OBJECTIVE: To assess the impact of adjuvant chemotherapy for the management of breast cancer on s... more OBJECTIVE: To assess the impact of adjuvant chemotherapy for the management of breast cancer on subsequent patient employment. DESIGN: Retrospective cohort study. SETTING: University-affiliated community hospital cancer center. PATIENTS: Patients who were 18 to 65 years old and were diagnosed as having breast cancer stages 0, I, II, and IIIa between January 1986 and January 1991 were contacted and asked whether they had been employed at the time of the diagnosis. The 145 patients who had breast cancer and who had been working at the time of diagnosis completed a questionnaire, which included questions regarding demographic characteristics, employment history, and the reasons for any period of unemployment. The 76 patients who had received adjuvant chemotherapy were compared with the 69 who had not. MEASUREMENTS AND RESULTS: The main endpoint was return to work by one, three, six, and 12 months after surgery. Of the 76 patients who had received chemotherapy, 70 (92%) had resumed work by 12 months after treatment began. Of the 69 who had not been treated with chemotherapy, 65 (94%) had resumed work in 12 months. The proportions of patients who had returned to work by one, three, and six months were similar in the two groups. Regression analyses demonstrated no significant confounding or interaction of adjuvant treatment with age, menopausal status, marital status, years of education, or type of job in regard to return to work. CONCLUSIONS: Adjuvant chemotherapy does not delay or prevent return to work in women treated for early-stage breast cancer.
Tracheoesophageal fistula (TEF) is a devastating complication of malignancies; however, those ass... more Tracheoesophageal fistula (TEF) is a devastating complication of malignancies; however, those associated with Hodgkin's disease (HD) may carry a better prognosis. We present a patient with recurrent HD and TEF.
Gossypol, a polyphenolic compound which depletes cellular energy by inhibition of several intrace... more Gossypol, a polyphenolic compound which depletes cellular energy by inhibition of several intracellular dehydrogenases, has been shown to have antiproliferative activity against human glial tumor cell lines in vitro and in nude mouse xenografts. Human trials of gossypol as a male contraceptive have demonstrated safety of long-term administration. We studied the activity of Gossypol 10 mg PO bid in 27 patients with pathologically confirmed glial tumors which had recurred after radiation therapy. Fifteen patients had glioblastoma, 11 patients anaplastic astrocytoma, 1 patient relapsed low grade glioma. Response was assessed every 8 weeks using CT/MRI scan and clinical criteria including decadron requirement. Treatment was continued until disease progression. Two patients had partial response (PR); 4 had stable disease for 8 weeks or more. One patient maintained a PR with improved KPS for 78 weeks. The other had a PR lasting 8 weeks. Toxicity was mild: 2 heavily pretreated patients had mild thrombocytopenia, 5 patients developed hypokalemia, 3 patients developed grade 2 hepatic toxicity and peripheral edema. Gossypol levels measured by HPLC did not correlate with response or toxicity in this study. We conclude that gossypol is well tolerated and has a low, but measurable, response rate in a heavily pretreated, poor-prognosis group of patients with recurrent glioma. The presumed novel mechanism of action, lack of significant myelosuppression, and activity in patients with advance glioma support further study of gossypol as an antineoplastic agent.
shown that the effectiveness of acupressure bands in reducing chemotherapy-related nausea is rela... more shown that the effectiveness of acupressure bands in reducing chemotherapy-related nausea is related to patients' expectations of efficacy.
International Journal of Radiation Oncology Biology Physics, 2004
Purpose: To determine the safety and toxicity of carmustine (BCNU) and temozolomide (TMZ) with ra... more Purpose: To determine the safety and toxicity of carmustine (BCNU) and temozolomide (TMZ) with radiotherapy (RT) in newly diagnosed anaplastic astrocytoma. Methods and Materials: Patients >18 years old with anaplastic astrocytoma, a Karnofsky performance status score of >60, and adequate pulmonary function were eligible. All patients provided informed consent. Standard RT started within 5 weeks of diagnosis. In both arms, 150 mg/m 2 of TMZ was given on Days 1-5 of RT. In Arm 1, 200 mg/m 2 of carmustine was given on Day 1 of RT. In Arm 2, 150 mg/m 2 of carmustine was given on Day 5 of RT. After RT, TMZ and carmustine were repeated for a total of six cycles. Results: A total of 15 and 14 patients were enrolled in the two pilot arms. Because of hematologic and pulmonary toxicities, dose reductions by the second cycle of therapy occurred in >70% of the patients in Arm 1 and >50% in Arm 2 despite a reduction in the carmustine dose. Conclusion: The results of these pilot studies have implications for the design of studies testing the initial treatment of brain tumors. Because of the poor tolerance of the combination, the multicooperative group Phase III study consists of two randomized arms of single-agent carmustine vs. single-agent TMZ.
This experiment examined the efficacy of an acustimulation wrist band for the relief of chemother... more This experiment examined the efficacy of an acustimulation wrist band for the relief of chemotherapy-induced nausea using a randomized three-arm clinical trial (active acustimulation, sham acustimulation, and no acustimulation) in 96 women with breast cancer who experienced nausea at their first chemotherapy treatment. Five outcomes related to wrist band efficacy (acute nausea, delayed nausea, vomiting, QOL, and total amount of antiemetic medication used) were examined. The five outcomes were examined separately using analysis of covariance controlling for age and severity of past nausea. There were no significant differences in any of these study measures among the three treatment conditions (P Ͼ 0.1 for all). Study results do not support the hypothesis that acustimulation bands are efficacious as an adjunct to pharmacological antiemetics for control of chemotherapyrelated nausea in female breast cancer patients. J Pain Symptom Manage 2005;29:376-384. Ć 2005 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.
Seventy-eight female breast cancer patients were assessed for fatigue, depression, overall mood, ... more Seventy-eight female breast cancer patients were assessed for fatigue, depression, overall mood, and circadian rhythm at their second and fourth on-study chemotherapy cycles as part of a larger study examining the efficacy of paroxetine in reducing chemotherapy-induced fatigue. The Multidimensional Assessment of Fatigue (MAF), the Fatigue Symptom Checklist (FSCL), the Center for Epidemiologic Studies-Depression [CES-D) questionnaire, the Hamilton Depression Inventory (HDI), and the Profile of Mood States (POMS) were completed by patients at home 7 days after each treatment to assess symptom severity. Circadian rhythm was assessed over a 72-h period with the Mini-Motionlogger Actigraph (Ambulatory Monitoring, Ardsley, NY), starting 6 days after treatment. Daily patterns of sleep and activity were compared across the 3-day period by autocorrelation analyses to calculate a circadian rhythm score for each patient, with higher scores associated with lower disruption. Comparisons of fatigue, depression, and mood with patient circadian rhythm measures taken after the second cycle indicate that all five paper and pencil measures correlated well with the measure of circadian rhythm (all r partial <–0.30, all P<0.05). Changes in the fatigue, depression and mood measures from the second on-study treatment to the fourth were significantly correlated with concurrent changes in circadian rhythm (MAF r=–0.31; P=0.04; FSCL r=–0.30; P=0.04; CES-D r=–0.39; P=0.008; HDI r=–0.34; P=0.03; POMS r=–0.40; P=.007). These findings provide evidence that circadian rhythm disruption is involved in the experience of fatigue and depression in cancer patients.
As an adjunct to standard antiemetics for the relief of chemotherapy-induced nausea and vomiting ... more As an adjunct to standard antiemetics for the relief of chemotherapy-induced nausea and vomiting (NV), 739 patients were randomly assigned to either: 1) acupressure bands, 2) an acustimulation band, or 3) a no band control condition. Patients in the acupressure condition experienced less nausea on the day of treatment compared to controls (P Ͻ 0.05). There were no significant differences in delayed nausea or vomiting among the three treatment conditions. Additional analyses revealed pronounced gender differences. Men in the acustimulation condition, but not the acupressure condition, had less NV compared to controls (P Ͻ 0.05). No significant differences among the three treatment conditions were observed in women, although the reduction in nausea on the day of treatment in the acupressure, compared to the no band condition, closely approached statistical significance (P ϭ 0.052). Expected efficacy of the bands was related to outcomes for the acupressure but not the acustimulation conditions. J Pain Symptom Manage 2003;26:731-742. Ć 2003 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.
Previous studies have shown that acupressure bands can reduce chemotherapy-related nausea. Patien... more Previous studies have shown that acupressure bands can reduce chemotherapy-related nausea. Patients' expectations of efficacy account for part of this outcome. We conducted a three-arm randomized clinical trial to investigate the effectiveness of acupressure bands in controlling radiation therapy-induced nausea and to test whether an informational manipulation designed to increase expectation of efficacy would enhance the effectiveness of the acupressure bands. Patients who experienced nausea at prior treatments were randomized to either standard care (Arm 1, n = 29) or standard care plus acupressure bands with either neutral (Arm 2, n = 30) or positive (Arm 3, n = 29) information regarding the efficacy of the bands. Patients reported nausea for two days prior to randomization (baseline) and for five days following using a 7-point semantic rating scale (1 = not nauseated to 7 = extremely nauseated). Patients in Arms 2 and 3 combined reported greater reduction in average nausea than patients in Arm 1 (P = 0.01; mean bands = 0.70, mean no bands = 0.10). This equates to a 23.8% decrease in nausea in the band groups compared to a 4.8% decrease in the control group, a 19% difference. The informational manipulation failed to alter efficacy expectations and there was no statistically significant difference in nausea between patients in Arms 2 and 3. Acupressure bands are an effective, low-cost, non-intrusive, well-accepted, and safe adjunct to standard antiemetic medication. An attempt to boost the efficacy of the acupressure bands by providing positive information was not successful.
Background. Fatigue can significantly interfere with a cancer patient’s ability to fulfill daily ... more Background. Fatigue can significantly interfere with a cancer patient’s ability to fulfill daily responsibilities and enjoy life. It commonly co-exists with depression in patients undergoing chemotherapy, suggesting that administration of an antidepressant that alleviates symptoms of depression could also reduce fatigue. Methods. We report on a double-blind clinical trial of 94 female breast cancer patients receiving at least four cycles of chemotherapy randomly assigned to receive either 20 mg of the selective serotonin re-uptake inhibitor (SSRI) paroxetine (Paxil®, SmithKline Beecham Pharmaceuticals) or an identical-appearing placebo. Patients began their study medication seven days following their first on-study treatment and continued until seven days following their fourth on-study treatment. Seven days after each treatment, participants completed questionnaires measuring fatigue (Multidimensional Assessment of Fatigue, Profile of Mood States-Fatigue/Inertia subscale and Fatigue Symptom Checklist) and depression (Profile of Mood States-Depression subscale [POMS-DD] and Center for Epidemiologic Studies-Depression [CES-D]). Results. Repeated-measures ANOVAs, after controlling for baseline measures, showed that paroxetine was more effective than placebo in reducing depression during chemotherapy as measured by the CES-D (p=0.006) and the POMS-DD (p=0.07) but not in reducing fatigue (all measures, ps > 0.27). Conclusions. Although depression was significantly reduced in the 44 patients receiving paroxetine compared to the 50 patients receiving placebo, indicating that a biologically active dose was used, no significant differences between groups on any of the measures of fatigued were observed. Results suggest that modulation of serotonin may not be a primary mechanism of fatigue related to cancer treatment.
OBJECTIVE: To assess the impact of adjuvant chemotherapy for the management of breast cancer on s... more OBJECTIVE: To assess the impact of adjuvant chemotherapy for the management of breast cancer on subsequent patient employment. DESIGN: Retrospective cohort study. SETTING: University-affiliated community hospital cancer center. PATIENTS: Patients who were 18 to 65 years old and were diagnosed as having breast cancer stages 0, I, II, and IIIa between January 1986 and January 1991 were contacted and asked whether they had been employed at the time of the diagnosis. The 145 patients who had breast cancer and who had been working at the time of diagnosis completed a questionnaire, which included questions regarding demographic characteristics, employment history, and the reasons for any period of unemployment. The 76 patients who had received adjuvant chemotherapy were compared with the 69 who had not. MEASUREMENTS AND RESULTS: The main endpoint was return to work by one, three, six, and 12 months after surgery. Of the 76 patients who had received chemotherapy, 70 (92%) had resumed work by 12 months after treatment began. Of the 69 who had not been treated with chemotherapy, 65 (94%) had resumed work in 12 months. The proportions of patients who had returned to work by one, three, and six months were similar in the two groups. Regression analyses demonstrated no significant confounding or interaction of adjuvant treatment with age, menopausal status, marital status, years of education, or type of job in regard to return to work. CONCLUSIONS: Adjuvant chemotherapy does not delay or prevent return to work in women treated for early-stage breast cancer.
Tracheoesophageal fistula (TEF) is a devastating complication of malignancies; however, those ass... more Tracheoesophageal fistula (TEF) is a devastating complication of malignancies; however, those associated with Hodgkin&#39;s disease (HD) may carry a better prognosis. We present a patient with recurrent HD and TEF.
Gossypol, a polyphenolic compound which depletes cellular energy by inhibition of several intrace... more Gossypol, a polyphenolic compound which depletes cellular energy by inhibition of several intracellular dehydrogenases, has been shown to have antiproliferative activity against human glial tumor cell lines in vitro and in nude mouse xenografts. Human trials of gossypol as a male contraceptive have demonstrated safety of long-term administration. We studied the activity of Gossypol 10 mg PO bid in 27 patients with pathologically confirmed glial tumors which had recurred after radiation therapy. Fifteen patients had glioblastoma, 11 patients anaplastic astrocytoma, 1 patient relapsed low grade glioma. Response was assessed every 8 weeks using CT/MRI scan and clinical criteria including decadron requirement. Treatment was continued until disease progression. Two patients had partial response (PR); 4 had stable disease for 8 weeks or more. One patient maintained a PR with improved KPS for 78 weeks. The other had a PR lasting 8 weeks. Toxicity was mild: 2 heavily pretreated patients had mild thrombocytopenia, 5 patients developed hypokalemia, 3 patients developed grade 2 hepatic toxicity and peripheral edema. Gossypol levels measured by HPLC did not correlate with response or toxicity in this study. We conclude that gossypol is well tolerated and has a low, but measurable, response rate in a heavily pretreated, poor-prognosis group of patients with recurrent glioma. The presumed novel mechanism of action, lack of significant myelosuppression, and activity in patients with advance glioma support further study of gossypol as an antineoplastic agent.
shown that the effectiveness of acupressure bands in reducing chemotherapy-related nausea is rela... more shown that the effectiveness of acupressure bands in reducing chemotherapy-related nausea is related to patients' expectations of efficacy.
International Journal of Radiation Oncology Biology Physics, 2004
Purpose: To determine the safety and toxicity of carmustine (BCNU) and temozolomide (TMZ) with ra... more Purpose: To determine the safety and toxicity of carmustine (BCNU) and temozolomide (TMZ) with radiotherapy (RT) in newly diagnosed anaplastic astrocytoma. Methods and Materials: Patients >18 years old with anaplastic astrocytoma, a Karnofsky performance status score of >60, and adequate pulmonary function were eligible. All patients provided informed consent. Standard RT started within 5 weeks of diagnosis. In both arms, 150 mg/m 2 of TMZ was given on Days 1-5 of RT. In Arm 1, 200 mg/m 2 of carmustine was given on Day 1 of RT. In Arm 2, 150 mg/m 2 of carmustine was given on Day 5 of RT. After RT, TMZ and carmustine were repeated for a total of six cycles. Results: A total of 15 and 14 patients were enrolled in the two pilot arms. Because of hematologic and pulmonary toxicities, dose reductions by the second cycle of therapy occurred in >70% of the patients in Arm 1 and >50% in Arm 2 despite a reduction in the carmustine dose. Conclusion: The results of these pilot studies have implications for the design of studies testing the initial treatment of brain tumors. Because of the poor tolerance of the combination, the multicooperative group Phase III study consists of two randomized arms of single-agent carmustine vs. single-agent TMZ.
This experiment examined the efficacy of an acustimulation wrist band for the relief of chemother... more This experiment examined the efficacy of an acustimulation wrist band for the relief of chemotherapy-induced nausea using a randomized three-arm clinical trial (active acustimulation, sham acustimulation, and no acustimulation) in 96 women with breast cancer who experienced nausea at their first chemotherapy treatment. Five outcomes related to wrist band efficacy (acute nausea, delayed nausea, vomiting, QOL, and total amount of antiemetic medication used) were examined. The five outcomes were examined separately using analysis of covariance controlling for age and severity of past nausea. There were no significant differences in any of these study measures among the three treatment conditions (P Ͼ 0.1 for all). Study results do not support the hypothesis that acustimulation bands are efficacious as an adjunct to pharmacological antiemetics for control of chemotherapyrelated nausea in female breast cancer patients. J Pain Symptom Manage 2005;29:376-384. Ć 2005 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.
Seventy-eight female breast cancer patients were assessed for fatigue, depression, overall mood, ... more Seventy-eight female breast cancer patients were assessed for fatigue, depression, overall mood, and circadian rhythm at their second and fourth on-study chemotherapy cycles as part of a larger study examining the efficacy of paroxetine in reducing chemotherapy-induced fatigue. The Multidimensional Assessment of Fatigue (MAF), the Fatigue Symptom Checklist (FSCL), the Center for Epidemiologic Studies-Depression [CES-D) questionnaire, the Hamilton Depression Inventory (HDI), and the Profile of Mood States (POMS) were completed by patients at home 7 days after each treatment to assess symptom severity. Circadian rhythm was assessed over a 72-h period with the Mini-Motionlogger Actigraph (Ambulatory Monitoring, Ardsley, NY), starting 6 days after treatment. Daily patterns of sleep and activity were compared across the 3-day period by autocorrelation analyses to calculate a circadian rhythm score for each patient, with higher scores associated with lower disruption. Comparisons of fatigue, depression, and mood with patient circadian rhythm measures taken after the second cycle indicate that all five paper and pencil measures correlated well with the measure of circadian rhythm (all r partial <–0.30, all P<0.05). Changes in the fatigue, depression and mood measures from the second on-study treatment to the fourth were significantly correlated with concurrent changes in circadian rhythm (MAF r=–0.31; P=0.04; FSCL r=–0.30; P=0.04; CES-D r=–0.39; P=0.008; HDI r=–0.34; P=0.03; POMS r=–0.40; P=.007). These findings provide evidence that circadian rhythm disruption is involved in the experience of fatigue and depression in cancer patients.
As an adjunct to standard antiemetics for the relief of chemotherapy-induced nausea and vomiting ... more As an adjunct to standard antiemetics for the relief of chemotherapy-induced nausea and vomiting (NV), 739 patients were randomly assigned to either: 1) acupressure bands, 2) an acustimulation band, or 3) a no band control condition. Patients in the acupressure condition experienced less nausea on the day of treatment compared to controls (P Ͻ 0.05). There were no significant differences in delayed nausea or vomiting among the three treatment conditions. Additional analyses revealed pronounced gender differences. Men in the acustimulation condition, but not the acupressure condition, had less NV compared to controls (P Ͻ 0.05). No significant differences among the three treatment conditions were observed in women, although the reduction in nausea on the day of treatment in the acupressure, compared to the no band condition, closely approached statistical significance (P ϭ 0.052). Expected efficacy of the bands was related to outcomes for the acupressure but not the acustimulation conditions. J Pain Symptom Manage 2003;26:731-742. Ć 2003 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.
Previous studies have shown that acupressure bands can reduce chemotherapy-related nausea. Patien... more Previous studies have shown that acupressure bands can reduce chemotherapy-related nausea. Patients' expectations of efficacy account for part of this outcome. We conducted a three-arm randomized clinical trial to investigate the effectiveness of acupressure bands in controlling radiation therapy-induced nausea and to test whether an informational manipulation designed to increase expectation of efficacy would enhance the effectiveness of the acupressure bands. Patients who experienced nausea at prior treatments were randomized to either standard care (Arm 1, n = 29) or standard care plus acupressure bands with either neutral (Arm 2, n = 30) or positive (Arm 3, n = 29) information regarding the efficacy of the bands. Patients reported nausea for two days prior to randomization (baseline) and for five days following using a 7-point semantic rating scale (1 = not nauseated to 7 = extremely nauseated). Patients in Arms 2 and 3 combined reported greater reduction in average nausea than patients in Arm 1 (P = 0.01; mean bands = 0.70, mean no bands = 0.10). This equates to a 23.8% decrease in nausea in the band groups compared to a 4.8% decrease in the control group, a 19% difference. The informational manipulation failed to alter efficacy expectations and there was no statistically significant difference in nausea between patients in Arms 2 and 3. Acupressure bands are an effective, low-cost, non-intrusive, well-accepted, and safe adjunct to standard antiemetic medication. An attempt to boost the efficacy of the acupressure bands by providing positive information was not successful.
Background. Fatigue can significantly interfere with a cancer patient’s ability to fulfill daily ... more Background. Fatigue can significantly interfere with a cancer patient’s ability to fulfill daily responsibilities and enjoy life. It commonly co-exists with depression in patients undergoing chemotherapy, suggesting that administration of an antidepressant that alleviates symptoms of depression could also reduce fatigue. Methods. We report on a double-blind clinical trial of 94 female breast cancer patients receiving at least four cycles of chemotherapy randomly assigned to receive either 20 mg of the selective serotonin re-uptake inhibitor (SSRI) paroxetine (Paxil®, SmithKline Beecham Pharmaceuticals) or an identical-appearing placebo. Patients began their study medication seven days following their first on-study treatment and continued until seven days following their fourth on-study treatment. Seven days after each treatment, participants completed questionnaires measuring fatigue (Multidimensional Assessment of Fatigue, Profile of Mood States-Fatigue/Inertia subscale and Fatigue Symptom Checklist) and depression (Profile of Mood States-Depression subscale [POMS-DD] and Center for Epidemiologic Studies-Depression [CES-D]). Results. Repeated-measures ANOVAs, after controlling for baseline measures, showed that paroxetine was more effective than placebo in reducing depression during chemotherapy as measured by the CES-D (p=0.006) and the POMS-DD (p=0.07) but not in reducing fatigue (all measures, ps > 0.27). Conclusions. Although depression was significantly reduced in the 44 patients receiving paroxetine compared to the 50 patients receiving placebo, indicating that a biologically active dose was used, no significant differences between groups on any of the measures of fatigued were observed. Results suggest that modulation of serotonin may not be a primary mechanism of fatigue related to cancer treatment.
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