Synergistic Survival: A New Phenomenon Connected to Adverse Events of First-Line Sunitinib Treatment in Advanced Renal Cell Carcinoma

Krisztián Nagyiványi, Barna Budai, Krisztina Bíró, Fruzsina Gyergyay, László Noszek, Zsófia Küronya, Hajnalka Németh, Péter Nagy, L. Géczi

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Background: The aim was to assess the relationship between treatment efficacy and adverse events (AEs) for patients with advanced renal cell carcinoma treated with first-line sunitinib. Patients and Methods: 274 patients were treated with sunitinib (50 mg/d, 4-weeks-on and 2-weeks-off schedule). Physical and laboratory evaluations were done every sixth week. AEs were diagnosed at every visit. Clinical response was assessed every 3 months. The objective response rate (ORR), median progression-free (mPFS) and median overall survival (mOS) and AEs were evaluated. Besides χ2 and log rank tests, multivariate Cox regression analysis and for synergism 1-sided t tests were used. Results: The ORR was 25%. After a median follow-up of 32 months, the mPFS and mOS were 9 and 19 months, respectively. Hypertension, diarrhea, hypothyroidism, mucositis, hand-foot syndrome (HFS), skin toxicity, and leukopenia were the most frequent treatment-associated AEs. Significantly longer (P <.01) mPFS and mOS were observed when hypertension, diarrhea, HFS, hypothyroidism, skin toxicity, or leukopenia occurred. A statistically significant synergistic effect of the listed AEs was observed for progression-free survival (P <.001) and overall survival (P <.001). Multivariate analysis revealed that besides the prognostic category, the higher number of AEs (3-6 vs. 0-2) was an independent marker of longer mPFS (24 vs. 5 months, respectively; P <.001) and mOS (51 vs. 9 months, respectively; P <.001). Conclusion: Results of this study provide evidence for the synergistically enhanced efficacy of sunitinib treatment in patients who present multiple AEs. These AEs are diagnosed routinely and their coexistence can help physicians to predict which group of patients would benefit the most from first-line sunitinib treatment.

Original languageEnglish
JournalClinical Genitourinary Cancer
DOIs
Publication statusAccepted/In press - Sep 30 2015

Fingerprint

Renal Cell Carcinoma
Survival
Hand-Foot Syndrome
Leukopenia
Hypothyroidism
Diarrhea
Hypertension
Therapeutics
Skin
Mucositis
Disease-Free Survival
Appointments and Schedules
Multivariate Analysis
Regression Analysis
sunitinib
Physicians

Keywords

  • Advanced renal cell carcinoma
  • Adverse events
  • First-line sunitinib
  • Predictive marker
  • Synergistic survival

ASJC Scopus subject areas

  • Oncology
  • Urology

Cite this

Synergistic Survival : A New Phenomenon Connected to Adverse Events of First-Line Sunitinib Treatment in Advanced Renal Cell Carcinoma. / Nagyiványi, Krisztián; Budai, Barna; Bíró, Krisztina; Gyergyay, Fruzsina; Noszek, László; Küronya, Zsófia; Németh, Hajnalka; Nagy, Péter; Géczi, L.

In: Clinical Genitourinary Cancer, 30.09.2015.

Research output: Contribution to journalArticle

Nagyiványi, Krisztián ; Budai, Barna ; Bíró, Krisztina ; Gyergyay, Fruzsina ; Noszek, László ; Küronya, Zsófia ; Németh, Hajnalka ; Nagy, Péter ; Géczi, L. / Synergistic Survival : A New Phenomenon Connected to Adverse Events of First-Line Sunitinib Treatment in Advanced Renal Cell Carcinoma. In: Clinical Genitourinary Cancer. 2015.
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AU - Budai, Barna

AU - Bíró, Krisztina

AU - Gyergyay, Fruzsina

AU - Noszek, László

AU - Küronya, Zsófia

AU - Németh, Hajnalka

AU - Nagy, Péter

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N2 - Background: The aim was to assess the relationship between treatment efficacy and adverse events (AEs) for patients with advanced renal cell carcinoma treated with first-line sunitinib. Patients and Methods: 274 patients were treated with sunitinib (50 mg/d, 4-weeks-on and 2-weeks-off schedule). Physical and laboratory evaluations were done every sixth week. AEs were diagnosed at every visit. Clinical response was assessed every 3 months. The objective response rate (ORR), median progression-free (mPFS) and median overall survival (mOS) and AEs were evaluated. Besides χ2 and log rank tests, multivariate Cox regression analysis and for synergism 1-sided t tests were used. Results: The ORR was 25%. After a median follow-up of 32 months, the mPFS and mOS were 9 and 19 months, respectively. Hypertension, diarrhea, hypothyroidism, mucositis, hand-foot syndrome (HFS), skin toxicity, and leukopenia were the most frequent treatment-associated AEs. Significantly longer (P <.01) mPFS and mOS were observed when hypertension, diarrhea, HFS, hypothyroidism, skin toxicity, or leukopenia occurred. A statistically significant synergistic effect of the listed AEs was observed for progression-free survival (P <.001) and overall survival (P <.001). Multivariate analysis revealed that besides the prognostic category, the higher number of AEs (3-6 vs. 0-2) was an independent marker of longer mPFS (24 vs. 5 months, respectively; P <.001) and mOS (51 vs. 9 months, respectively; P <.001). Conclusion: Results of this study provide evidence for the synergistically enhanced efficacy of sunitinib treatment in patients who present multiple AEs. These AEs are diagnosed routinely and their coexistence can help physicians to predict which group of patients would benefit the most from first-line sunitinib treatment.

AB - Background: The aim was to assess the relationship between treatment efficacy and adverse events (AEs) for patients with advanced renal cell carcinoma treated with first-line sunitinib. Patients and Methods: 274 patients were treated with sunitinib (50 mg/d, 4-weeks-on and 2-weeks-off schedule). Physical and laboratory evaluations were done every sixth week. AEs were diagnosed at every visit. Clinical response was assessed every 3 months. The objective response rate (ORR), median progression-free (mPFS) and median overall survival (mOS) and AEs were evaluated. Besides χ2 and log rank tests, multivariate Cox regression analysis and for synergism 1-sided t tests were used. Results: The ORR was 25%. After a median follow-up of 32 months, the mPFS and mOS were 9 and 19 months, respectively. Hypertension, diarrhea, hypothyroidism, mucositis, hand-foot syndrome (HFS), skin toxicity, and leukopenia were the most frequent treatment-associated AEs. Significantly longer (P <.01) mPFS and mOS were observed when hypertension, diarrhea, HFS, hypothyroidism, skin toxicity, or leukopenia occurred. A statistically significant synergistic effect of the listed AEs was observed for progression-free survival (P <.001) and overall survival (P <.001). Multivariate analysis revealed that besides the prognostic category, the higher number of AEs (3-6 vs. 0-2) was an independent marker of longer mPFS (24 vs. 5 months, respectively; P <.001) and mOS (51 vs. 9 months, respectively; P <.001). Conclusion: Results of this study provide evidence for the synergistically enhanced efficacy of sunitinib treatment in patients who present multiple AEs. These AEs are diagnosed routinely and their coexistence can help physicians to predict which group of patients would benefit the most from first-line sunitinib treatment.

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KW - Predictive marker

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