Quality of life outcomes from a randomized phase III trial of cisplatin with or without topotecan in advanced carcinoma of the cervix: a Gynecologic Oncology Group Study

Department of Psychiatry and Behavioral Sciences , Northwestern University, Evanston, Illinois, United States
Journal of Clinical Oncology (Impact Factor: 18.43). 07/2005; 23(21):4617-25. DOI: 10.1200/JCO.2005.10.522
Source: PubMed


To prospectively assess the impact of treatment with cisplatin alone or in combination with topotecan (CT) on quality of life (QOL) in patients with advanced or recurrent cervical cancer, and to explore the prognostic value of baseline QOL scores.
Patients entered on Gynecologic Oncology Group (GOG) Protocol 179 were expected to complete QOL assessments at four time points using Functional Assessment of Cancer Therapy-General (FACT-G), Cervix subscale (Cx subscale), FACT/GOG-Neurotoxicity subscale (NTX subscale), Brief Pain Inventory (BPI), and UNISCALE (UNI). Adjusting for patient age, baseline scores, and effects of time, we longitudinally examined treatment effect on QOL during and after chemotherapy.
Among patients randomly allocated to receive cisplatin (n = 146) or CT (n = 147), there were no statistically significant differences in QOL up to 9 months after randomization despite more hematologic toxicity in the combination arm. QOL assessments were completed at rates of 98%, 85%, 68%, and 59%, respectively, for the four time points, with similar rates and reasons for nonparticipation between regimens. Baseline FACT-G (P = .0016) and BPI (P = .0001) scores were significantly associated with patient age; older patients had better QOL and less pain. Baseline UNI was positively correlated with FACT-G (r = 0.66; P < .001) and Cx subscale (r = 0.29; P < .001), and negatively related to BPI (r = -0.41; P < .0001). Baseline FACT-Cx (FACT-G + Cx subscale) was associated with survival.
Despite increased toxicity, CT did not significantly reduce patient QOL when compared with cisplatin alone. Patient-reported QOL measures may be an important prognostic tool in advanced cervix cancer.

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    • "Furthermore, significant differences in the PWB, FWB, CCS, FACT-G and FACT-Cx, were also found among the five groups categorized by level of performance status. The results show that known-group validity is good in Chinese cultural context, consistent with the results in US women with cervical cancer [15]. That implies that the FACT-Cx has adequate known-group validity cross-culturally. "
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    ABSTRACT: Background The Functional Assessment of Cancer Therapy (FACT) is one of the most commonly used self-report instruments for evaluation of health-related quality of life in oncology patients. However, cultural considerations necessitate testing of the subscales in different populations. We sought to qualitatively and quantitatively investigate the applicability and psychometric properties of the Chinese version of the FACT-Cervix (FACT-Cx) in Chinese women with cervical cancer. Methods Ten personal interviews were conducted in order to explore patients’ opinions about the scale and its items in depth. In addition the questionnaire was administered to 400 women with cervical cancer to test its psychometric properties. Reliability was assessed using Cronbach’s alpha coefficient and item-subscale correlation while validity was evaluated using factor analysis and known-group validity. Results Some items related to sex and the ability to give birth were questioned in the personal interviews, mostly regarding their significance and acceptance in the Chinese cultural context. The Cronbach’s alphas of FACT-Cx and the subscales were greater than 0.7, except for the cervical-cancer-specific subscale which was 0.57. Factor analysis demonstrated that the FACT-G construct generally paralleled the original. There were significant differences in the FACT-Cx and some subscales between those receiving and not receiving treatment and among the patients with different performance status. Conclusions In general, psychometric properties of the Chinese version supported its use with cervical cancer patients in Mainland China. Further work is needed to improve the psychometric adequacy of the cervical-cancer-specific subscale and adjust it to cultural considerations.
    Health and Quality of Life Outcomes 10/2012; 10(1):124. DOI:10.1186/1477-7525-10-124 · 2.12 Impact Factor
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    • "As indicated in Table 1, the majority of patients were non-Hispanic white, between the ages of 40–69 years, and with recurrent cervical cancer treated with chemo-radiation therapy prior to enrollment. At study entry, all patients enrolled reported similar mean scores in all QoL outcomes as reported previously in the literature [4] [5] [11]. However, Table 2 describes the mean and standard deviations for the various subscales analyzed. "
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    ABSTRACT: To determine associations between pretreatment health-related quality of life subscales with progression-free (PFS) and overall survival (OS) in advanced and recurrent cervical cancer. Patients included those participating in Gynecologic Oncology Group advanced or recurrent cervical cancer phase III treatment trials who completed the Functional Assessment of Cancer Therapy for patients with cervical cancer (FACT-Cx) and a single-item pain scale at study entry. The FACT-Cx includes five domains: physical (PWB), emotional (EWB), social (SWB), functional well being (FWB), and cervix cancer subscale (CCS). A high quality of life (QoL) score reflects better QoL. After stratifying by protocol and adjusting for patient and disease characteristics, a Cox proportional hazards model was fitted for each subscale as a continuous variable. If statistically significant, (p<0.05), an analysis on mean item scores (MIS) was performed. Nine-hundred-ninety-one patients were enrolled from 1997 to 2007. The majority (87%) had recurrent disease. After adjustment for covariates and predictors, only the PWB domain (better physical QoL) was associated with improved OS [HR 0.96 95% CI 0.95-0.98; p<0.001]. When classifying patients based on the MIS of each subscale, the patients with the lowest risk of death were likely to report less compromised QoL (MIS>3) for PWB [HR 0.44 (0.33-0.58) P<0.001], FWB [0.49 (0.38-0.62) P<0.001], and CCS [0.48 (0.38-0.61) P<0.001]. The pretreatment patient-reported PWB as measured by the PWB subscale of the FACT-Cx, is significantly associated with survival in advanced cervical cancer trials, even after controlling for known prognostic factors.
    Gynecologic Oncology 02/2012; 125(2):315-9. DOI:10.1016/j.ygyno.2012.01.047 · 3.77 Impact Factor
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    • "[56]. Known-group validation could distinguish subgroups of patients with different types of treatment [56]. "
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    ABSTRACT: Women with cervical cancer now have relatively good 5-year survival rates. Better survival rates have driven the paradigm in cancer care from a medical illness model to a wellness model, which is concerned with the quality of women's lives as well as the length of survival. Thus, the assessment of quality of life among cervical cancer survivors is increasingly paramount for healthcare professionals. The purposes of this review were to describe existing validated quality of life instruments used in cervical cancer survivors, and to reveal the implications of quality of life measurement for Chinese cervical cancer survivors. A literature search of five electronic databases was conducted using the terms cervical/cervix cancer, quality of life, survivors, survivorship, measurement, and instruments. Articles published in either English or Chinese from January 2000 to June 2009 were searched. Only those adopting an established quality of life instrument for use in cervical cancer survivors were included. A total of 11 validated multidimensional quality of life instruments were identified from 41 articles. These instruments could be classified into four categories: generic, cancer-specific, cancer site-specific and cancer survivor-specific instruments. With internal consistency varying from 0.68-0.99, the test-retest reliability ranged from 0.60-0.95 based on the test of the Pearson coefficient. One or more types of validity supported the construct validity. Although all these instruments met the minimum requirements of reliability and validity, the original versions of these instruments were mainly in English. Selection of an instrument should consider the purpose of investigation, take its psychometric properties into account, and consider the instrument's origin and comprehensiveness. As quality of life can be affected by culture, studies assessing the quality of life of cervical cancer survivors in China or other non-English speaking countries should choose or develop instruments relevant to their own cultural context. There is a need to develop a comprehensive quality of life instrument for Chinese cervical cancer survivors across the whole survivorship, including immediately after diagnosis and for short- (less than 5 years) and long-term (more than 5 years) survivorship.
    Health and Quality of Life Outcomes 03/2010; 8(1):30. DOI:10.1186/1477-7525-8-30 · 2.12 Impact Factor
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