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| ID | Type | Description | Link |
|---|---|---|---|
| MSKCC-07113 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with pancreatic cancer that can be removed by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE:
Patients undergo tumor tissue and blood sample collection periodically for correlative studies. Samples are analyzed for protein expression and tumor markers (CEA and CA19-9) pre- and post-neoadjuvant therapy via proteomic analysis. Tumor tissue samples are also banked for research purposes.
After completion of study treatment, patients are followed every 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine And Oxaliplatin | Experimental | A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine hydrochloride | Drug | 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival at 18 Months | Percentage of participants that were alive or survived at 18 months after randomization | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (Follow-Up Time) | From Baseline until 2 Years and Follow-Up, up to 120 months | |
| Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy | Baseline and 2 years | |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed pancreatic adenocarcinoma
No histology other than adenocarcinoma (e.g., neuroendocrine cancer or acinar cancer)
Radiographically resectable pancreatic cancer, as determined by a surgical oncologist
No evidence of distant metastases by CT scan
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Bilirubin ≤ 4.0 mg/dL (if > 3.0, stented and known to be declining)
Serum creatinine ≤ 1.6 mg/dL
INR < 1.5 (therapeutic INR is allowed for patients receiving therapeutic anticoagulation)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after completion of study therapy
No active infection, except for resolving cholangitis, that would preclude study enrollment
No other malignancy within the past 3 years except for curatively treated basal cell carcinoma of the skin, cervical intraepithelial neoplasia, or localized prostate cancer with a PSA of < 5.0 ng/mL within ≥ 4 weeks of study entry (other circumstances with a recent concurrent or active malignancy will be adjudicated on a case-by-case basis by the principle investigator [PI] or co-PI)
No known hypersensitivity to any of the components of oxaliplatin or gemcitabine
No hypersensitivity to CT scan IV contrast dye not suitable for premedication
No peripheral neuropathy ≥ grade 2
No known HIV or hepatitis B or C infection (active, previously treated, or both)
No other medical condition, including mental illness or substance abuse that, deemed by the investigator, would preclude study participation
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Eileen O'Reilly, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Peter J. Allen, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065-0009 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24901360 | Derived | O'Reilly EM, Perelshteyn A, Jarnagin WR, Schattner M, Gerdes H, Capanu M, Tang LH, LaValle J, Winston C, DeMatteo RP, D'Angelica M, Kurtz RC, Abou-Alfa GK, Klimstra DS, Lowery MA, Brennan MF, Coit DG, Reidy DL, Kingham TP, Allen PJ. A single-arm, nonrandomized phase II trial of neoadjuvant gemcitabine and oxaliplatin in patients with resectable pancreas adenocarcinoma. Ann Surg. 2014 Jul;260(1):142-8. doi: 10.1097/SLA.0000000000000251. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine And Oxaliplatin | A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles. protein expression analysis proteomic profiling diagnostic laboratory biomarker analysis adjuvant therapy neoadjuvant therapy therapeutic conventional surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| oxaliplatin | Drug | 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles. |
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| protein expression analysis | Genetic |
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| proteomic profiling | Genetic |
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| diagnostic laboratory biomarker analysis | Other |
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| adjuvant therapy | Procedure |
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| neoadjuvant therapy | Procedure |
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| therapeutic conventional surgery | Procedure |
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| RECIST Radiologic Response to Neoadjuvant Therapy |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR +PR |
| 2 years |
| Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy | Baseline and 2 years |
| Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy | Percentage change in specific tumor marker (Carcinoembryonic antigen, CEA) levels in response to neoadjuvant therapy | Baseline and 2 years |
| Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy | Percent change in specific tumor marker (Cancer Antigen 19-9, Ca 19-9) levels in response to neoadjuvant therapy | Baseline and 2 years |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine And Oxaliplatin | A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles. protein expression analysis proteomic profiling diagnostic laboratory biomarker analysis adjuvant therapy neoadjuvant therapy therapeutic conventional surgery |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Standard Deviation | years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival at 18 Months | Percentage of participants that were alive or survived at 18 months after randomization | Posted | Number | 95% Confidence Interval | percentage of participants | 18 months |
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| Secondary | Overall Survival (Follow-Up Time) | Posted | Median | Full Range | months | From Baseline until 2 Years and Follow-Up, up to 120 months |
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| Secondary | Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy | Posted | Median | Full Range | ng/ml | Baseline and 2 years |
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| Secondary | RECIST Radiologic Response to Neoadjuvant Therapy | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR +PR | Posted | Number | participants | 2 years |
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| Secondary | Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy | Posted | Median | Full Range | U/ml | Baseline and 2 years |
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| Secondary | Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy | Percentage change in specific tumor marker (Carcinoembryonic antigen, CEA) levels in response to neoadjuvant therapy | Posted | Median | Full Range | percent change | Baseline and 2 years |
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| Secondary | Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy | Percent change in specific tumor marker (Cancer Antigen 19-9, Ca 19-9) levels in response to neoadjuvant therapy | Posted | Median | Full Range | percent change | Baseline and 2 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gemcitabine And Oxaliplatin | A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles. protein expression analysis proteomic profiling diagnostic laboratory biomarker analysis adjuvant therapy neoadjuvant therapy therapeutic conventional surgery | 25 | 39 | 25 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction-Hypersensitivity | Immune system disorders | CTCAE v3.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment |
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| Ascites (non-malignant) | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | CTCAE v3.0 | Systematic Assessment |
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| Ischemia cerebrovascular | Nervous system disorders | CTCAE v3.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | CTCAE v3.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment |
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| General disorder | General disorders | CTCAE v3.0 | Systematic Assessment |
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| Sudden death | General disorders | CTCAE v3.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE v3.0 | Systematic Assessment |
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| Fever | General disorders | CTCAE v3.0 | Systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE v3.0 | Systematic Assessment |
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| Anemia (Hemoglobin decrease) | Blood and lymphatic system disorders | CTCAE v3.0 | Systematic Assessment |
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| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE v3.0 | Systematic Assessment |
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| Abdominal infection | Infections and infestations | CTCAE v3.0 | Systematic Assessment |
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| Biliary tract infection | Infections and infestations | CTCAE v3.0 | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment |
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| Bladder infection | Infections and infestations | CTCAE v3.0 | Systematic Assessment |
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| Wound infection | Infections and infestations | CTCAE v3.0 | Systematic Assessment |
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| Skin infection | Infections and infestations | CTCAE v3.0 | Systematic Assessment |
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| Infections and infestations -other | Infections and infestations | CTCAE v3.0 | Systematic Assessment |
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| Injection site reaction | General disorders | CTCAE v3.0 | Systematic Assessment |
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| Pancreatic anastomotic leak | Injury, poisoning and procedural complications | CTCAE v3.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | Systematic Assessment |
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| Pain | General disorders | CTCAE v3.0 | Systematic Assessment |
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| Urogenital disorder | Renal and urinary disorders | CTCAE v3.0 | Systematic Assessment |
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| Chills | General disorders | CTCAE v3.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | CTCAE v3.0 | Systematic Assessment |
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| Vascular access complication | Injury, poisoning and procedural complications | CTCAE v3.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aspartate aminotransferase increased | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Alkaline phosphatase increased | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| White blood cell decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eileen O'Reilly | Memorial Sloan-Kettering Cancer Center | 646-888-4182 | oreillye@mskcc.org |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| D017024 | Chemotherapy, Adjuvant |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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| >=65 years |
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