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K.L. Davis
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MINI 31 - ALK (ID 158)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:S. Malik, I. Ou
- Coordinates: 9/09/2015, 18:30 - 20:00, Mile High Ballroom 1a-1f
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MINI31.03 - Crizotinib Outcomes in ALK-Positive Advanced NSCLC Patients with Brain Metastases (ID 1363)
18:40 - 18:45 | Author(s): K.L. Davis
- Abstract
- Presentation
Background:
Crizotinib is an oral small-molecule tyrosine kinase inhibitor, which was approved in the United States (US) in August of 2011 for the treatment of anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). There are currently limited data on crizotinib treatment and related outcomes in ALK-positive advanced NSCLC patients with brain metastases at diagnosis in real world settings. The main objective of the current analyses was to assess and report the response rates in the ALK-positive advanced lung cancer patients with brain metastases treated with crizotinib in regular clinical practice.
Methods:
Physicians in the US (N=107) and Canada (N=40) were recruited from cancer centers or teaching hospitals (48%) or free standing oncology clinics (47%) to abstract data retrospectively from medical records of adult (≥18 years) patients diagnosed with ALK-positive advanced NSCLC and treated with crizotinib as first- or later-line therapy from 8/1/2011-3/31/2013 (for the US) or 4/12012-3/31/2013 (for Canada) in non-clinical trial settings. IRB approval was obtained. A secure web-based form was used by physicians to abstract data and all patient data were de-identified and anonymous. Descriptive analyses were conducted to summarize objective response rate (ORR) in the subgroup with brain metastases. One-year survival rates from initiation of crizotinib were descriptively analyzed for the subgroup with brain metastases using the Kaplan-Meier method.
Results:
Data were extracted from 212 patient records in US (N=147) and Canada (N=65), which included 33 ALK-positive advanced NSCLC patients with brain metastases present prior to crizotinib initiation. The mean (SD) patient age at diagnosis for these 33 patients was 57.4 (12.0) years and a majority were male (58%), Caucasian (76%), current or former smokers (67%), ECOG status 0 or 1 (55%), adenocarcinoma histology (85%) and initially diagnosed at the locally advanced or metastatic stage (70%). The majority (71%) of these patients had been treated with either whole brain radiotherapy (16 patients) or stereotactic radiosurgery (8 patients) prior to initiation of crizotinib treatment. Of these 33 patients, 21 received crizotinib as 1[st] line therapy for advanced ALK-positive NSCLC. Approximately 61% were alive at time of medical record data abstraction. The ORR was estimated to be 61% and 60% for these patients with brain metastases who received crizotinib as 1[st] and later line treatment, respectively. The Kaplan-Meier estimates of 1-year survival from crizotinib initiation were 81% and 77% in patients with brain metastases, who received crizotinib as 1[st] line and later line treatment, respectively.
Conclusion:
In ALK-positive advanced NSCLC patients with brain metastases, complete or partial response was reported in majority of patients during treatment with crizotinib in real world settings.
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P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.01-018 - Response Rate and Outcomes in Crizotinib Treated Advanced ALK-Positive NSCLC Patients (ID 929)
09:30 - 09:30 | Author(s): K.L. Davis
- Abstract
Background:
Crizotinib is an oral small-molecule tyrosine kinase inhibitor, which was approved in the United States (US) in August of 2011 for the treatment of anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). In clinical studies, crizotinib has demonstrated robust response rates and significantly greater efficacy than chemotherapy. However, there is currently limited data on crizotinib treatment and related outcomes in real-world practice settings. The main objective of the current study was to assess the treatment patterns and outcomes of ALK-positive advanced NSCLC patients treated with crizotinib in regular clinical practice.
Methods:
Physicians in the US (N= 107) and Canada (N= 40) were recruited from cancer centers/teaching hospitals (48%) or free standing oncology clinics (47%), to abstract data retrospectively from medical records of adult (≥18 years) patients diagnosed with ALK-positive advanced NSCLC and treated with crizotinib as first or later line therapy between August 1, 2011, and March 31, 2013 (for the US) or April 1, 2012 and March 31, 2013 (for Canada) in non-clinical trial settings. IRB approval was obtained. A secure web-based form was used by physicians to abstract data and all patient data were de-identified and anonymous. Descriptive analyses were conducted to assess treatment patterns and objective response rate (ORR). Progression-free survival (PFS) and overall survival (OS) were descriptively analyzed using the Kaplan-Meier method.
Results:
Data were extracted from 212 patient records in US (N=147) and Canada (N=65). The mean (SD) patient age was 58.9 (9.5) years and a majority were male (69%), Caucasian (79%), current or former smokers (67%), ECOG status 0 or 1 (75%), adenocarcinoma histology (90%) and initially diagnosed at the metastatic stage (71%). Cough, fatigue, and dyspnea were the most common symptoms present (71%, 65%, and 55%, respectively) at the time of metastatic NSCLC diagnosis. Approximately 65% (n=137) of patients initiated crizotinib as first-line therapy and the mean ± SD duration of crizotinib treatment was 8.7 ± 4.9 months. Approximately 37% of the patients were deceased at time of medical record abstraction. Disease progression following initial response was the most frequently reported (59%) reason for treatment discontinuation and 35% received additional systemic chemotherapy post-crizotinib. Approximately 90% of patients had no changes (reduction or escalation) in crizotinib dose. Among patients experiencing progression during crizotinib treatment, the most common sites of progressive metastases were liver (35%), bone (30%), and contralateral lung (28%). The crizotinib ORR was estimated to be 66% for the overall cohort (69% first line and 60% for later line). The median (95% CI) PFS from crizotinib initiation was 9.5 (8.7, 10.1) months in the overall cohort. Median (95% CI) OS from crizotinib initiation was 23.4 (19.5, ‒) months for the overall cohort. Based on Kaplan-Meier estimation, 1- and 2-year survival rates from crizotinib initiation were 82% and 49%, respectively.
Conclusion:
Response rates in patients treated with crizotinib in real world settings seem to align with data reported previously from clinical studies. Median OS in patients treated with crizotinib in the real world settings examined here was approximately 2 years from crizotinib treatment initiation.
