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Alok Goel
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P1.01 - Advanced NSCLC (ID 757)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.01-023 - ALK-Positive NSCLC: A TMH Experience (ID 10491)
09:30 - 09:30 | Author(s): Alok Goel
- Abstract
Background:
ALK gene rearranged NSCLC are a rare subset of lung cancers. However, treatment with crizotinib leads to an improvement in outcomes. In this study, we have audited the outcomes of ALK-rearranged NSCLC at our institute.
Method:
This was a subset analysis of a prospective observational study. It was approved by the institutional ethics committee and was carried out in accordance with good clinical practice guidelines and declaration of Helsinki. For this analysis all Alk rearranged NSCLC patients, diagnosed at our center between November 2011- April 2017 were selected. The treatment received and the outcomes were noted. Progression-free survival and Overall survival were estimated using Kaplan-Meier method.
Result:
We had diagnosed 257 patients during this period. The median age was 50 years ( 23-77 years). There were 102 females (39.7%) and 155 males (60.3%). Only 49 patients were smokers (19.1%). The ECOG PS was 0-1 in 197 patients (76.7%), 2 in 28 patients (10.9%) and 3-4 in 32 patients (12.4%). The median number of sites of metastasis was 2 (0-7). Brain metastasis was seen in 36 patients (14.0%). The upfront treatment received was crizotinib in 168 patients (65.3%), pemetrexed -platinum doublet in 57 patients (22.2%), taxane-platinum in 4 patients (1.6%), gemcitabine-platinum in 4 patients (1.6%), others in 14 patients (5.4%). The crizotinib received was started upfront in 88 patients and after a few cycles chemotherapy in 80 patients. In these 80 patients, 53 patients were started as soon as the ALK rearrangement report was available while 27 patients were started after a few cycles once finances were available. The median PFS for crizotinib was 16.1 months versus 11.4 months in pemetrexed platinum (p-0.159) The median PFS in the patients receiving upfront crizotinib was 17.1 months versus 14.7 months in patients receiving crizotinib after the switch (p-0.399). The median overall OS was 39.9 months and it was similar between the two strategies of crizotinib(p-0.964). There were 57 patients (22.1%) who never received crizotinib. The median OS in patients who never received crizotinib was 11.0 months versus it was not reached in patients receiving crizotinib in any line (p-0.000). The 3 year OS in patients receiving crizotinib in any line was 67.0%.
Conclusion:
Crizotinib substantial improves outcomes in ALK-rearranged patients whether given upfront or post start of few cycles of chemotherapy.
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P2.03 - Chemotherapy/Targeted Therapy (ID 704)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.03-027 - Comparative Longitudinal Toxicity Analysis of EGFR Mutated NSCLC Treated with Either Pemetrexed Carboplatin or Gefitinib (ID 8967)
09:30 - 09:30 | Author(s): Alok Goel
- Abstract
Background:
Toxicity analysis in randomized studies is classically reported as maximum grade toxicity occurring during the course of treatment. Unfortunately, the duration of toxicity is neglected. Patients receiving targeted therapy like gefitinib frequently have low grade continuous toxicities. Longitudinal toxicity analysis may be a more appropriate method of quantifying and comparing toxicity.
Method:
EGFR mutated NSCLC patients treated with gefitinib or pemetrexed-carboplatin as a part of randomized study were selected for this analysis. Patients were evaluated on the 7th day after the start of therapy and then on days 15, 21, 42, 63, 84,105 and then subsequently every 2 months till progression. Toxicities in accordance with CTCAE version 4.02 occurring during each visit were documented at each visit. Three toxicities were selected for this analysis and these were diarrhea, skin rash and fatigue. R software was used for analysis. Maximum grade toxicity and longitudinal time -toxicity analysis was performed. Toxicities were compared between the 2 arms using both methods.
Result:
Among the 290 patients, half each were randomized to gefitinib and pemetrexed-carboplatin arm respectively. Any grade diarrhea was seen in 22 % of patients receiving gefitinib as opposed to 12% receiving pemetrexed-platinum (p-0.12%). Similar higher proportion of toxicity was seen in gefitinib arm for skin rash (33% versus 13%, p-0.00).The proportion of fatigue in gefitinib and pemetrexed -platinum arm were similar (6% versus 9%, p-0.59). The longitudinal time-toxicity analysis revealed that both rash and diarrhea were higher and more sustained in gefitinib arm. The difference area under the curve for rash and diarrhea were 10 units (p-0.192) and 21.89 units (p-0.09) respectively. The fatigue was similar in both arms (p-0.779)
Conclusion:
Longitudinal time -toxicity analysis provides information which is clinically relevant and might impact patients quality of life and hence should be performed in patients receiving targeted therapies.
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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): Alok Goel
- 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
