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Prabhat Singh Malik



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    EP1.01 - Advanced NSCLC (ID 150)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 2
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.01-17 - Predictors of Survival Outcomes with Chemotherapy in Advanced NSCLC Patients with Performance Status 2 and Above and Without Driver Mutation (Now Available) (ID 1287)

      08:00 - 18:00  |  Author(s): Prabhat Singh Malik

      • Abstract
      • Slides

      Background

      Platinum-based combination chemotherapy is recommended as the standard treatment for patients with advanced non-small-cell lung cancer (NSCLC), but its benefit is limited to patientswith performance status (PS) of 0 or 1. However, it is not clear whether these benefits apply to patients with poor performance status (PS 2 and above) and there are no predictors of outcome to suggest whom to treat .This population accounts for a significant portion (up to 30%) of patients of our practice and some of them have been treated with systemic chemotherapy based on clinician’s discretion.We have analyzed the outcome of these patientswho have been treated with chemotherapy despite poor performance status.

      Method

      We performed a retrospective analysis of patients of advanced NSCLC with poor PS (ECOG PS 2 or more) registered at our lung cancer clinic between January 2016 and December 2017 and treated with systemic chemotherapy. Patients with driver mutations who were treated with first line TKIs were excluded. Hospital case records were reviewed for baseline characteristics, treatment details and outcome data. Patients who haven’t come to the hospital in last 3 months were contacted on phone.

      Result

      A total of 95 patients were found to be eligible for this analysis. Median age was 62 years (30-84 years, including 23(24%) patients 70 years or above. At presentation out of these 95 patients, 63(66%) were smokers,31(32%) had cytological proven pleural/pericardial effusion, 10(10.5%) patients had brain metastasis and 34(35.5%) had extra thoracic metastasis (≥2 sites).Majority(64%) patients had ECOGPS 2 but 36 % had PS 3 or 4 also and 44(46%) had one or more associated comorbidities. The most common chemotherapy regimen used was weekly paclitaxel and carboplatin(57.8%) followed by pemetrexed and carboplatin (16.8%).Majority (64%) patients could complete 4or more cycles of chemotherapy however 15 patients (15.7%) could receive only one cycle and 20(21%) patients even received maintenance chemotherapy. Chemotherapy was interrupted due to poor tolerance in 20(21%) patients and grade ¾ toxicity seen in 22(23%) % patients. At least one point improvement in ECOG PS from baseline was observed in 43 patients (45%) after 4 cycles of chemotherapy. Objective response and disease control rates were 20 % and 48.42% % respectively.Aftera median follows up of 8.6 months, median progression free survival was 6.2 months (95%CI 5-10.33).On univariate analysis ,neutrophil –lymphocytic ratio (<5 vs >5 )and induction regimen (weekly Taxol+Platinum vs rest) were significantly associated(p=0.02 and p= 0.04 respectively) with better median PFS

      Conclusion

      Systemic chemotherapy in modified doses and schedules in advanced NSCLC patients with PS 2 and above is feasible and may be associated with better symptom palliation with clinical benefit and improvement in survival.neutrophil –lymphocytic ratio (<5 vs >5 )and induction regimen (weekly Taxol+Platinum vs rest) are predictors of better median PFS . Further studies addressing this neglected subgroup are indicated.

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      EP1.01-91 - Outcomes with Systemic Chemotherapy with Weekly Regimen in Advanced NSCLC Patients with PS 2 and Above and Without Driver Mutation (Now Available) (ID 1173)

      08:00 - 18:00  |  Author(s): Prabhat Singh Malik

      • Abstract
      • Slides

      Background

      Platinum-based combination chemotherapy is recommended as the standard treatment for patients with advanced NSCLC, but its benefit is limited to patientswith performance status (PS) of 0 or 1. However, it is not clear whether these benefits apply to patients with poor PS( 2 and above)). These patients have inferior outcomes and have been excluded from clinical trials. We have analyzed the outcome of these patients who have been treated with weekly chemotherapy despite poor performance status.

      Method

      We performed a retrospective analysis of patients of advanced NSCLC with poor PS (ECOG PS 2 or more) registered at our lung cancer clinic between January 2016 and December 2017 and treated with weekly chemotherapy. Patients with driver mutations who were treated with first line TKIs were excluded. Hospital case records were reviewed for baseline characteristics, treatment details and outcome data.

      Result

      A total of 68 patients were found to be eligible for this analysis. Median age was 63.5 years (30-77 years, including 17(25%) patients 70 years or above. At presentation out of these 68 patients, 50(73.5%) were smokers,22(32%) had cytological proven pleural/pericardial effusion, 7(10.2%) patients had brain metastasis and 35(51.5%) had extra thoracic metastasis (≥2 sites). Majority(61%) patients had ECOGPS 2 but 39 % had PS 3 or 4 also and 29(42%) had one or more associated comorbidities. The most common chemotherapy regimen used was weekly paclitaxel and carboplatin(82.8%) followed by single agent paclitaxel(17.8%).Majority (63%) patients could complete 4 or more cycles of chemotherapy however 9 patients (13.2%) could receive only one cycle and 16(23%) patients even received maintenance chemotherapy. Chemotherapy was interrupted due to poor tolerance in 10(14.7%) patients and grade ¾ toxicity seen in 16(23%) % patients. At least one point improvement in ECOG PS from baseline was observed in 33 patients (48.5%) after 4 cycles of chemotherapy and objective response and disease control rates were 23.5 % and 50% % respectively. After a median follows up of 13 months, median progression free survival was 7.3 months.

      Conclusion

      Systemic chemotherapy in modified doses and schedules in advanced NSCLC patients with PS 2 and above is feasible and may be associated with better symptom palliation with clinical benefit and improvement in survival. Further studies addressing this neglected subgroup are indicated.

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    P1.01 - Advanced NSCLC (ID 158)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.01-02 - Pemetrexed-Carboplatin Versus Paclitaxel (Weekly)-Carboplatin as First Line Chemotherapy in Advanced Non-Squamous NSCLC (Now Available) (ID 2952)

      09:45 - 18:00  |  Presenting Author(s): Prabhat Singh Malik

      • Abstract
      • Slides

      Background

      Platinum doublet chemotherapy has been standard of care in treatment naïve advanced non-small cell lung cancer (NSCLC) without targetable driver mutation until recent approvals of first line immune check point inhibitors. Pemetrexed-platinum combination has been preferred over other combinations in non-squamous NSCLC (ns-NSCLC). However there has been no direct comparison to Paclitaxel-carboplatin.

      Method

      This open label randomized control trial was designed to compare Pemetrexed-Carboplatin versus Paclitaxel (weekly)-Carboplatin combination in treatment naive advanced/metastatic ns-NSCLC without driver mutations and ECOG PS 0-2. The study was powered to detect superiority of Pemerexed-Carboplatin over Paclitaxel-Carboplatin by 15% in terms of 6 months PFS rates (primary outcome) and total 182 events were required for the same. Patients received either Pemetrexed 500 mg/m2 and Carboplatin AUC 5 every 3 weekly cycle for 4 cycles (with standard vitamin supplementation) or Paclitaxel 80 mg/m2 day 1, day 8 and day 15 with Carboplatin AUC 5 every 4 weekly cycles for 4 cycles. Patients in both arms were allowed to receive Pemetrexed maintenance in absence of progressive disease after 4 cycles. Patients, in whom EGFR mutation or ALK rearrangement were detected after randomization, were allowed to receive appropriate targeted therapy after 4 cycles or earlier as per physician’s discretion. The trial was approved by institute ethics committee and registered with CTRI (CTRI/2016/12/007605).

      Result

      A total of 180 patients were enrolled between April 2016 and January 2019. The study was terminated early due to slow accrual, however at the time of analysis (31stMarch 2019) total 129 events (70.8% of required) had occurred. Finally, 164 patients were evaluable, 83 in Pemetrexed-Carboplatin arm and 81 in Pacitaxel-Carboplatin arm. After a median follow up time of 15 months, PFS rates at 6 months were not different in two treatment arms (43.3% vs 43.2%; p=0.98). Median PFS were 5.63 months (95%CI 3.73-7.3) in Pemetrexed-Carboplatin arm and 5.03 months (95%CI 2.63-7.43) in Paclitaxel-Carboplatin arm (p=0.61; HR 1.09(95%CI 0.77-1.54). Median overall survival wasn’t different, 13.4 months (95%CI 8.6-17.63) and 10.13 (95%CI 7.6-19.7) respectively (p=0.11; HR 1.07(95%CI 0.71-1.61). All grade toxicities were similar except for alopecia and peripheral neuropathy, which were significantly higher in the Paclitaxel arm.

      Baseline Characteristics of the patients
      Characteristics

      Pemetrexed arm

      N (%)=83

      Paclitaxel arm

      N(%)= 81
      p
      Median Age 52 years (29-65) 52 years (28-65) 0.6

      Gende

      Males

      Females

      56 (67.47%)

      27 (32.5%)

      58 (71.6%)

      23 (28.4%)
      0.61

      Smoking Status

      Non smokers

      Smokers

      45 (54.22%)

      38 (45.78%)

      39 (48.15%)

      42 (51.85%)
      0.5

      ECOG PS

      0

      1

      2

      9 (10.84%)

      51 (61.45%)

      23 (27.71%)

      3 (3.7%)

      57 (70.37%)

      21 (25.9%)
      0.18

      Histology

      Adenocarcinoma

      NSCLC- NOS

      83 (100%)

      0

      76 (95%)

      4 (5%)
      0.039

      EGFR mutation

      Positive

      Negative

      Not available

      20 (24.39%)

      47 (57.32%)

      16 (19.2%)

      18 (22.2%)

      48 (59.26%)

      15 (18.52%)
      0.94

      ALK rearrangement

      Positive

      Negative

      Not available

      08 (9.76%)

      50 (60.98%)

      25 (30.12%)

      07 (8.64%)

      50 (61.73%)

      24 (29.61%)
      0.66

      Stage (AJCC 7th)

      Stage 3B

      Stage 4

      02 (2.41%)

      81 (97.59%)

      03 (3.7%)

      78 (96.3%)
      0.59

      Pleural/Pericardial Effusion

      Present

      Absent

      32 (38.55%)

      51 (61.45%)

      27 (33.33%)

      54 (66.67%)
      0.48

      Brain metastasis

      Present

      Absent/ Not evaluated

      16 (19.28%)

      67 (80.7%)

      16 (19.75%)

      65 (80.2%)
      0.93

      Conclusion

      Pemetrexed-Carboplatin is not superior to Paclitaxel (weekly) -Carboplatin as first-line regimen in advanced ns-NSCLC in terms of 6 months PFS rates.

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