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Ryan Gentzler
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OA01 - Improving Outcomes in Locoregional NSCLC I (ID 892)
- Event: WCLC 2018
- Type: Oral Abstract Session
- Track: Treatment of Locoregional Disease - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 10:30 - 12:00, Room 107
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OA01.07 - Updated Results of a Phase II Trial of Concurrent Chemoradiation with Consolidation Pembrolizumab in Patients with Unresectable Stage III NSCLC (ID 13961)
11:35 - 11:45 | Author(s): Ryan Gentzler
- Abstract
- Presentation
Background
Concurrent chemoradiation (CRT) has been the standard Rx for pts with unresectable stage III NSCLC. A recent phase III trial (PACIFIC) of consolidation durvalumab [PDL-1 inhibitor] demonstrated improved median PFS vs. placebo (16.8 vs. 5.6 mo, HR 0.52, p<0.001). 12-mo (55.9% vs. 35.3%) and 18-mo (44.2% vs. 27%) PFS were also improved. Toxicity was manageable with a grade 3-4 pneumonitis rate of 3.4%, and 4 patients experienced grade 5 pneumonitis. We report updated results of a phase 2 trial of consolidation pembrolizumab [PD-1 inhibitor] following concurrent CRT in patients with unresectable stage III NSCLC.
a9ded1e5ce5d75814730bb4caaf49419 Method
After completion of CRT with carboplatin/paclitaxel, cisplatin/etoposide, or cisplatin/pemetrexed + 59-66.6 Gy XRT, those pts w/o PD after 4-8 weeks off CRT received pembro 200 mg IV q3wk for up to 1 yr. The primary endpoint was time to metastatic disease or death [TMDD]. Key secondary endpoints included PFS, OS, and toxicity.
4c3880bb027f159e801041b1021e88e8 Result
93 pts enrolled [92 eligible for efficacy analysis]. Median f/u was 18.6 mo and median age 66 (45-84). 64.1% male and 35.9% female. Stages were 59.8% IIIA and 40.2% IIIB. 55.4% non-SqCC and 43.5% SqCC with 1 mixed histology. 94.6% were current/former smokers. Chemo regimens included carbo/pac (71.7%), cis/etop (26.1%), cis/pemetrexed (2.2%). Median number of cycles of pembro was 13.5 [1-19]. 16% received < 4 cycles; 84% received > 4 cycles; 37% completed 1 yr pembro. Median TMDD was 22.4 months (95% CI 17.9-NR). Median OS was NR (95% CI 22.4-NR), and the estimates of 1-yr and 2-yr OS were 81% and 61.9% respectively. Median PFS was 17 months (95% CI 11.9-NR). 12, 18, and 24-month PFS were 60.2%, 49.9%, and 44.6% respectively. 16 (17.2%) pts developed G≥2 pneumonitis, 5 (5.4%) had G3-4 pneumonitis. There was 1 pneumonitis-related death. In those developing G≥2 pneumonitis, the median time was 8.4 wks [1.1-48.3]. No other G 3/4 toxicities exceeded 5% except dyspnea (5.4%).
8eea62084ca7e541d918e823422bd82e Conclusion
Consolidation pembrolizumab following CRT substantially improves TMDD and PFS compared with historical controls. Prelim OS data is promising and suggests a substantial gain in outcomes of patients with stage III NSCLC is possible with consolidation pembrolizumab. These data will be updated further prior to the World Conference on Lung Cancer Meeting.
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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: 1
- Moderators:
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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P2.01-39 - Can Benefit or Futility in Treating Advanced Nsclc Be Determined Early Using the LCSS 3-Item Global Index (3-IGI) PRO? (ID 12299)
16:45 - 18:00 | Author(s): Ryan Gentzler
- Abstract
Background
Background: Early assessment of the effect of treatment for advanced NSCLC can prevent unnecessary exposure to toxic and costly therapy while aiding in decision making to continue or change treatment. In a prior analysis in patients with mesothelioma (Symanowski JCO 2014), a 20% decline from baseline after 2 cycles of chemotherapy in the 3-Item Global Index of the LCSS identified patients unlikely to benefit. The 3-IGI (which evaluates: 1) global distress, 2) patient rated activities, and 3) quality of life, all in single VAS scales) takes less than 2 minutes to assess.
a9ded1e5ce5d75814730bb4caaf49419 Method
Methods: 164 patients with NSCLC receiving chemotherapy or checkpoint inhibitors were prospectively evaluated with the LCSS at baseline and every 3 weeks using electronic media. Patients were also randomized 1:1 so that their physicians knew the results of the LCSS immediately in half of the patients.
4c3880bb027f159e801041b1021e88e8 Result
Results: Patients: Stage IV 92%; first line 73%; female 43%; median PS 1; mean age 63. The LCSS was completed after 2 cycles of treatment and prior to planning for the next cycle (generally 6 weeks after baseline; representing 91% of the 148 patients living). Patients with a 20% decline in the 3-IGI compared with baseline had a median survival of 7.6 months, contrasted to 15.8 months for those without this degree of 3-IGI decline (p = 0.01); 1 year survivals = 26% versus 62%. Even with the marked PRO decline after 2 treatment cycles, patients in the 20% decline group received a median of 2.3 more cycles of the same chemotherapy (median cost = $10,712 per patient). In the 50% of patients for which their physicians knew the ongoing LCSS results, fewer chemotherapy and imaging studies were performed, but the differences were not significant (p = 0.8).
8eea62084ca7e541d918e823422bd82e Conclusion
Conclusions: Assessing change from baseline with the 3-IGI of the LCSS identifies after only 2 cycles of treatment those patients who have poor response and survival outcomes if continued on the same therapy. This PRO assessment is rapid, easy, and inexpensive. Physicians need to consider the impact of decline on decision options given that even when physicians were aware of the worsening PRO they often did not act on the findings. Patient responses to this validated PRO questionnaire provide valuable information that is not otherwise attainable. Responding to 3-IGI changes can result in better decisions concerning continuing or changing treatment, lessening toxicity, and savings in cost of unhelpful treatment.
Supported by: NIH/NCI R01 CA157409
6f8b794f3246b0c1e1780bb4d4d5dc53
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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: 1
- Moderators:
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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P3.01-09 - Impact of Urban or Rural Residence on Overall Survival for Patients with Metastatic Non-Squamous NSCLC (ID 12735)
12:00 - 13:30 | Author(s): Ryan Gentzler
- Abstract
Background
Although data suggests that disparities in ethnicity impact survival outcomes in lung cancer, little is known about whether disparities according to primary residence (rural vs urban) impact survival outcomes in metastatic non-squamous, non-small cell lung cancer (ns-NSCLC).
a9ded1e5ce5d75814730bb4caaf49419 Method
This is a retrospective study of 176 patients with stage IV ns-NSCLC treated at our institution from 2014-2016. Patients were classified as urban or rural residents based on zip codes using the RUCA and SAS zip code databases. Socioeconomic factors were derived from the AHRF database. Risk of death and overall survival (OS) were calculated using COX proportional hazards regression.
4c3880bb027f159e801041b1021e88e8 Result
Baseline characteristics are in Table 1. Patients from rural zip codes had worse median OS (12.2 mo, 95% CI 5.1-16.0) compared to patients from urban zip codes (15.7 mo, 95% CI 9.6-27.9), with a hazard ratio (HR) of 1.589 (95% CI 1.052-2.401, p=0.0278). When adjusted for age, gender, smoking status, median income, percent in poverty per county, and EGFR mutational status, these results remained significant (HR 1.670, 95% CI 1.016-2.743, p=0.0376). A secondary analysis based on median household income (MHI) showed that those from regions with MHI less than the median of the cohort were 1.931 times more likely to die than those from regions with greater MHI (95% CI 1.038-3.595, p=0.0378).
Table 1. Baseline patient characteristics Characteristic Rural Urban Total (%) 76 (43.2) 100 (56.8) Median age in years 65 64 Male gender (%) 36 (47.4) 50 (50) Race/ethnicity White 66 (86.8) 75 (75.0) Black 9 (11.8) 16 (16.0) Hispanic 1 (1.3) 2 (2.0) Other 0 7 (7.0) Ever-smokers (%) 65 (85.5) 80 (80.0) Median household income in dollars 52818 63343 Percent persons in poverty 14.4 14.3 EGFR mutation present (%) 14 (18.4) 19 (19.0)
8eea62084ca7e541d918e823422bd82e Conclusion
Overall survival for rural patients with metastatic ns-NSCLC was inferior to those living in urban areas. This risk was more pronounced after adjusting for potential confounders. Those from regions with MHI below the median also had increased risk of death compared to those from areas above the median, suggesting that rural financial toxicity may influence lung cancer survival in our area. Further efforts to characterize the socioeconomic determinants of poorer outcomes in rural areas are needed and could support the formation of programs aimed at improving access to care.
6f8b794f3246b0c1e1780bb4d4d5dc53
