Clinical trial NCT00720941: Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma
Official title: Study VEG108844, A Study of Pazopanib Versus Sunitinib in the Treatment of Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Renal Cell
Keywords: SUTENT
Locally advanced and/or metastatic renal cell carcinoma
Pazopanib
Sunitinib
GW786034
Renal cell carcinoma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-07-23
Enrollment: 1110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a randomized, open-label, parallel group Phase III non inferiority study to evaluate the efficacy and safety of pazopanib compared with sunitinib in subjects with advanced renal cell carcinoma (RCC) who had not received prior systemic therapy for advanced or metastatic RCC.

Detailed description: Approximately 876 eligible subjects (approximately 438 per treatment arm) were planned to be enrolled over the course of the study. However, due to higher than expected withdrawal rates and discordance rates between independent review committee (IRC) and investigator assessments of progression, the protocol was amended (Protocol Amendment 4) to increase the number of subjects to approximately 1100 total by including all subjects enrolled in CPZP034A2301 (hereafter referred as Study A2301) and CPZP034A2201 (a sub study of CPZP034A2301, hereafter referred as Study A2201 with NCT01147822).

The subjects were centrally randomized in 1:1 ratio to receive either 800mg pazopanib to be administered once daily orally continuous dosing or 50mg sunitinib to be administered in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment. Subjects were permitted to receive supportive care throughout the study including transfusion of blood and blood products, treatment with antibiotics, anti-emetics, anti-diarrheal agents, analgesics, erythropoietin, or bisphosphonates, when appropriate. The study treatment continued until subjects experience disease progression, unacceptable toxicity, withdraw consent, or death.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Diagnosis of renal cell carcinoma with clear-cell component histology.
* Received no prior systemic therapy (interleukin-2, interferon-alpha, chemotherapy, bevacizumab, mTOR inhibitor, sunitinib, sorafenib or other VEGF TKI) for advanced or metastatic RCC
* Locally advanced or metastatic renal cell carcinoma
* Measurable disease by CT or MRI
* Karnofsky performance scale status of \>=70
* Age \>=18 years
* A female is eligible to enter and participate in this study if she is of: non-childbearing or agrees to use adequate contraception.
* Adequate organ system function
* Total serum calcium concentration \<12.0mg/dL
* Left ventricular ejection fraction \>= lower limit of institutional normal.

Exclusion Criteria:

* Pregnant or lactating female (unless agrees to refrain from nursing throughout the treatment period and for 14 days following the last dose of study)
* History of another malignancy (unless have been disease-free for 3 years)
* History or clinical evidence of central nervous system (CNS) metastases (unless have previously-treated CNS metastases and meet all 3 of the following criteria are: are asymptomatic, have had no evidence of active CNS metastases for \>=6 months prior to enrolment, and have no requirement for steroids or enzyme-inducing anticonvulsants)
* Clinically significant gastrointestinal abnormalities including, but not limited to: malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, known intraluminal metastatic lesion/s with suspected bleeding, Inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
* Presence of uncontrolled infection.
* Prolongation of corrected QT interval (QTc) \> 480 milliseconds
* History of any one or more of the following cardiovascular conditions within the past 12 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association
* History of cerebrovascular accident including transient ischemic attack within the past 12 months
* History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months (unless had recent DVT and have been treated with therapeutic anti-coagulating agents for at least 6 weeks)
* Poorly controlled hypertension (defined as systolic blood pressure of \>=150mmHg or diastolic blood pressure of \>=90mmHg). Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry
* Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
* Evidence of active bleeding or bleeding susceptibility
* Spitting/coughing up blood within 6 weeks of first dose of study drug
* Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
* Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study.
* Use any prohibited medications within 14 days of the first dose of study medication.
* Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
* Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors (eg. bevacizumab, sunitinib, sorafenib, etc), or are mTOR inhibitors (eg. temsirolimus, everolimus, etc).
* Is now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug, any cancer therapy (surgery, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy)
* Any ongoing toxicity from prior anti-cancer therapy that is \>Grade 1 and/or that is progressing in severity.
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or sunitinib.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: From randomization until the earliest date of disease progression or date of death from any cause, assessed up to approximately 39 months
Secondary outcomes:
measure: Overall Survival
timeFrame: From randomization until date of death from any cause, assessed up to approximately 62 months
measure: Overall Response Rate (ORR) as Assessed by Independent Review
timeFrame: From randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months
measure: Time to Response
timeFrame: From randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months
measure: Duration of Response (DOR)
timeFrame: From the date of the first documented response (CR or PR) to the date of first documented progression or death due to any cause, assessed up to approximately 39 months
measure: Number of Participants With Adverse Events
timeFrame: From study treatment start date till 28 days safety follow-up, assessed up to approximately 152 months
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores at Day 28 of Cycles 1-4
timeFrame: Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
measure: Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease-related Symptoms-physical (DRS-P) Domain Score at Day 28 of Cycles 1-4
timeFrame: Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
measure: Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease Related Symptoms-emotional (DRS-E) Domain Score at Day 28 of Cycles 1-4
timeFrame: Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
measure: Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Treatment Side Effects (TSE) Domain Score at Day 28 of Cycles 1-4
timeFrame: Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
measure: Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Functional Well Being (FWB) Domain Score at Day 28 of Cycles 1-4
timeFrame: Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
measure: Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Total Score at Day 28 of Cycles 1-4
timeFrame: Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
measure: Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Scale Worst Soreness Scores at Day 28 of Cycles 1-4
timeFrame: Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
measure: Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Mouth and Throat Soreness Score at Day 28 of Cycles 1-4
timeFrame: Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
measure: Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Foot Soreness Scores at Day 28 of Cycles 1-4
timeFrame: Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
measure: Summary of Analysis for the Cancer Treatment Satisfaction Questionnaire (CTSQ) Score at Day 28 of Cycles 1-4
timeFrame: Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
measure: Mean Number of Non-study Medical Visits, Telephone Consultations, Hospital Days, and Emergency Room (ER) Visits Per 30 Days Through Week 24
timeFrame: From Day 1 up to Week 24
measure: Mean Number of Laboratory Visits, Radiology Visits, Home Healthcare Visits, and Medical Procedures at Day 28 of Cycles 1-4
timeFrame: Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
Other outcomes:
measure: All Collected Deaths
timeFrame: Pre-treatment deaths: Up to 21 days prior to treatment. On-treatment deaths: Up to 129 months. Post-treatment deaths: up to 152 months.
Locations:
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facility: Novartis Investigative Site
state: Alabama
city: Tucson
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city: Little Rock
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city: South San Francisco
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city: Vallejo
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city: Denver
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state: Maryland
city: Boston
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state: Massachusetts
city: Worcester
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city: Detroit
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city: Duluth
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city: Minneapolis
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city: Tupelo
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city: Kansas City
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state: Missouri
city: Kansas City
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city: Lincoln
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state: Nebraska
city: Las Vegas
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state: Nevada
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state: Nevada
city: Lebanon
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city: Hackensack
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state: New Jersey
city: Buffalo
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state: New York
city: Hickory
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city: Dayton
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city: Portland
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city: Charleston
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state: South Carolina
city: Charleston
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city: Mount Pleasant
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city: San Antonio
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city: Tyler
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city: Salem
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city: Seattle
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state: New South Wales
city: Kogarah
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state: New South Wales
city: Randwick
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state: New South Wales
city: Waratah
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state: New South Wales
city: Westmead
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state: New South Wales
city: Bedford Park
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state: South Australia
city: Hobart
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state: Tasmania
city: Heidelberg
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state: Victoria
city: Wodonga
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state: Victoria
city: Calgary
country: Canada
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state: Alberta
city: Edmonton
country: Canada
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state: Alberta
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Winnipeg
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state: Manitoba
city: Moncton
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Oshawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
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facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
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state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Guangzhou
country: China
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state: Guangdong
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Beijing
country: China
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city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
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city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Tianjin
country: China
facility: Novartis Investigative Site
city: Kirchheim
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Sigmaringen
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Muenchen
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Planegg
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Marburg
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Offenbach
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Hannover
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Aachen
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Duisburg
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Homburg
country: Germany
facility: Novartis Investigative Site
state: Saarland
city: Eisleben
country: Germany
facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Leipzig
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Plauen
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Galway
country: Ireland
facility: Novartis Investigative Site
city: Tallaght, Dublin
country: Ireland
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
state: Campania
city: Meldola (FC)
country: Italy
facility: Novartis Investigative Site
state: Emilia-Romagna
city: Ravenna
country: Italy
facility: Novartis Investigative Site
state: Emilia-Romagna
city: Pordenone
country: Italy
facility: Novartis Investigative Site
state: Friuli-Venezia-Giulia
city: Roma
country: Italy
facility: Novartis Investigative Site
state: Lazio
city: Milano
country: Italy
facility: Novartis Investigative Site
state: Lombardia
city: Arezzo
country: Italy
facility: Novartis Investigative Site
state: Toscana
city: Ehime
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
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city: Hokkaido
country: Japan
facility: Novartis Investigative Site
city: Hokkaido
country: Japan
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city: Ibaraki
country: Japan
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city: Iwate
country: Japan
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city: Kanagawa
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Okayama
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Shizuoka
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Yamagata
country: Japan
facility: Novartis Investigative Site
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
city: Daejeon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Goyang-si, Gyeonggi-Do
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Alkmaar
country: Netherlands
facility: Novartis Investigative Site
city: Amsterdam
country: Netherlands
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city: Breda
country: Netherlands
facility: Novartis Investigative Site
city: Den Haag
country: Netherlands
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Sittard-geleen
country: Netherlands
facility: Novartis Investigative Site
city: Tilburg
country: Netherlands
facility: Novartis Investigative Site
city: Utrecht
country: Netherlands
facility: Novartis Investigative Site
city: Badalona
country: Spain
facility: Novartis Investigative Site
city: Barakaldo (Vizcaya)
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
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city: Gerona
country: Spain
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city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Pamplona
country: Spain
facility: Novartis Investigative Site
city: Lund
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Uppsala
country: Sweden
facility: Novartis Investigative Site
city: Kaohsiung Hsien
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taoyuan
country: Taiwan
facility: Novartis Investigative Site
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
state: Gloucestershire
city: Northwood
country: United Kingdom
facility: Novartis Investigative Site
state: Middlesex
city: Bebington, Wirral
country: United Kingdom
facility: Novartis Investigative Site
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: Cambridge
country: United Kingdom
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: Leeds
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Nottingham
country: United Kingdom
facility: Novartis Investigative Site
city: Sheffield
country: United Kingdom
facility: Novartis Investigative Site
city: Swansea
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Sheng X, Jin J, He Z, Huang Y, Zhou A, Wang J, Ren X, Ye D, Zhang X, Qin S, Zhou F, Wang B, Guo J. Pazopanib versus sunitinib in Chinese patients with locally advanced or metastatic renal cell carcinoma: pooled subgroup analysis from the randomized, COMPARZ studies. BMC Cancer. 2020 Mar 14;20(1):219. doi: 10.1186/s12885-020-6708-8.
citation: Sternberg CN, Motzer RJ, Hutson TE, Choueiri TK, Kollmannsberger C, Bjarnason GA, Paul Nathan, Porta C, Grunwald V, Dezzani L, Han J, Tannir NM. COMPARZ Post Hoc Analysis: Characterizing Pazopanib Responders With Advanced Renal Cell Carcinoma. Clin Genitourin Cancer. 2019 Dec;17(6):425-435.e4. doi: 10.1016/j.clgc.2019.01.015. Epub 2019 Feb 6.
citation: Guo J, Jin J, Oya M, Uemura H, Takahashi S, Tatsugami K, Rha SY, Lee JL, Chung J, Lim HY, Wu HC, Chang YH, Azad A, Davis ID, Carrasco-Alfonso MJ, Nanua B, Han J, Ahmad Q, Motzer R. Safety of pazopanib and sunitinib in treatment-naive patients with metastatic renal cell carcinoma: Asian versus non-Asian subgroup analysis of the COMPARZ trial. J Hematol Oncol. 2018 May 22;11(1):69. doi: 10.1186/s13045-018-0617-1.
citation: Grunwald V, Dietrich M, Pond GR. Early tumor shrinkage is independently associated with improved overall survival among patients with metastatic renal cell carcinoma: a validation study using the COMPARZ cohort. World J Urol. 2018 Sep;36(9):1423-1429. doi: 10.1007/s00345-018-2297-4. Epub 2018 Apr 13.
citation: Beaumont JL, Salsman JM, Diaz J, Deen KC, McCann L, Powles T, Hackshaw MD, Motzer RJ, Cella D. Quality-adjusted time without symptoms or toxicity analysis of pazopanib versus sunitinib in patients with renal cell carcinoma. Cancer. 2016 Apr 1;122(7):1108-15. doi: 10.1002/cncr.29888. Epub 2016 Jan 27.
citation: Goldstein D, Rosenberg JE, Figlin RA, Townsend RR, McCann L, Carpenter C, Pandite L. Is change in blood pressure a biomarker of pazopanib and sunitinib efficacy in advanced/metastatic renal cell carcinoma? Eur J Cancer. 2016 Jan;53:96-104. doi: 10.1016/j.ejca.2015.10.006. Epub 2015 Dec 15.
citation: Sorich MJ, Kichenadasse G, Rowland A, Woodman RJ, Mangoni AA. Angiotensin system inhibitors and survival in patients with metastatic renal cell carcinoma treated with VEGF-targeted therapy: A pooled secondary analysis of clinical trials. Int J Cancer. 2016 May 1;138(9):2293-9. doi: 10.1002/ijc.29972. Epub 2016 Jan 6.
citation: Lai JS, Beaumont JL, Diaz J, Khan S, Cella D. Validation of a short questionnaire to measure symptoms and functional limitations associated with hand-foot syndrome and mucositis in patients with metastatic renal cell carcinoma. Cancer. 2016 Jan 15;122(2):287-95. doi: 10.1002/cncr.29655. Epub 2015 Oct 12.
citation: Motzer RJ, Hutson TE, Cella D, Reeves J, Hawkins R, Guo J, Nathan P, Staehler M, de Souza P, Merchan JR, Boleti E, Fife K, Jin J, Jones R, Uemura H, De Giorgi U, Harmenberg U, Wang J, Sternberg CN, Deen K, McCann L, Hackshaw MD, Crescenzo R, Pandite LN, Choueiri TK. Pazopanib versus sunitinib in metastatic renal-cell carcinoma. N Engl J Med. 2013 Aug 22;369(8):722-31. doi: 10.1056/NEJMoa1303989.