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Marta Batus
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P2.01 - Advanced NSCLC (Not CME Accredited Session) (ID 950)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 3
- Moderators:
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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P2.01-12 - Ramucirumab+Docetaxel Usage Following Rapid Disease Progression in Real World Advanced Non-Small Cell Lung Cancer Patients (ID 14359)
16:45 - 18:00 | Presenting Author(s): Marta Batus
- Abstract
Background
In the Phase III REVEL study, the overall treatment effect of ramucirumab+docetaxel (ram+doc) in patients with rapid disease progression (RDP), defined as disease progression ≤ 12 weeks after start of prior platinum-based chemotherapy, was consistent with that observed in the intent-to-treat population. This real-world, retrospective study described baseline characteristics, treatment patterns, and clinical outcomes among RDP patients subsequently treated with ram+doc in the United States.
a9ded1e5ce5d75814730bb4caaf49419 Method
Advanced non-small cell lung cancer (aNSCLC) patients receiving ram+doc as 2nd line or 3rd line therapy between March 2015 - May 2017 after platinum-based chemotherapy, with ≥ 3 months of potential follow-up, were identified in the Flatiron Health EHR-derived database. Analyses were conducted for RDP and non-RDP patients. Overall survival (OS) was measured from start of 1st line therapy. Real-world progression-free survival (rwPFS) and time-to-progression (rwTTP) were measured from start of ram+doc. OS, rwPFS, and rwTTP were estimated using Kaplan-Meier method.
4c3880bb027f159e801041b1021e88e8 Result
Baseline characteristics were generally similar across RDP (n=49) and non-RDP (n=123) patients with respect to age, gender, and race. Non-RDP patients more often had stage IV disease at diagnosis and non-squamous histology. Among patients with ECOG performance status (PS) reported (n=101, 58.7%), a higher proportion of RDP patients had ECOG PS > 2 (18.4%) than non-RDP patients (9.8%). The majority of patients received ram+doc as 3rd line therapy and the median duration of ram+doc treatment was similar for RDP and non-RDP patients. The most frequently administered chemotherapy regimen prior to ram+doc was carboplatin+pemetrexed for RDP patients and carboplatin+pemetrexed+bevacizumab for non-RDP patients.
RDP was associated with shorter median OS (13.2 [95% CI: 10.3 - 15.8] vs. 21.6 [95% CI: 17.1-24.1] months, log-rank P < 0.01) whereas median rwPFS (3.0 [1.8 - 4.1] vs. 3.6 [2.9 - 4.1] months, log-rank P = 0.74) and median rwTTP (4.6 [95% CI: 3.5 - 7.9] vs. 5.5 [95% CI: 4.1 - 7.4] months, log-rank P = 0.81) on ram+doc were similar between the RDP vs. non-RDP groups, respectively.
8eea62084ca7e541d918e823422bd82e Conclusion
While this real-world cohort shows that RDP correlates with poorer OS, similar rwPFS and rwTTP were observed with ram+doc among aNSCLC patients with RDP vs. non-RDP. This study did not assess the effects of ram+doc vs. other subsequent treatments in patients with RDP. Further research is needed to identify RDP risk factors and to aid in development of optimal treatments for aNSCLC patients with the most aggressive disease.
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P2.01-34 - Prognostic Value of Neutrophil to Lymphocyte Ratio for Metastatic NSCLC Patients Treated with Immunotherapy and Ramucirumab Plus Docetaxel. (ID 14081)
16:45 - 18:00 | Presenting Author(s): Marta Batus
- Abstract
Background
High NLR has been associated with inferior OS in metastatic NSCLC patients. We previously demonstrated a significant relationship between a high NLR at baseline and at follow-up and poorer OS in patients with metastatic NSCLC. Case series suggest potentially improved benefits of cytotoxic chemotherapy administration post immunotherapy but little is known about whether high NLR is associated with inferior outcomes in patients receiving salvage ramucirumab plus docetaxel (RD). We evaluated the potential predictive value of NLR in pts with metastatic NSCLC who received at least one cycle of immunotherapy and treated with RD regimen.
a9ded1e5ce5d75814730bb4caaf49419 Method
Retrospective analysis of patients with metastatic NSCLC who received at least one cycle of nivolumab or pembrolizumab and treated with RD regimen between April 2015 and May 2017. Patient demographics including NLR, RD and immunotherapy starting dates, and date of progression were recorded. Associations between NLR and both PFS and OS were assessed using Mann-Whitney-Wilcoxon tests. Cutoffs of NLR of 5.0 (based on published data) were analyzed for differences in median OS and PFS.
4c3880bb027f159e801041b1021e88e8 Result
Of 62 patients analyzed, 47% were male, 81% former smoker, 76% Caucasian and 76% patients who were treated with RD regimen also received immunotherapy during their treatment course. For entire cohort, baseline NLR ≤ 5 was associated with superior survival (median OS 20.86 mos for NLR ≤ 5 vs 5.78 mos for NLR >5, p=0.01) and superior PFS (median PFS 6.01 mos for NLR ≤ 5 vs 2.76 mos for NLR >5, p=0.03). Another significant predictor of OS was albumin at baseline (HR= 0.44, p = 0.01) and at 6 weeks (HR= 0.38, (p = 0.01). Patients who received immunotherapy had significantly superior OS than those who did not receive immunotherapy (median not reached vs 7.43 mos, p =0.03) within one-year follow-up.
8eea62084ca7e541d918e823422bd82e Conclusion
Low NLRs and higher albumins at baseline & 6 weeks were associated with a prolonged PFS and OS in patients with metastatic NSCLC who were treated with RD regimen. In this small retrospective study, longer OS was observed in pts treated with RD regimen and immunotherapy. Pts who did not receive immunotherapy had shorter OS. Additional data are needed to evaluate the impact of treatment sequence.
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P2.01-61 - Body Mass Index over Time is Associated with Overall Survival in Advanced NSCLC Patients Treated with Immunotherapy. (ID 13880)
16:45 - 18:00 | Author(s): Marta Batus
- Abstract
Background
Cachexia has been associated with inferior outcomes for patients with stage III/IV NSCLC (aNSCLC). This study evaluates the potential relationship between baseline and longitudinal body mass index (BMI) with progression free survival (PFS) and overall survival (OS) in aNSCLC patients on nivolumab or pembrolizumab.
a9ded1e5ce5d75814730bb4caaf49419 Method
Patients with aNSCLC who received at least once cycle of nivolumab or pembrolizumab between January 2015 and January 2017 were identified in our pharmacy database. Patient demographics, longitudinal BMIs, treatment start date, date of progression, and last follow-up were recorded. OS and PFS were assessed by log-rank tests and Cox proportional hazard analysis. Time-dependent Cox model based analyses were used to assess the association between time dependent BMIs.
4c3880bb027f159e801041b1021e88e8 Result
The study included 162 aNSCLC patients. Median age 68 yrs, male/female 40.1%/59.9%. BMI values were obtained longitudinally at baseline, 6 wks, and 12 wks. Median BMI: baseline 24.69, at 6 wks 24.75, and at 12 wks 24.89. Median change in BMI: baseline to 6 wks = -0.50 (range: -5.79 to +2.92), baseline to 12 wks = -0.33 (range: -6.52 to +3.41), and 6 wks to 12 wks = -0.21 (range: -4.56 to +2.73). Hazard ratios for change in BMI with OS: baseline to 6 wks HR 0.7198 (p=0.0010), baseline to 12 wks HR 0.8703 (p=0.0553), and 6 wks to 12 wks HR 0.8284 (p=0.0668).
8eea62084ca7e541d918e823422bd82e Conclusion
Change in BMI over time is associated with OS in aNSCLC patients treated with nivolumab or pembrolizumab. Although decrease in BMI may simply be a prognostic marker for treatment with immune checkpoint inhibitors, it is possible that understanding potential relationships between cachexia and the immune system may be useful in developing strategies to improve response to immunotherapy.
6f8b794f3246b0c1e1780bb4d4d5dc53
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P2.12 - Small Cell Lung Cancer/NET (Not CME Accredited Session) (ID 961)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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P2.12-16 - Significant Tumor Regression and Toxicity with Nivolumab Plus Ipilimumab in Small Cell Lung Cancer Patients Following Radiation (ID 13928)
16:45 - 18:00 | Author(s): Marta Batus
- Abstract
Background
Nivolumab plus ipilimumab demonstrated an approximately 20 percent response rate in patients with Small Cell Lung Cancer (SCLC) who had received 1 or more previous regimen (Antonia et al., 2016). The study did not include data on the clinical response and toxicity in patients who had received previous radiotherapy.
However, there is pre-clinical (Deng et al., 2015; Dovedi et al., 2017) and clinical evidence (Antonia et al., 2017) that radiation may potentiate effectiveness of anti - PD-1/PDL-1 immune checkpoint inhibitors.
Tumor responses and toxicities in six patients with progressive SCLC treated with second line nivolumab plus ipilimumab after chest radiotherapy and/or radiotherapy to a metastatic site are described.
a9ded1e5ce5d75814730bb4caaf49419 Method
This is a retrospective study of 6 patients who had received radiotherapy within 90 days to at least 1 site of gross disease. Response to immunotherapy was assessed by CT scans approximately 8 weeks after beginning treatment. RECIST criteria was utilized in determining responses. Patients were followed for at least 120 days after initiation of immunotherapy.
4c3880bb027f159e801041b1021e88e8 Result
Three patients with extensive stage SCLC progressed after chemotherapy at 79, 98, and 125 days prior to starting immunotherapy. Three patients with limited stage SCLC progressed after chemotherapy/radiation at 23, 99, 304 days prior to starting immunotherapy. All six patients had grade 3 or 4 toxicities that required discontinuation or delay of immunotherapy. Toxicities included two patients with myasthenia gravis, two patients with grade 3 rashes, one patient with grade 3 fatigue and one patient with grade 3 stomatitis. At time of initial re-assessment CT scan, four patients had partial response and two patients had stable disease. At 120 days, all six patients had tumor responses.
Currently, four patients continue with durable responses. One patient has remained progression free at 182 days after receiving one dose of nivolumab plus ipilimumab. One patient has remained progression free at 197 days after two doses of nivolumab plus ipilimumab. Two patients have remained progression free at 183 and 209 days after two doses of nivolumab plus ipilimumab followed by nivolumab maintenance. In two patients, progression occurred at 132 and 192 days after receiving two doses of nivolumab plus ipilimumab without maintenance nivolumab.
8eea62084ca7e541d918e823422bd82e Conclusion
These observations support that combined immune checkpoint inhibitors following radiation are associated with severe immune mediated toxicity in SCLC patients. The rapid tumor responses and relatively long disease control in these patients with aggressive disease suggest that modified versions of this treatment strategy should be considered.
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P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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P3.01-05 - Mature Progression-Free Survival in Stage IV Non-Small Cell Lung Cancer Patients Treated With Pemetrexed Maintenance Therapy (ID 12667)
12:00 - 13:30 | Presenting Author(s): Marta Batus
- Abstract
Background
Pemetrexed maintenance therapy is associated with superior survival in stage IV Non-Squamous, Non-small Cell Lung Cancer patients. We have observed long term disease control in real world patients treated with Pemetrexed(Pem)/Platinum(Plat) +/- Bevacizumab(Bev) followed by Pem +/- Bev maintenance therapy. To our knowledge, there is no mature data regarding the tail of the Progression Free Survival (PFS) curve in these patients. The objectives of this retrospective analysis are to determine the frequency of long term disease control on Pem+/- Bev maintenance and to identify parameters associated with absence of disease progression.
a9ded1e5ce5d75814730bb4caaf49419 Method
Our study looked at patients with Stage IV nsqNSCLC who received first line Pem/Plat followed by Pem maintenance between May 2010 and December 2017. We identified 241 patients from our database and analyzed their demographics, lab values, dates of therapy, and dates of progression. PFS was estimated by the Kaplan-Meier method and associations with patient characteristics were assessed by log-rank tests and Cox proportional hazards analysis.
4c3880bb027f159e801041b1021e88e8 Result
Median age was 66 years, 60% female, and 72% Caucasian. Baseline ECOG performance status (PS) was 0(22%), 1(50%) and ≥ 2(22%). Disease progression was observed in 233 of 241 pts. with median PFS of 6.2 months. Absence of disease progression was observed in 34 pts. (14.2%) at 2 years, 19 pts. (7.9%) at 3 years, and 3 pts. (1.2%) at 5 years. Improved PFS was strongly associated with lower baseline neutrophil: lymphocyte ratio (NLR) when using NLR≤3.5 vs >3.5 (median PFS 9.7 mo vs 5.2 mo, p =0.004) as well as in a continuous scale (HR=1.04, p < 0.001). ECOG PS of 0/1 was also associated with superior PFS (p<.001).
8eea62084ca7e541d918e823422bd82e Conclusion
The similarity in median PFS in our patients (6.2 mo) and clinical trial data suggests that our group of real world patients did not have uniquely favorable baseline characteristics. Although long term absence of progression may have been solely due to favorable natural history of disease, we believe that it was also due to Pem maintenance. As a result, continued development of Pem plus immunotherapy regimens in nsqNSCLC may result in a higher rate of long term disease control.
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P3.01-19 - Sequencing of Ramucirumab+Docetaxel Post-Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer Patients (ID 14281)
12:00 - 13:30 | Author(s): Marta Batus
- Abstract
Background
The Phase III REVEL study demonstrated the efficacy and safety of ramucirumab+docetaxel (ram+doc) in advanced non-small cell lung cancer (aNSCLC) patients who had disease progression on prior platinum-based chemotherapy (chemo). Given recent positive data disclosures supporting the use of chemo+immune checkpoint inhibitor (ICI) combinations in frontline, there is a need for additional data on the sequencing of ram+doc post-ICIs.
a9ded1e5ce5d75814730bb4caaf49419 Method
Baseline characteristics and outcomes were assessed for aNSCLC patients identified in the Flatiron Health EHR-derived database, who received ram+doc as 3rd line therapy (3L) between March 2015 - May 2017 in the United States after 1st or 2nd line platinum-based chemotherapy, with ≥ 3 months of potential follow-up. Analyses were conducted for the overall cohort and among the subset of patients who received 3L ram+doc post-ICI. Overall survival (OS) was calculated from start of 1st line therapy. Real-world progression-free survival (rwPFS) and time-to-progression (rwTTP) were measured from start of 3L ram+doc. OS, rwPFS, and rwTTP were estimated using Kaplan-Meier method.
4c3880bb027f159e801041b1021e88e8 Result
Among platinum-treated patients who subsequently received ram+doc in 3L overall (N=98), of whom the majority (n=65, 66.3%) received ram+doc post-ICI, the median age was 66 years and the majority were male (54.1%), Caucasian (67.4%), and had nonsquamous histology (81.6%). Of the 61 (62.2%) with available ECOG performance status (PS) data, 72.1% had ECOG PS of 0 or 1. Baseline characteristics were similar between the overall cohort and ram+doc post-ICI patients, as were clinical outcomes between the two groups (Table 1).
8eea62084ca7e541d918e823422bd82e ConclusionTable 1. Clinical Outcomes for 3L Ram+Doc Treated Patients
3L Ram+Doc (Overall)
n=98
3L Ram+Doc (Post-ICI)
n= 65
Median OS (95% CI), month
19.1 (16.3 - 23.7)
19.0 (15.7 - 23.7)
Median PFS (95% CI), month
3.6 (3.0 - 4.2)
3.6 (3.0 - 4.6)
Median TTP (95% CI), month
5.5 (4.0 - 7.9)
5.5 (3.6 - 7.9)
In this real-world platinum-treated cohort, most 3L ram+doc usage was post-ICI. Clinical outcomes for ram+doc post-ICI patients were consistent with those for the overall 3L ram+doc cohort. These data may support the use of ram+doc post-ICI among platinum-treated patients with aNSCLC. Further research is needed to evaluate the efficacy and safety of ram+doc following chemo+ICI combinations.
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