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14 Phase II trial evaluating efficacy and safety of standard of care with or without bevacizumab in platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
  1. N Nishikawa1,
  2. T Shoji2,
  3. T Enomoto1,
  4. M Abe3,
  5. A Okamoto4,
  6. T Saito5,
  7. T Oishi6,
  8. S Nagase7,
  9. M Mori8,
  10. Y Inokuchi9,
  11. SK Kamiura10 and
  12. T Sugiyama11
  1. 1Niigata University, Japan
  2. 2Iwate Medical University School of Medicine, Japan
  3. 3Shizuoka Cancer Center, Japan
  4. 4The Jikei University School of Medicine, Japan
  5. 5Hachinohe Red Cross Hospital, Japan
  6. 6Tottori University School of Medicine, Japan
  7. 7Yamagata University, Japan
  8. 8Aichi Cancer Center Hospital, Japan
  9. 9Kitasato University Hospital, Japan
  10. 10Osaka International Cancer Institute, Japan
  11. 11St. Mary’s Hospital, Japan


Introduction There are no ongoing clinical trials investigating bevacizumab efficacy beyond disease progression in platinum-resistant recurrent ovarian cancer; however, improving outcomes in these patients is a critical unmet need.

Methods This open-label, randomized phase II trial (JGOG3023; UMIN000017247) enrolled patients aged ≥20 years with histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with platinum-resistant disease (progression occurring ≤6 months from completing ≥3 platinum cycles, including bevacizumab). Patients were randomized 1:1 to single-agent chemotherapy (group A) or single-agent chemotherapy combined with bevacizumab (group B). The primary endpoint was investigator-assessed PFS. Secondary endpoints included OS, ORR, and safety.

Abstract 14 Table 1

Summary of grade ≥3 adverse events with a causal relationship with treatment occurring in ≥3% of patients

Abstract 14 Figure 1

PFS by investigator assessment (ITT population)

Abstract 14 Figure 2

Forest plot of PFS by subgroup (ITT population)

Results Patient characteristics were balanced between group A (n=51) and group B (n=52). Median PFS was longer in group B versus group A (4.0 [95% CI: 3.0–5.7] vs 3.1 [2.5–4.6] months; HR, 0.54 [0.32–0.90]; one-sided p=0.0082) (figure 1). Maximum tumor diameter and ascites were significantly associated with greater prolongation in PFS in group B (figure 2). Median OS was numerically longer in group B versus group A (15.3 vs 11.3 months; HR, 0.67 [0.38–1.17]; two-sided p=0.1556). ORR was 13.7% and 25.0% in group A and B, respectively. The safety profile was similar across both groups (table 1).

Conclusion These results suggest chemotherapy combined with bevacizumab has efficacy beyond disease progression. A phase III trial is warranted to confirm our findings.

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