Virtual Library

Start Your Search

Federico Maldonado



Author of

  • +

    MA08 - Clinical Trials in Brain Metastases (ID 906)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 15:15 - 16:45, Room 203 BD
    • +

      MA08.02 - Prophylactic Cranial Irradiation Reduces the Risk of Brain Metastases in High-Risk Lung Cancer Patients: EGFR and ALK Mutations (ID 13496)

      15:20 - 15:25  |  Author(s): Federico Maldonado

      • Abstract
      • Presentation
      • Slides

      Background

      Prophylactic Cranial Irradiation (PCI) is considered standard-of-care for small-cell lung cancer, due to consistent findings of a reduced risk of developing brain metastases (BM) and a survival benefit. The role of PCI for patients with Non-small cell lung cancer (NSCLC) is less well established, since a clear survival benefit has not been identified, although high-risk subgroups have been identified, including patients with driver mutations and with elevated carcinoembryonic antigen (CEA) levels.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We assessed the use of PCI compared to observation in patients with stage IV NSCLC (NCT01603849). PCI dose was set 25 Gy/10 f. An amendment to the original record was requested so that patients who received PCI after January 2016 had hippocampal sparing. Primary end point was Intracranial Progression-Free survival (IPFS), secondary was overall survival (OS).

      4c3880bb027f159e801041b1021e88e8 Result

      84 patients were included, 43 were randomized to observation and 41 to PCI. 83.3% had a driver mutation (DM). Baseline characteristics were well balanced among groups. Median IPFS was 21.0 months (95%CI 16.2-25.9). Factors which were independently, positively associated with IPFS included ECOG (p=0.012) and therapeutic arm (p=0.006). PCI was associated with lower odds of progression to CNS (OR:0.16 (0.04–0.53), p=0.006).Cumulative incidence of BM at 1-yr was higher among patients without PCI (22% vs. 3%, p<0.001). Relative risk for IPFS in patients with DM was 0.29 (0.10-0.82, p=0.01), HR for OS was 0.48 (0.20-1.16, p=0.098). Median OS was higher in the PCI group compared to control [42.8 (95%CI: 28.1–57.6) vs. 25.9 (95%CI: 17.7 – 34.2)] months. Last, PCI was associated with lower hazards of death, 0.47 (0.24–0.95), p=0.035.rt-prof figure.png

      8eea62084ca7e541d918e823422bd82e Conclusion

      PCI significantly increases IPFS and decreases risk of death in patients with advanced NSCLC, without neurocognitive impairment or decreased QoL. This intervention appears to be particularly useful for patients with good performance status and driver mutations. PCI increased IPFS without neurocognitive impairment or decreased QoL.

      6f8b794f3246b0c1e1780bb4d4d5dc53

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

  • +

    MA25 - Oligometastasis: Defining, Treating, and Evaluating (ID 929)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Oligometastatic NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 13:30 - 15:00, Room 203 BD
    • +

      MA25.10 - Complete Response by PET-CT After Radical Treatment in Oligometastatic Non-Small Cell Lung Cancer Predicts Longer Survival   (ID 14232)

      14:35 - 14:40  |  Author(s): Federico Maldonado

      • Abstract
      • Presentation
      • Slides

      Background

      Evidence is rapidly accumulating for the use of radical treatment approaches for patients with oligometastatic Non-small cell lung cancer (NSCLC). Several limitations remain, however, to further strengthen the use of radical therapy as opposed to standard maintenance therapy, including a lack of robust markers to predict patient response. In this study, we assessed the utility of reaching a complete response (CR) by PET-CT in patients with oligometastatic disease after radical treatment (NCT02805530).

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We included patients with stage IV NSCLC who presented with ≤5 synchronous, any-site metastases (oligometastatic disease) as assessed by PET-CT. Patients received 4 initial cycles of systemic treatment. Following, patients were evaluated by PET-CT and those with stable disease and partial response received radical treatment to the primary site and metastases (surgery, radiotherapy, chemotherapy plus radiotherapy, radiofrequency and SBRT alone or in any combination). Response to radical treatment was evaluated by PET-CT. Maintenance treatment was permitted.

      4c3880bb027f159e801041b1021e88e8 Result

      37 patients were included in the analysis. Mean age was 55.7. At diagnosis 43.2% of patients presented with CNS metastases. After 4 cycles of first-line therapy, 100% of patients received treatment to the primary site, while 83.8% also received therapy to metastases. Following radical treatment, 19 (51.4%) patients achieved a CR by PET-CT, while 18 (48.6%) had a partial response (NON-CR). Median PFS was 26.2 months (95%CI 12.2-40.1), and was positively affected by CR by PET-CT (NR vs. 14.3 [95%CI 11.9-16.7]; p<0.001). Median overall survival (OS) was NR. OS was also positively affected by CR by PET-CT (42-month survival: 82.5%±18 for CR vs. 34.4%±28 for NON-CR by PET-CT; p=0.01).

      8eea62084ca7e541d918e823422bd82e Conclusion

      Patients with oligometastatic NSCLC who undergo radical treatment and reach a CR by PET-CT show a significant improvement in survival outcomes. Our results suggest that CR by PET-CT could serve as a surrogate marker for prolonged survival in this patient sufigure rc petct.pngbgroup.

      6f8b794f3246b0c1e1780bb4d4d5dc53

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

  • +

    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
    • +

      P1.01-03 - Effect of Prophylactic Cranial Irradiation on Cognitive Function and QoL in NSCLC Patients at High Risk of Brain Metastases (ID 14166)

      16:45 - 18:00  |  Author(s): Federico Maldonado

      • Abstract
      • Slides

      Background

      Up to 50% of NSCLC patients develop brain metastases (BM). Prophylactic Cranial Irradiation (PCI) is a potentially useful strategy to prevent this event, although its use remains controversial due to inherent risks. Therefore, actions such as dose adjustment for Whole Brain Radiotherapy (WBRT), or hippocampal-sparing techniques have been explored. We evaluated the impact of PCI on cognitive function and Quality of Life (QoL).

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Within the clinical trial NCT01603849 we evaluated a total of 84 histologically-confirmed NSCLC patients with high risk of developing BM (adenocarcinomas harboring oncodrivers (EGFR or ALK) and/or carcinoembryonic antigen (CAE) level at diagnosis ≥20 pg/mL). Patients were randomized 1:1, 41 to receive PCI and 43 to observation. Cognitive function (CF) was evaluated before and after treatment and at 6, 9 and 12 months with Mini Mental State Examination (MMSE). Reliable Change Index was used to evaluate the effect on CF. QoL was assessed through the European Organization for Research and Treatment of Cancer (EORTC-QLQ-30). Differences between groups were compared with Mann Whitney U and Friedman test. OS was estimated from the first MRI assessing the absence of BM until death/last follow-up with Kaplan-Meier and compared with Log-Rank test.

      4c3880bb027f159e801041b1021e88e8 Result

      83.3% of patients presented an EGFR-mutation (n=60) or ALK-rearrangement (n=6). Median OS was 42.8 vs. 25.9 months among patients with or without PCI (p=0.031). MMSE scores and median score values for global QoL, fatigue and cognitive functioning did not differ among groups or at baseline and follow-up. There were also no differences in percentual change at 1-yr (Table).

      Clinical changes (MMSE)

      3 months

      6 months

      9 months

      1 yr

      n/N (%)

      n/N (%)

      n/N (%)

      n/N (%)

      Without PCI

      Without Changes

      38/43 (88.4)

      34/42 (81)

      34/42 (81.0)

      29/37 (78.4)

      Cognitive Deterioration

      0/43 (0)

      2/42 (4.8)

      0/42 (0)

      0/37(0)

      Cognitive Improvement

      5/43 (11.6)

      6/42 (14.2)

      8/42 (19.0)

      8/37 (21.6)

      With PCI

      Without Changes

      39/41 (95.1)

      31/34 (91.2)

      31/34 (91.2)

      27/31(87.1)

      Cognitive Deterioration

      1/41 (2.4)

      0/34 (0)

      0/34 (0)

      1/31(3.2)

      Cognitive Improvement

      1/41 (2.4)

      3/34 (8.8)

      3/34 (8.8)

      3/31 (9.7)

      Baseline

      3 months

      6 months

      9 months

      1 yr

      p-Value (*)

      Diff. at 1 yr

      Median (IQR)

      Median (IQR)

      Median (IQR)

      Median (IQR)

      Median (IQR)

      Median (IQR)

      Global QoL

      Without PCI

      66.7 (50.0 - 83.3)

      66.7 (50.0 - 83.3)

      66.7 (64.6 - 83.3)

      83.3 (66.7 - 85.4)

      83.3 (75.0 - 87.5)

      <0.001

      8.3 (0.0 - 29-2)

      With PCI

      66.7 (50.0 - 83.3)

      66.7 (50.0 - 83.3)

      66.6 (66.7 - 83.3)

      83.3 (66.7 - 83.3)

      83.3 (75.0 - 83.3)

      <0.001

      0.0 (0 - 25.0)

      p-Value (diff between groups)

      0.956

      0.786

      0.903

      0.172

      0.595

      0.791

      Fatigue

      Without PCI

      22.2 (11.1 - 44.4)

      33.3 (22.2 - 44.4)

      22.2 (11.1 - 44.4)

      22.2 (11.1 - 44.4)

      22.2 (11.1 - 33.3)

      <0.001

      0.0 (-22.2 - 0.0)

      With PCI

      22.2 (5.6 -33.3)

      33.3 (11.1 - 33.3)

      22.2 (8.3 - 33.3)

      22.2 (8.3 - 33.3)

      22.2 (0.0 - 33.3)

      <0.001

      0 (0 - 0)

      p-Value (diff between groups)

      0.493

      0.132

      0.942

      0.931

      0.93

      0.553

      Cognitive

      Without PCI

      83.3 (66.7 - 100.0)

      83.3 (66.7 - 100.0)

      83.3 (66.7 - 100.0)

      73.3 (83.3 - 100.0)

      73.3 (83.3 - 100.0)

      0.004

      0 (0 - 0)

      With PCI

      83.3 (66.7 - 100.0)

      83.3 (66.7 - 100.0)

      83.3 (66.7 - 100.0)

      91.7 (70.8 - 100.0)

      83.3 (83.3 - 100.0)

      0.017

      0.0 (0.0 - 0.0)

      p-Value (diff between groups)

      0.854

      0.983

      0.521

      0.411

      0.757

      0.734

      8eea62084ca7e541d918e823422bd82e Conclusion

      PCI was not associated with significant differences in MMSE and QoL scores, furthermore there were no differences when assessing specific subscales (e.g. fatigue and cognitive functioning). These results along with the clinical benefit in OS highlight the benefit of this approach particularly among patients at high risk of developing BM.

      6f8b794f3246b0c1e1780bb4d4d5dc53

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

  • +

    P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
    • +

      P3.01-69 - Stereotactic Ablative Radiotherapy Improves Progression-Free Survival &amp; Local Control in Oligometastatic Lung Cancer Patients (ID 13059)

      12:00 - 13:30  |  Presenting Author(s): Federico Maldonado

      • Abstract
      • Slides

      Background

      Non-small cell lung cancer (NSCLC) represents approximately 75% of the histological types of lung cancer. In patients with oligometastatic NSCLC, definitive treatment to primary tumor and low thoracic tumor burden are associated with better outcomes. The use of stereotactic ablative radiotherapy (SABR) has demonstrated high rates of local control for lung metastases and long-term survival improvement. The aim of this study is to evaluate Local Control (LC), Progression Free Survival (PFS) and toxicity of patients with oligometastatic NSCLC treated with SABR.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      A prospective study was conducted with oligometastatic NSCLC patients. From July 2016 to December 2017, with a median follow up of 21.7 months, eighteen patients were enrolled. All patients received systemic therapy, those with partial response (PR), assessed by PET CT, were referred for SABR treatment (45-60 Gy in 3-7 fractions) to the thoracic lesion (primary or metastatic) depending on location, size and number of lesions, always keeping BED (Biologically Effective Dose) >100 Gy for tumor.

      4c3880bb027f159e801041b1021e88e8 Result

      Eighteen patients were treated with SABR, response to treatment was as follows: global response was 94%, partial response 22% and complete response 72.2%. Mean time to progression after SABR treatment was 7.04 months (CI 95% 0.27-17.84 months). Progression free survival since beginning of any treatment was 20.14 months (CI 95% 12.92 - 27.35 months). The pattern of recurrence/progression was as follows: local (in field) 1/18, regional (mediastinal lymph node) 1/18 and systemic 4/18, 12/18 did not show any recurrence. Sixteen patients developed grade 1 pneumonitis; one patient developed grade 2 pneumonitis and grade 3 pneumonitis was reported in one patient. Only three patients required treatment with steroids (16.7%).

      8eea62084ca7e541d918e823422bd82e Conclusion

      SABR is a suitable and well-tolerated therapeutic option for patients with oligometastatic NSCLC. SABR have shown to improve local control and increase progression-free survival. Future clinical trials are required to fully evaluate the effects of this treatment.

      6f8b794f3246b0c1e1780bb4d4d5dc53

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.