Dataset Information

Quality of life and survival survey of cancer cachexia in advanced non-small cell lung cancer patients-Japan nutrition and QOL survey in patients with advanced non-small cell lung cancer study.

ABSTRACT:

Purpose

Although cancer cachexia is mainly characterized by persistent loss of body weight (BW), usually in response to a malignancy, the pathophysiology of cachexia remains unresolved. To elucidate the relationship between the loss of BW and other related clinical factors, we conducted a nationwide, multi-institutional, prospective, observational study in patients with advanced non-small cell lung cancer (NSCLC).

Methods

Treatment-naïve stage IV NSCLC patients with an Eastern Cooperative Oncology Group performance status (PS) of 0-2 were eligible. BW, handgrip strength (HGS), quality of life (QOL), Karnofsky Performance Scale (KPS), biochemical parameters, and survival were evaluated at baseline and every 4 weeks for 1 year. The relationship between BW loss and other factors was examined by linear regression analysis. Estimated survival curves were drawn by the Kaplan-Meier method and applied by the log-rank test. Clinical factors associated with cancer cachexia were identified through principal component analysis. The generalized estimating equation approach was used to analyze the deterioration of QOL resulting from the progression of cachexia.

Results

A total of 406 patients were analyzed. BW loss was significantly associated with worsening of QOL, HGS, KPS, and biochemical parameters. The incidence of BW loss was observed throughout the study period. Overall survival was significantly shorter in patients as BW loss progressed. BW loss, decrease in HGS, anorexia, and fatigue were identified as core factors of cachexia that contributed to the deterioration of QOL.

Conclusion

BW loss most likely deteriorated QOL and shortened survival in patients with advanced NSCLC and should be closely monitored.

SUBMITTER: Takayama K

PROVIDER: S-EPMC4917580 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Publications

Quality of life and survival survey of cancer cachexia in advanced non-small cell lung cancer patients-Japan nutrition and QOL survey in patients with advanced non-small cell lung cancer study.

Takayama Koichi K Atagi Shinji S Imamura Fumio F Tanaka Hiroshi H Minato Koichi K Harada Toshiyuki T Katakami Nobuyuki N Yokoyama Takuma T Yoshimori Kozo K Takiguchi Yuichi Y Hataji Osamu O Takeda Yuichiro Y Aoe Keisuke K Kim Young Hak YH Yokota Soichiro S Tabeta Hiroshi H Tomii Keisuke K Ohashi Yasuo Y Eguchi Kenji K Watanabe Koshiro K

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 20160322 8

<h4>Purpose</h4>Although cancer cachexia is mainly characterized by persistent loss of body weight (BW), usually in response to a malignancy, the pathophysiology of cachexia remains unresolved. To elucidate the relationship between the loss of BW and other related clinical factors, we conducted a nationwide, multi-institutional, prospective, observational study in patients with advanced non-small cell lung cancer (NSCLC).<h4>Methods</h4>Treatment-naïve stage IV NSCLC patients with an Eastern Coo ...[more]

PMID: 27003901

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Project description:Background:Cancer anorexia-cachexia is a debilitating condition frequently observed in NSCLC patients, characterized by decreased body weight, reduced food intake, and impaired quality of life. Anamorelin, a novel selective ghrelin receptor agonist, has anabolic and appetite-enhancing activities. Patients and methods:ROMANA 3 was a safety extension study of two phase 3, double-blind studies that assessed safety and efficacy of anamorelin in advanced NSCLC patients with cachexia. Patients with preserved Eastern Cooperative Oncology Group ?2 after completing 12?weeks (w) on the ROMANA 1 or ROMANA 2 trials (0-12?weeks) could enroll in ROMANA 3 and continue to receive anamorelin 100?mg or placebo once daily for an additional 12w (12-24?weeks). The primary endpoint of ROMANA 3 was anamorelin safety/tolerability (12-24?weeks). Secondary endpoints included changes in body weight, handgrip strength (HGS), and symptom burden (0-24?weeks). Results:Of the 703 patients who completed ROMANA 1 and ROMANA 2, 513 patients entered ROMANA 3 (anamorelin, N?=?345, mean age 62.0?years; placebo, N?=?168; mean age 62.2?years). During ROMANA 3, anamorelin and placebo groups had similar incidences of treatment-emergent adverse events (TEAEs; 52.2% versus 55.7%), grade??3 TEAEs (22.4% versus 21.6%), and serious TEAEs (12.8% versus 12.6%). There were 36 (10.5%) and 23 (13.8%) deaths in the anamorelin and placebo groups, respectively; none were drug-related. Improvements in body weight and anorexia-cachexia symptoms observed in the original trials were consistently maintained over 12-24?weeks. Anamorelin, versus placebo, significantly increased body weight from baseline of original trials at all time points (P?<?0.0001) and improved anorexia-cachexia symptoms at weeks 3, 6, 9, 12, and 16 (P?<?0.05). No significant improvement in HGS was seen in either group. Conclusion:During the 12-24?weeks ROMANA 3 trial, anamorelin continued to be well tolerated. Over the entire 0-24w treatment period, body weight and symptom burden were improved with anamorelin. Clinical trial registration numbers:ROMANA 1 (NCT01387269), ROMANA 2 (NCT01387282), and ROMANA 3 (NCT01395914).

Dataset Information

Quality of life and survival survey of cancer cachexia in advanced non-small cell lung cancer patients-Japan nutrition and QOL survey in patients with advanced non-small cell lung cancer study.

Purpose

Methods

Results

Conclusion

Publications

Quality of life and survival survey of cancer cachexia in advanced non-small cell lung cancer patients-Japan nutrition and QOL survey in patients with advanced non-small cell lung cancer study.

Similar Datasets

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