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S. Iyer
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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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MINI31.12 - Quality of Life for Crizotinib vs. Chemotherapy in Asian ALK-Positive NSCLC Patients (ID 845)
19:35 - 19:40 | Author(s): S. Iyer
- Abstract
- Presentation
Background:
PROFILE 1014 compared the efficacy and safety of the ALK inhibitor crizotinib with platinum based chemotherapy in previously untreated advanced ALK-positive advanced NSCLC (Pfizer; NCT01154140). The primary endpoint was progression-free survival. The main objective of this post-hoc analysis was to compare patient-reported symptom and global quality of life (QOL) between crizotinib and chemotherapy in the subgroup of patients of Asian ethnicity in the ongoing study PROFILE 1014.
Methods:
Patients in the ongoing PROFILE 1014 study were randomized to crizotinib (250 mg PO bid; n= 172) or chemotherapy (pemetrexed 500 mg/m[2] + either cisplatin 75 mg/m[2] or carboplatin AUC 5–6; all IV q3w for ≤6 cycles; n= 171). Patient-reported outcomes were assessed at baseline, day 7 and day 15 of cycle 1, day 1 of subsequent 3-week cycles and end of treatment using the validated cancer specific questionnaire EORTC QLQ-C30 and its lung cancer module QLQ-LC13. Validated translations of the questionnaires in Asian languages (Japanese, Chinese, Korean etc) were made available. Higher scores (range 0−100) indicated higher symptom severity or better functioning/QOL. A positive change from baseline score indicates improvement for global QOL/functioning and deterioration in symptoms. Repeated measures mixed-effects analyses were performed to compare change from baseline scores between the treatment arms, with no adjustments made for multiple comparisons.
Results:
Of 343 patients randomized, 46% were of Asian ethnicity (crizotinib, n=77; chemotherapy, n=80). Completion rates at baseline were ≥95% in each group and scores were balanced. A statistically significantly greater overall improvement from baseline was observed with crizotinib compared with chemotherapy for global QOL (5.6 vs -7.7; p<0.001), emotional functioning (9.5 vs 2.7;p<0.05), physical functioning (5.0 vs - 2.7 p<0.001) and role functioning (3.7 vs. -7.2;p<0.001). A statistically significantly greater overall improvement was observed with crizotinib compared with chemotherapy for cough (-17.3 vs. -11.2; p<0.05), dyspnea (-9.5 vs.-1.1; p<0.001), pain in arm or shoulder (-11.4 vs.-2.2; p<0.001), pain in chest (-7.3 vs.3.3; p<0.001), pain in other parts (-11.2 vs. -0.4;p<0.001), fatigue (-9.9 vs. 3.9; p<0.001), insomnia (-10.3vs. -2.0; p<0.05), pain (-12.2 vs.-1.2; p<0.001) and appetite loss (-5.3 vs. 5.7; p<0.001). A statistically significantly greater overall deterioration was observed in the crizotinib arm for diarrhea (12.6 vs. 2.4; p<0.001) compared with chemotherapy. No statistically significant differences were observed for social functioning, sore mouth, dysphagia, nausea & vomiting, constipation and alopecia between crizotinib and chemotherapy.
Conclusion:
Consistent with previously reported results in the overall study population, treatment with crizotinib showed statistically significantly greater overall improvement in patient-reported lung cancer symptoms and global QOL compared with chemotherapy in the subgroup of patients of Asian ethnicity with previously untreated advanced ALK-positive NSCLC.
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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): S. Iyer
- 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.
