Could interferon still play a role in metastatic renal cell carcinoma? A randomized study of two schedules of sorafenib plus interferon-alpha 2a (RAPSODY)

Sergio Bracarda, Camillo Porta, Corrado Boni, Armando Santoro, Claudia Mucciarini, Antonio Pazzola, Enrico Cortesi, Donatello Gasparro, Roberto Labianca, Francesco Di Costanzo, Alfredo Falcone, Michela Cinquini, Claudia Caserta, Chiara Paglino, Verena De Angelis

Research output: Contribution to journalArticle

Abstract

Background: Sorafenib has proven efficacy in metastatic renal cell carcinoma (mRCC). Interferon (IFN) has antiangiogenic activity that is thought to be both dose- and administration-schedule dependent. Objective: To compare two different schedules of IFN combined with sorafenib. Design, setting, and participants: Single-stage, prospective, noncomparative, randomized, open-label, multicenter, phase 2 study on previously untreated patients with mRCC and Eastern Cooperative Oncology Group performance status 0-2. Intervention: Sorafenib 400 mg twice daily plus subcutaneous IFN, 9 million units (MU) three times a week (Arm A) or 3 MU five times a week (Arm B). Outcome measurements and statistical analysis: Primary end points were progression-free survival (PFS) for each arm and safety. Data were evaluated according to an intent-to-treat analysis. Results and limitations: A total of 101 patients were evaluated. Median PFS was 7.9 mo in Arm A and 8.6 mo in Arm B (p = 0.049) and the median duration of response was 8.5 and 19.2 mo, respectively (p = 0.0013). Nine partial responses were observed in Arm A, and three complete and 14 partial responses were observed in Arm B (17.6% vs 34.0%; p = 0.058); 24 and 21 patients (47% and 42%), respectively, achieved stable disease. The most common grade 3-4 toxicities were fatigue plus asthenia (28% vs 16%; p = 0.32) and hand-foot skin reactions (20% vs 18%). Conclusions: Sorafenib plus frequent low-dose IFN showed good efficacy and tolerability. Further investigations should be warranted to identify a possible positioning of this intriguing regimen (6% complete response rate) in the treatment scenario of mRCC.

Original languageEnglish
Pages (from-to)254-261
Number of pages8
JournalEuropean Urology
Volume63
Issue number2
DOIs
Publication statusPublished - Feb 2013

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Renal Cell Carcinoma
Interferons
Appointments and Schedules
Arm
Disease-Free Survival
Asthenia
interferon alfa-2a
sorafenib
Fatigue
Foot
Hand
Safety
Skin

Keywords

  • Antiangiogenic therapy
  • Interferon-α2a
  • Renal cell carcinoma
  • Sorafenib

ASJC Scopus subject areas

  • Urology

Cite this

Could interferon still play a role in metastatic renal cell carcinoma? A randomized study of two schedules of sorafenib plus interferon-alpha 2a (RAPSODY). / Bracarda, Sergio; Porta, Camillo; Boni, Corrado; Santoro, Armando; Mucciarini, Claudia; Pazzola, Antonio; Cortesi, Enrico; Gasparro, Donatello; Labianca, Roberto; Di Costanzo, Francesco; Falcone, Alfredo; Cinquini, Michela; Caserta, Claudia; Paglino, Chiara; De Angelis, Verena.

In: European Urology, Vol. 63, No. 2, 02.2013, p. 254-261.

Research output: Contribution to journalArticle

Bracarda, S, Porta, C, Boni, C, Santoro, A, Mucciarini, C, Pazzola, A, Cortesi, E, Gasparro, D, Labianca, R, Di Costanzo, F, Falcone, A, Cinquini, M, Caserta, C, Paglino, C & De Angelis, V 2013, 'Could interferon still play a role in metastatic renal cell carcinoma? A randomized study of two schedules of sorafenib plus interferon-alpha 2a (RAPSODY)', European Urology, vol. 63, no. 2, pp. 254-261. https://doi.org/10.1016/j.eururo.2012.08.027
Bracarda, Sergio ; Porta, Camillo ; Boni, Corrado ; Santoro, Armando ; Mucciarini, Claudia ; Pazzola, Antonio ; Cortesi, Enrico ; Gasparro, Donatello ; Labianca, Roberto ; Di Costanzo, Francesco ; Falcone, Alfredo ; Cinquini, Michela ; Caserta, Claudia ; Paglino, Chiara ; De Angelis, Verena. / Could interferon still play a role in metastatic renal cell carcinoma? A randomized study of two schedules of sorafenib plus interferon-alpha 2a (RAPSODY). In: European Urology. 2013 ; Vol. 63, No. 2. pp. 254-261.
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abstract = "Background: Sorafenib has proven efficacy in metastatic renal cell carcinoma (mRCC). Interferon (IFN) has antiangiogenic activity that is thought to be both dose- and administration-schedule dependent. Objective: To compare two different schedules of IFN combined with sorafenib. Design, setting, and participants: Single-stage, prospective, noncomparative, randomized, open-label, multicenter, phase 2 study on previously untreated patients with mRCC and Eastern Cooperative Oncology Group performance status 0-2. Intervention: Sorafenib 400 mg twice daily plus subcutaneous IFN, 9 million units (MU) three times a week (Arm A) or 3 MU five times a week (Arm B). Outcome measurements and statistical analysis: Primary end points were progression-free survival (PFS) for each arm and safety. Data were evaluated according to an intent-to-treat analysis. Results and limitations: A total of 101 patients were evaluated. Median PFS was 7.9 mo in Arm A and 8.6 mo in Arm B (p = 0.049) and the median duration of response was 8.5 and 19.2 mo, respectively (p = 0.0013). Nine partial responses were observed in Arm A, and three complete and 14 partial responses were observed in Arm B (17.6{\%} vs 34.0{\%}; p = 0.058); 24 and 21 patients (47{\%} and 42{\%}), respectively, achieved stable disease. The most common grade 3-4 toxicities were fatigue plus asthenia (28{\%} vs 16{\%}; p = 0.32) and hand-foot skin reactions (20{\%} vs 18{\%}). Conclusions: Sorafenib plus frequent low-dose IFN showed good efficacy and tolerability. Further investigations should be warranted to identify a possible positioning of this intriguing regimen (6{\%} complete response rate) in the treatment scenario of mRCC.",
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T1 - Could interferon still play a role in metastatic renal cell carcinoma? A randomized study of two schedules of sorafenib plus interferon-alpha 2a (RAPSODY)

AU - Bracarda, Sergio

AU - Porta, Camillo

AU - Boni, Corrado

AU - Santoro, Armando

AU - Mucciarini, Claudia

AU - Pazzola, Antonio

AU - Cortesi, Enrico

AU - Gasparro, Donatello

AU - Labianca, Roberto

AU - Di Costanzo, Francesco

AU - Falcone, Alfredo

AU - Cinquini, Michela

AU - Caserta, Claudia

AU - Paglino, Chiara

AU - De Angelis, Verena

PY - 2013/2

Y1 - 2013/2

N2 - Background: Sorafenib has proven efficacy in metastatic renal cell carcinoma (mRCC). Interferon (IFN) has antiangiogenic activity that is thought to be both dose- and administration-schedule dependent. Objective: To compare two different schedules of IFN combined with sorafenib. Design, setting, and participants: Single-stage, prospective, noncomparative, randomized, open-label, multicenter, phase 2 study on previously untreated patients with mRCC and Eastern Cooperative Oncology Group performance status 0-2. Intervention: Sorafenib 400 mg twice daily plus subcutaneous IFN, 9 million units (MU) three times a week (Arm A) or 3 MU five times a week (Arm B). Outcome measurements and statistical analysis: Primary end points were progression-free survival (PFS) for each arm and safety. Data were evaluated according to an intent-to-treat analysis. Results and limitations: A total of 101 patients were evaluated. Median PFS was 7.9 mo in Arm A and 8.6 mo in Arm B (p = 0.049) and the median duration of response was 8.5 and 19.2 mo, respectively (p = 0.0013). Nine partial responses were observed in Arm A, and three complete and 14 partial responses were observed in Arm B (17.6% vs 34.0%; p = 0.058); 24 and 21 patients (47% and 42%), respectively, achieved stable disease. The most common grade 3-4 toxicities were fatigue plus asthenia (28% vs 16%; p = 0.32) and hand-foot skin reactions (20% vs 18%). Conclusions: Sorafenib plus frequent low-dose IFN showed good efficacy and tolerability. Further investigations should be warranted to identify a possible positioning of this intriguing regimen (6% complete response rate) in the treatment scenario of mRCC.

AB - Background: Sorafenib has proven efficacy in metastatic renal cell carcinoma (mRCC). Interferon (IFN) has antiangiogenic activity that is thought to be both dose- and administration-schedule dependent. Objective: To compare two different schedules of IFN combined with sorafenib. Design, setting, and participants: Single-stage, prospective, noncomparative, randomized, open-label, multicenter, phase 2 study on previously untreated patients with mRCC and Eastern Cooperative Oncology Group performance status 0-2. Intervention: Sorafenib 400 mg twice daily plus subcutaneous IFN, 9 million units (MU) three times a week (Arm A) or 3 MU five times a week (Arm B). Outcome measurements and statistical analysis: Primary end points were progression-free survival (PFS) for each arm and safety. Data were evaluated according to an intent-to-treat analysis. Results and limitations: A total of 101 patients were evaluated. Median PFS was 7.9 mo in Arm A and 8.6 mo in Arm B (p = 0.049) and the median duration of response was 8.5 and 19.2 mo, respectively (p = 0.0013). Nine partial responses were observed in Arm A, and three complete and 14 partial responses were observed in Arm B (17.6% vs 34.0%; p = 0.058); 24 and 21 patients (47% and 42%), respectively, achieved stable disease. The most common grade 3-4 toxicities were fatigue plus asthenia (28% vs 16%; p = 0.32) and hand-foot skin reactions (20% vs 18%). Conclusions: Sorafenib plus frequent low-dose IFN showed good efficacy and tolerability. Further investigations should be warranted to identify a possible positioning of this intriguing regimen (6% complete response rate) in the treatment scenario of mRCC.

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KW - Interferon-α2a

KW - Renal cell carcinoma

KW - Sorafenib

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