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Ovarian Cancer
Pazopanib Maintenance Therapy in East Asian Women With Advanced Epithelial Ovarian Cancer: Results From AGO-OVAR16 and an East Asian Study
  1. Jae-Weon Kim, MD, PhD*,
  2. Sven Mahner, MD†,
  3. Ling-Ying Wu, MD‡,
  4. Tadahiro Shoji, MD, PhD§,
  5. Byoung-Gie Kim, MD, PhD∥,
  6. Jian-Qing Zhu, RN,
  7. Tadao Takano, MD, PhD#,
  8. Sang-Yoon Park, MD, PhD**,
  9. Bei-Hua Kong, MD, PhD†,‡,
  10. Qiang Wu, MD, PhD†,‡,
  11. Kung-Liahng Wang, MD§§,
  12. Hextan YS Ngan, MD∥∥,
  13. Ji-Hong Liu, MD, PhD¶¶,
  14. Li-Hui Wei, MD##,
  15. Ionel Mitrica, PhD***,
  16. Pingkuan Zhang, MSc†††,
  17. Rocco Crescenzo, DO†††,
  18. Qiong Wang, PhD†††,
  19. Charles J. Cox, PhD‡‡‡,
  20. Philipp Harter, MD§,§§ and
  21. Andreas du Bois, MD, PhD§,§§
  1. * KGOG and Seoul National University, Seoul, Korea;
  2. † AGO Germany and University Medical, Center Hamburg-Eppendorf, Hamburg, Germany;
  3. ‡ Cancer Hospital, CAMS & PUMC, Beijing, China;
  4. § JGOG and Iwate Medical University School of Medicine, Morioka, Japan;
  5. ∥ KGOG and Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea;
  6. Zhejiang Cancer Hospital, Hangzhou, China;
  7. # JGOG and Tohoku University, Sendai, Japan;
  8. ** KGOG and National Cancer Center, Goyang, Korea;
  9. †† Qilu Hospital, Shandong University, Shandong, China; and
  10. ‡‡ Jiangsu Cancer Hospital, Nanjing, China;
  11. §§ Mackay Memorial Hospital, Taipei, Taiwan;
  12. ∥∥ The University of Hong Kong, Hong Kong, China;
  13. ¶¶ Sun Yat-Sen University Cancer Center, Guangzhou, China; and
  14. ## Peking University People’s Hospital, Beijing, China;
  15. *** GlaxoSmithKline, Collegeville, PA;
  16. ††† Novartis Pharmaceuticals Corporation, East Hanover, NJ;
  17. ‡‡‡ GlaxoSmithKline, Stevenage, England; and §§§AGO Germany and Kliniken Essen Mitte, Essen, Germany.
  1. Address correspondence and reprint requests to Jae-Weon Kim, MD, PhD, Department of Obstetrics and Gynecology, Seoul National University, Seoul, Korea. E-mail: kjwksh{at}snu.ac.kr.

Abstract

Objective The recent phase 3 trial AGO-OVAR16 demonstrated that pazopanib maintenance improved median progression-free survival in patients with ovarian cancer whose disease did not progress during first-line treatment. However, this improvement was not seen in the subset of East Asian patients. The current analysis evaluated the efficacy and safety of pazopanib maintenance in East Asian patients from AGO-OVAR16 and a separate East Asian study.

Materials and Methods East Asian patients from AGO-OVAR16 (n = 209) and the East Asian study (N = 145) were randomized 1:1 to receive pazopanib 800 mg/d or placebo for up to 24 months. The primary end point for each study was progression-free survival by RECIST (Response Evaluation Criteria in Solid Tumors) based on investigator assessment. Clinical and genetics data were analyzed separately by study or pooled according to separate predetermined statistical plans.

Results Pazopanib maintenance had a detrimental effect on median progression-free survival versus placebo in East Asian patients from the combined studies (n = 354; 17.9 vs 21.5 months; hazard ratio, 1.114; 95% confidence interval, 0.818–1.518; P = 0.4928). Pazopanib maintenance showed a disadvantage in overall survival in East Asian patients from AGO-OVAR16 versus placebo (hazard ratio, 1.706; 95% confidence interval, 1.010–2.883; P = 0.0465); overall survival analysis was not performed in the East Asian study because of insufficient event numbers. Pazopanib-treated patients had a significantly higher incidence of grade 3 or higher hypertension (27%) and neutropenia (13%) versus placebo.

Conclusions The treatment effect of maintenance pazopanib in East Asian patients seemed to differ from that in non-Asian patients. In study-specific and pooled analyses, none of the potential factors analyzed could satisfactorily explain the different efficacy results of pazopanib in East Asian patients.

  • Ovarian cancer
  • Asian women
  • Pazopanib
  • Maintenance therapy
  • Progression-free survival

https://doi.org/10.1097/IGC.0000000000000602

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