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A. Janu
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P3.01 - Advanced NSCLC (ID 621)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.01-076 - QTWiST Analysis to Compare the Benefit of Gefitinib Versus Pemetrexed Platinum for Patients with EGFR Mutated NSCLC (ID 10431)
09:30 - 09:30 | Author(s): A. Janu
- Abstract
Background:
In an open-label, Phase 3 randomized study (Clinical trial registry of India: CTRI/2015/08/006113), Gefitinib was found to be superior to Pemetrexed-Platinum in terms of progression-free survival in patients with EGFR mutated NSCLC. In this analysis, we aimed to assess the benefit of gefitinib over Pemetrexed platinum using quality-adjusted time without symptom or toxicity analysis method.
Method:
In this phase III, randomized study EGFR activating mutated patients were randomized in 1:1 fashion to either receive pemetrexed-carboplatin followed by maintenance pemetrexed or gefitinib till progression. Patients post progression received the treatment received in other arm if they were fit. These patients were followed up until death. Toxicity during the whole course of treatment was documented in accordance with CTCAE version 4.02 criteria. For QTWiST analysis, the overall survival and progression-free survival were documented. The overall survival was partitioned in 3 health states. These were TOX, TWiST, and REL. TOX state comprised of time in months spent by the patient in grade 2 or above toxicity post randomization but before the first progression. TWiST state comprised of time in months spent by the patient post randomization but before the first progression without grade 2 or above toxicity. REL state was defined as the time in months spent post the first progression until death. RStudio will be used for analysis. The data will be censored for this analysis on 30th June 2017. The restricted mean of all three health states would be calculated using non-parametric 500 boot straps. The time spent in each state will be weighted by a corresponding health-state utility coefficient for QTWiST calculation. A threshold utility analysis will be performed using utility values between 0-1. Where 0 represents a health state similar to death and 1 represents a perfect health state.
Result:
The restricted mean health state duration in months for each state with its 95% CI for each arm, the difference between the 2 arms for each health state with its 95%CI and corresponding p-value will be provided. The results of threshold utility analysis with the corresponding QTWiST difference between the 2 arms with p-value would be presented.
Conclusion:
LBA: Not applicable
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P3.03 - Chemotherapy/Targeted Therapy (ID 719)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.03-015 - ROS-1 Rearranged Non Small Cell Lung Cancer and Crizotinib: An Indian Experience (ID 9315)
09:30 - 09:30 | Author(s): A. Janu
- Abstract
Background:
ROS1 is a receptor tyrosine kinase that belongs to insulin receptor family.It acts as a driver oncogene in 1 to 2% of NSCLC patients. ALK and ROS1 Kinase domain share 77% amino acid identity within the ATP-binding sites. Crizotinib binds with high affinity to both ALK and ROS1, Crizotinib is approved for patients with the ROS1 translocation including those who have received chemotherapy and those who are treatment naive. This is based on a phase 1 expansion study which enrolled 50 patients with ROS1 rearrangement. Over 80 percent of patients had received one or more prior chemotherapy treatment regimens. The objective response rate was 72 percent. The median duration of response was 17.6 months, and the median progression-free survival was 19.2 months.A retrospective series from Europe which included 32 patients reported 80% response rates and a PFS of 9.1 months.In this paper, we report our experience with ROS1 rearranged NSCLC from India.
Method:
Advanced NSCLC with the presence of ROS1 fusion (FISH) patients whose demographic data were retrieved from prospective lung cancer audit database Response by RECIST 1.1 criteria, side effects using CTCAE v 4.02
Result:
Among 11 patients more than 1/4[th] of patients had PS of ≥2. Nearly 1/2 of patients had comorbidities and extrathoracic disease while none with brain or adrenal metastasis.Eight received platinum-based doublet chemotherapy, two oral EGFR TKI, and one upfront crizotinib. Four patients among those who received platinum doublet were subsequently exposed to crizotinib Among the 4 patients platinum-based doublet, 2 (PR)and 2 (SD).Out of 5 patients who received crizotinib, 3 patients experienced grade ½ fatigue and grade ½ vomiting. Grade ½ transaminitis, visual symptoms, grade ½ diarrhea, grade ½ neutropenia and asymptomatic bradycardia, grade ½ neutropenia and thrombocytopenia were seen in 1 patient each. Out of 8 patients who received chemotherapy 3 patients had grade ½ anemia, grade ½ vomiting. There was one mortality in non-crizotinib group.Out of 5 patients who received crizotinib, 4 patients had PR (80%).With a median follow-up of 9 months, median PFS and OS were 5.4 months and 8.5 months respectively for the entire cohort.Median PFS and OS was not reached for those who received crizotinib compared to median PFS of 2.5 months and median OS of 4.2 months(<0.01).Estimated 1 year OS was 80% for those who received crizotinib and 18% for who did not.
Conclusion:
In conclusion, Crizotinib is effective with acceptable side effect profile in patients with ROS1 rearranged NSCLC in our population
