Descriptive Observational Study ALK-2016-CPHG
- Conditions
- NSCLCALK Gene Rearrangement or ROS1 Gene RearrangementCrizotinib
- Registration Number
- NCT03718117
- Lead Sponsor
- Pfizer
- Brief Summary
Descriptive Observational Study.
Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals
- Detailed Description
Describe the characteristics of patients treated with crizotinib Describe efficacy, safety, observance and QoL.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Age: Line of Treatment Baseline Body Weight: Line of Treatment and Gene Rearrangement Baseline Body weight in kilograms (kg) measured at baseline were reported.
Body Mass Index (BMI): Line of Treatment and Gene Rearrangement Baseline BMI was obtained by dividing body weight in kilograms (kg) by height in meters square (m\^2).
Gender: Line of Treatment Baseline Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement Baseline Number of participants were classified according to smoking status as non-smoker, ex-smoker (did not smoke in at least 1 year prior to baseline) and current-smoker.
Number of Pack Years: Line of Treatment and Gene Rearrangement Baseline The number of pack-years was calculated at baseline for ex-smokers and current smokers by multiplying the number of packs they consumed per day and the number of years that the participant had smoked this quantity of packs. Combined data is reported for ex-smokers and current smokers.
Duration of Smoking and Duration of Quitting Smoke: Line of Treatment and Gene Rearrangement Baseline Duration of smoking: a) for ex-smokers, duration of smoking (years) was calculated by subtracting start year with year of smoking stop, b) for current smokers, duration of smoking (years) was calculated by subtracting start year with year of Inclusion visit date. Combined data of duration of smoking is reported for ex-smokers and current smokers. Duration of quitting smoke (years) for ex-smokers was calculated by subtracting year of smoking stop with year of inclusion visit date.
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement Baseline Number of participants were categorized as yes or no, according to have undergone assessment with ECOG performance status. ECOG performance status was used to measure quality of life of oncology participants with scores running from 0 (no severity) to 5 (maximum severity); where 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity, ambulatory, able to carry out light or sedentary work; 2= ambulatory, capable of all self-care, unable to carry out any work activity, up greater than (\>) 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed or chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead.
Number of Participants Categorized According to ECOG Performance Status Scores: Line of Treatment and Gene Rearrangement Baseline ECOG performance status was used to measure quality of life of oncology patients with scores running from 0 (no severity) to 5 (maximum severity); where 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity, ambulatory, able to carry out light or sedentary work; 2= ambulatory, capable of all self-care, unable to carry out any work activity, up \>50% of waking hours; 3= capable of only limited self-care, confined to bed or chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead. Participants were categorized according to ECOG performance status scores of 0-1 and \>=2.
Time Since Diagnosis of NSCLC: Treatment and Gene Rearrangement Baseline Time since diagnosis of NSCLC (months) was calculated as: inclusion visit date minus date of the biopsy that enabled making the diagnosis divided by 365.35/12. If the day of the diagnosis was missing, it was replaced by the 15th of the month for calculation.
Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement Baseline Participants were categorized according to type of tumor's histology as adenocarcinoma, carcinoma indifferencier and other.
Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement Baseline Participants were categorized according to tumor stage as IIIA/B or IVA/B classified as per Tumor Node Metastasis (TNM), 8th edition. TNM: based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant (other parts of body) metastasis. Stages included: stage 0 (no evidence of cancer cells), stage l (T1N0M0), stage IIA (T0N1M0, T1N1M0, T2N0M0), stage IIB (T2N1M0, T3N0M0), stage IIIA (T0N2M0, T1N2M0, T2N3M0, T3N1 or N2M0), stage IIIb (T4 any NM0, any TN3M0), stage IIIC (any TN3M0), stage IV (any T any NM1), where T0= early form of tumor, T1=\<2 centimeter (cm), T2 =2-5 cm, T3=\>2 cm, T4=large sized, N0= not spread to LN, N1= spread to 1 to 3, N2= spread to 4 to 9, N3= spread \>10 axillary LN, M0= no metastasis, M1= metastasis. Tumor stage categories with at least 1 participant in any reporting arm are reported.
Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement Baseline Participants were categorized according to location of tumor: upper right lobe, upper left lobe, middle right lobe, lower right lobe, and lower left lobe.
Number of Participants Categorized According to Presence of Metastases: Line of Treatment and Gene Rearrangement Baseline Participants were categorized according to presence of metastases as Yes or No.
Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement Baseline Participants were categorized according to number of metastatic sites.
Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement Baseline Participants were categorized according to the location of metastases. Participant could have more than 1 location of metastases.
Time Since the First Strategy Start to Crizotinib Initiation: Line of Treatment and Gene Rearrangement Baseline Time since the first strategy start to crizotinib initiation (months) was calculated as: crizotinib initiation date minus start date of the first strategy divided by 365.35/12. If the start date was missing, it was replaced by the 15th of the month for calculation.
Number of Participants Categorized as "Yes" or "No" for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement Baseline Number of participants were categorized according to the different lines of chemotherapy.
Number of Cycles for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement Baseline In this outcome measure, median of number of cycles for different lines of chemotherapy were reported.
Duration of Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement Baseline In this outcome measure, median duration of different lines of chemotherapy was reported. Duration of chemotherapy (months) was calculated as = End date of the last cycle minus start date of the first cycle plus 1 divided by 365.25/12. If the day of the date was missing, it was replaced by the 15th of the month. If the month of the date was missing, the duration was considered as missing.
Number of Participants Categorized as "Yes" or "No" for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement Baseline In this outcome measure, participants were categorized according to the previous treatments received. Participant could have received more than 1 type of previous therapies.
Dose of Previous Brain Irradiation and Radiotherapies: Line of Treatment and Gene Rearrangement Baseline In this outcome measure, median of dose of brain irradiation and radiotherapies were reported.
Duration of Previous Brain Irradiation Therapy and Radiotherapies: Line of Treatment and Gene Rearrangement Baseline In this outcome measure, duration of previous brain irradiation therapy and radiotherapies was reported.
- Secondary Outcome Measures
Name Time Method Number of Participants Categorized According to Diagnostic Method to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement Baseline In this outcome measure, the number of participants were categorized according to diagnostic method used to detect ALK and ROS1 gene rearrangement.
Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement Baseline In this outcome measure, number of participants were categorized according to origin of specimen to detect ALK and ROS1 gene rearrangement. Origins of specimen included: primitive tumor, thoracic lymph node, extrathoracic lymph node, bone, adrenal glands and pleural.
Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement Baseline In this outcome measure, number of participants were categorized according to analysis platform to detect ALK and ROS1 gene rearrangement. Analysis platform included following sites: University hospital center (UHC) Alsace Cancer center of Strasbourg - Hospital Center of Mulhouse - Hospital Center of Colmar; UHC Aquitaine - Hospital Center de Bordeaux - La Réunion; UHC Bourgogne - Hospital Center of Dijon, UHC of Tours - Orléans; UHC Haute-Normandie - Hospital Center of Rouen, Ile-de-France AP - HP; UHC Languedoc Roussillon - Hospital Center of Montpellier - UHC of Nîmes; UHC Nord-Pas-de-Calais - Hospital Center of Lille; UHC Pays-de-la-Loire - Hospital Center of Nantes; UHC Pays-de-la-Loire - Hospital Center of Angers; UHC Picardie, Amiens; UHC Provence Alpes Côte d'Azur - Hospital Center of Nice; UHC Provence Alpes Côte d'Azur - Hospital Center of Marseille; UHC Rhône Alpes - Hospital Center of Lyon; UHC Rhône Alpes - Hospital Center of Grenoble; and other platform.
Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement Baseline In this outcome measure, number of participants were categorized according to the techniques used to detect ALK and ROS1 gene rearrangement. Techniques involved were: Immunohistochemistry (IHC); Fluorescence in situ hybridisation (FISH); Reverse transcriptase polymerase chain reaction (RT-PCR); Next-Generation Sequencing (NGS); Other; and Associations-FISH, IHC, IHC+FISH, IHC+FISH+NGS, NGS.
Duration Between Sending and Receipt of ALK and ROS1 Results: Line of Treatment and Gene Rearrangement Baseline Duration between sending and receipt of ALK for positive ALK was calculated in days by subtracting the date sent to the platform from date when positive ALK result was received. Duration between sending and receipt of ROS1 for positive ROS1 was calculated in days by subtracting the date sent to the platform from date when positive ROS1 result was received.
Number of Participants Among Whom Search for Other Biological Markers Was Carried Out: Line of Treatment and Gene Rearrangement Baseline In this outcome measure, number of participants were categorized "Yes" or "No" for search of other biological markers.
Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 Month 3, 6, 9, 12, 15 and 18 Number of participants were categorized according to clinical response as evaluated by physician. Clinical response was categorized into disease improvement, disease stabilization or disease degradation.
Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 Month 3, 6, 9, 12, 15 and 18 Number of participants were categorized according to tumor response per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Tumor response included total (complete) response (CR), partial response (PR), stable disease (SD) or disease progression (PD) on imaging. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Persistence of one or more non-target lesion and/or maintenance of tumor marker level above the normal limits. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. Unequivocal progression of existing non-target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 Month 3, 6, 9, 12, 15 and 18 Time since diagnosis to progression (months) was calculated as: progression date minus date of biopsy that enabled making the diagnosis divided by 365.35/12. If the day of the diagnosis was missing, it was replaced by the 15th of the month for calculation. If the day of the progression was missing, it was replaced by the 1st of the month for calculation.
Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 Month 3, 6, 9, 12, 15 and 18 In this outcome measure, number of participants whose progression was noted at primary tumor site were reported.
Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 Month 3, 6, 9, 12, 15 and 18 In this outcome measure, number of participants whose progression was noted at already existing metastasis sites were reported.
Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 Month 3, 6, 9, 12, 15 and 18 In this outcome measure, participants were categorized according to location of progression in already existing metastasis which were located at adrenal glands, bone, brain, liver, lymph node, pleural, plueral liver, pleural lymph node, brain pleural, and kidney. Only those rows are reported with at least 1 participant as data for any reporting arm.
Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 Month 3, 6, 9, 12, 15 and 18 In this outcome measure, participants with new metastases as the site of progression were reported.
Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 Month 3, 6, 9, 12, 15 and 18 In this outcome measure, number of participants were categorized according to progression at location of new metastases. Location of new metastases included contralateral lung, extrathoracic lymph node, brain, liver, bone, adrenal glands, lymphangite carcinomateuse and pleural. Only those categories in which at least 1 participant had data were reported.
Treatment Duration Until Progression With Brain Metastases Baseline Treatment duration until progression with brain metastases (weeks) was calculated as: (\[date of progression - first treatment intake date\] + 1) divided by 7. If the day of the progression was missing, it was replaced by the 1st of the month for calculation.
Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 Month 3, 6, 9, 12, 15 and 18 In this outcome measure, number of participants were categorized on the basis of conduction of biopsy on progression as "Yes' or "No".
Objective Response Rate (ORR) Maximum up to 18 months The objective response rate was defined as the percentage of participants with complete response (CR) or partial response (PR) based on RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Persistence of one or more non-target lesion and/or maintenance of tumor marker level above the normal limits.
Disease Control Rate (DCR) at Month 12 and 18 Month 12, 18 DCR at 12 and 18 months was defined as the percentage of participants with CR, PR or SD at 12 and at 18 months. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Persistence of one or more non-target lesion and/or maintenance of tumor marker level above the normal limits. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions), taking as reference the smallest sum diameters while on study.
European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 Baseline, Month 3, 6, 9, 12, 15, 18 EORTC QLQ-LC13 consisted of following symptom scales/items: coughing, haemoptysis, dyspnoea, dyspnoea when resting, dyspnoea when walking, dyspnoea when stairs, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts and pain relief after medication. The dyspnoea scale was only calculated if all three items had been answered. Some respondents ignore question "dyspnoea when stairs" because they never climbed stairs. Hence if item "dyspnoea when stairs" was missing then items "dyspnoea when resting" and "dyspnoea when walking" was used as single-item measures under item "dyspnoea". Transformed scores for each item ranged from 0 to 100, higher score is indicative of a higher response level (a high score for a symptom scale/item represents a high level of symptomatology/problems).
Time to Median Progression Free Survival (Months) With Its 95%CI 18 months PFS was defined as the time between the treatment start (date of the first Crizotinib intake) and the date of the first disease progression or the all-cause death. Participants who did not progress or were still alive at the end of the study or at the date of cut-off were censored at the last disease evaluation date.
18-Month Overall Survival (OS) Rate (95%CI) 18 months OS was defined as the time from the date of first dose of study drug to the date of death due to any cause. Participants last known to be alive were censored at the date of last contact. 18-month OS rates was assessed by Kaplan-Meier method with right censoring.
Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 Month 3, 6, 9, 12, 15 and 18 Compliance to study drug was evaluated using Morisky score. The questionnaire consisted of 4 questions in which the scale was 0 for "yes" (indicating poor compliance) and 1 for "no" (indicating good compliance). The items were summed to give a range of scores from 0 to 4. A score of 4 indicated high compliance, 2-3 indicated medium compliance and 0-1 indicated low compliance.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Up to maximum of 18 months AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Serious AE: any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and all Non-SAEs.
Trial Locations
- Locations (26)
Centre Hospitalier General Beziers, Service De Pneumologie
🇫🇷Beziers, France
Centre Hospitalier Metropole de Savoie-Site de Chambery
🇫🇷Chambery, France
Le Mans Hospital Center
🇫🇷Le Mans, France
Centre Hospitalier Chalon sur Saone William Morey
🇫🇷Chalon sur Saone, France
Centre Hospitalier Départemental Les Oudairies
🇫🇷La Roche Sur Yon Cedex 9, France
Centre Hospitalier de Troyes, Service de Pneumologie - Oncologie Thoracique
🇫🇷Troyes, France
Hopital Robert Ballanger, Service de Pneumologie
🇫🇷Aulnay sous Bois, France
Hopitaux Civils de Colmar - Hopital Louis Pasteur
🇫🇷Colmar Cedex, France
Hopitaux du Leman
🇫🇷Thonon les Bains, France
Centre Hospitalier de Macon
🇫🇷Macon cedex, France
Centre Hospitalier ALPES LEMAN
🇫🇷Contamine sur Arve, France
Centre Hospitalier Intercommunal Frejus
🇫🇷Frejus, France
CHD Vendee
🇫🇷La Roche Sur Yon, France
Centre Hospitalier des Deux Vallees - Longjumeau BP 125
🇫🇷Longjumeau, France
Hopital Europeen - Service de Pneumologie
🇫🇷Marseille, France
GHR Mulhouse Sud Alsace
🇫🇷Mulhouse, France
Centre Hospitalier Regional d Orleans
🇫🇷Orleans, France
Groupe Hospitalier Sud Reunion
🇫🇷Saint Pierre La Réunion, France
Centre Hospitalier de Villefranche sur Saone - BP80436
🇫🇷Villefranche sur Saone, France
Centre Hospitalier Intercommunal du Pays d'Aix-Pertuis,Service de Pneumologie
🇫🇷Aix en Provence, France
Clinique de l Europe
🇫🇷Amiens, France
Centre Hospitalier d Avignon
🇫🇷Avignon, France
Centre Hospitalier de Beauvais
🇫🇷Beauvais, France
Centre Hospitalier de Cannes
🇫🇷Cannes, France
Centre Hospitalier de l'Agglomeration de Nevers
🇫🇷Nevers, France
Centre Hospitalier Annecy Genevois
🇫🇷Pringy, France