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  • 1
    Electronic Resource
    Electronic Resource
    Impact of nausea/vomiting on quality of life as a visual analogue scale-derived utility score (1996)
    Springer
    Supportive care in cancer 4 (1996), S. 435-439 
    Details
    ISSN: 1433-7339
    Keywords: Utility score ; Rating scale ; Quality of life ; Nausea/vomitng
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Pharmacoeconomic analysis is often based upon incremental cost per increase in survival (cost-effectiveness). Using this definition supportive care measures, which increase quality but not quantity of life, generate a zero denominator and cannot be directly compared with other components of health care cost. Cost-utility analysis, which measures incremental cost per increase in quality-adjusted life-years (QALY), where QALY=utility score x time at risk, addresses this problem, since successful supportive intervention increases the utility score and thus provides a finite denominator in QALY even when absolute survival is unchanged. However, utility scores for various supportive care modalities have not been well defined. As a pilot study to generate a first approximation of a utility score for nausea/vomiting, we used a rating scale technique and administered two visual analogue scale questions to 30 patients completing a cycle of chemotherapy. Patients rated their global quality of life during their previous cycle of chemotherapy with hypothetical absence or presence of nausea/vomiting as the only variable. The study population included 8 male and 22 female patients, with a median age of 56 years. The most common malignancies were breast cancer (8 patients), lung cancer (7 patients), and hematologic malignancies (7 patients). On a 100 mm visual analogue scale, the mean score for overall quality of life during chemotherapy was 79 mm without nausea/vomiting and 27 mm with nausea/vomiting (P〈0.001, pairedt-test). The implied marked increase in utility with relief of nausea/vomiting suggests a significant impact on cost-utility analysis. Similar methodology could be used to estimate utility scores in other areas of supportive care.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01880641
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  • 2
    Electronic Resource
    Electronic Resource
    Innovative approaches in the treatment of emesis (1996)
    Springer
    Supportive care in cancer 5 (1996), S. 9-11 
    Details
    ISSN: 1433-7339
    Keywords: Key words Antiemetic treatment ; Pharmacoeconomics ; Supportive care
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract  Over the last 15 years, appreciation of the role of dopaminergic (D2) receptors and serotonergic (5-HT3) receptors has led to the development of a series of highly effective antiemetic agents. However, in spite of the suggestion of additional significant receptors (such as the NK-1 receptor and the opiate μ receptor), recent innovations in antiemetic treatment have concentrated on refinement of schedule, route, and dose. Single-dose regimens and oral formulations improve the convenience of antiemetic administration, while identification of the minimum effective dose has important economic implications. Involvement of experienced supportive care investigators in objective determination of utility scores for various supportive care modalities will be vital for rational inclusion of supportive care in pharmacoeconomic analysis, critical pathways, and clinical guidelines.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01681955
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  • 3
    Electronic Resource
    Electronic Resource
    Innovative approaches in the treatment of emesis (1997)
    Springer
    Supportive care in cancer 5 (1997), S. 9-11 
    Details
    ISSN: 1433-7339
    Keywords: Antiemetic treatment ; Pharmacoeconomics ; Supportive care
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Over the last 15 years, appreciation of the role of dopaminergic (D2) receptors and serotonergic (5-HT3) receptors has led to the development of a series of highly effective antiemetic agents. However, in spite of the suggestion of additional significant receptors (such as the NK-1 receptor and the opiate μ receptor), recent innovations in antiemetic treatment have concentrated on refinement of schedule, route, and dose. Singledose regimens and oral formulations improve the convenience of antiemetic administration, while identification of the minimum effective dose has important economic implications. Involvement of experienced supportive care investigators in objective determination of utility scores for various supportive care modalities will be vital for rational inclusion of supportive care in pharmacoeconomic analysis, critical pathways, and clinical guidelines.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01681955
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    Paper (German National Licenses)
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  • 4
    Electronic Resource
    Electronic Resource
    Efficacy and safety of different doses of granisetron for the prophylaxis of cisplatin-induced emesis (1997)
    Springer
    Supportive care in cancer 5 (1997), S. 31-37 
    Details
    ISSN: 1433-7339
    Keywords: Granisetron ; Antiemetic therapy ; Cancer chemotherapy ; Cisplatin ; Emesis
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The purpose of this study was to evaluate the efficacy and safety of four different doses of granisetron when administered as a single intravenous (i.v.) dose for prophylaxis of cisplatin-induced emesis in a multicenter, randomized, parallel-group, double-blind investigation. A total of 353 chemotherapy-naive patients were enrolled, stratified according to cisplatin dose (moderate dose: 50–80 mg/m2,n = 169; high dose: 81–120 mg/m2,n = 184) and randomized to one of four granisetron doses: 5, 10, 20, or 40 µ/kg. Control of emesis was evaluated by the percentages of patients attainingcomplete response (no vomiting or retching, and no rescue medication) andmajor response (≤2 episodes of vomiting or retching, and no rescue medication). Patients were assessed on an inpatient basis for 18–24 h. Safety analyses consisted of adverse events and laboratory parameter changes. Complete response rates over 24 h after chemotherapy were 23%, 48%, 48%, and 44% for granisetron doses of 5, 10, 20, and 40 µg/kg, respectively, in the combined patient population (P=0.011 for linear trend); 29%, 56%, 58%, and 41%, respectively, in the moderate-dose cisplatin stratum (P=0.278 for linear trend); and 18%, 41%, 40%, and 47%, respectively, in the high-dose cisplatin stratum (P = 0.011 for linear trend). Transient headache was the most frequently reported adverse event (19%). There was no evidence of association between increased dose and headache. A single 10-, 20- or 40-µg/kg dose of granisetron is comparably effective in controlling nausea and vomiting associated with moderateor high-dose cisplatin chemotherapy. Granisetron was safe and well tolerated at all doses.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01681959
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  • 5
    Electronic Resource
    Electronic Resource
    Examination of the correlation of serum metoclopramide levels with antiemetic efficacy in patients receiving cisplatin (1987)
    Springer
    Cancer chemotherapy and pharmacology 20 (1987), S. 332-336 
    Details
    ISSN: 1432-0843
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary The existence of a threshold serum metoclopramide level above which total protection from cisplatin-induced vomiting is more likely to occur has been proposed. We monitored serum metoclopramide levels prior to the third metoclopramide dose in the first cisplatin treatment cycle in patients receiving metoclopramide 2 mg/kg×4 as part of a randomized double-blind cross-over study comparing single-agent metoclopramide with combination metoclopramide and dexamethasone. Serum samples from 35 patients (17 receiving single-agent metoclopramide and 18 receiving the combination) were analyzed using reverse-phase high-pressure liquid chromatography (HPLC). A wide variation in metoclopramide levels was observed (range 273–3380 ng/ml). Serum levels obtained from the same patient on multiple treatment cycles were well correlated, and the addition of dexamethasone did not alter serum metoclopramide levels. No threshold level could be identified for the two groups (single-agent or combination antiemetic therapy) considered individually or considered together. However, significantly more vomiting episodes and a lower incidence of total protection were noted in patients with metoclopramide levels above 1469 ng/ml receiving metoclopramide alone. This effect was nullified in the combination antiemetic group. Our data do not support a directly proportional relationship between serum metoclopramide level and antiemetic protection. However, a non-linear relationship with a possible agonist/antagonist effect is suggested.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00262587
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  • 6
    Electronic Resource
    Electronic Resource
    Progressive paresthesias after cessation of therapy with very high-dose cisplatin (1989)
    Springer
    Cancer chemotherapy and pharmacology 25 (1989), S. 62-64 
    Details
    ISSN: 1432-0843
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Control of cisplatin-induced nephrotoxicity and nausea/vomiting has enabled the development of very high-dose cisplatin regimens (monthly total dose, 200 mg/m2). Neurotoxicity is now recognized to be the dose-limiting toxicity of these regimens. However, during a pilot study involving 5 mg/m2 vinblastine and 100 mg/m2 cisplatin given every 28 days on days 1 and 8 for the treatment of advanced non-small-cell lung cancer, we noted a high incidence of progressive peripheral neuropathy, which continued for several months after the discontinuation of cisplatin chemotherapy. Of the six patients treated, four received at least three cycles of therapy (median total cisplatin dose, 685 mg/m2; range, 500–725 mg/m2). All four patients developed a progressive peripheral neuropathy, with a worsening of toxicity by 1–3 grades over the 2–3 months after cisplatin discontinuation. One patient progressed from grade I (mild paresthesia) to grade IV (inability to ambulate) over a period of 3 months after the discontinuation of therapy. Stricter rules for early dose deescalation and discontinuation may be required for very high-dose cisplatin regimens. Delayed progressive neuropathy should be recognized as a possible late complication of this form of therapy.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00694340
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  • 7
    Electronic Resource
    Electronic Resource
    Randomized double-blind comparison of three dose levels of intravenous ondansetron in the prevention of cisplatin-induced emesis (1993)
    Springer
    Cancer chemotherapy and pharmacology 32 (1993), S. 268-272 
    Details
    ISSN: 1432-0843
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The selective 5-hydroxytryptamine3 (5HT3) antagonist ondansetron has been shown to be an effective antiemetic in patients receiving cisplatin chemotherapy. This double-blind study compared the efficacy and safety of three doses of intravenous ondansetron in the prevention of nausea and vomiting associated with high-dose (≥100 mg/m2) cisplatin chemotherapy. A total of 125 patients were randomized (1∶1∶1) to receive 0.015, 0.15, or 0.30 mg/kg every 4 h for a total of 3 doses. All patients were monitored for emetic episodes, adverse events, and laboratory safety parameters for 24 h following cisplatin administration. The 0.15-mg/kg dose was superior to the 0.015-mg/kg dose with respect to the median number of emetic episodes (P=0.033) and complete response (no emetic episodes,P=0.005). No statistically significant difference was found between the 0.15 and the 0.30-mg/kg groups. The most common adverse event was headache. Three 0.15-mg/kg doses of intravenous ondansetron are safe, effective, and adequate for the control of cisplatin-induced emesis.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00686171
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  • 8
    Electronic Resource
    Electronic Resource
    Treatment of poor-prognosis extensive disease small-cell lung cancer with an all-oral regimen of etoposide and cyclophosphamide – a Southwest Oncology Group clinical and pharmacokinetic study (1999)
    Springer
    Cancer chemotherapy and pharmacology 44 (1999), S. 461-468 
    Details
    ISSN: 1432-0843
    Keywords: Key words Etoposide ; Cyclophosphamide ; Oral chemotherapy ; Pharmacodynamics ; Small-cell lung cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Purpose: An all-oral regimen of etoposide and cyclophosphamide was developed for use in poor-prognosis extensive disease small-cell lung cancer. Limited pharmacokinetic sampling was used to derive a pharmacodynamic model predictive of myelosuppression early in the course of therapy. Patients and methods: Eligible patients were chemotherapy-naive and had extensive disease small-cell lung cancer with either SWOG performance status 2 or serum albumin 〈3.5 g/dl. The first cohort (n = 18) received etoposide orally at 50 mg daily and cyclophosphamide orally at 50 mg daily days 1–14 every 28 days. Due to good hematologic tolerance, the second cohort (n = 39) received both agents orally at 50 mg twice daily days 1–14 every 28 days. Plasma etoposide levels were determined in samples drawn at baseline, and at 1 h, 2 h, and 23.5 h (trough) after the first dose. Linear regression analysis was used to determine pharmacokinetic and demographic parameters predictive of myelosuppression. Results: A total of 173 treatment cycles were delivered. Patients on the daily regimen had a 22% response rate (complete and partial), a 22% unconfirmed response rate, and a 5-month median survival, while patients on the twice-daily regimen had a 28% response rate (complete and partial), a 13% unconfirmed response rate, and a 7-month median survival. Granulocytopenia and alopecia were the most common toxicities seen. Significant granulocytopenia could be predicted for the twice-daily regimen according to the formula ln(AGC nadir)=7.80 − 1.88(trough), with an increased incidence of granulocytopenia if the etoposide trough value was ≥1.49 μg/ml. Conclusion: Oral etoposide and oral cyclophosphamide given days 1–14 every 28 days is well tolerated and results in an acceptable response rate and median survival in poor-prognosis (poor performance status or low serum albumin) extensive disease small-cell lung cancer. A trough etoposide level obtained within 24 h of starting therapy can predict severe granulocytopenia.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002800051119
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  • 9
    Electronic Resource
    Electronic Resource
    Treatment of non-small-cell lung cancer with vinblastine and very high-dose cisplatin. A Southwest Oncology Group study (1991)
    Springer
    Cancer chemotherapy and pharmacology 28 (1991), S. 211-213 
    Details
    ISSN: 1432-0843
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Suggestions of a dose-response effect for cisplatin in non-small-cell lung cancer have contributed to the development of very high-dose cisplatin regimens (200 mg/m2 per cycle). We treated 53 eligible patients with metastatic or recurrent non-small-cell lung cancer with a combination of 100 mg/m2 cisplatin and 4 mg/m2 vinblastine, each given on days 1 and 8 of a 28-day cycle. We observed no complete response and 4 partial responses (8%). Median survival was 6 months. Toxicities of grade III or greater included leukopenia (11 cases), nausea/vomiting (6 cases), thrombocytopenia (2 cases), anemia (2 cases), and elevation of transaminase (1 case). Neurotoxicity has been reported to be a major problem in several other very high-dose cisplatin regimens. The low level of neurotoxicity observed in this study may be attributable to the median cumulative cisplatin dose of 〈600 mg/m2. This vinblastine/very high-dose cisplatin regimen showed minor activity against non-small-cell lung cancer. The level of activity did not surpass that of standard-dose (100 mg/m2 per cycle) cisplatin-containing regimens.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00685511
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  • 10
    Electronic Resource
    Electronic Resource
    Future of the management of emesis (1994)
    Springer
    Supportive care in cancer 2 (1994), S. 301-303 
    Details
    ISSN: 1433-7339
    Keywords: Emesis ; Receptors Serotonergic ; Opiate ; Adrenergic
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Development of effective antiemesis had depended upon identification of critical neurotransmitter receptors within the emetic reflex arc. Investigations of cholinergic, histaminergic, dopaminergic, and serotonergic receptors led to our present generation of antiemetics. Opiate and adrenergic receptors are the likely targets of the next generation of antiemetics. The recently identified critical neurotransmitter receptors (opiate, adrenergic, and serotonergic) also provide a link to cancer pain, anticipatory vomiting, and cancer anorexia respectively. Future collaborations are likely to include investigators from various areas of supportive care working together on these common problems.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00365582
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