851P - A phase IV multicenter study of the efficacy and safety of sunitinib as first-line therapy in Chinese patients with metastatic renal cell carcinoma...

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anti-Cancer Agents & Biologic Therapy
Renal Cell Cancer
Presenter Shukui Qin
Authors S.K. Qin1, J. Jin2, J. Guo3, J. Wang4, F. Zhou5, Y. Huang6, X. Ren7, D. Ye8, Q. Wang9, S. Pan10
  • 1Nanjing Bayi Hospital, 210002 - Nanjing/CN
  • 2Urology, Peking University First Hospital, 100034 - Beijing/CN
  • 3Department Of Renal Cancer And Melanoma, Peking University Cancer Hospital and Institute, 100142 - Beijing/CN
  • 4Chinese Academy Of Medical Sciences And Peking Union Medical College, Cancer Hospital/Institute, 100021 - Beijing/CN
  • 5Cancer Center, Sun Yat-sen University, 510060 - Guangzhou/CN
  • 6Urology, Shanghai Renji Hospital, 200127 - Shanghai/CN
  • 7Biotherapy, Tianjin Medical University Cancer Institute and Hospital, 300060 - Tianjin/CN
  • 8Urology, Fudan University Shanghai Cancer Center, 200032 - Shanghai/CN
  • 9Global Research And Development, Pfizer, 200041 - Shanghai/CN
  • 10Clinical Statistics, Pfizer, 10017 - New York/US

Abstract

Background

Based on the effectiveness and safety profile established in two single-arm phase II trials and a pivotal phase III trial versus interferon-alfa, sunitinib is approved worldwide for advanced RCC. Here we report a single-arm, open-label phase IV study to assess use of sunitinib as first-line therapy in Chinese patients with mRCC.

Methods

Treatment-naïve patients aged ≥18 yr with ECOG performance status 0/1 and histologically confirmed mRCC received oral sunitinib 50 mg/d on the approved 4-wk-on-2-wk-off schedule. Treatment continued until disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was progression-free survival (PFS). Tumor measurements were performed at screening, regular intervals, suspected disease progression, to confirm response, and end of treatment/withdrawal. Safety was assessed regularly using NCI CTCAE version 3.0.

Results

105 patients received treatment. Mean age was 54.6 yr, 75% were male, and mean BMI was 23.9 kg/m2. The most common site of baseline metastases was the lungs (76%). Median (range) number of treatment cycles completed was 8 (0–27). All patients discontinued treatment; reasons included disease progression/relapse (63%) and treatment-related AEs (8%). In 105 treated patients, median PFS was 61.7 wk (14.2 mo; 95% CI: 45.1–106.3 wk) and median overall survival (OS) was 133.4 wk (30.7 mo; lower bound of 95% CI: 94.1 wk). In 103 evaluable patients, objective response rate (ORR) was 31.1% (95% CI: 22.3–40.9%). Most treatment-emergent AEs were grade 1/2 severity and the most common were hand-foot syndrome (64%), decreased white blood cell count (52%), fatigue (51%), decreased platelet count (51%), diarrhea (49%), and decreased appetite (43%). There were no occurrences of treatment-emergent congestive heart failure, left ventricular dysfunction, or cardiomyopathy.

Conclusions

With median PFS of 61.7 wk (14.2 mo) and OS of 133.4 wk (30.7 mo), these results compare favorably with those of the phase III trial, while ORR of 31.1% is comparable. The AE profile is acceptable and generally similar to that in other single-agent sunitinib studies and/or in patients with advanced RCC.

Disclosure

Q. Wang: Employed by Pfizer Inc. as a clinician.

S. Pan: Employed by Pfizer Inc. as a Director of Clinical Statistics and holds Pfizer stock.

All other authors have declared no conflicts of interest.