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Background <p>Considering high frequency of recurrence and usage of poly (ADP-ribose) polymerase inhibitor (PARPi) maintenance, long-term usage of PARPi certainly has been a trend for relapsed ovarian cancer. However, the quality of life (QOL) and symptom control in these patients still remains to be clarified, especially after a long-term period of PARPi maintenance. Herein, we collected the patient-reported outcomes (PROs) in platinum-sensitive recurrent ovarian cancer (PSROC) receiving niraparib, a highly selective PARPi, as maintenance therapy after approximately 3 years.</p> Methods <p>This study enrolled 604 patients screened from 3154 PSROC all over the country. PROs data were collected at 1, 2 and 3 months after enrollment based on questionnaires, including the European QOL Scale five-dimension five-level (EQ-5D-5&#xa0;L), the European QOL-visual analogue scale (EQ-VAS) and the Functional Assessment of Cancer Therapy–Ovarian Symptoms Index (FOSI).</p> Results <p>The median period of niraparib maintenance was 34.8 months (range: 30.5–46.7 months) in 604 PSROC. Stage III-IV, BRCA mutation were found in 54.6% (<i>n</i> = 330) and 23.4% (<i>n</i> = 104) ( of patients before recurrence, respectively. For PROs data, QOL and symptom control remained stable and considerable throughout follow-up. The least square mean (LS mean) of EQ-5D-5L health utility index (HUI), EQ-VAS and FOSI were 0.974 (SE 0.001), 83.7 (SE 0.248) and 30.8 (SE 0.033), respectively. LS mean change of EQ-5D-5&#xa0;L HUI, EQ-VAS and FOSI from baseline to the final timepoint were − 0.004 (SE 0.001), -0.609 (SE 0.248) and − 0.359 (SE 0.033), respectively. Subgroup analysis indicated no significant difference in EQ-5D-5&#xa0;L HUI, EQ-VAS and FOSI scores between BRCA mutation group and BRCA wildtype group (<i>p</i> &gt; 0.05 at three timepoints), with PROs data similar to the whole 604 PSROC in both subgroups.</p> Conclusions <p>PRO-based surveillance showed satisfactory QOL and stable symptom control in PSROC after long-term period of niraparib maintenance, regardless of BRCA status. This real-world research highlights the significance of long-term usage of niraparib and PROs in PSROC management.</p>

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Patient-reported outcomes after long-term period of niraparib maintenance in platinum-sensitive recurrent ovarian cancer: a prospective, multicenter cohort study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月26日

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  • Ming Du,
  • Peng Peng,
  • Dongyan Cao,
  • Ninghai Cheng,
  • Liangqing Yao,
  • Yang Sun,
  • Jundong Li,
  • Hui Zhang,
  • Ge Lou,
  • Jie Tang,
  • Danbo Wang,
  • Yue Wang,
  • Guonan Zhang,
  • Yang Xiang

摘要

Background

Considering high frequency of recurrence and usage of poly (ADP-ribose) polymerase inhibitor (PARPi) maintenance, long-term usage of PARPi certainly has been a trend for relapsed ovarian cancer. However, the quality of life (QOL) and symptom control in these patients still remains to be clarified, especially after a long-term period of PARPi maintenance. Herein, we collected the patient-reported outcomes (PROs) in platinum-sensitive recurrent ovarian cancer (PSROC) receiving niraparib, a highly selective PARPi, as maintenance therapy after approximately 3 years.

Methods

This study enrolled 604 patients screened from 3154 PSROC all over the country. PROs data were collected at 1, 2 and 3 months after enrollment based on questionnaires, including the European QOL Scale five-dimension five-level (EQ-5D-5 L), the European QOL-visual analogue scale (EQ-VAS) and the Functional Assessment of Cancer Therapy–Ovarian Symptoms Index (FOSI).

Results

The median period of niraparib maintenance was 34.8 months (range: 30.5–46.7 months) in 604 PSROC. Stage III-IV, BRCA mutation were found in 54.6% (n = 330) and 23.4% (n = 104) ( of patients before recurrence, respectively. For PROs data, QOL and symptom control remained stable and considerable throughout follow-up. The least square mean (LS mean) of EQ-5D-5L health utility index (HUI), EQ-VAS and FOSI were 0.974 (SE 0.001), 83.7 (SE 0.248) and 30.8 (SE 0.033), respectively. LS mean change of EQ-5D-5 L HUI, EQ-VAS and FOSI from baseline to the final timepoint were − 0.004 (SE 0.001), -0.609 (SE 0.248) and − 0.359 (SE 0.033), respectively. Subgroup analysis indicated no significant difference in EQ-5D-5 L HUI, EQ-VAS and FOSI scores between BRCA mutation group and BRCA wildtype group (p > 0.05 at three timepoints), with PROs data similar to the whole 604 PSROC in both subgroups.

Conclusions

PRO-based surveillance showed satisfactory QOL and stable symptom control in PSROC after long-term period of niraparib maintenance, regardless of BRCA status. This real-world research highlights the significance of long-term usage of niraparib and PROs in PSROC management.