REGISTRY OF COMPLETE RESPONSES TO SUNITINIB IN SPANISH PATIENTS WITH METASTATIC RENAL CELL CARCINOMA (ATILA)

REGISTRY OF COMPLETE RESPONSES TO SUNITINIB IN SPANISH PATIENTS WITH METASTATIC RENAL CELL CARCINOMA (ATILA STUDY)

Observational, retrospective, multicentre study in spanish patients with metastatic Renal Cell Carcinoma (mRCC) treated with sunitinib as a first-line treatment (treatment with previous cytokine therapy is accepted) according to clinical practice who obtained a complete response (CR) to treatment in one of these 2 situations:

1. Complete response (CR) obtained exclusively with first-line sunitinib treatment (sunitinib CR).
2. Response obtained after a period of time on treatment with sunitinib in which local treatment was also performed (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) to achieve the total macroscopic disappearance of the disease, according to the opinion of the physician responsible for the patient (CR + local treatment).

Study Overview

• Status: Completed
• Conditions: Carcinoma, Renal Cell

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• Spain
  • A Coruña, Spain, 15011
    • Complexo Hospitalario Universitario de Ferrol
  • Badajoz, Spain, 06080
    • Hospital Universitario Infanta Cristina
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant
  • Barcelona, Spain, 08243
    • Hospital Clínico de Barcelona
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Guadalajara, Spain, 19002
    • Hospital Universitario de Guadalajara
  • Jaén, Spain, 23007
    • Complejo Hospitalario de Jaén
  • León, Spain, 24080
    • Hospital Universitario de Leon
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti / Servicio de Oncología Médica
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon Y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28040
    • Hospital Clínico San Carlos de Madrid
  • Ourense, Spain, 32005
    • Complexo Hospitalario Universitario de Ourense
  • Segovia, Spain, 40002
    • Complejo Asistencial de Segovia
  • Sevilla, Spain, 41014
    • Hospital De Valme
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
  • Valencia, Spain, 46009
    • Instituto Valenciano de Oncologia
  • València, Spain, 46017
    • Hospital Universitario Doctor Peset
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08908
      • Hospital Duran I Reynals
    • Manresa, Barcelona, Spain, 08243
      • Hospital San Juan de Dios
    • Sabadell, Barcelona, Spain, 08208
      • Hospital Parc Taulí de Sabadell
    • Terrassa, Barcelona, Spain, 08221
      • Hospital Universitario Mutua Terrassa
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario de Marqués de Valdecilla
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Hospital Universitario Fundación Alcorcón
    • Leganés, Madrid, Spain, 28911
      • Hospital Universitario Severo Ochoa
    • Parla, Madrid, Spain, 28981
      • Hospital Infanta Cristina
    • Toledo, Madrid, Spain, 45004
      • Hospita Virgen de la Salud
  • Mallorca
    • Palma de Mallorca, Mallorca, Spain, 07120
      • Hospital Universitario Son Espases
  • Tenerife
    • Santa Cruz de Tenerife, Tenerife, Spain, 38010
      • Hospital Universitario Nuestra Señora de Candelaria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patient population eligible for this study includes any patient with advanced or metastatic renal cell cancer who has been treated with Sunitinib and has achieved CR of the tumour and its metastases at any time during treatment and according to the usual assessment criteria in daily clinical practice, whether it was obtained with sunitinib alone or if a local treatment was needed to eradicate all the lesions: (surgery of the residual metastases, radiofrequency ablation or radiotherapy)

Description

Inclusion Criteria:

1. Patients who are 18 year-old or over who have been treated for metastatic renal cell carcinoma with sunitinib as first-line treatment (treatment with prior cytokine therapy is accepted) between 2007 and 30 September 2018 and who have obtained as a best treatment response the total remission of the disease in the opinion of the doctor in charge from a clinical, radiological and/or macroscopic point of view. This response must have been reached through two possible strategies:

   A) Systemic treatment with sunitinib alone. B) Treatment with sunitinib and subsequent local treatment for one or more residual lesions that have not responded to the drug (traditional surgery, radiotherapy, SBRT (Stereotactic Body Radiation Therapy)).

2. The duration of CR must have been confirmed with at least 2 consecutive imaging tests, without having a limit in the duration of this response. Although the patient had progressed subsequently, he/she may be included in this registry.
3. Patients from any risk group
4. Tumours of any histology

Exclusion Criteria:

1. Patients treated with another drug other than Sunitinib.
2. Patients with no radiology reports proving CR.
3. Patients with no record of the dose and regimen received with Sunitinib.
4. Patients who achieved complete remission after 30 September 2018.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Subjects with reported metastatic renal cell carcinoma; The subjects have been treatment with sunitinib and they reached complete remission

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Complete Remission of Lesions	Time to complete remission of lesions was calculated as the difference between treatment start date and complete response (CR) confirmation date. As per response evaluation criteria in solid tumors (RECIST) version (v) 1.1, CR = disappearance of all known target and all non-target lesions and the absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 millimeter (mm). CR was confirmed with 2 consecutive computed tomography (CT) scans performed with at least 4 weeks between them during the follow-up of participants. Confirmation from the oncologist and radiologist was required at each site.	From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)
Duration of Complete Remission (DOR)	DOR was defined as the time from date on which the CR was identified until tumor progression, the change of treatment due to unacceptable toxicity, death from any cause or until the date of the last follow-up at the close of study. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of >=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.	From first documented CR date until progression/death or change of treatment due to unacceptable toxicity or last follow-up date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)
Progression Free Survival (PFS)	PFS was calculated as the time from the date of CR confirmation (2nd CT scan) until the date of progression/death or change of treatment for unacceptable toxicity or censored on the date of the last follow-up. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of >=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Analysis was performed using Kaplan-Meier method.	From CR confirmation date until progression/death or change of treatment due to unacceptable toxicity/last follow-up date, up to maximum of approximately 13 years (data collected, observed retrospectively for approximately 10 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis	Time to CR: difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures <10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site. Heng prognostic model identified KPS of <80 at treatment initiation, period from diagnosis to start of treatment for metastatic disease <1year, anemia, hypercalcemia, neutrophilia, thrombocytosis as prognostic factors. Participants were classified into 3 prognosis group: favorable(0 factor), intermediate(1-2 factors) and poor(3 or more factors). KPS measured ability of participants with cancer to perform ordinary tasks. KPS scores range: 0 (dead) to 100 (normal, no complaint). High KPS score= participant better able to carry out daily activities.	From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)
Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis at Least 2 Consecutive CT Scans	Time to CR: difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures <10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site. Heng prognostic model identified KPS of <80 at treatment initiation, period from diagnosis to start of treatment for metastatic disease <1year, anemia, hypercalcemia, neutrophilia, thrombocytosis as prognostic factors. Participants were classified into 3 prognosis group: favorable(0 factor), intermediate(1-2 factors) and poor(3 or more factors). KPS measured ability of participants with cancer to perform ordinary tasks. KPS scores range: 0(dead) to 100(normal, no complaint). High KPS score=participant better able to carry out daily activities.	From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)
Time to Achieve CR in Participants Classified According to Previous Nephrectomy Status	Time to achieve CR according to previous nephrectomy status were reported in this outcome measure. Time to CR was calculated as the difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures <10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site.	From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)
Time to Achieve CR in Participants Classified According to Histology Type	Time to achieve CR according to type of histology as clear cell, non-clear cell and sarcomatoid were reported in this outcome measure. Time to CR was calculated as the difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures <10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site.	From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)
Duration of Response Based on Type of Treatment Received	Duration of response was defined as the time from date on which the CR was identified until the date of the CT scan conforming tumor progression, the change of treatment due to unacceptable toxicity, death from any cause or until the date of the last follow-up at the close of study. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of >=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Analysis was performed using Kaplan-Meier method.	From first documented CR date until progression/death or change of treatment due to unacceptable toxicity or last follow-up date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)
Number of Participants With Dose Interruption		From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)
Number of Participants Who Received Subsequent Local Treatment	Local treatments were the following: traditional surgery, radiotherapy, or stereotactic body radiation therapy (SBRT), to achieve the total macroscopic disappearance of the disease along with CR, according to the opinion of the physician responsible for the participant.	Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)
Number of Participants Who Discontinued Sunitinib Treatment Due to Toxicity	Number of participants who discontinued sunitinib treatment due to toxicity were reported in this outcome measure.	From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)
Number of Participants With Grade 3 or Higher Toxicity to Sunitinib	Number of participants with Grade 3 or higher toxicity as per common terminology criteria for adverse events (CTCAE) version 4 were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death.	From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 17, 2019
• Primary Completion (ACTUAL): November 3, 2020
• Study Completion (ACTUAL): November 3, 2020

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (ACTUAL): April 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 13, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Prognosis; Carcinoma, Renal Cell; Sunitinib; Angiogenesis Inhibitors; Disease-Free Survival; Protein Kinase Inhibitors
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma
• Other Study ID Numbers: A6181227; ATILA (OTHER: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No