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Sushmita Pathy
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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: 3
- 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): Sushmita Pathy
- Abstract
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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EP1.01-77 - Locally Advanced Non Small Cell Lung Cancer - Treatment Outcome in Real World Setting (Now Available) (ID 1626)
08:00 - 18:00 | Author(s): Sushmita Pathy
- Abstract
Background
Lung cancer is one of the leading cancers in India. About two-thirds present in advanced /metastatic stage. The mainstay therapy for advanced non small cell lung cancer (NSCLC) is concurrent chemoradiation. Locoregional failure constitutes the predominant failure pattern.
A larger proportion of the patients are treated with palliative intent. The current study evaluates the demographic profile, treatment pattern, and outcome and radiation practice for palliative treatment at a tertiary care academic medical institution.
Method
Medical records of patients treated between June 2016- June 2018 were evaluated Clinical presentation, treatment details and outcome was recorded. Case records with incomplete workup or treatment was excluded.
Result
A total of 181 patients of NSCLC were registered of which 108 were metastatic at presentation 96 patients received palliative radiotherapy and are analysed. 11 patients has pulmonary metastasis and 85 had extrapulmonary metastasis of which 21 patients had multiple extrapulmonary disease.
Ninety-six patients received palliative radiotherapy. 84 patients had ≤ 1comorbidity. Most of the patients were aged ≤65years (80%) with a female preponderance. Cough, chest pain and dyspnea each were present in one-third of patients. Twenty-six patients had bony pain, 18 had symptoms of raised intracranial pressure and 7 patients had SVCO.
Adenocarcinoma was the commonest histology observed in 86.4% patients. Bone was the most common site of metastasis, seen in 65(65.7%) patients; followed by brain in 23(24%).
Palliative radiotherapy was given to primary in 13(13.5%), brain in 27(28%), bone in 56(58%). Palliative radiotherapy to weight bearing sites was treated with 8Gy in single fraction. Whole brain radiotherapy was treated with 20Gy in 5 fractions. 65% of patients received palliative chemotherapy. Platinum- taxane and platinum- pemetrexed regimens were the most common regimen practiced for among squamous and adenocarcinoma histology respectively. Median follow up was 6.6 months (2 to 37 months). Median time for oncological intervention was 1.2 months (0.1 to 5.4months). Median PFS was 6months (IQR 3- 11.2months)
Conclusion
The study concludes that a large proportion of patients present in advanced/metastatic disease. In the metastatic setting bone metastasis was the most common site followed by brain. The outcome is dismal and newer treatment techniques /modalities may result in improved outcome in this group of patients.
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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): Sushmita Pathy
- Abstract
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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EP1.18 - Treatment of Locoregional Disease - NSCLC (ID 208)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Treatment of Locoregional Disease - NSCLC
- Presentations: 2
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.18-25 - Definitive Radiotherapy in Lung Cancer – A Glimpse Over the Narrow Window (ID 2128)
08:00 - 18:00 | Author(s): Sushmita Pathy
- Abstract
Background
Lung cancer is one of the leading global malignancies. Locally advanced NSCLC (LA-NSCLC) comprises of a significant proportion of patient burden. Despite advances in the treatment definitive radiotherapy is delivered only to a small proportion of patients.
The current study was carried out to analyze various factors associated with change of curative treatment plan to palliative treatment at a tertiary cancer Centre
Method
Medical records of patients of LA-NSCLC lung cancer treated between June 2016 to June 2018 were evaluated. Clinical presentation, evaluation, treatment details and outcome were recorded. Patients who were not eligible for radical treatment were excluded. All patients were taken for radical treatment but could not receive definitive radiotherapy were analyzed
Result
Of 67 patients of LA-NSCLC 8 patients that were non metastastic were planned for upfront palliative intent.25 patients needed change in their treatment plan to palliative treatment. Majority of them were ≥ 65years. Median number of chemotherapy cycles was 2 (0-6). Patients were assessed after 2 cycles of chemotherapy for concurrent chemoradiation as our institute practice. Patients were assessed at the end of 2nd chemotherapy. Reasons for ineligibility was noted and categorized into patient, tumor and treatment factors.
Factors for change in treatment plan were divided as (i) Patient related factors included, treatment defaults, poor compliance, financial and social reasons, ECOG performance status at the end of chemotherapy, comorbidities, which accounted for 30.3%. (ii)Tumor related factors included, disease progression, poor response to chemotherapy, which accounted for 54.5%. (iii)Treatment factors included ,risk of toxicity due to large volume disease, volume not able to cover in one radiotherapy portal, poor respiratory reserve, which added up for remaining 15.2% of patients.
Palliative radiotherapy to primary tumor alone was delivered in 25 patients,5 patients received palliative radiotherapy to primary and brain2 patients received palliative radiotherapy to bone and I received radiation to brain alone.
The median time to diagnose and stage was 0.65months (0.06 to 3.6 months). Median time to start chemotherapy was 0.8 months (0.16 to 7.3 months).
Conclusion
Eligibility for definitive radiotherapy is a dynamic decision which need to be reviewed at every stage of treatment. Timely radical intervention need not necessarily translate into radical radiotherapy. Feasibility of definitive radiotherapy pass through a narrow window and multiple factors play pivotal role in it.
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EP1.18-26 - Treatment Patterns and Clinical Outcomes in Locally Advanced Non Small Cell Lung Cancer: Experience from Tertiary Care Centre (Now Available) (ID 42)
08:00 - 18:00 | Presenting Author(s): Sushmita Pathy
- Abstract
Background
Lung Cancer comprises a significant global cancer burden.About two-thirds patients with non small cell lung cancer, present in advanced/metastatic stage, of which the locally advanced group account for 30%.Combined modality approach with definitive chemoradiation is feasible in only a small proportion of patients. Several factors play a role in deciding the treatment and outcome In developing countries access to cancer centres and waiting period for oncological intervention and radiation therapy also significantly affect the management.The current study evaluates the demographic profile, treatment pattern, outcome and Radiotherapy practice and patient care at a tertiary care academic medical institution.
Method
Archives patients of locally advanced Non Small Cell lung cancer(LA-NSCLC) treated at our centre between, June 2016-June 2018 were included in our study. Clinical , demographic characteristics, treatment patterns, outcomes was recorded. Radiotherpy practice and patient care process including integration of radiation therapy with other specilities,waiting time, compliance to treatment was documented. Case records with incomplete work up or treatment was excluded. Univariate and multivariate analysis of factors on survival and overall survival was analysed.
Result
174 patients were treated during the study period. The distribution as per histology include Squamous cell carcinoma 54, Adenocarcinoma 108,Others (adenosquamous,poorly differentiated) 12. The median age was 57 years(35-84) with male preponderance .Only 67 patients belonged to locally advanced group and remaining 107 presented with metastastic disease. 59 patients of LA-NSCLC group were planned for definitive chemoradiation comprising of two cycles of induction chemotherapy followed by concurrent chemoradiation. 34 patients eventually underwent the planned treatment.The reason for conversion to palliative radiotherapy included disease progression during induction chemotherapy(18),poor performance status(7),large volume disease and risk of toxicity with radical dose ,defaulters(3). Median follow up was 11 months (range 0.7-29), overall survival 9.4 months(range 1.7-44.8). Median overall treatment time was 44 days.Progression free survival 8.9 months(range 1.6-28.6).Time to start any oncological intervention was 1 month(0.1-4.3) and time to start radiotherapy was 2.1 months(0.1-5.4). Adherence to treatment was 91.2%.Age ≥65 and performance status ≥2 were significant for overall survival in univariate analysis but did not confer any significance in multivariate analysis.
Conclusion
The study concludes that more than 60%of patients with Non small cell lung cancer present with metastatic disease. Only about a third are suitable for definitive chemoradiation and eventually only 20% undergo the planned treatment. Adherence to treatment is good in definitive setting
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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 | Author(s): Sushmita Pathy
- Abstract
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 (%)=83Paclitaxel arm
N(%)= 81p Median Age 52 years (29-65) 52 years (28-65) 0.6 Gende
Males
Females56 (67.47%)
27 (32.5%)
58 (71.6%)
23 (28.4%)0.61 Smoking Status
Non smokers
Smokers45 (54.22%)
38 (45.78%)39 (48.15%)
42 (51.85%)0.5 ECOG PS
0
1
29 (10.84%)
51 (61.45%)
23 (27.71%)3 (3.7%)
57 (70.37%)
21 (25.9%)0.18 Histology
Adenocarcinoma
NSCLC- NOS83 (100%)
076 (95%)
4 (5%)0.039 EGFR mutation
Positive
Negative
Not available20 (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 402 (2.41%)
81 (97.59%)03 (3.7%)
78 (96.3%)0.59 Pleural/Pericardial Effusion
Present
Absent32 (38.55%)
51 (61.45%)27 (33.33%)
54 (66.67%)0.48 Brain metastasis
Present
Absent/ Not evaluated16 (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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P1.18 - Treatment of Locoregional Disease - NSCLC (ID 190)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Treatment of Locoregional Disease - NSCLC
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.18-11 - Dose Dense Paclitaxel and Carboplatin as Neoadjuvant Therapy for Resectable/Borderline Resectable NSCLC - A Phase II Trial (Now Available) (ID 1604)
09:45 - 18:00 | Author(s): Sushmita Pathy
- Abstract
Background
Neoadjuvant chemotherapy in locally advanced NSCLC is controversial. Available data suggest modest benefit and ideal regimen is unknown. Dose dense approach has not yet been tested in neoadjuvant setting.
Method
This phase II trial tested a novel approach of dose dense paclitaxel at 80mg/m2on d1, d8, d15 with three weekly carboplatin at AUC-6 for 4 cycles. Only patients with ECOG PS 0-2 with non-bulky N2 (defined as single lymph node < 2cm or multiple LNs or conglomerate, all < 2cm) were included in the study. Response assessment was done after two and four cycles. Primary end point was objective response rate. Relative dose intensity was calculated to define safety and tolerability. Secondary end points included progression free survival (PFS) and recurrence free survival (RFS) for patients who underwent surgery. IEC approved the study and the trial was registered with CTRI (ref no-CTRI/2016/05/006916).
Result
A total of 33 patients were included in the study. Male to female ratio was 1.75:1. The median age was 54 years (40-78) and majority were smokers (78.8%). Most common histology was squamous cell carcinoma (57.6%) followed by adenocarcinoma (36.4%). Sixteen patients (48.48%) had N2 disease by PET out of which only three were TBNA positive, all were non bulky (<2cm). Around 76% of patients were able to complete the planned 4 cycles of treatment with only one patient having CTCAE ver 5 grade ¾ toxicity. Objective response rate was 61.3%. Relative dose intensity of 80.25% was maintained in patients who completed 4 cycles. Around 58% patients required dose modification, most common reasons included peripheral neuropathy (47%), myalgia (16%), diarrohea (10.5%) and neutropenia (10.5%). A total of 138 grade ½ toxicity events were reported in the study over 12 courses of chemotherapy, with nausea (48.5%), myalgia (42.4%), neutropenia (30.3%), peripheral neuropathy (27.3%) and diarrhea (27.3%) being the most common. Thirteen patients underwent surgery with majority undergoing lobectomy (77%). After a median follow-up time of 19.3 months, median PFS was 11.1 months (95%CI 7.26-18.16) and median overall survival was 26.63 (95% CI 15.03-NR). TNM stage on CT/PET and PET response to NACT significantly correlated with progression free survival on univariate analysis. In patients who underwent surgery, median RFS was 17.36 months (95%CI 6.5-31.86) and 2 year RFS rates were 25%.
Conclusion
Dose dense therapy with paclitaxel/ carboplatin is feasible, safe and efficacious and can be considered for N2 negative/ low node burden patients.
