Overall survival and updated results from a phase II study of sunitinib in Japanese patients with metastatic renal cell carcinoma.

Abstract

BACKGROUND:

In a phase II, open-label, multicentre Japanese study, sunitinib demonstrated antitumour activity and acceptable tolerability in metastatic renal cell carcinoma patients. Final survival analyses and updated results are reported.

METHODS:

Fifty-one Japanese patients with a clear-cell component of metastatic renal cell carcinoma (25 treatment-naïve; 26 cytokine-refractory) received sunitinib 50 mg orally, once daily (Schedule 4/2). Overall and progression-free survivals were estimated by the Kaplan-Meier method. Objective response rate (per Response Evaluation Criteria in Solid Tumours) and safety were assessed with an updated follow-up.

RESULTS:

First-line and pretreated patients received a median 6.0 and 9.5 treatment cycles, respectively. Investigator-assessed, end-of-study objective response rate was 52.0, 53.8 and 52.9% in first-line, pretreated and overall intent-to-treat populations, respectively. The median progression-free survival was 12.2 and 10.6 months in first-line and pretreated patients, respectively. Fourteen patients per group died (56 and 54%), and the median overall survival was 33.1 and 32.5 months, respectively. The most common treatment-related Grade 3 or 4 adverse events and laboratory abnormalities were fatigue (24%), hand-foot syndrome (18%), decreased platelet count (55%), decreased neutrophil count (53%) and increased lipase (49%). No Grade 5 treatment-related adverse events occurred. Forty patients (78%) required dose reduction, and 13 (25%) discontinued, due to treatment-related adverse events.

CONCLUSIONS:

With the median overall survival benefit exceeding 2.5 years, and acceptable tolerability, in first-line and pretreated Japanese metastatic renal cell carcinoma patients with Eastern Cooperative Oncology Group performance status 0/1, sunitinib showed a favourable risk/benefit profile, similar to Western studies. However, there was a trend towards greater efficacy and more haematological adverse events in Japanese patients.

• Authors: Yoshihiko Tomita, Nobuo Shinohara, Takeshi Yuasa, Hiroyuki Fujimoto, Masashi Niwakawa, Soichi Mugiya, Tsuneharu Miki, Hirotsugu Uemura, Norio Nonomura, Masayuki Takahashi, Yoshihiro Hasegawa, Naoki Agata, Brett Houk, Seiji Naito, Hideyuki Akaza
• Journal: Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 40 Issue 12 Pg. 1166-72 (Dec 2010) ISSN: 1465-3621 [Electronic] England
• PMID: 20713418 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Angiogenesis Inhibitors
• Indoles
• Pyrroles
• Sunitinib

Topics

• Adult
• Aged
• Angiogenesis Inhibitors (administration & dosage, adverse effects, therapeutic use)
• Asian People (statistics & numerical data)
• Carcinoma, Renal Cell (drug therapy, mortality, secondary)
• Disease-Free Survival
• Drug Administration Schedule
• Female
• Humans
• Indoles (administration & dosage, adverse effects, therapeutic use)
• Japan (epidemiology)
• Kaplan-Meier Estimate
• Kidney Neoplasms (drug therapy, mortality, pathology)
• Male
• Middle Aged
• Pyrroles (administration & dosage, adverse effects, therapeutic use)
• Sunitinib
• Treatment Outcome