Clinical efficacy and prognostic factors of tumor progression in Japanese patients with advanced renal cell carcinoma treated with sorafenib

Tsunenori Kondo, Hayakazu Nakazawa, Mototsugu Oya, Go Kimura, Yasuhisa Fujii, Takashi Hatano, Nozomu Kawata, Haruki Kume, Masashi Morita, Koichi Nakajima, Yoshio Ohno, Takatsugu Okegawa, Shunji Takahashi, Yoshiaki Wakumoto, Shigeo Horie

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Objective: Result of clinical trial for registration purpose is often difficult to generalize because of its limited population in number and inclusion criteria. Methods: To understand the efficacy of sorafenib under daily medical practice, we retrospectively investigated therapeutic outcomes of 175 Japanese patients with advanced renal cell carcinoma treated with sorafenib at 15 centers. Results: The objective response rate and disease control rate were 15.4 and 77.1%, respectively, being similar to those in the Phase II study in Japanese patients (19.4 and 73.6 months). Any tumor shrinkage was observed with 53% of patients, while tumor control without growth was in 61%. Lung lesions were more sensitive to sorafenib than other lesions, in terms of any tumor shrinkage (54%) and the extent of maximal shrinkage, while tumor control was better in lymph node metastases (77%) than in lung (69%). Liver was worse in any tumor shrinkage (35%), tumor control (55%) and the extent of tumor growth. Slightly, shorter median overall survival of 21.1 months compared with Phase II clinical trial (25.3 months) is likely to be attributable to different patient population, because median overall survival was improved to 26.4 months when the population was matched to that in Phase II trial. Univariate and multivariate analyses identified prognostic factors for worse overall survival, including intermediate and poor Memorial Sloan-Kettering Cancer Center risk, Eastern Cooperative Oncology Group performance status ≥1, the presence of non-clear cell component and the presence of liver metastasis.Conclusions: In conclusion, the present study confirmed the efficacy of sorafenib in the real-world setting on advanced renal cell carcinoma.

Original languageEnglish
Article numberhyu200
Pages (from-to)274-280
Number of pages7
JournalJapanese Journal of Clinical Oncology
Volume45
Issue number3
DOIs
Publication statusPublished - 2015 Mar 1

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Renal Cell Carcinoma
Neoplasms
Survival
Population
Neoplasm Metastasis
Lung
Phase II Clinical Trials
sorafenib
Liver
Cellular Structures
Growth
Multivariate Analysis
Lymph Nodes
Clinical Trials

Keywords

  • Carcinoma
  • Metastasis
  • Neoplasm
  • Prognosis
  • Real-world practice
  • Renal cell
  • Sorafenib

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Radiology Nuclear Medicine and imaging
  • Medicine(all)

Cite this

Clinical efficacy and prognostic factors of tumor progression in Japanese patients with advanced renal cell carcinoma treated with sorafenib. / Kondo, Tsunenori; Nakazawa, Hayakazu; Oya, Mototsugu; Kimura, Go; Fujii, Yasuhisa; Hatano, Takashi; Kawata, Nozomu; Kume, Haruki; Morita, Masashi; Nakajima, Koichi; Ohno, Yoshio; Okegawa, Takatsugu; Takahashi, Shunji; Wakumoto, Yoshiaki; Horie, Shigeo.

In: Japanese Journal of Clinical Oncology, Vol. 45, No. 3, hyu200, 01.03.2015, p. 274-280.

Research output: Contribution to journalArticle

Kondo, T, Nakazawa, H, Oya, M, Kimura, G, Fujii, Y, Hatano, T, Kawata, N, Kume, H, Morita, M, Nakajima, K, Ohno, Y, Okegawa, T, Takahashi, S, Wakumoto, Y & Horie, S 2015, 'Clinical efficacy and prognostic factors of tumor progression in Japanese patients with advanced renal cell carcinoma treated with sorafenib', Japanese Journal of Clinical Oncology, vol. 45, no. 3, hyu200, pp. 274-280. https://doi.org/10.1093/jjco/hyu200
Kondo, Tsunenori ; Nakazawa, Hayakazu ; Oya, Mototsugu ; Kimura, Go ; Fujii, Yasuhisa ; Hatano, Takashi ; Kawata, Nozomu ; Kume, Haruki ; Morita, Masashi ; Nakajima, Koichi ; Ohno, Yoshio ; Okegawa, Takatsugu ; Takahashi, Shunji ; Wakumoto, Yoshiaki ; Horie, Shigeo. / Clinical efficacy and prognostic factors of tumor progression in Japanese patients with advanced renal cell carcinoma treated with sorafenib. In: Japanese Journal of Clinical Oncology. 2015 ; Vol. 45, No. 3. pp. 274-280.
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AU - Kondo, Tsunenori

AU - Nakazawa, Hayakazu

AU - Oya, Mototsugu

AU - Kimura, Go

AU - Fujii, Yasuhisa

AU - Hatano, Takashi

AU - Kawata, Nozomu

AU - Kume, Haruki

AU - Morita, Masashi

AU - Nakajima, Koichi

AU - Ohno, Yoshio

AU - Okegawa, Takatsugu

AU - Takahashi, Shunji

AU - Wakumoto, Yoshiaki

AU - Horie, Shigeo

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N2 - Objective: Result of clinical trial for registration purpose is often difficult to generalize because of its limited population in number and inclusion criteria. Methods: To understand the efficacy of sorafenib under daily medical practice, we retrospectively investigated therapeutic outcomes of 175 Japanese patients with advanced renal cell carcinoma treated with sorafenib at 15 centers. Results: The objective response rate and disease control rate were 15.4 and 77.1%, respectively, being similar to those in the Phase II study in Japanese patients (19.4 and 73.6 months). Any tumor shrinkage was observed with 53% of patients, while tumor control without growth was in 61%. Lung lesions were more sensitive to sorafenib than other lesions, in terms of any tumor shrinkage (54%) and the extent of maximal shrinkage, while tumor control was better in lymph node metastases (77%) than in lung (69%). Liver was worse in any tumor shrinkage (35%), tumor control (55%) and the extent of tumor growth. Slightly, shorter median overall survival of 21.1 months compared with Phase II clinical trial (25.3 months) is likely to be attributable to different patient population, because median overall survival was improved to 26.4 months when the population was matched to that in Phase II trial. Univariate and multivariate analyses identified prognostic factors for worse overall survival, including intermediate and poor Memorial Sloan-Kettering Cancer Center risk, Eastern Cooperative Oncology Group performance status ≥1, the presence of non-clear cell component and the presence of liver metastasis.Conclusions: In conclusion, the present study confirmed the efficacy of sorafenib in the real-world setting on advanced renal cell carcinoma.

AB - Objective: Result of clinical trial for registration purpose is often difficult to generalize because of its limited population in number and inclusion criteria. Methods: To understand the efficacy of sorafenib under daily medical practice, we retrospectively investigated therapeutic outcomes of 175 Japanese patients with advanced renal cell carcinoma treated with sorafenib at 15 centers. Results: The objective response rate and disease control rate were 15.4 and 77.1%, respectively, being similar to those in the Phase II study in Japanese patients (19.4 and 73.6 months). Any tumor shrinkage was observed with 53% of patients, while tumor control without growth was in 61%. Lung lesions were more sensitive to sorafenib than other lesions, in terms of any tumor shrinkage (54%) and the extent of maximal shrinkage, while tumor control was better in lymph node metastases (77%) than in lung (69%). Liver was worse in any tumor shrinkage (35%), tumor control (55%) and the extent of tumor growth. Slightly, shorter median overall survival of 21.1 months compared with Phase II clinical trial (25.3 months) is likely to be attributable to different patient population, because median overall survival was improved to 26.4 months when the population was matched to that in Phase II trial. Univariate and multivariate analyses identified prognostic factors for worse overall survival, including intermediate and poor Memorial Sloan-Kettering Cancer Center risk, Eastern Cooperative Oncology Group performance status ≥1, the presence of non-clear cell component and the presence of liver metastasis.Conclusions: In conclusion, the present study confirmed the efficacy of sorafenib in the real-world setting on advanced renal cell carcinoma.

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KW - Metastasis

KW - Neoplasm

KW - Prognosis

KW - Real-world practice

KW - Renal cell

KW - Sorafenib

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