Quality of Life and Adverse Events: Prognostic Relationships in Long-Term Ovarian Cancer Survival.

BACKGROUND There is a critical need to identify patient characteristics associated with long-term ovarian cancer survival. METHODS Quality of life (QOL), measured by the Functional Assessment of Cancer Therapy-Ovarian-Trial Outcome Index (FACT-O-TOI), including physical, functional and ovarian-specific subscales, was compared between long-term (LTS) (8+ years) and short-term (STS) (<5 years) survivors of GOG 218 at baseline, before cycles 4, 7, 13, 21, and 6 months post-treatment using linear and longitudinal mixed models adjusted for covariates. Adverse events (AEs) were compared between survivor groups at each assessment using generalized linear models. All p-values are two-sided. RESULTS QOL differed statistically significantly between STS (N = 1115) and LTS (N = 260) (p < .001). Baseline FACT-O-TOI and FACT-O-TOI change were independently associated with long-term survival (OR = 1.05, 95% CI = 1.03-1.06 and OR = 1.06, 95% CI = 1.05-1.07, respectively). A 7-point increase in baseline QOL was associated with a 38.0% increase in probability of LTS, while a 9-point increase in QOL change was associated with a 67.0% increase in odds for LTS. QOL decreased statistically significantly with increasing AE quartiles (cycle 4 quartiles: 0-5 v. 6-8 v. 9-11 v. ≥12 AEs, p = .01; cycle 21 quartiles: 0-2 v. 3 v. 4-5 v. ≥6 AEs, p = .001). Further, LTS reported statistically significantly better QOL compared to STS (p = .03 and p = .01, cycles 4 and 21, respectively), with similar findings across higher AE grades. CONCLUSION Baseline and longitudinal QOL change scores distinguished long versus short-term survivors and are robust prognosticators for long term survival. Results have trial design and supportive care implications, providing meaningful prognostic value in this understudied population.

[1]  Zahra S. Razaee,et al.  Evaluating Treatment Tolerability in Cancer Clinical Trials Using the Toxicity Index , 2020, Journal of the National Cancer Institute.

[2]  Versione,et al.  Common Terminology Criteria for Adverse Events , 2020, Definitions.

[3]  Danielle M. Enserro,et al.  Final Overall Survival of a Randomized Trial of Bevacizumab for Primary Treatment of Ovarian Cancer. , 2019, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[4]  A. du Bois,et al.  Patient-reported outcomes in ovarian cancer: are they key factors for decision making? , 2018, Expert review of anticancer therapy.

[5]  V. Gebski,et al.  Health-related quality of life and patient-centred outcomes with olaparib maintenance after chemotherapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT Ov-21): a placebo-controlled, phase 3 randomised trial. , 2018, The Lancet. Oncology.

[6]  L. Minasian,et al.  Disparities in health-related quality of life in women undergoing treatment for advanced ovarian cancer: the role of individual-level and contextual social determinants , 2018, Supportive Care in Cancer.

[7]  Corneel Coens,et al.  Quality of life as a prognostic indicator of survival: A pooled analysis of individual patient data from canadian cancer trials group clinical trials , 2018, Cancer.

[8]  A. Abernethy,et al.  Quality of life is significantly associated with survival in women with advanced epithelial ovarian cancer: An ancillary data analysis of the NRG Oncology/Gynecologic Oncology Group (GOG-0218) study. , 2017, Gynecologic oncology.

[9]  M. Socinski,et al.  Feasibility Assessment of Patient Reporting of Symptomatic Adverse Events in Multicenter Cancer Clinical Trials , 2017, JAMA oncology.

[10]  M. Stockler,et al.  Quality of life predicts overall survival in women with platinum-resistant ovarian cancer: an AURELIA substudy , 2017, Annals of oncology : official journal of the European Society for Medical Oncology.

[11]  K. Baggerly,et al.  Quality of life among long-term survivors of advanced stage ovarian cancer: A cross-sectional approach. , 2017, Gynecologic oncology.

[12]  C. Fuchs,et al.  Associations of quality of life (QoL) with adverse events and tumor response in patients with advanced gastric cancer: Exploratory analyses from RAINBOW and REGARD. , 2017, Annals of oncology : official journal of the European Society for Medical Oncology.

[13]  E. Kohn,et al.  The generalizability of NCI-sponsored clinical trials accrual among women with gynecologic malignancies. , 2016, Gynecologic oncology.

[14]  Deborah Schrag,et al.  Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. , 2016, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[15]  E. Bandera,et al.  Racial/Ethnic Disparities in Ovarian Cancer Treatment and Survival , 2016, Clinical Cancer Research.

[16]  J. Temel,et al.  A Systematic Review of Adherence to Oral Antineoplastic Therapies. , 2016, The oncologist.

[17]  Martha Donoghue,et al.  Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms , 2016, Clinical Cancer Research.

[18]  C. Gotay Fatigue and mortality: from description to action. , 2015, The Lancet. Oncology.

[19]  R. Cress,et al.  Characteristics of Long-Term Survivors of Epithelial Ovarian Cancer , 2015, Obstetrics and gynecology.

[20]  M. Clark,et al.  Improving Adherence to Cancer Treatment by Addressing Quality of Life in Patients With Advanced Gastrointestinal Cancers. , 2015, Journal of pain and symptom management.

[21]  A. Ziogas,et al.  Spatial analysis of adherence to treatment guidelines for advanced-stage ovarian cancer and the impact of race and socioeconomic status. , 2014, Gynecologic oncology.

[22]  M. Taphoorn,et al.  Does change in health-related quality of life score predict survival? Analysis of EORTC 08975 lung cancer trial , 2014, British Journal of Cancer.

[23]  D. Osoba,et al.  A global analysis of multitrial data investigating quality of life and symptoms as prognostic factors for survival in different tumor sites , 2014, Cancer.

[24]  B. Monk,et al.  Patient reported outcomes of a randomized, placebo-controlled trial of bevacizumab in the front-line treatment of ovarian cancer: a Gynecologic Oncology Group Study. , 2013, Gynecologic oncology.

[25]  F. Penedo,et al.  Social influences on clinical outcomes of patients with ovarian cancer. , 2012, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[26]  K. Gil,et al.  The association between quality of life domains and overall survival in ovarian cancer patients during adjuvant chemotherapy: a Gynecologic Oncology Group Study. , 2012, Gynecologic oncology.

[27]  P. Marchetti,et al.  Treatment-related side effects and quality of life in cancer patients , 2012, Supportive Care in Cancer.

[28]  B. Monk,et al.  Incorporation of bevacizumab in the primary treatment of ovarian cancer. , 2011, The New England journal of medicine.

[29]  E. Petru,et al.  Prospective assessment of quality of life in long‐term ovarian cancer survivors , 2011, International journal of cancer.

[30]  D. Cella,et al.  Minimally important differences were estimated for six Patient-Reported Outcomes Measurement Information System-Cancer scales in advanced-stage cancer patients. , 2011, Journal of clinical epidemiology.

[31]  S. Kaasa,et al.  Health care providers underestimate symptom intensities of cancer patients: A multicenter European study , 2010, Health and quality of life outcomes.

[32]  Alexia Iasonos,et al.  Adverse symptom event reporting by patients vs clinicians: relationships with clinical outcomes. , 2009, Journal of the National Cancer Institute.

[33]  Murielle Mauer,et al.  Baseline quality of life as a prognostic indicator of survival: a meta-analysis of individual patient data from EORTC clinical trials. , 2009, The Lancet. Oncology.

[34]  D. Cella,et al.  Validation of FACT/GOG-AD subscale for ovarian cancer-related abdominal discomfort: a Gynecologic Oncology Group study. , 2008, Gynecologic oncology.

[35]  C. Gotay,et al.  The prognostic significance of patient-reported outcomes in cancer clinical trials. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[36]  M. Kris,et al.  Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. , 2006, The Lancet. Oncology.

[37]  B. Monk,et al.  Quality-of-life comparisons in a randomized trial of interval secondary cytoreduction in advanced ovarian carcinoma: a Gynecologic Oncology Group study. , 2005, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[38]  G. Norman,et al.  Interpretation of Changes in Health-related Quality of Life: The Remarkable Universality of Half a Standard Deviation , 2003, Medical care.

[39]  D. Cella,et al.  Reliability and validity of the functional assessment of cancer therapy-ovarian. , 2001, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[40]  M. van der Aa,et al.  No improvement in long-term survival for epithelial ovarian cancer patients: A population-based study between 1989 and 2014 in the Netherlands. , 2018, European journal of cancer.

[41]  M. Carey,et al.  The prognostic effects of performance status and quality of life scores on progression-free survival and overall survival in advanced ovarian cancer. , 2008, Gynecologic oncology.

[42]  J. Beaumont,et al.  Measuring health-related quality of life and neutropenia-specific concerns among older adults undergoing chemotherapy: validation of the Functional Assessment of Cancer Therapy–Neutropenia (FACT-N) , 2007, Supportive Care in Cancer.

[43]  D. Osoba,et al.  Quality of life scores: An independent prognostic variable in a general population of cancer patients receiving chemotherapy , 2004, Quality of Life Research.

[44]  R. Hays,et al.  Estimating clinically significant differences in quality of life outcomes , 2004, Quality of Life Research.