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G. Struebbe
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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): G. Struebbe
- 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-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): G. Struebbe
- 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
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P3.02a-025 - PROs With Ceritinib Versus Chemotherapy in Patients With Previously Untreated ALK-rearranged Nonsquamous NSCLC (ASCEND-4) (ID 5128)
14:30 - 14:30 | Author(s): G. Struebbe
- Abstract
Background:
Here, we present the patient-reported outcomes (PROs) of ceritinib versus chemotherapy as first-line treatment for advanced ALK+ NSCLC.
Methods:
Untreated, ALK+, advanced, nonsquamous NSCLC patients (N=376) were randomized (1:1) to ceritinib 750 mg/day (n=189) or chemotherapy (n=187; [pemetrexed 500 mg/m[2 ]plus cisplatin 75 mg/m[2] or carboplatin AUC 5-6] for 4 cycles followed by maintenance pemetrexed). PROs were assessed using EORTC quality-of-life questionnaire (QLQ-C30), the lung cancer module (QLQ-LC13), Lung Cancer Symptom Scale (LCSS), and EQ-5D.
Results:
Median treatment exposure was 66.4 weeks for ceritinib and 26.9 weeks for chemotherapy. PRO compliance was high, ≥80% at most timepoints. Ceritinib significantly prolonged time to deterioration of lung cancer-specific symptoms (pain, dyspnea, and cough) versus chemotherapy in both LCSS and QLQ-LC13 instruments (composite endpoints for LCSS, HR=0.61 [0.41, 0.90]; and QLQ-LC13, HR=0.48 [0.34, 0.69]). Time to deterioration in LC13 questionnaire was significantly longer with ceritinib versus chemotherapy (23.6 [20.7, NE] vs 12.6 [8.9, 14.9] months) (Table). In the QLQ-C30 instrument, 4 of 5 functional domains and 6 of 9 symptom scales improved with ceritinib (P< 0.05); 2 scales related to gastrointestinal symptoms indicated deterioration for ceritinib. In agreement with most other scales showing symptom improvement, ceritinib demonstrated significant improvements in Global Health Status/QoL in the same instrument (QLQ-C30, P<0.001) as well as for EQ-5D-5L index (P<0.001) and EQ-5D-5L VAS (P<0.05 from cycle 13 until 49). Figure 1
Conclusion:
Untreated ALK+ NSCLC patients experienced significantly greater improvements in lung cancer-specific symptoms on treatment with ceritinib. General health status was significantly improved with ceritinib versus chemotherapy. Overall, PRO results from all 4 instruments independently showed improvements highlighting the consistency and robustness of these findings.
