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Psychosocial domain in quality of life as an independent prognostic factor for survival and tumor response in patients with advanced non-small cell lung cancer (NSCLS)
Supportiue Care developing role of a Generic Macmillan Specialist •92-• The Nurse in a Lung Cancer Service at a Large Teaching
271
findings should be considered in cancer treatments as well as design of future trials.
Hospital in the United Kingdom B.M Hutchcroft. On Behalf of the Sheffield Lung Cancer Group, UK One model of Support Nursing for Lung Cancer is for Generic Macmillan (Continuing Support) Specialist Nurses to subspecialise in one of the common cancers in line with the Calman-Hine recommendations of cancer care in the United Kingdom. This is the model that has been developed at Central Sheffield University Hospitals. The Generic Macmillan Nurse specialising in Lung Cancer attends the weekly Multidisciplinary Team (MDT) meetings and the following fast track Lung Cancer clinic. In the 9 months from April to December 1999 there were 263 referrals to the fast track Lung Cancer Clinic. 136 of these patients seen by the Support Nurse. Physicians identified those patients who needed emotional support at their first clinic attendance. The majority of the patients were referred at the time their diagnosis when their treatment options were being discussed with them. Some were identified during the weekly Multidisciplinary Team meetings. Others were referred through the nursing network. Problems encountered included depending on medical staff to identify patients who need emotional support and the stigma of impending death associated with the role of a Macmillan Nurse when the patient may be offered a potentially curative treatment. The level of emotional support care at all points in the patient journey was of the same high standard as in all Macmillan support work. The knowledge of care in the terminal phase of the disease was particularly helpful. Focussing on one cancer, lung, allowed resources to be effectively targeted. Generic Macmillan role is both practical and desirable in terms of the peer support it gives the post holder.
•2--8]
Psychosocial domain in quality of life as an independent prognostic factor for survival and tumor response in patients with advanced non-small cell lung cancer (NSCLS)
12 Matsumoto, K. Kobayashi, K. Eguchi, M. Shibuya, S. Morita, Y. Ohashi, Y. Yamaji. National Cancer Center Hospital East, Chiba; Saitama Cancer Center, Saitama; National Shikoku Cancer Center Hospital Ehime; Nippon Medical School, Tokyo; University of Tokyo, Tokyo; Mitoyo General Hospital Kagawa, Japan We evaluated the prognostic effects of the four domains: Functional (item 1-6), Physical (item 7-11), Mental (item 12-16) and Psychosocial (item 17-21) in QOL (QOL-ACD: M. Kurihara et al, PsychoOncology 8: 355-363, 1999) at baseline on survival and tumor response in 390 untreated patients with advanced NSCLC, who were randomly assigned to receive CDDP + CPT-11, CDDP + VDS, or CPT-11 alone in two mulUcenter phase III studies (N. Masuda et al, A1774, and S. Niho et al, A1897, ASCO 1999). Regarding survival, Cox regression was conducted to obtain hazard ratios (together with 95% C.I.) for scores of the four domains at baseline, with adjustment for the study, the first-line chemotherapy and known prognostic factors that are associated with overall survival in NSCLC: Stage (IV/IIIB), PS (1/0, 2/0), Gender (Male/Female), Weight loss (>=5%/<5%), Albumin (<=3.5/>3.5 g/dl), LDH (>=530/<530 lUll). Concerning tumor response, logistic regression was performed to obtain odds ratios (response/nonresponse) with adjustment for the same covariates as Cox regression. Cox regression evidenced that all of the known prognostic factors were significantly related to survival and revealed that the psychosocial domain (<=2.2: Worse status/>2.2: Better status) was an independent prognostic factor with a dramatic significance (adjusted hazard ratio, 1.73; 95% C.I., 1.29-2.31; P < 0.001). Logistic regression revealed that the psychosocial domain was significantly associated with the probability of tumor response (adjusted odds ratio, 0.36; 95% C.I., 0.18-0.72; P = 0.004). Furthermore, it was revealed that item 17: "Did you worry about your disease?" was the most significant one in the psychosocial domain, that was associated with both survival and tumor response. We concluded that the psychosocial domain was an important prognostic-factor for survival and response, and these
Tuesday, 12 September 2000 POSTER SESSION
Supportive Care ~-]
Epoetin alfa improves hemoglobin levels and quality of life for lung cancer patients receiving chemotherapy
J. Crawford, J. Glaspy, G. Demetri, J. Gabrilove. Duke University Medical Center, Durham, NC; Univ of California Los Angeles, California; Dana-Father Cancer Institute and Harvard Medical School, Boston, MA; Mt. Sinai Medical Center, New York, NY, USA
Study Objective: To evaluate the efficacy of epoetin alfa in improving hemoglobin levels, decreasing transfusion requirements, and improving quality of life when used as a adjunct to chemotherapy in anemic lung cancer patients. Design: A subanalysis of lung cancer patients who participated in three prospective phase IV studies designed to assess the clinical benefits of once-weekly or three-times-weekly epoetin alfa therapy. Setting and Patients: Lung cancer patients with anemia who were receiving chemotherapy were treated in community-based oncology practices in the United States. Interventions: Patients in the once-weekly study received epoetin alfa 40,000 U subcutaneously (SC), which could be increased to 60,000 U once-weekly depending on hemoglobin response. In the first and second three-times-weekly studies, patients were treated with epoetin alfa 150 U/kg and 10,000 U SC three-times-weekly, respectively, with doubling of the dose if response was inadequate. Maximum treatment duration for all 3 studies was 16 weeks. Results: A total of 1,720 lung cancer patients were evaluable for hematopoietic response and 1,296 were evaluable for analyses of linear analog scale assessment (LASA) of energy, activity, and overall quality of life. Once-weekly and three-times-weekly epoetin alfa resulted in a significant improvement in hemoglobin levels and transfusion use within 2 months of epoetin alfa therapy and improved self-reported LASA scores, improvements in quality-of-life parameters were significantly correlated with increased hemoglobin levels and were independent of lung tumor response. Epoetin alfa was well tolerated. Conclusions: Epoetin alfa increases hemoglobin levels, decreases transfusion use, and improves quality-of-life parameters during chemotherapy in patents with lung cancer. The clinical benefits and safety profiles of the once-weekly and three-times-weekly schedules appear to be similar.
•3•
Evaluation of the prognostic value of a simple patientassessed functional impairment scale in lung cancer
R.J. Stephens 1, P. Hopwood2. For the UK Medical Research Council (MRC) Lung Cancer Working Party; 1Cancer Division, MRC Clinical Trials Unit, London, UK; 2The Cancer Research Campaign Psychological Medicine Group, Christie Hospital NHS Trust, Manchester, UK
Background: Clinician-rated performance status (PS) is one of the most important prognostic factors for survival in lung cancer. Patientrated functional impairment is widely advocated as part of the assessment of Quality of Life, but its value as a prognostic factor is unknown. Aims: To confirm the structure of a short, clinically informative, functional impairment scale derived from the activities of daily living (ADL) scale of the Rotterdam Symptom Checklist (RSCL), and then to assess the prognostic value of the scale in patients with lung cancer.
271
findings should be considered in cancer treatments as well as design of future trials.
Hospital in the United Kingdom B.M Hutchcroft. On Behalf of the Sheffield Lung Cancer Group, UK One model of Support Nursing for Lung Cancer is for Generic Macmillan (Continuing Support) Specialist Nurses to subspecialise in one of the common cancers in line with the Calman-Hine recommendations of cancer care in the United Kingdom. This is the model that has been developed at Central Sheffield University Hospitals. The Generic Macmillan Nurse specialising in Lung Cancer attends the weekly Multidisciplinary Team (MDT) meetings and the following fast track Lung Cancer clinic. In the 9 months from April to December 1999 there were 263 referrals to the fast track Lung Cancer Clinic. 136 of these patients seen by the Support Nurse. Physicians identified those patients who needed emotional support at their first clinic attendance. The majority of the patients were referred at the time their diagnosis when their treatment options were being discussed with them. Some were identified during the weekly Multidisciplinary Team meetings. Others were referred through the nursing network. Problems encountered included depending on medical staff to identify patients who need emotional support and the stigma of impending death associated with the role of a Macmillan Nurse when the patient may be offered a potentially curative treatment. The level of emotional support care at all points in the patient journey was of the same high standard as in all Macmillan support work. The knowledge of care in the terminal phase of the disease was particularly helpful. Focussing on one cancer, lung, allowed resources to be effectively targeted. Generic Macmillan role is both practical and desirable in terms of the peer support it gives the post holder.
•2--8]
Psychosocial domain in quality of life as an independent prognostic factor for survival and tumor response in patients with advanced non-small cell lung cancer (NSCLS)
12 Matsumoto, K. Kobayashi, K. Eguchi, M. Shibuya, S. Morita, Y. Ohashi, Y. Yamaji. National Cancer Center Hospital East, Chiba; Saitama Cancer Center, Saitama; National Shikoku Cancer Center Hospital Ehime; Nippon Medical School, Tokyo; University of Tokyo, Tokyo; Mitoyo General Hospital Kagawa, Japan We evaluated the prognostic effects of the four domains: Functional (item 1-6), Physical (item 7-11), Mental (item 12-16) and Psychosocial (item 17-21) in QOL (QOL-ACD: M. Kurihara et al, PsychoOncology 8: 355-363, 1999) at baseline on survival and tumor response in 390 untreated patients with advanced NSCLC, who were randomly assigned to receive CDDP + CPT-11, CDDP + VDS, or CPT-11 alone in two mulUcenter phase III studies (N. Masuda et al, A1774, and S. Niho et al, A1897, ASCO 1999). Regarding survival, Cox regression was conducted to obtain hazard ratios (together with 95% C.I.) for scores of the four domains at baseline, with adjustment for the study, the first-line chemotherapy and known prognostic factors that are associated with overall survival in NSCLC: Stage (IV/IIIB), PS (1/0, 2/0), Gender (Male/Female), Weight loss (>=5%/<5%), Albumin (<=3.5/>3.5 g/dl), LDH (>=530/<530 lUll). Concerning tumor response, logistic regression was performed to obtain odds ratios (response/nonresponse) with adjustment for the same covariates as Cox regression. Cox regression evidenced that all of the known prognostic factors were significantly related to survival and revealed that the psychosocial domain (<=2.2: Worse status/>2.2: Better status) was an independent prognostic factor with a dramatic significance (adjusted hazard ratio, 1.73; 95% C.I., 1.29-2.31; P < 0.001). Logistic regression revealed that the psychosocial domain was significantly associated with the probability of tumor response (adjusted odds ratio, 0.36; 95% C.I., 0.18-0.72; P = 0.004). Furthermore, it was revealed that item 17: "Did you worry about your disease?" was the most significant one in the psychosocial domain, that was associated with both survival and tumor response. We concluded that the psychosocial domain was an important prognostic-factor for survival and response, and these
Tuesday, 12 September 2000 POSTER SESSION
Supportive Care ~-]
Epoetin alfa improves hemoglobin levels and quality of life for lung cancer patients receiving chemotherapy
J. Crawford, J. Glaspy, G. Demetri, J. Gabrilove. Duke University Medical Center, Durham, NC; Univ of California Los Angeles, California; Dana-Father Cancer Institute and Harvard Medical School, Boston, MA; Mt. Sinai Medical Center, New York, NY, USA
Study Objective: To evaluate the efficacy of epoetin alfa in improving hemoglobin levels, decreasing transfusion requirements, and improving quality of life when used as a adjunct to chemotherapy in anemic lung cancer patients. Design: A subanalysis of lung cancer patients who participated in three prospective phase IV studies designed to assess the clinical benefits of once-weekly or three-times-weekly epoetin alfa therapy. Setting and Patients: Lung cancer patients with anemia who were receiving chemotherapy were treated in community-based oncology practices in the United States. Interventions: Patients in the once-weekly study received epoetin alfa 40,000 U subcutaneously (SC), which could be increased to 60,000 U once-weekly depending on hemoglobin response. In the first and second three-times-weekly studies, patients were treated with epoetin alfa 150 U/kg and 10,000 U SC three-times-weekly, respectively, with doubling of the dose if response was inadequate. Maximum treatment duration for all 3 studies was 16 weeks. Results: A total of 1,720 lung cancer patients were evaluable for hematopoietic response and 1,296 were evaluable for analyses of linear analog scale assessment (LASA) of energy, activity, and overall quality of life. Once-weekly and three-times-weekly epoetin alfa resulted in a significant improvement in hemoglobin levels and transfusion use within 2 months of epoetin alfa therapy and improved self-reported LASA scores, improvements in quality-of-life parameters were significantly correlated with increased hemoglobin levels and were independent of lung tumor response. Epoetin alfa was well tolerated. Conclusions: Epoetin alfa increases hemoglobin levels, decreases transfusion use, and improves quality-of-life parameters during chemotherapy in patents with lung cancer. The clinical benefits and safety profiles of the once-weekly and three-times-weekly schedules appear to be similar.
•3•
Evaluation of the prognostic value of a simple patientassessed functional impairment scale in lung cancer
R.J. Stephens 1, P. Hopwood2. For the UK Medical Research Council (MRC) Lung Cancer Working Party; 1Cancer Division, MRC Clinical Trials Unit, London, UK; 2The Cancer Research Campaign Psychological Medicine Group, Christie Hospital NHS Trust, Manchester, UK
Background: Clinician-rated performance status (PS) is one of the most important prognostic factors for survival in lung cancer. Patientrated functional impairment is widely advocated as part of the assessment of Quality of Life, but its value as a prognostic factor is unknown. Aims: To confirm the structure of a short, clinically informative, functional impairment scale derived from the activities of daily living (ADL) scale of the Rotterdam Symptom Checklist (RSCL), and then to assess the prognostic value of the scale in patients with lung cancer.