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      Quality-of-life evaluation for advanced non-small-cell lung cancer: a comparison between vinorelbine plus gemcitabine followed by docetaxel versus paclitaxel plus carboplatin regimens in a randomized trial: Japan Multinational Trial Organization LC00-03 (BRI LC03-01)

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          Abstract

          Background

          A randomized trial of vinorelbine plus gemcitabine followed by docetaxel (VGD) versus paclitaxel plus carboplatin (PC) in patients with advanced non-small-cell lung cancer showed no difference in overall survival (median survival time: 13.6 versus 14.1 months) between the two treatment groups. We report here the results of quality-of-life (QOL) study initiated in the mid-course of this randomized trial.

          Methods

          The patients themselves assessed the Functional Assessment of Cancer Therapy (FACT)-Lung (FACT-L), FACT-Taxane and the Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp) QOL instruments at baseline and 6, 12 and 18 weeks after the treatment. The primary endpoint was a comparison of total QOL score for each assessment instrument between the two groups.

          Results

          Sixty-eight patients from the trial (VGD, 34; PC, 34) who submitted baseline questionnaires and at least one questionnaire over the course of treatment were eligible. Longitudinal analysis showed a significant difference in slope of the FACT-Taxane score (p = 0.004) between treatment regimens over time, but no difference was found in FACT-L score (p = 0.311) and FACIT-Sp score (p = 0.466) between the two groups.

          Conclusions

          The significant difference in slope of FACT-Taxane score favored the VGD regimen. These data should be considered in treatment decision-making for patients with advanced non-small-cell lung cancer.

          Trial registration

          NCT00242983.

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          Most cited references13

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          Reliability and validity of the Functional Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument.

          The FACT-L (version 3) is a 44-item self-report instrument which measures multidimensional quality of life. Available in eight languages, it is currently being used in several Phase II and III lung cancer clinical trials. Reliability and validity of the 33-item version 2 of the FACT-General (FACT-G) have previously been published. This paper reports further validation data on the FACT-G with a subsample of lung cancer patients from the original publication and, more importantly, presents data on the Lung Cancer Subscale (LCS). The nine LCS questions were administered along with the FACT-G to 116 patients with lung cancer. Internal consistency (coefficient alpha) was improved from 0.53 to 0.68 by dropping two questions which were uncorrelated with the others. A subset of 41 patients was tested again at 2 months to evaluate sensitivity to change in performance status rating (PSR) and to obtain estimates of a clinically meaningful change score for the FACT-G and the 7-item LCS. Using a linear test for trend, sensitivity to change in performance status rating (PSR) was obtained with the Total score (P = 0.03), the Physical Well Being (PWB) subscale (P = 0.02), the Functional Well Being (FWB) subscale (P = 0.05), and the LCS (P = 0.03). A 21-item Trial Outcome Index (TOI), combining scores on PWB, FWB and LCS, was highly reliable (coefficient a = 0.89) and sensitive to change in PSR F(1,38) = 4.84 (P = 0.01). This TOI is probably the most relevant and precise indicator of patient-reported quality of life available for lung cancer patients who complete the FACT-L while participating in an oncology clinical trial. The FACT-L may also be of benefit in evaluating quality of life in patients with lung diseases other than cancer.
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            Measuring the side effects of taxane therapy in oncology: the functional assesment of cancer therapy-taxane (FACT-taxane).

            Cancer chemotherapy with some of the taxane class of agents can be associated with significant neurotoxicity, arthralgias, myalgias, and skin changes that may offset the therapeutic benefits of taxane use. The authors developed and tested a set of questions to assess these important side effects of taxane therapy from the patient's perspective. The current study evaluated the taxane subscale of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system. Reliability, validity, and responsiveness to expected change were evaluated in the context of an ongoing clinical trial comparing four cycles of carboplatin plus paclitaxel with a strategy of carboplatin plus paclitaxel until disease progression in patients with advanced nonsmall cell lung carcinoma (NSCLC). The 16-item Taxane subscale score and the 11-item peripheral neuropathy subset both demonstrated excellent internal consistency and concurrent validity, and the scores worsened as one would predict during a 12-week treatment course of taxane therapy. Results of the psychometric analyses supported the use of this subscale for measuring the unwanted adverse consequences of effective cancer therapies. Measuring the patient perception of treatment side effects also allowed a preliminary exploration of the relative quality of life (QOL) impact of symptom relief and treatment toxicity. The results indicated that toxicity and symptom improvement may make relatively equivalent contributions to total QOL as measured by the summary score from a multidimensional QOL instrument, the Functional Assessment of Cancer Therapy-General. However, symptom status and improvement appear to play a stronger role than taxane toxicity in patients' global rating of their QOL. Future research might examine this question of competing benefits as a potential aid to decision-making regarding the administration of toxic therapies in the setting of advanced disease. Copyright 2003 American Cancer Society.
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              Epidemiology of lung cancer prognosis: quantity and quality of life.

              Ping Yang (2008)
              Primary lung cancer is very heterogeneous in its clinical presentation, histopathology, and treatment response; and like other diseases, the prognosis consists of two essential facets: survival and quality of life (QOL). Lung cancer survival is mostly determined by disease stage and treatment modality, and the 5-Year survival rate has been in a plateau of 15% for three decades. QOL is focused on life aspects that are affected by health conditions and medical interventions; the balance of physical functioning and suffering from treatment side effects has long been a concern of care providers as well as patients. Obviously needed are easily measurable biologic markers to stratify patients before treatment for optimal results in survival and QOL and to monitor treatment responses and toxicities. Targeted therapies toward the mechanisms of tumor development, growth, and metastasis are promising and actively translated into clinical practice. Long-term lung cancer (LTLC) survivors are people who are alive 5 Years after the diagnosis. Knowledge about the health and QOL in LTLC survivors is limited because outcome research in lung cancer has been focused mainly on short-term survival. The independent or combined effects of lung cancer treatment, aging, smoking and drinking, comorbid conditions, and psychosocial factors likely cause late effects, including organ malfunction, chronic fatigue, pain, or premature death among lung cancer survivors. New knowledge to be gained should help lung cancer survivors, their healthcare providers, and their caregivers by providing evidence for establishing clinical recommendations to enhance their long-term survival and health-related QOL.
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                Author and article information

                Journal
                BMC Cancer
                BMC Cancer
                BioMed Central
                1471-2407
                2011
                17 August 2011
                : 11
                : 356
                Affiliations
                [1 ]Otemae Hospital, 1-5-3 Otemae, Chuo-ku, Osaka, 540-0008, Japan
                [2 ]Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
                [3 ]National Hospital Organization, Kinki-chuo Chest Medical Center, 1180 Nagasone-cho, Kita-ku, Sakai, 591-8555, Japan
                [4 ]Department of Biostatistics and Clinical Epidemiology, University of Toyama Graduate School, 2630 Sugitani, Toyama, 930-0194, Japan
                [5 ]National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
                [6 ]National Hospital Organization Shikoku Cancer Center, 160 Minami Umemoto-cho, Matsuyama, 791-0280, Japan
                [7 ]Translational Research Informatics Center, 1-5-4 Minatojima-minamimachi, Chuo-ku, Kobe, 650-0047, Japan
                [8 ]The Japan Multinational Trial Organization, 474 Uehonnojimae-cho, Teramachi-Oike agaru, Nakagyo-ku, Kyoto, 604-0925, Japan
                Article
                1471-2407-11-356
                10.1186/1471-2407-11-356
                3179458
                21849041
                2960ef1d-0371-4e5e-b051-d7e3969cabb7
                Copyright ©2011 Kawahara et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 30 July 2010
                : 17 August 2011
                Categories
                Research Article

                Oncology & Radiotherapy
                Oncology & Radiotherapy

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