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

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.

The role of positive psychological changes in anxiety and depression of patients with ovarian tumors and their partners: an observational study from the population-based PROFILES registry.

PURPOSE: It is unknown whether positive psychological changes (e.g., in life perspective, self-perception, and social relationships) after being diagnosed with ovarian cancer can reduce anxiety and depression in patients and their partners. The first aim of the present study was to assess differences in anxiety and depression between patients diagnosed with an ovarian tumor and their partners. The second aim was to explore the mutual associations of patients' and partners' posttraumatic growth and their anxiety and depressive symptoms. METHODS: Participants included 130 Dutch couples of which one partner was diagnosed with a borderline ovarian tumor or ovarian cancer between 2000 and 2010, as registered by the Netherlands Cancer Registry. In September 2011, a questionnaire was sent including the Hospital Anxiety and Depression Scale (anxiety and depression) and Cancer Survivors (Partners) Unmet Needs measure (positive psychological changes). RESULTS: A one-way multivariate analysis of variance showed that patients reported higher anxiety than partners, without differences in depression. Contrasting to our expectations, an actor-partner interdependence model revealed no mutual dyadic associations between positive psychological changes and anxiety or depressive symptoms. CONCLUSIONS: Based on these findings, positive psychological change seems to be an independent construct unrelated to anxiety or depression in couples diagnosed with ovarian tumors. Still, as ovarian tumor patients and partners suffer from high anxiety and depression, further research investigating how these feelings can be reduced in couples dealing with an ovarian tumor is necessary.

The impact of the survivorship care plan on health care use: 2-year follow-up results of the ROGY care trial.

PURPOSE: The purpose of this paper was to assess the impact of survivorship care plan (SCP) provision and moderating factors on health care use following endometrial cancer treatment. METHODS: Women newly diagnosed with endometrial cancer were included in a pragmatic cluster randomized trial at 12 hospitals in the Netherlands and were randomly assigned to SCP or usual care (n = 221; 75% response). The SCP was generated using the web-based Registrationsystem Oncological GYnecology (ROGY) and provided tailored information regarding disease, treatment, and possible late-effects. Cancer-related use of general practitioner, specialist, and additional health care was collected through questionnaires after diagnosis and at 6-, 12-, and 24-month follow-up and compared using linear multilevel regression analyses. RESULTS: Women who received an SCP had more cancer-related primary care visits compared to the usual care arm during the first year after diagnosis (ß = 0.7, p < 0.01). At 6-month follow-up, women in the SCP group used more additional health care compared to women receiving usual care (24 vs. 11%, p = 0.04). Women with anxious symptoms (p = 0.03) and women who received radiotherapy (p = 0.01) had a higher primary care use within the first year after treatment, when receiving an SCP. CONCLUSIONS: The SCP increases primary health care consumption the first year after treatment, particularly in women treated with radiotherapy and women with anxious symptoms. IMPLICATIONS FOR CANCER SURVIVORS: These findings imply that the SCP enables women in need of supportive care to seek relevant care at an early stage after treatment. Whether this results in improved patient-reported outcomes in the long-term needs to be further studied.

Effects of Survivorship Care Plans on patient reported outcomes in ovarian cancer during 2-year follow-up - The ROGY care trial.

OBJECTIVE: The aim of this study was to assess the long-term impact of an automatically generated Survivorship Care Plan (SCP) on patient reported outcomes in ovarian cancer in routine clinical practice. Outcome measures included satisfaction with information provision and care, illness perceptions and health care utilization. METHODS: In this pragmatic cluster randomized trial, twelve hospitals in the South of the Netherlands were randomized to 'SCP care' or 'usual care'. All newly diagnosed ovarian cancer patients in the 'SCP care' arm received an SCP that was automatically generated by the oncology provider, by clicking a button in the web-based Registrationsystem Oncological GYnecology (ROGY). Ovarian cancer patients (N=174, mean age 63.3, SD=11.4; all stages) completed questionnaires directly after initial treatment and after 6, 12 and 24months. RESULTS: First questionnaires were returned from 61 (67%) ovarian cancer patients in the 'SCP care' arm and 113 (72%) patients in the 'usual care' arm. In the 'SCP care' arm, 66% (N=41) of the patients reported receipt of an SCP. No overall differences were observed between the trial arms on satisfaction with information provision, satisfaction with care or health care utilization. Regarding illness perceptions, patients in the 'SCP care' arm had lower beliefs that the treatment would help to cure their disease (overall, 6.7 vs. 7.5, P<0.01). CONCLUSIONS: SCPs did not increase satisfaction with information provision or care in ovarian cancer patients. Our trial results suggest that ovarian cancer patients may not benefit from an SCP. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01185626.