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. 2022 Jun 28:42:101035.
doi: 10.1016/j.gore.2022.101035. eCollection 2022 Aug.

The progression-free survival ratio as outcome measure in recurrent ovarian carcinoma patients: Current and future perspectives

Nienke van de Kruis  1 , Phyllis van der Ploeg  1   2 , Jody H C Wilting  1 , M Caroline Vos  3 , Anna M J Thijs  4 , Joanne de Hullu  5 , Petronella B Ottevanger  6 , Christianne Lok  7 , Jurgen M J Piek  1
Affiliations

The progression-free survival ratio as outcome measure in recurrent ovarian carcinoma patients: Current and future perspectives

Nienke van de Kruis et al. Gynecol Oncol Rep. .

Abstract

Objective: Clinical efficacy of cytostatic anticancer agents can be determined with the progression-free survival (PFS) ratio. This outcome measure compares PFS achieved by a new treatment (PFS2) to the PFS of the most recent treatment on which the patient has experienced progression (PFS1). Clinical benefit has been defined as a PFS-ratio (PFS2/PFS1) > 1.3. However, in order to demonstrate significant benefit, trial designs require an assumption on the proportion of patients who reach this ratio during palliative options. For ovarian carcinoma, data is lacking to support this assumption. Therefore in this study, we assess the PFS-ratio in recurrent ovarian carcinoma patients treated with current palliative options.

Methods: We included 67 patients with recurrent high-grade serous (HGSC, 73.1%) or low-grade (LGOC, 26.9%) ovarian carcinoma. We determined the median PFS-ratio and investigated the association with clinicopathological characteristics.

Results: Overall, we observed a median PFS-ratio of 0.69. The proportion of patients with a PFS-ratio > 1.3 was 22.4%. For HGSC patients, the median PFS-ratio was significantly lower than for LGOC patients (respectively, 0.58 and 1.26, p = 0.007). Multivariate logistic regression analysis revealed that the LGOC subtype and CA125 tumor marker concentration were independent factors related to a PFS-ratio > 1.3.

Conclusions: Although the PFS-ratio represents a meaningful outcome measure in studies investigating cytostatic anticancer agents, we conclude that it is influenced by tumor histology and biological behavior. In future research, these factors should be taken into account when determining thresholds for clinical benefit in trial designs.

Keywords: Growth-modulation index; Ovarian cancer; Ovarian carcinoma; Progression-free survival ratio; Time to progression ratio.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Distribution of the progression-free survival (PFS) times in recurrent ovarian carcinoma patients.
Fig. 2
Fig. 2
Comparison of the progression-free survival (PFS) times of the included patients displayed per histological subtype. The patients on the right of the blue line reached a PFS-ratio > 1.3. *LGOC = low-grade ovarian carcinoma; **HGSC = high-grade serous ovarian carcinoma.
See this image and copyright information in PMC

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