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C.H. Reynolds
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ED 04 - How to Set up a Multidisciplinary Lung Cancer Program Within a Community Care Environment and Provide Everyone with the Best Care for Lung Cancer (ID 4)
- Event: WCLC 2015
- Type: Education Session
- Track: Community Practice
- Presentations: 1
- Moderators:J.M. Luna, S.E. Witta
- Coordinates: 9/07/2015, 14:15 - 15:45, Mile High Ballroom 2a-3b
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ED04.04 - Differences in Rural/Urban Care (ID 1785)
14:15 - 15:45 | Author(s): C.H. Reynolds
- Abstract
- Presentation
Abstract:
The rapid changes in lung cancer treatment,with the development of new treatment modalities such as immunotherapy, coupled with the emergence of low-dose CT screening for lung cancer have made mutli-modality thoracic oncology programs even more vital than previously. Howerver, almost all of these programs are in urban areas, despite a great need in rural communities. Epidemiologic studies show that rural areas have higher lung cancer and all cancer mortality than urban areas (Singh et al J Ca Epidemiol 2011) with even greater disparity in minority and socio-economically disadvantaged rural populations. An analysis of the SEER database found that rural residence had no impact on stage-specific lung cancer survival with the exception of Stage I (Atkins et al, Am J Crit Care Med 191:2015;A3595). Tobacco use is more prevalent in rural communities and may account for much of the higher lung cancer mortality seen in these communities (ALS monograph, Cutting Tobacco's Rural Roots: Tobacco Use in Rural Communities, 2014). It does appear that rural residents are more likely to be diagnosed with an advanced stage of lung cancer than their urban peers (Wen et al, Ann Pub Health and Res 2015 2:1011 ; Johnson et al, Lung Cancer 2014 83:401-7). Survival was lower in rural areas with greater poverty and less educated residents. In addition, rural residents were less likely to receive radiotherapy and chemotherapy, and those in less educated areas were less likely to undergo surgery or chemotherapy (Johnson et al). Another study found poorer outcomes in Stage I lung cancer in rural areas, perhaps due to less access to surgical care (Atkins, op cit). Kim et al compared barriers to clinical trial participation in rural and urban areas of South Carolina (Kim et al, J Comm Health 2013). They found no significant difference between rural and urban residents in willingness to participate in clinical trials but found that rural residents perceived less access to less access to, and awareness and knowledge of, clinical trials. A study funded by the Rand Corporation found that physicians who participated in tumor boards weekly were more likely to enroll lung cancer patients in clinical trials (Kiehl et al, J Onc Practice 2015 11:E267-78). This suggests that rural thoracic oncology programs are likely to improve clinical trial participation by rural residents by improving access and physician particiapation. It is not just access to therapeutic modalities in lung cancer that differs between rural and urban areas; supportive/ palliative care is also different. An analysis of the SEER database found disparities in end of life care as well. Medicare beneficiaries in rural areas had more ER visits in the last 90 days of life than urban residents. Urban residents had more ICU days in the last 90 days of life and were more likely to be enrolled in hospice programs. Minority and lower socioeconomic patients were less likely to use hospice and had more ICU days, inpatient days, and ER visits in the last 90 days of life (Nayar et al, J Comm Health 2014 39:1012-9). These disparities are of particular note since several studies have shown that early palliative care improves survival in lung and other cancers. Greater prevalence of rural thoracic oncology programs may improve access to potentially curative modalities, particularly for early stage disease. Given the higher prevalence of tobacco use in rural populations, these programs should ideally include smoking cessation efforts. Since rural residents are more likely to be diagnosed with advanced lung cancer, the implementation of low-dose CT screening is likely to be particularly beneficial in these communities. It seems likely that rural areas with thoracic oncology programs will have better rates of clinical trial access and participation. Incorparation of early effective palliative care into these programs may improve outcomes and help reduce the disparities seen in end of life care and survival in rural areas. However, resources are often limited in small rural hospitals, so it may be difficult to provide all of these services.
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ORAL 02 - PD1 Axis Immunotherapy 2 (ID 87)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:E.B. Garon, H.J. Ross
- Coordinates: 9/07/2015, 10:45 - 12:15, Four Seasons Ballroom F1+F2
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ORAL02.02 - Safety and Efficacy of Nivolumab in an Ongoing Trial of a PD-L1+/- Patient Population with Metastatic Non-Small Cell Lung Cancer (ID 851)
10:45 - 12:15 | Author(s): C.H. Reynolds
- Abstract
- Presentation
Background:
Nivolumab (NIVO), a fully human IgG4 programmed death-1 (PD-1), immune checkpoint inhibitor antibody, has demonstrated durable responses and tolerability in heavily pretreated patients with advanced non-small cell lung cancer (NSCLC). NIVO was recently approved for the treatment of patients with metastatic squamous (SQ) NSCLC with progression on or after platinum-based chemotherapy. Conducted mostly in community-based oncology centers, this ongoing trial explores the safety of NIVO in patients with previously-treated PD-L1[+/-] metastatic SQ or non-squamous (NSQ) NSCLC.
Methods:
Eligible patients are enrolled in 4 subgroups: 1) SQ, performance status (PS) 0–1, ≥2 prior therapies; 2) SQ, PS 0–1, 1 prior therapy; 3) NSQ, PS 0–1, ≥1 prior therapy; and 4) SQ or NSQ, PS 2, ≥1 prior therapy. Patients with both PD-L1[+] and PD-L1[-] tumors are eligible. Patients receive NIVO 3 mg/kg IV (60 minutes) Q2W either until progressive disease (PD)/unacceptable toxicity (Cohort A) or for 1 year with the possibility of retreatment upon disease progression (Cohort B). Primary objective is to estimate incidence of high-grade (CTCAE v4.0 Grade 3–4 and 5), select treatment-related adverse events (STRAEs); exploratory efficacy assessments include ORR, PFS, and OS.
Results:
From 4/16/14 to 12/31/14, 824 patients were treated and have demographic and safety data available; 483 patients remained on study as of 12/31/2014. 395 patients had evaluable radiographic tumor assessments at first assessment (Week 9). Demographics, safety, and tumor response by PD-L1 status are reported. Figure 1
Conclusion:
Safety and tolerability are consistent with prior NIVO experience and no new safety signals have been identified in this trial of SQ/NSQ NSCLC patients. Immune-related toxicities are manageable in a community practice setting using previously-developed safety algorithms. The frequency of STRAEs of interest was similar between patients with PS 0–1 and those with PS 2. Early data from this large, multicenter trial suggests that patients with pretreated advanced NSCLC benefit from NIVO therapy regardless of tumor PD-L1 status, histology type, and PS status.
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-099 - nab-Paclitaxel as Maintenance Therapy in Patients with Squamous Cell NSCLC (ABOUND.sqm) (ID 3122)
09:30 - 17:00 | Author(s): C.H. Reynolds
- Abstract
Background:
Patients with squamous cell (SCC) non-small cell lung cancer (NSCLC) may be at risk of poorer outcomes and have fewer treatment options than those with other histologies. Furthermore, no randomized studies have demonstrated the benefit of maintenance therapy in these patients. In a phase III trial, first-line treatment with nab-paclitaxel plus carboplatin (nab-P/C) demonstrated a 68% improvement in the overall response rate (ORR; 41% vs 24%; P < 0.001) and a trend toward improved overall survival (OS; median, 10.7 vs 9.5 months; HR 0.890; P = 0.310) compared with solvent-based paclitaxel plus C in a subset of patients with advanced SCC NSCLC (Socinski et al. Ann Oncol. 2013;24:2390-2396). An exploratory analysis of the phase III trial demonstrated that therapy with nab-P/C beyond 4 cycles of first-line treatment was effective in the subset of patients with SCC NSCLC who did not progress (from the time of randomization, median progression-free survival [PFS] and OS were 6.8 and 13.8 months, respectively), and no new safety signals were noted (Socinski et al. IASLC 2013 [abstract 3438]). In the open-label, multicenter phase III ABOUND.sqm trial, the efficacy and safety of nab-P maintenance therapy after nab-P/C induction therapy will be evaluated in patients with advanced SCC NSCLC.
Methods:
During the induction part of the study, approximately 540 patients will be treated with 4 cycles of nab-P 100 mg/m[2] intravenously (IV; 30-minute infusion) on days 1, 8, and 15 plus IV C AUC 6 on day 1 every 21 days. Patients with a complete response (CR), a partial response (PR), or stable disease (SD) will be eligible for maintenance. In the maintenance part of the study, approximately 260 patients will be randomized 2:1 to nab-P 100 mg/m[2] on days 1 and 8 every 21 days plus best supportive care (BSC) or BSC alone until disease progression. Patients will be stratified by disease stage (IIIB vs IV), response to induction therapy (CR/PR vs SD), and ECOG performance status at the end of induction (0 vs 1). Key eligibility criteria include histologically or cytologically confirmed stage IIIB/IV SCC NSCLC, no prior chemotherapy for metastatic disease, ECOG performance status ≤ 1, adequate organ function, no active brain metastases, and preexisting peripheral neuropathy grade < 2. ClinicalTrials.gov identifier NCT02027428.Key Endpoints Primary PFS from randomization into the maintenance part of the study Secondary Safety OS from randomization into the maintenance part of the study ORR during the induction and maintenance parts of the study Exploratory Correlation between pretreatment tumor characteristics and response to treatment Association between changes in tumor characteristics and acquisition of resistance to therapy at the time of treatment failure during maintenance Correlation between genetic polymorphisms and treatment efficacy and/or toxicity Healthcare resource utilization during the maintenance part of the study Changes in quality of life
Results:
Not applicable.
Conclusion:
Not applicable.
