-0.98], p=0.005) and PFS (0.80 [0.77-0.84], p<0.0001) compared with 2LT alone. Absolute 1-year OS and PFS benefit for AA were +1.9% [95% CI: -0.3%;+4.1%] and +3.6% [+2.0%;+5.2%] respectively. According to the 3 types of combinations (mAb AA + CT, TKI AA + CT, AA + E), there was no significant interaction for OS. Interaction was significant for PFS (p=0.004): HR=0.78 [0.72-0.85], 0.86 [0.80-0.91] and 0.70 [0.63-0.77] respectively. There was a significant reduction of AA benefit on OS when age increased: 0.86 [0.75-0.99], 0.89 [0.81-0.97], 0.94 [0.87-1.02] and 1.04 [0.93-1.17] for pts <50, 50-59, 60-69 and ≥70 respectively (interaction p=0.009). Effect of AA was independent of sex (p=0.98) and performance status (0, ≥1; p=0.78) and ethnicity (Asian, non-Asian, p=0.38). Subgroup results were similar for PFS.

      Conclusion

      In the 2LT of advanced NSCLC, adding AA modestly but significantly prolongs OS and PFS. This appears independent of type of AA drugs, but the observed benefit may be higher in younger pts.

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    PL05 - Affordable and Accessible Lung Cancer Care (Japanese, Mandarin, Spanish Translation Available) (ID 146)

    • Event: WCLC 2020
    • Type: Plenary
    • Track: N.A.
    • Presentations: 1
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      PL05.08 - How to Double Cancer Cure Rate by 2025 (ID 3933)

      18:00 - 20:00  |  Presenting Author(s): Giorgio Vittorio Scagliotti

      • Abstract
      • Slides

      Abstract not provided

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    PS01 - Presidential Symposium (Japanese, Mandarin, Spanish Translation Available) (ID 143)

    • Event: WCLC 2020
    • Type: Plenary
    • Track: N.A.
    • Presentations: 1
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      PS01.04 - International Tailored Chemotherapy Adjuvant Trial : ITACA Trial. Final Results (ID 1820)

      07:00 - 09:00  |  Author(s): Giorgio Vittorio Scagliotti

      • Abstract
      • Slides

      Introduction

      Adjuvant platinum-based chemotherapy in early stage non-small cell lung cancer confers a modest 5% overall survival benefit. Different strategies have been investigated to improve these results. mRNA expression of some genes was correlated with the sensitivity or resistance to specific anticancer agents. We aimed to evaluate the predictive utility of the mRNA expression levels of molecular markers ERCC1 and TS.

      Methods

      An open label, randomized, comparative phase III investigator-initiated study (EudraCT 2008-001764-36) of adult patients (aged > 18 years), with an ECOG performance status of 0 or 1 and with a completely resected stage II-III NSCLC according to the 6th edition of the TNM staging System was planned. We enrolled patients from 17 Italian centers and 13 German Centers within 6-12 weeks after radical surgery.

      Genomic analyses were performed soon after surgery and then patients were randomly assigned in each of the 4 genomic subgroups to investigator’s choice of platinum-based chemotherapy (C1-2-3-4) or chemotherapy defined by the molecular markers. In the tailored arm patients with tumors that had high ERCC1 and high TS received single-agent docetaxel (T1); patients with high ERCC1 and low TS received single-agent pemetrexed (T2); patients with low ERCC1 and high TS received cisplatin and gemcitabine (T3); finally, patients with low ERCC1 and low TS received cisplatin and pemetrexed (T4). All anticancer drugs were administered according to standard doses and schedules. We randomly allocated patients with 1:1 ratio centrally using permuted blocks sizes and stratified by stage and smoking status. The primary end point of the study was overall survival according to an intent to treat analysis. For the final statistical analysis all the control arms were grouped in one (control arm) and all tailored chemotherapies in another one (experimental arm).

      Results

      Between December 2008 and August 2014, 773 patients were enrolled and randomly assigned to the treatment groups: 389 to arms C and 384 to arms T (T1, n=148, T2, n=43, T3, N=101, T4, N=92).

      Six hundred and ninety patients were included in the intent to treat analysis. In the control arm the following regimens were used: cisplatin /gemcitabine (n=159, 50.0%), cisplatin /viborelbine (n=123, 38.7%), cisplatin/docetaxel (n=23, 7.2%), platinum/pemetrexed (n=5, 1.6%), others (n=8, 2.5%). At a median follow up of 28.2 months (IQR: 9.9-55.8 months), 86 (24.9%) and 68 (19.8%) patients were deceased in arms C and T, respectively. The estimated median overall survival in arm C was 83.5 months (95%CI: 60.1-not defined) and in arm T was 96.4 months (95%CI: 81.8-not defined; hazard ratio (group T vs. group C) was 0.76 (95%CI: 0.55-1.04; p=0.091). Grade 3-5 toxicities that were reported more frequently in arm C (control) than in arm T (tailored) were neutropenia (18.9% vs 13.4%), leukopenia (13.3% vs 3.9%), thrombocytopenia (7.7% vs 3.3%) and anaemia (2.7% vs 0.9%).

      Conclusion

      In completely resected stage II-III NSCLC tailoring adjuvant chemotherapy on the basis of the mRNA expression of selected genes do not confer a statistically significant survival advantage in terms of overall survival and relapse-free survival and toxicity was less commonly reported in the customization arms.

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    PS02 - Presidential Symposium (Re-Broadcast) (Japanese, Mandarin, Spanish Translation Available) (ID 275)

    • Event: WCLC 2020
    • Type: Plenary
    • Track: N.A.
    • Presentations: 1
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      PS02.04 - International Tailored Chemotherapy Adjuvant Trial : ITACA Trial. Final Results (ID 4285)

      18:00 - 20:00  |  Author(s): Giorgio Vittorio Scagliotti

      • Abstract
      • Slides

      Introduction
      Adjuvant platinum-based chemotherapy in early stage non-small cell lung cancer confers a modest 5% overall survival benefit. Different strategies have been investigated to improve these results. mRNA expression of some genes was correlated with the sensitivity or resistance to specific anticancer agents. We aimed to evaluate the predictive utility of the mRNA expression levels of molecular markers ERCC1 and TS. Methods

      An open label, randomized, comparative phase III investigator-initiated study (EudraCT 2008-001764-36) of adult patients (aged > 18 years), with an ECOG performance status of 0 or 1 and with a completely resected stage II-III NSCLC according to the 6th edition of the TNM staging System was planned. We enrolled patients from 17 Italian centers and 13 German Centers within 6-12 weeks after radical surgery.

      Genomic analyses were performed soon after surgery and then patients were randomly assigned in each of the 4 genomic subgroups to investigator’s choice of platinum-based chemotherapy (C1-2-3-4) or chemotherapy defined by the molecular markers. In the tailored arm patients with tumors that had high ERCC1 and high TS received single-agent docetaxel (T1); patients with high ERCC1 and low TS received single-agent pemetrexed (T2); patients with low ERCC1 and high TS received cisplatin and gemcitabine (T3); finally, patients with low ERCC1 and low TS received cisplatin and pemetrexed (T4). All anticancer drugs were administered according to standard doses and schedules. We randomly allocated patients with 1:1 ratio centrally using permuted blocks sizes and stratified by stage and smoking status. The primary end point of the study was overall survival according to an intent to treat analysis. For the final statistical analysis all the control arms were grouped in one (control arm) and all tailored chemotherapies in another one (experimental arm).

      Results

      Between December 2008 and August 2014, 773 patients were enrolled and randomly assigned to the treatment groups: 389 to arms C and 384 to arms T (T1, n=148, T2, n=43, T3, N=101, T4, N=92).

      Six hundred and ninety patients were included in the intent to treat analysis. In the control arm the following regimens were used: cisplatin /gemcitabine (n=159, 50.0%), cisplatin /viborelbine (n=123, 38.7%), cisplatin/docetaxel (n=23, 7.2%), platinum/pemetrexed (n=5, 1.6%), others (n=8, 2.5%). At a median follow up of 28.2 months (IQR: 9.9-55.8 months), 86 (24.9%) and 68 (19.8%) patients were deceased in arms C and T, respectively. The estimated median overall survival in arm C was 83.5 months (95%CI: 60.1-not defined) and in arm T was 96.4 months (95%CI: 81.8-not defined; hazard ratio (group T vs. group C) was 0.76 (95%CI: 0.55-1.04; p=0.091). Grade 3-5 toxicities that were reported more frequently in arm C (control) than in arm T (tailored) were neutropenia (18.9% vs 13.4%), leukopenia (13.3% vs 3.9%), thrombocytopenia (7.7% vs 3.3%) and anaemia (2.7% vs 0.9%).

      Conclusion
      In completely resected stage II-III NSCLC tailoring adjuvant chemotherapy on the basis of the mRNA expression of selected genes do not confer a statistically significant survival advantage in terms of overall survival and relapse-free survival and toxicity was less commonly reported in the customization arms.

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