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Journal of Clinical Oncology, Vol 22, No 4 (February 15), 2004: pp. 725-729
© 2004 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2004.09.040
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Randomized, Double-Blind, Dose-Finding Study of Dexamethasone in Preventing Acute Emesis Induced by Anthracyclines, Carboplatin, or Cyclophosphamide:

The Italian Group for Antiemetic Research

From the Italian Group for Antiemetic Research

Address reprint requests to Fausto Roila, MD, Medical Oncology Division, Policlinico Hospital, 06122 Perugia, Italy; e-mail: roila.fausto{at}libero.it


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 PATIENTS AND METHODS
 RESULTS
 DISCUSSION
 Appendix
 Authors' Disclosures of...
 REFERENCES
 
PURPOSE: Different doses and schedules of dexamethasone, combined with a 5-HT3 antagonist, are used to prevent acute emesis induced by anthracyclines, carboplatin, or cyclophosphamide. Therefore, we planned a randomized, double-blind, dose finding study aimed to identify the preferred dose and schedule of dexamethasone.

PATIENTS AND METHODS: All consecutive chemotherapy-naive patients enrolled onto study were randomly assigned to receive for the prevention of acute emesis, during the first 24 hours, one of the following dexamethasone regimens, in combination with ondansetron 8 mg intravenously (IV): for arm A, 8 mg IV before chemotherapy plus 4 mg orally every 6 hours for four doses, starting at the same time of the chemotherapy; for arm B, 24 mg IV single dose before chemotherapy; and for arm C, 8 mg IV single dose before chemotherapy. All patients received from day 2 to 5 oral dexamethasone 4 mg bid.

RESULTS: A total of 587 patients were enrolled, and 585 were assessed according to the intention-to-treat principle (195 patients in each arm). The rate of complete protection from acute vomiting and nausea, respectively, was not significantly different among the three groups (arm A, 84.6% and 66.7%; arm B, 83.6% and 56.9%; arm C, 89.2% and 61.0%), nor was the rate of complete protection from delayed vomiting and nausea, respectively (arm A, 81.0% and 46.7%; arm B, 81.3% and 45.1%; arm C, 79.8% and 46.1%). The incidence of delayed vomiting and nausea was strictly dependent on the presence of acute vomiting and nausea. Adverse events were mild and not significantly different among the three groups.

CONCLUSION: Dexamethasone 8 mg single dose IV before chemotherapy, in combination with a 5-HT3 antagonist, should be considered the preferred dose to prevent acute emesis induced by anthracyclines, carboplatin, or cyclophosphamide.


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
PATIENTS AND METHODS
 RESULTS
 DISCUSSION
 Appendix
 Authors' Disclosures of...
 REFERENCES
 
A combination of a 5-HT3 antagonist plus dexamethasone is the standard antiemetic prophylaxis for the prevention of acute emesis induced by anthracyclines, carboplatin, or cyclophosphamide used alone or in combination [1-3]. In a study in which the combination of dexamethasone with a 5-HT3 antagonist was demonstrated superior with respect to dexamethasone alone or the 5-HT3 antagonist alone, dexamethasone was administered as 8 mg intravenously (IV) plus 4 mg orally every 6 hours for four doses starting contemporarily with chemotherapy [4]. With that dose and schedule of dexamethasone, approximately 90% of patients achieved complete protection from acute vomiting, and these results have been confirmed in another large study [5]. In two other studies, in which the combination of a 5-HT3 antagonist plus dexamethasone was found superior to metoclopramide plus dexamethasone, dexamethasone was used as single IV doses of 16-20 mg before the chemotherapy administration [6,7]. Therefore, as can easily be seen, in the combination with a 5-HT3 antagonist, different doses and schedules of dexamethasone are used to prevent acute emesis in patients submitted to anthracyclines, carboplatin, or cyclophosphamide, but no dose-finding studies have been performed to identify its preferred dose. This prompted us to carry out a prospective, multicenter, randomized, double-blind dose-finding study comparing three different doses and schedules of dexamethasone in combination with the same 5-HT3 antagonist (ondansetron).


   PATIENTS AND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 PATIENTS AND METHODS
RESULTS
 DISCUSSION
 Appendix
 Authors' Disclosures of...
 REFERENCES
 
Patients
All consecutive adult chemotherapy-naive patients scheduled to receive cyclophosphamide 600 to 1,000 mg/m2, doxorubicin ≥ 50 mg/m2, epirubicin ≥ 75 mg/m2, or carboplatin ≥ 300 mg/m2 used either alone or combined with other chemotherapeutic agents, were included in the study. Criteria for exclusion were treatment on days 2 to 4 after chemotherapy with other agents, except fluorouracil, etoposide, teniposide, vinorelbine, vindesine, vinblastine, and vincristine; the presence of nausea and vomiting or the use of antiemetics in the 24 hours before chemotherapy; severe concurrent illness other than neoplasia; other causes of vomiting (eg, gastrointestinal obstruction, CNS metastases, or hypercalcemia); controindications to dexamethasone administration (eg, active peptic ulceration); concurrent therapy with corticosteroids (unless given as physiological supplement) or benzodiazepines (unless given for night sedation); concurrent abdominal radiotherapy; and pregnancy. Patients with WBC less than 3,000 µL or platelet less than 70,000 µL were also excluded.

Study Design and Antiemetic Therapy
This was a multicenter, randomized, double-blind, parallel study. Using a list of computer-generated random permuted blocks of 12 patients for each center, patients randomly received one of the following doses and schedules of dexamethasone: 8 mg IV 30 minutes before chemotherapy and 4 mg orally every 6 hours for four doses starting contemporarily with chemotherapy (treatment arm A); 24 mg IV 30 minutes before chemotherapy (treatment arm B); and 8 mg IV 30 minutes before chemotherapy (treatment arm C). Patients of these last two groups received four placebo capsules every 6 hours in the first 24 hours to ensure study blindness. On day 1 all patients received ondansetron 8 mg IV 15 minutes before chemotherapy. On days 2 to 5, all patients received oral dexamethasone 4 mg every 12 hours. As rescue medication, patients received metoclopramide 20 mg IM or IV in the first 24 hours and prochlorperazine 10 mg suppositories on day 2 to 5.

Response Assessment
Patients filled out a questionnaire for day 1 and a diary card for days 2 to 8 in which they reported the presence and the intensity of nausea and the number of vomiting episodes, as well as any adverse events. After 24 hours from the chemotherapy administration, the investigators called patients by phone to record as soon as possible the presence or absence of acute emesis. This information was used as comparator with that contained in the questionnaire. An emetic episode was defined as a single vomit or retch, or any number of continuous vomiting episodes or retches. It was required that one emetic episodes be separated from another by an absence of vomiting or retching for at least 1 minute. The absence of emetic episodes was defined as complete protection from vomiting. Nausea was recorded according to a graded scale: 0, none; 1, mild (did not interfere with normal daily life); 2, moderate (interfered with normal daily life); and 3, severe (patients bedridden because of nausea). The absence of nausea was defined as complete protection from nausea.

Statistical Analysis
The sample size was calculated under the following assumptions: complete control of acute vomiting is achieved in 90% of patients treated with ondansetron plus dexamethasone 8 mg IV plus 4 mg 4 times orally; ondansetron plus dexamethasone 8 mg IV allows to 75% of patients to be completely protected against acute vomiting, and ondansetron plus dexamethasone 24 mg IV to 82.5% of patients. Five-hundred seventy patients were necessary to identify a clinically meaningful difference of 15% among the three treatments, with 80% probability of finding a significant difference, fixing {alpha} = 0.05 for a two-tailed test.

Comparisons of complete protection from vomiting, nausea, and nausea and vomiting among the three arms were performed using Fisher's exact test generalized by Freeman-Halton, and, when significant, Fisher's exact test for each independent contrast was used, adjusting for Bonferroni's inequality. Multifactorial analysis was carried out using logistic models, assuming as dependent variable the presence or absence of acute (delayed) vomiting or nausea. Age (in three classes: < 50 years, 50 to 64 years, and ≥ 65 years), motion sickness (yes or no), setting of chemotherapy administration (inpatient or outpatient), alcohol intake (yes or no) and use of anthracycline (epirubicin, doxorubicin)-containing chemotherapy (yes or no) were considered as prognostic factors. In addition, in analyzing delayed vomiting or nausea, the dependence on presence or absence of acute vomiting or nausea was also assumed as an explanatory variable. G-test for the evaluation of the overall effect of each factor and Wald's test for each pairwise comparison between its levels were used. All P values refer to two-tailed tests. The study was approved by the local ethics committees at the participating institutions, and all patients gave their written informed consent.


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 PATIENTS AND METHODS
 RESULTS
DISCUSSION
 Appendix
 Authors' Disclosures of...
 REFERENCES
 
From February 2000 to June 2002, all consecutive chemotherapy-naive cancer patients treated with anthracyclines, carboplatin, or cyclophosphamide in 23 Italian centers and one Yugoslavian oncological center were enrolled onto the study. A total of 587 patients took part in the study, and 585 were assessable for acute emesis according to the intention-to treat principle (195 patients in each arm). Two patients were lost to follow-up. Only seven patients did not take the four planned capsules in the first 24 hours: one patient in arm A and three patients in each arm of B and C. Reasons for this were error (three patients), failure of antiemetic treatment (three patients) and adverse events (one patient). According to the intention-to-treat principle, the assessed patients for delayed emesis were 195, 193, and 193 in arm A, B, and C, respectively. Four patients did not come back with their diary card, and, therefore, they were assessed only for acute emesis.

The prescribed tablets of dexamethasone to control delayed emesis were taken by 511 of 581 patients (88.0%). Seventy patients, almost equally distributed among the three arms of the study (data not shown), stopped taking oral dexamethasone because of error (20 patients), failure of antiemetic therapy (13 patients), adverse events (18 patients), refusal (two patients), or unknown reasons (17 patients). As shown in Table 1, patient characteristics were well balanced among the three arms of the study. Almost all patients were females treated for breast cancer.


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  		Table 1. Patient Characteristics

 
Acute Emesis
The rate of complete protection from acute vomiting, nausea, and nausea and vomiting was not significantly different among the three groups (Table 2). Also, complete protection from acute, moderate, and severe nausea was not different (85.1% with 8 mg IV plus 4 mg orally for 4 times v 82.6% with 24 mg IV and 89.2% with 8 mg IV).


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  		Table 2. Results in the First 24 Hours

 
The multifactorial analysis confirmed that the effectiveness of the three doses and schedules of dexamethasone was not significantly different. The most important prognostic factors able to explain the variability of acute vomiting and nausea were anthracycline-containing chemotherapy, age, and setting of chemotherapy administration. In fact, complete protection from vomiting and nausea, respectively, was achieved by 81.6% and 53.5% of patients who received anthracyclines and by 92.1% and 73.0% of those who did not (P < .004 and P < .001, respectively), by 76.5% and 47.5% of patients less than 50 years old, by 89.8% and 63.6% of those aged 50 to 64 years, and by 93.9% and 81.1% of those aged ≥ 65 years. All differences with respect to the results achieved by the youngest patients were significant (for vomiting and nausea, respectively, P < .002 and P < .008 for the second age class; P < .003 and P < .001 for the third class). Moreover, complete protection from acute nausea was found significantly superior in the oldest patients with respect to 50- to 64-year-old patients (P < .006). Finally, complete protection from acute vomiting and nausea was significantly superior among inpatients (98.0% and 82.0%, respectively) than among outpatients (84.7% and 59.6%, P < .048/P < .013, respectively).

Delayed Emesis
On days 2 to 5, all patients were treated with oral dexamethasone. The rate of complete protection from delayed (days 2 to 8) vomiting, nausea, and nausea and vomiting was not significantly different among the three arms (Table 3). Only a few patients, who had no emesis on days 2 to 5, had delayed vomiting and nausea on days 6 to 8 (three of five patients on arm A, the one patient in arm B, and two of two patients in arm C).


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  		Table 3. Results on Days 2 Through 8

 
Overall, the incidence of delayed vomiting and nausea was strictly dependent on the presence of acute vomiting and nausea. In particular, among patients with or without complete protection from acute vomiting, the rates of complete protection from delayed vomiting were 87.9% and 43.3%, respectively, in arm A; 91.9% and 29.1%, respectively, in arm B; and 85.5% and 30.0%, respectively, in arm C. Among patients with or without complete protection from acute nausea, the respective rates of complete protection from delayed nausea were 66.4% and 9.2%, in arm A; 68.2% and 14.3 in arm B; and 66.9%13.3% in arm C.

The multifactorial analysis confirmed that there were no differences in complete protection from delayed vomiting and nausea among the three doses and schedules of dexamethasone. The only significant prognostic factor for delayed vomiting or nausea was the presence of acute vomiting or nausea (P < .001/P < .001).

Adverse Events
Adverse events on day 1 were mild and not significantly different among the three groups of patients (Table 4). Asthenia and headache were the most frequent adverse events reported. Again, on days 2 to 8, the incidence of adverse events was not significantly different (data not shown).


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  		Table 4. Adverse Events on Day 1

 

   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 PATIENTS AND METHODS
 RESULTS
 DISCUSSION
Appendix
 Authors' Disclosures of...
 REFERENCES
 
A combination of a 5-HT3 antagonist plus dexamethasone is the treatment of choice to prevent acute emesis induced by anthracyclines, carboplatin, or cyclophosphamide. In contrast with cisplatin-treated patients, for whom a dose-finding study showed 20 mg IV single dose before chemotherapy as the preferred dose [8], the dose of dexamethasone to be used for the prevention of acute emesis induced by anthracyclines, carboplatin, or cyclophosphamide has until now not been studied. This is the first large double-blind, randomized, dose-finding study evaluating different doses and schedules of dexamethasone in this subgroup of patients. The study clearly shows that for preventing acute emesis, dexamethasone 8 mg single dose IV before chemotherapy has an effectiveness similar to that of a 24 mg single dose IV and 8 mg IV followed by 4 mg orally for four times. This is in contrast with what is recommended by some authors who considered repeated and high doses of dexamethasone necessary for the prevention of acute emesis induced by anthracyclines, carboplatin, or cyclophosphamide [9]. Therefore, the combination of a 5-HT3 antagonist with an 8 mg single dose IV before chemotherapy did not reduce the complete protection rates from delayed vomiting and nausea with respect to similar combinations containing a higher single dose or repeated doses of dexamethasone.

Nevertheless, the study was carried out, enrolling consecutive patients, only 3% of whom were men. Although this probably is the composition of the patient population undergoing these chemotherapeutic regimens, caution should be exercised in extrapolating the results of this study to the male population. This study also confirms the importance of some prognostic factors for acute emesis induced by anthracyclines, carboplatin, or cyclophosphamide, such as the type of chemotherapy, age, and setting of chemotherapy administration, as well as the dependence effect of delayed emesis on the results achieved in the first 24 hours.

Of course, using only a single dose IV of dexamethasone administered immediately before chemotherapy can improve the compliance of patients with antiemetic therapy. Even if in our study, the compliance of patients with the four capsules to be administered in the first 24 hours was high in clinical practice, a simplified schedule of the antiemetic prophylaxis could be preferred by the patients. Adverse events were similar among the three different doses and schedules, and the study confirms the good tolerability of dexamethasone-containing antiemetic treatment, even administered at the highest doses.

In conclusion, the combination of dexamethasone 8 mg IV single dose with a 5-HT3 antagonist should be considered the preferred treatment in the prophylaxis of acute emesis induced by anthracyclines, carboplatin, or cyclophosphamide.


   Appendix
TOP
 ABSTRACT
 INTRODUCTION
 PATIENTS AND METHODS
 RESULTS
 DISCUSSION
 Appendix
Authors' Disclosures of...
 REFERENCES
 
Investigators and collaborating centers: Medical Oncology Division, Perugia: C. Basurto, M. Betti, V. Bonciarelli, M. Cianchetti, F. Roila, M. Tonato; Department of Medicine and Public Health, University L’Aguila: E. Ballatori; Medical Oncology Division, Belgrade: S. Susnjar, Z. Neskovic-Konstantinovic, Lj. Stamatovic, Z. Marinkovic; Dept. of Oncology and Hematology, A.O. S. Carlo, Potenza: G. Rosati, L. Manzione, A. Rossi, D. Germano, R. Romano; Medical Oncology Division, "Renzetti Hospital", Lanciano: A. Nuzzo, L. Laudadio, N. D'Ostilio, S. Forciniti; Medical Oncology Service, 'S. Maria' Hospital, Terni: F. Buzzi, R. Bartolucci, G. Fumi, S. Catanzani; Medical Oncology Division, Frosinone: T. Gamucci, V. Ferraresi, G. Trombetta, A. Vaccaro; Medical Oncology Service, Sassari: A. Contu, N. Olmeo, G. Baldino; Medical Oncology Division, Sanremo: E. Campora, A. Venturino, G. Addamo; Medical Oncology Service, Fabriano: R.R. Silva, L. Giuliodori, R. Bisonni; Medical Oncology Division, Ravenna: C. Dazzi, A. Cariello, F. Zumaglini; Medical Oncology Division, Campus Biomedico, Roma: G. Tonini, D. Santini, B. Vincenzi; Medical Oncology Division, Legnano hospital, Legnano: S. Fava, E. Grimi, M. Luoni; Medical Oncology Division, Negrar Hospital, Verona: V. Picece, M. Nicodemo, E. Recaldin; Medical Oncology Division, Ferrara: D. Donati, G. Margutti; Medical Oncology Service, "La Sapienza" University, Roma: E. Cortesi, G. D'Auria; Medical Oncology Service, Teramo: A. Lalli, F. Di Giandomenico; Medical Oncology Division, University, Cagliari: B. Massidda, M.T. Ionta; Medical Oncology Division, Pesaro: P. Alessandroni, A.M. Baldelli; Medical Oncology Service, Foligno: D. Pinaglia, M. Sassi; Medical Oncology Dept., University, Modena: R. Sabbatini, M. Maur; Medical Oncology Service, Città di Castello: S. Porrozzi, S. Bravi; Medical Oncology Division, S.Eugenio Hospital, Roma: M. Antimi; Medical Oncology Division, Avellino: C. Gridelli; Medical Oncology Division, Hospital, Busto Arsizio: C. Verusio; Institute for Oncology and Radiology of Serbia, Belgrade, and Monteregro: Snezana Bosnjak.


   Authors' Disclosures of Potential Conflicts of Interest
TOP
 ABSTRACT
 INTRODUCTION
 PATIENTS AND METHODS
 RESULTS
 DISCUSSION
 Appendix
 Authors' Disclosures of...
REFERENCES
 
The authors indicated no potential conflicts of interest.


   ACKNOWLEDGMENTS
 
We thank GSK Italy for furnishing ondansetron and dexamethasone for the study and for printing the Clinical Record Forms.


   NOTES
 
Presented at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago IL, May 31-June 3, 2003.

Authors' disclosures of potential conflicts of interest are found at the end of this article.


   REFERENCES
TOP
 ABSTRACT
 INTRODUCTION
 PATIENTS AND METHODS
 RESULTS
 DISCUSSION
 Appendix
 Authors' Disclosures of...
 REFERENCES
 
1. Prevention of chemotherapy- and radiotherapy-induced emesis: Results of the Perugia Consensus Conference—Antiemetic Subcommittee of the Multinational Association of Supportive Care in Cancer (MASCC). Ann Oncol 9:811-819, 1998[Abstract/Free Full Text]

2. Gralla RJ, Osoba D, Kris MG, et al: Recommendations for guidelines for the use of antiemetics: Evidence-based clinical practice guidelines. J Clin Oncol 17:2971-2994, 1999[Free Full Text]

3. ESMO: ESMO recommendations for prophylaxis of chemotherapy-induced nausea and vomiting. Ann Oncol 12:1059-1060, 2001[Free Full Text]

4. Dexamethasone, granisetron, or both for the prevention of nausea and vomiting during chemotherapy for cancer: The Italian Group for Antiemetic Research. N Engl J Med 332:1-5, 1995[Abstract/Free Full Text]

5. Dexamethasone alone or in combination with ondansetron for the prevention of delayed nausea and vomiting induced by chemotherapy: The Italian Group for Antiemetic Research. N Engl J Med 342:1554-1559, 2000[Abstract/Free Full Text]

6. Soukop M, McQuade B, Hunter E, et al: Ondansetron compared with metoclopramide in the control of emesis and quality of life during repeated chemotherapy for breast cancer. Oncology 49:295-304, 1992[CrossRef][Medline]

7. Du Bois A, Mckenna CJ, Andersson H, et al: A randomised, double-blind, parallel-group study to compare the efficacy and safety of ondansetron plus dexamethasone with metoclopramide plus dexamethasone in the prophylaxis of nausea and emesis induced by carboplatin chemotherapy. Oncology 54:7-14, 1997[Medline]

8. Double-blind, dose-finding study of four intravenous doses of dexamethasone in the prevention of cisplatin-induced acute emesis: Italian Group for Antiemetic Research. J Clin Oncol 16:2937-2942, 1998[Abstract/Free Full Text]

9. Roila F, Tonato M, Del Favero A: Treatment of Moderately Emetogenic Chemotherapy-Induced Nausea and Vomiting, in Dicato M (ed): Medical Management of Cancer Treatment Induced Emesis. London, UK, Martin Dunitz Ltd, 1998, pp 87-101

Submitted September 9, 2003; accepted December 10, 2003.


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