AT THE 2016 ASCO ANNUAL MEETING

CHICAGO (FRONTLINE MEDICAL NEWS) – Physical function, role function, global health status and abdominal/gastrointestinal symptoms (AGIS) each predicted overall survival and were significantly associated with the early cessation of chemotherapy among women with platinum-resistant/refractory recurrent ovarian cancer in the Gynecologic Cancer InterGroup (GCIG) Symptom Benefit Study.

The findings from the international prospective cohort study suggest that baseline assessment of quality of life could help identify patients with platinum-resistant/refractory recurrent ovarian cancer (PRR-ROC) who are unlikely to benefit from palliative chemotherapy, Dr. Felicia Roncolato reported at the annual meeting of the American Society of Clinical Oncology.

In 570 women with PRR-ROC enrolled in the Symptom Benefit Study, median overall survival was 11.1 months and median progression-free survival was 3.6 months.

Factors shown on multivariable analysis to predict overall survival included hemoglobin (hazard ratio, 0.94 per 10 g/L increase), ascites (HR, 1.60), AGIS (HR, 1.24), platelets (HR, 1.10 per 100 x 109 unit increase), Log CA125 (HR, 1.18 per unit increase), and neutrophil:lymphocyte ratio (HR, 1.79 for 5 or more). These were all statistically significant predictors of overall survival, said Dr. Roncolato of St. George Hospital, Sydney.

As for baseline quality of life data as a predictor of overall survival, the hazard ratios were 1.60 for low physical function, 1.54 for low role function, 1.55 for global health status, 2.37 for worst vs. least AGIS, and 1.75 for intermediate vs. least AGIS. After adjusting for all of these clinical factors, the multivariable analysis showed that low physical function, role function, and global health status, and worst AGIS remained statistically significant predictors of overall survival (HR, 1,45, 1.37, 1.34, 1.49, and 1.49, respectively). Median overall survival was 7 vs. 12 months in those with lower vs. higher physical function, role function, and global health status, 9 months vs. 14 months for those with lower vs. higher role function scores, and 8, 11, and 18 months in those with worst, intermediate, and least AGIS.

A sensitivity analysis supported the validity of the cut-points used for each of these scores, Dr. Roncolato noted.

As for early cessation of chemotherapy, 110 of the 570 women (19%) stopped chemotherapy within 8 weeks. Most (46%) stopped due to disease progression; other reasons for early cessation included death (18%), patient preference (12%), “other” (12%), adverse event (7%), and clinician preference (6%).

In these women, median progression-free survival and median overall survival were 1.3 months and 2.9 months, respectively, Dr. Roncolato said.

On univariable analysis, the same four quality of life domains (physical function, role function, global health status, and AGIS) each were significantly associated with overall survival (odds ratios were 2.45 for low physical function, 2.71 for low role function, 2.38 for global health status, 2.31 for worst vs. least AGIS, and 1.17 for intermediate vs. least AGIS).

Most patients with ovarian cancer have advanced stage disease at diagnosis and develop recurrent disease despite initial response, and most ultimately develop platinum resistant/refractory disease, Dr. Roncolato said.

The goals of treatment are to improve length and quality of life, but response rates are low; median progression-free survival is 3 months, and median overall survival is less than 12 months, she noted.

“To date there is no evidence that chemotherapy actually increases overall survival in the resistant/refractory setting, and one of our biggest challenges is identifying the patients who are most and least likely to benefit,” she said, adding that over the last decade, little has changed in terms of chemotherapy outcomes remaining poor in patients with PRR-ROC (median overall survival of about 45% at 12 months).

A substantial number of patients stop treatment early.

The Symptom Benefit Study was designed based on a recommendation of the 3rd GCIG Ovarian Cancer Consensus meeting, which called for more robust and reliable methods to quantify symptom improvement in patients with platinum-resistant/refractory ovarian cancer. The primary aim of the study was to develop criteria for quantifying symptom benefit for clinical trials in such patients. The initial portion of the study was known as MOST (Measure of Ovarian Cancer Symptoms and Treatment Concerns). The aim of the current portion of the study was to identify baseline characteristics associated with early cessation of chemotherapy and with poor overall survival.

Patients included in the study were women with PRR-ROC and patients receiving a third or subsequent line of treatment. All had a life expectancy of more than 3 months, and had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3.

Quality of life measures, including EORTC QLQ-C30 , QLQ-OV28, and others were performed at baseline and before each cycle of chemotherapy.

“The health-related quality of life scores identified a subset of women with resistant/refractory disease who have a very poor prognosis. It’s more informative than a clinician-assigned ECOG performance status, and including baseline health-related quality of life together with clinical prognostic factors improved the prediction of survival in women with PRR-ROC,” Dr. Roncolato said, adding that having this additional prognostic information could improve stratification in clinical trials, patient-doctor communication about prognosis, and clinical decision-making.

This study was funded by the Australian National Health and Medical Research Council. Dr. Roncolato reported having no disclosures.

sworcester@frontlinemedcom.com

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