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K. Culver
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P3.02a - Poster Session with Presenters Present (ID 470)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 3
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02a-007 - Monitoring for and Characteristics of Crizotinib Progression: A Chart Review of ALK+ Non-Small Cell Lung Cancer Patients (ID 4443)
14:30 - 14:30 | Author(s): K. Culver
- Abstract
Background:
Crizotinib is recommended as first-line therapy for non-small cell lung cancer (NSCLC) patients with ALK rearrangements. Following the approval of second-generation ALK inhibitors for patients who progress on or are intolerant to crizotinib, this study describes how physicians monitor for progression, diagnose progression, and alter treatments following progression on crizotinib therapy.
Methods:
A panel of US oncologists was surveyed regarding their monitoring practices and criteria for diagnosing progression on crizotinib. From March to June 2016, the oncologists provided data retrospectively from the medical charts of their adult patients diagnosed with locally-advanced or metastatic ALK+ NSCLC who progressed on crizotinib following the US approval of the first second-generation ALK inhibitor, ceritinib, in April 2014. Time to clinician-defined progression and treatment changes following progression were assessed using the medical chart data.
Results:
28 oncologists responded to the survey. Data was abstracted on 74 ALK+ NSCLC patients who progressed on crizotinib. 49% of the patients were male; 50% were never smokers. 81% of patients received crizotinib in first line; the median age at initiation was 61 years. Most physicians (71%) reported monitoring for radiographic progression every 3-4 months. In terms of course of action when new lesions are detected, physician response varied: most physicians (75%) prefer to add local therapy and resume crizotinib following a symptomatic isolated lesion, while, following multiple symptomatic lesions, 96% and 64% of physicians prefer to switch to a new therapy depending upon whether the lesions were systemic or isolated to the brain, respectively. Among the study sample, progression on crizotinib, as defined by physicians, was detected after a median of 10.4 months. 86% of patients discontinued crizotinib within 30 days of diagnosis of the physician-defined progression. Among all patients who discontinued, 77% switched to ceritinib, 14% to chemotherapy, and 1% to alectinib; the remaining 7% did not receive additional systemic antineoplastic therapy.
Conclusion:
The findings from this physician survey and retrospective chart review of ALK+ NSCLC crizotinib-treated patients suggest that physician response to the development of new lesions varies depending upon the location and extent of the lesions. Once physicians considered their patients to have progressed, most immediately switched their patients to ceritinib, a second-generation ALK inhibitor.
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P3.02a-022 - Experiences of Patients Receiving Treatment with Ceritinib to Treat ALK+ Non-Small Cell Lung Cancer: A Qualitative Study (ID 6072)
14:30 - 14:30 | Author(s): K. Culver
- Abstract
Background:
Ceritinib (Zykadia) is a recently approved second-line agent for anaplastic lymphoma kinase (ALK+) non-small cell lung cancer (NSCLC). The current study sought to describe healthcare providers’ (HCPs) decisions to treat with ceritinib and to describe patient-reported side effects, perceived effectiveness and attitudes toward ceritinib.
Methods:
One-on-one telephone interviews were conducted with HCPs caring for patients treated with ceritinib using a semi-structured interview guide designed to explore treatment decision-making, adverse events (AEs) and their management. Patients with current or past experience of ceritinib completed semi-structured telephone interviews designed to capture their experience. A thematic analysis of interview transcripts was conducted using qualitative analysis software, MaxQDA.
Results:
Study participants comprised 10 HCPs (6 oncologists, 4 nurses) and 18 patients (9 female) aged 34-78 years (mean=51.0; SD=11.3). HCPs reported relying on two main factors when deciding to switch patients to ceritinib or to next-line treatment after ceritinib: evidence of sufficient clear-cut progression and poor tolerance to treatment. Four HCPs reported considering clinical trials or other newly approved drugs instead of ceritinib. Patients and HCPs concurred that the most frequently reported side effects of ceritinib include diarrhea (n=15 patients; n=9 HCPs), nausea (n=13; n=10), vomiting (n=12; n=6), and abdominal pain (n=10; n=7). Dose reduction, antiemetic and anti-diarrheal medications, and home remedies (e.g. ginger ale, crackers) were reported as being effective at managing these side effects prophylactically or once they occurred. Taking ceritinib with food was reported by 5 patients and 4 HCPs, and helped to improve nausea, vomiting or abdominal pain. Patients reported that ceritinib was effective in achieving or maintaining symptom control for cough (n=12 of 12 patients symptomatic at diagnosis) and shortness of breath (n=9 of 11 patients symptomatic at diagnosis). Of 14 patients with lung tumors at start of ceritinib, 13 reported positive tumor response during treatment. Three of 7 patients with brain metastases achieved reduction or no evidence of disease with ceritinib in combination with other interventions (e.g., radiation). Patients were asked what they liked about ceritinib: tumor response and symptom control, an extension of life, or improvement in quality of life were key themes. Patient-reported dislikes included side effects and number of pills. Of 14 patients asked specifically, all stated the benefits of ceritinib outweigh its side effects.
Conclusion:
Patients perceived ceritinib as an effective treatment for ALK+NSCLC. AEs were reported to be manageable and patients were willing to manage these in order to experience the treatment benefits.
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P3.02a-023 - Treatment Patterns and Early Outcomes of ALK+ Non-Small Cell Lung Cancer Patients Receiving Ceritinib: A Chart Review Study (ID 4641)
14:30 - 14:30 | Author(s): K. Culver
- Abstract
Background:
Ceritinib is the first second-generation ALK inhibitor approved in the US to treat ALK+ non-small cell lung cancer (NSCLC) patients who progressed on or were intolerant to crizotinib. This study provides the first real-world description of the characteristics, treatment patterns, and early outcomes of ALK+ NSCLC patients who received ceritinib in clinical practice.
Methods:
From March to June 2016, 23 US oncologists provided data retrospectively from the medical charts of their adult patients diagnosed with locally-advanced or metastatic ALK+ NSCLC who received ceritinib following crizotinib therapy. Clinical characteristics, treatment patterns, and early outcomes on ceritinib were assessed. Best response on ceritinib was evaluated using RECIST criteria.
Results:
Participating oncologists reviewed charts of 58 ALK+ NSCLC patients treated with ceritinib. 41% of the patients were male, 52% were never smokers, and median age at ceritinib initiation was 63 years. Patients started ceritinib following a median of 10.6 months on crizotinib; 21% of patients had prior chemotherapy experience. At ceritinib initiation, many patients had multiple distant metastases, most commonly in the liver (60%), bone (53%), and brain (38%). While 71% initiated ceritinib at 750mg once daily, 19% received 600mg once daily, and 10% received 450mg once daily. 17% of patients were instructed to take ceritinib with food; 50% were instructed to fast. Median follow-up after ceritinib initiation was 3.8 months. Although follow-up was short, most patients achieved either a complete (8%) or partial (61%) response on ceritinib, regardless of metastatic site present at initiation (Table). Among the 21 patients who discontinued ceritinib, 6 received alectinib, 2 chemotherapy, 2 immunotherapy, and 11 received no further antineoplastic therapy.
Conclusion:
These early findings of ceritinib use in clinical practice suggest that ceritinib is effective at treating crizotinib-experienced ALK+ NSCLC patients, regardless of the location of metastatic sites. Future studies with longer follow-up are warranted. Figure 1
