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Journal of Clinical Oncology, Vol 24, No 27 (September 20), 2006: pp. 4472-4478 © 2006 American Society of Clinical Oncology. DOI: 10.1200/JCO.2006.05.6382 Delayed Nausea and Vomiting Continue to Reduce Patients' Quality of Life After Highly and Moderately Emetogenic Chemotherapy Despite Antiemetic Treatment
From the Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria; Outcomes Research, Merck & Co, Whitehouse Station, NJ; Department of Internal Medicine F, Hillerød Hospital, Hillerød; and the Department of Oncology, Copenhagen University Hospital Herlev, Herlev, Denmark Address reprint requests to Brigitte Bloechl-Daum, MD, Department of Clinical Pharmacology, Medical University of Vienna, Allgemeines Krankenhaus, Waehringer Guertel 18-20, A-1090 Vienna, Austria; e-mail: brigitte.bloechl-daum{at}meduniwien.ac.at
PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) are major adverse effects of cancer chemotherapy. We compared the impact of acute (during the first 24 hours postchemotherapy) and delayed (days 2 through 5 postchemotherapy) CINV on patients' quality of life (QoL) after highly or moderately emetogenic chemotherapy (HEC and MEC, respectively). PATIENTS AND METHODS: This prospective, multicenter, multinational study was conducted in 14 medical practices on cancer patients undergoing either HEC or MEC treatment. Patients recorded episodes of nausea and vomiting in a diary. Patients completed the Functional Living Index-Emesis (FLIE) questionnaire at baseline and on day 6. RESULTS: A total of 298 patients were assessable (67 HEC patients, 231 MEC patients). Emesis was reported by 36.4% of patients (13.2% acute, 32.5% delayed) and nausea by 59.7% (36.2% acute, 54.3% delayed). HEC patients reported significantly lower mean FLIE total score than MEC patients (95.5 v 107.8 respectively; P = .0049). Among all patients, the nausea score was significantly lower than the vomiting score (50.0 and 55.3, respectively; P = .0097). Of the 173 patients who experienced neither vomiting nor nausea during the first 24 hours postchemotherapy, 22.9% reported an impact of CINV on daily life caused by delayed CINV. CONCLUSION: CINV continues to adversely affect patients' QoL despite antiemetic therapy even after treatment with only moderately emetogenic chemotherapy regimens, and even in the subgroup of patients who do not experience nausea and vomiting during the first 24 hours. On the basis of the FLIE results in this study, nausea had a stronger negative impact on patients' daily lives than vomiting.
Chemotherapy-induced nausea and vomiting (CINV) remain major adverse effects of cancer chemotherapy.1 Antiemetic treatments, including serotonin (5-HT3) receptor antagonists and corticosteroids, have been instrumental in improving the control of vomiting among patients receiving chemotherapy.2,3 However, recent studies have demonstrated the need for improved therapeutic intervention in a number of areas.4 For example, Roscoe et al5 report that after the introduction of 5-HT3 receptor antagonists, the incidence of nausea may actually have risen despite the reduction in the incidence of vomiting. Furthermore, antiemetic treatments have been less effective in improving delayed nausea and vomiting than acute nausea and vomiting.6 Two meta-analyses of clinical trials have shown that 5-HT3 receptor antagonists with or without corticosteroids are not effective against delayed emesis and nausea.7,8 The lack of adequate CINV control may be partly attributed to the fact that antiemetic treatment regimens are guided by risk factors, including level of emetogenicity of chemotherapeutic agents.9 Emetic risk categories are based on experience rather than specific data, and the categories refer to acute emesis only.6,10 Moreover, the neuropharmacologic mechanism of delayed CINV (> 24 hours postchemotherapy) is not well understood, and prevention of delayed CINV has largely been based on empiric results. CINV adversely impact patients' quality of life11-14 From a list of chemotherapy-related adverse effects, patients rated nausea as their first and vomiting as their third most feared symptom.15 In a recent study, ovarian cancer patients included complete to almost complete control from CINV among the most favorable health states, just below perfect health and clinical remission.16 Against this background, the Anti Nausea Chemotherapy Registry (ANCHOR) study was designed to address two issues; (i) to prospectively compare, under current practice patterns, the incidence of acute and delayed nausea and emesis after highly and moderately emetogenic chemotherapy (HEC and MEC, respectively), and (ii) to assess the impact of acute and delayed nausea and vomiting after HEC and MEC on patients' quality of life (QoL). The Functional Living Index-Emesis (FLIE), a validated nausea- and vomiting-specific patient-reported outcome measure was used to evaluate the impact of CINV on patients' daily lives.17,18 Results on the incidence of CINV after HEC or MEC are reported elsewhere.19 In the following, we address the impact of CINV on patients' daily life.
Study Design and Setting This prospective, multicenter, observational study was conducted in 14 medical practices in Denmark, France, Italy, Germany, the United Kingdom, and the United States during 2001 to 2002. All centers were experienced in the administration of cancer chemotherapy. Centers were selected to allow for enrollment of a broad spectrum of patients requiring chemotherapy.
Patient Selection Criteria Patients were not eligible for participation in the study if they were scheduled to receive multiple-day chemotherapy, or if they had vomited during the 24-hour period preceding chemotherapy administration. The protocol was approved by the ethics committees/institutional review boards according to the requirements in each participating country. Written and signed informed consent was obtained from all patients before study entry.
Data Collection In addition, patients were asked to complete the FLIE, a self-administered questionnaire used to evaluate the impact of CINV on patients' daily lives. The development of the FLIE has been described previously.17,18 The FLIE instrument was modeled after the Functional Living Index-Cancer, a patient-completed multidimensional quality of life instrument. The FLIE is a validated nausea- and vomiting-specific patient-reported outcome instrument composed of two domains (vomiting and nausea) with nine identical items in each domain. The FLIE-item score was assessed at baseline (prechemotherapy) and on the morning of day 6 postchemotherapy. The first item in each domain asked the patient to rate how much nausea and vomiting he or she had experienced during the previous 5 days. The remaining eight items covered different sections influencing the patient's quality of daily life (ie, "recreation or leisure activities," "make meal/do tasks," "ability to enjoy meal," "enjoy drinking fluids," "see family/ friends," "daily functioning," "personal hardship," "hardship on others"). The FLIE-score was determined by summing the responses to the 18 questions on a seven-point analog scale. Therefore, the range of total scores possible is between 18 (all one responses on each scale) and 126 (all seven responses on each scale). A higher score corresponds to a higher QoL or less impact of CINV on daily life.20 No or minimal impact on daily life (NIDL) was defined as an average FLIE item score of more than 6 on the seven-point continuous visual analog scale or a total FLIE-Score of more than 108.
Data Analysis
Description of Patient Sample A total of 322 patients from 14 centers were enrolled in the study (patient disposition is shown in Fig 1). One patient was lost to follow-up, one patient died during the observation period; no questionnaires could be obtained from six patients. Questionnaires from 16 further patients had to be excluded from the analysis because of incomplete data or protocol violations. Hence, 298 patients were assessable: 85 were male, 213 were female, and the mean age was 55.5 years (standard deviation, 12.1 years). The most frequent diagnoses were breast (49.3%) and lung (17.8%) cancers. Sixty-seven (22.5%) patients received HEC; of these, 61 (91%) received cisplatin, and six (9%) dacarbazine. Two hundred thirty-one patients(77.5%) received MEC; of these 163 (70%) received regimens containing cyclophosphamide, doxorubicin, and/or epirubicin; 59 (25%) received carboplatin-containing regimens; and nine (5%) received other regimens.19
Antiemetic therapy consistent with the guidelines6,21,22 in force at the time and place of the study was used in most of the patients, and has been described in detail previously.19 Briefly, 282 patients (96.6%) received 5-HT3 receptor antagonists, and 227 (77.7%) received corticosteroids. Two hundred fifty patients (85.6%) received prophylaxis for delayed CINV (> 24 hours postchemotherapy). The most common duration of 5-HT3 receptor antagonist therapy and corticosteroid therapy was 3 days, with 71% of patients receiving 5-HT3 receptor antagonists and 55% of patients receiving a corticosteroid for at least that long.
Frequency of Emetic Episodes and Nausea During the 5-Day Period After Chemotherapy The daily incidence of emesis and its prevalence are reported in Table 1 and Figure 2. The prevalence of acute emesis was similar between HEC- and MEC-treated patients (11.9% and 13.2%, respectively), but HEC treated patients were significantly more likely to report delayed emesis than MEC treated patients (P < .05). On average, HEC treated patients reported more emetic episodes per day per patient than MEC treated patients for both the acute (3.1 v 2.5, respectively) and the delayed phase (1.4 v 1.2, respectively).
The daily incidence and severity of nausea are summarized in Table 2 and Figure 2. The rate of nausea plateaued between days 2 and 3. There were no significant differences in the rate of acute and delayed nausea between HEC- and MEC-treated patients, but HEC-treated patients reported greater nausea severity especially in days 2 through 5, as indicated by the mean VAS score during each period (Table 2).
Impact of Nausea and Vomiting on Patients' Daily Life At baseline, 95.3% of the patients reported NIDL with an average total FLIE score of 122.9. There was no difference between patients scheduled for HEC (93.9% NIDL, total FLIE score 123.1) and MEC (95.6% NIDL, total FLIE score 122.9) at baseline. Results from all items of the FLIE obtained on day 6 are summarized in Table 3. On day 6 postchemotherapy, the mean total FLIE score was 105.4; however, 61.0% of all patients reported that CINV had no or minimal impact on their daily life (ie, total FLIE score > 108). The average FLIE score indicates that patients receiving HEC experienced a greater impact of CINV on their daily life than patients receiving MEC (95.5 v 107.8, respectively P = .0049). Significantly fewer HEC than MEC patients (47.2% and 64.5%, respectively) reported NIDL (P = .0272).
Among all patients, the mean FLIE nausea domain score on day 6 was 50.0 (44.7 for HEC and 51.4 for MEC; P = .0024), whereas the mean FLIE vomiting domain score was 55.3 (50.3 for HEC and 56.5 for MEC; P = .0097), indicating that nausea had a stronger impact on daily life than vomiting (Table 3). This is also reflected by the NIDL data because only 53.1% of patients reported NIDL for nausea, compared with 73.4% with NIDL for vomiting (Fig 3). The greater impact of nausea on daily life is also emphasized by results from individual FLIE items shown in Figure 4: The change from baseline to day 6 was more pronounced for all individual nausea domain items than for the corresponding vomiting domain items.
Impact of Acute and Delayed CINV on Patients' Daily Life Table 4 reports the proportion of patients reporting NIDL for those with acute or delayed vomiting or nausea. On the basis of the total FLIE score, the observed trend is that patients with neither acutenor delayed nausea or vomiting are more likely to report NIDL than patients who reported both acute and delayed nausea or vomiting (78.3% v 20.8% for vomiting, 94.4 for v 26.5 for nausea). On average, patients with neither acute nor delayed nausea or vomiting report higher FLIE total scores than patients with both acute and delayed nausea or vomiting (115.9 v 72.1 for vomiting, 121.9 for v 86.2 for nausea).
Data in Table 4 show that only 155 (66.8%) of 232 patients without acute vomiting reported NIDL on day 6. Similarly, among the 168 patients who experienced no acute nausea, 129 (76.7%) reported NIDL on day 6.
It may seem self-evident that nausea and vomiting after chemotherapy have a negative impact on patients' health-related QoL, but there are little data from prospective clinical trials to demonstrate and quantitatively assess this adverse effect of treatment.20 Moreover, most studies of the QoL effects of nausea and vomiting are characterized by narrow patient selection criteria and are limited to well-defined chemotherapy regimens. Hence, it is not known to what extent the nausea- and vomiting-induced deterioration of QoL differs after chemotherapy regimens of different levels of emetogenicity. However, data on QoL deterioration would be useful to inform the choice of preventive antiemetic regimens. We set out to directly compare the incidence and QoL impact of nausea and vomiting after HEC and MEC in a representative sample of oncology patients under patterns of daily clinical practice. Incidence rates of CINV in our patients are in agreement with results from previous, similar studies.23,24 The central findings from this study were that both HEC and MEC patients reported delayed nausea and vomiting more often than acute nausea and vomiting. Although delayed emesis occurred in almost twice as many HEC as MEC patients, the rate of delayed nausea was unexpectedly similar after HEC and MEC treatment (60.3% v 52.4%, respectively). This indicates that level of emetogenicity may not be as strong a predictor of delayed nausea as might be assumed. The potential clinical relevance of this observation is emphasized by the finding that nausea had a stronger negative impact on QoL than vomiting. This was consistent across all items of the FLIE score (Fig 3), and more patients experienced an impact on daily life from nausea than from vomiting (Table 3; Fig 2). This is in concordance with the finding that 5-HT3 receptor antagonists, such as ondansetron and granisetron, have been successful in preventing vomiting, but less effective in the prevention of nausea.25 Both absolute FLIE scores and the proportions of patients reporting NIDL were significantly different between HEC- and MEC-treated groups, demonstrating that HEC patients suffered more of an impact on QoL. This finding, although not unexpected, has not, to our knowledge, been described previously. Nonetheless, our data (Table 3) indicate that the percentage of MEC patients who experienced an impact on daily living was as high as 35.5 for the FLIE total score and 42.6 for the nausea domain score (corresponding to 64.5% and 57.4% NIDL, respectively). This indicates that nearly one in two patients suffered an impact on daily life, primarily from nausea, even though they received only moderately emetogenic regimens. Our findings highlight the need for adequate prevention of CINV, even after MEC. Considering that most of our MEC patients received antiemetic treatment consistent with guidelines relevant at the time of this study, this also supports the notion that management of MEC patients may not have been adequately addressed, even in treatment guidelines for prevention of CINV.24 Results from this study may also be applied to assess the usefulness of acute CINV as a predictor of impact on QoL: It could be argued that the subgroup of patients who do not experience acute CINV are unlikely to suffer a negative impact on QoL and, hence, might be accorded lower priority for prevention of delayed CINV. This is not supported by our findings, as shown in Table 4. A considerable number of patients who had reported no episodes of nausea or vomiting during the first 24 hours after treatment suffered an impact on QoL during the postchemotherapy period. Results shown in Table 4 also indicate that patients who experienced delayed but not acute nausea were more likely to report an impact on daily living than patients who experienced only acute nausea. The corresponding FLIE scores indicate that delayed CINV has a more severe impact on daily living than acute CINV. This may be attributed to the greater length of time over which delayed CINV could be experienced. Several methodologic aspects of our study deserve discussion. Our prospective investigation was based on the FLIE score, a validated instrument with questions specifically addressing the impact of CINV on the physical abilities, social and emotional function, and ability to enjoy meals.20 Patient management and data acquisition were performed by experienced centers and personnel. The study was not restricted to a particular cancer type, and we have deliberately enrolled a heterogeneous group of cancer patients receiving a broad range of chemotherapies. This is expected to make our results relevant for extrapolation to most cancer patient populations on highly or moderately emetogenic treatments. The importance of the time of administration after chemotherapy of the QoL assessment has been addressed previously. Because CINV is most intense during the first 3 days after chemotherapy, it is critical that these days be included in the observation period. Moreover, the observation period must not be overly long to minimize recall bias that may result in loss of assay sensitivity.20,26 In this study, we administered the FLIE questionnaire in the morning of day 6, a period that was judged to be adequate on the basis of results from a previous study on the timing of QoL assessment of CINV26 and further validated in a clinical trial sample.18 Furthermore, the 5-day period is expected to include most CINV-related events without a relevant level of recall bias. Only treatment-naïve patients were enrolled in this study. This may limit extrapolation of our findings to the first cycle of chemotherapy because previous experience has shown that the antiemetic effect decreases during subsequent cycles.27 Hence, results of our study may underestimate the overall impact of CINV on patient's daily life during subsequent cycles of their chemotherapy. Guidelines on antiemetic prophylaxis for patients undergoing HEC have been amended since the time when this study was conducted.28 For these patients, a three-drug combination, including a neurokinin-1 receptor antagonist, may now offer better protection, but for MEC patients current guidelines are still in line with the practice pattern in our study.29 In conclusion, our findings support the notion that CINV continues to adversely affect patients' QoL, even after treatment with moderately emetogenic regimens, and even in the subgroup of patients who do not experience nausea and vomiting during the first 24 hours. Nausea has a stronger negative impact on QoL than vomiting. Patients in this study were included at the first cycle of chemotherapy. It is well known that the antiemetic effect of a serotonin receptor antagonist and a corticosteroid declines through subsequent cycles of HEC30 or MEC.31 This emphasizes the need for new and potent antiemetics. Recently, the American Society of Clinical Oncology has updated its guidelines for antiemetic use in oncology. The updated guidelines state that before patients are receiving chemotherapy of high emetic risk (eg, an anthracycline and cyclophosphamide), a three-drug regimen of a 5-HT3 serotonin receptor antagonist, dexamethasone, and aprepitant is recommended.32 The two-drug combination of dexamethasone and aprepitant is recommended for the prevention of delayed emesis in patients receiving cisplatin or other agents of high emetogenicity. Future studies will show whether this updated regimen will translate into an improved QoL for patients undergoing chemotherapy.
Although all authors completed the disclosure declaration, the following authors or their immediate family members indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. For a detailed description of the disclosure categories, or for more information about ASCO’s conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.
Dollar Amount Codes (A) < $10,000 (B) $10,000-$99,999 (C)
We thank the coinvestigators of the ANCHOR study for the recruitment of the patients used in the current study. These are Dr Gedske Daugaard, Rigshospitalet, Copenhagen, Denmark; Pr Gérard de Pouvourville, Institut Gustave Roussy (I.G.R.), Villejuif, France; Pr Joel Bloch, Groupe Hospitalier Pitié Salpétrière, Paris, France; Dr Bruno Heinrich, Klinikum Augsburg, Augsburg, Germany; Dr Giorgio Cruciani, Ospital Lugo di Ravenna, Lugo di Ravenna, Italy; Dr Bruno Daniele, Instituto Nazionale per lo studio e la cura dei tumori Napoli, Italy; Dr Mark Hill, Maidstone Hospital, Kent, United Kingdom; Dr Michael Garcia, Simon-Williamson Clinic Birmingham, AL; Dr Kelly B. Pendergrass, Kansas City Oncology and Hematology Group Kansas City, KS; Dr James D. Bearden III, Spartanburg Regional Medical Center, Spartanburg, SC; Dr Edward Rubenstein, MD Anderson Cancer Center, Houston, TX; and Dr Andrew Kellum, Tulepo Hospital, Tulepo, MS.
Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.
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Gralla RJ, Osoba D, Kris MG, et al: ASCO—Recommendations for use of antiemetics: Evidence-based clinical practice guidelines. J Clin Oncol 17:2971-2994, 1999 7. Geling O, Eichler HG: Should 5-HT3 receptor antagonists be administered beyond 24 hours following chemotherapy to prevent delayed emesis? Systematic re-evaluation of clinical evidence and drug cost implications. J Clin Oncol 23:1289-1294, 2005 8. Cancer Care Ontario Practice Guidelines Initiative: Use of 5-HT3 receptor antagonists in patients receiving moderately or highly emetogenic chemotherapy. Practice Guideline Report #12-3 2000, 1/2003 update. http://www.cancercare.on.ca/pdf/pebc12_3f.pdf 9. Pater J, Slamet L, Zee B, Osoba D, et al: Inconsistency of prognostic factors for post-chemotherapy nausea and vomiting. Support Care Cancer 2:161-166, 1994[CrossRef][Medline] 10. Hesketh PJ, Kris MG, Grunberg SM, et al: Proposal for classifying the acute emetogenicity of cancer chemotherapy. J Clin Oncol 15:103-109, 1997 11. 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De Boer-Dennert M, de Wit R, Schmitz PI, et al: Patient perceptions of the side-effects of chemotherapy: The influence of 5-HT3 antagonists. Br J Cancer 76:1055-1061, 1997[Medline] 16. Sun CC, Bodurka DC, Weaver CB, et al: Rankings and symptom assessments of side effects from chemotherapy: Insights from experienced patients with ovarian cancer. Support Care Cancer 13:219-227, 2005[CrossRef][Medline] 17. Lindley CM, Hirsch JD, O'Neill CV, et al: Quality of life consequences of chemotherapy-induced emesis. Qual Life Res 1:331-340, 1992[CrossRef][Medline] 18. Martin AR, Pearson JD, Cai B, et al: Assessing the impact of chemotherapy-induced nausea and vomiting on patients' daily lives: A modified version of the Functional Living Index-Emesis (FLIE) with 5-day recall. Support Care Cancer 11:522-527, 2003[CrossRef][Medline] 19. Grunberg SM, Deuson RR, Mavros P, et al: Incidence of chemotherapy-induced nausea and emesis after modern antiemetics: Perception versus reality. Cancer 100:2261-2268, 2004[CrossRef][Medline] 20. Ballatori E, Roila F: Impact of nausea and vomiting on quality of life in cancer patients during chemotherapy. Health Qual Life Outcomes 1:46, 2003[CrossRef][Medline] 21. Antiemetic Subcommittee of the Multinational Association of Supportive Care in Cancer (MASCC) Prevention of chemotherapy- and radiotherapy-induced emesis: Results of the Perugia Consensus Conference. Ann Oncol 8:811-819, 1998 22. Herrstedt J for the ESMO Task Force on Guidelines: ESMO recommendations for prophylaxis of chemotherapy-induced nausea and vomiting (NV). Ann Oncol 12:1059-1060, 2001 23. Passik SD, Navari RM, Jung SH, et al: A phase I trial of olanzapine (Zyprexa) for prevention of delayed emesis in cancer patients: A Hoosier Oncology group study. Cancer Invest 22:383-388, 2004[CrossRef][Medline] 24. Gralla RJ: New agents, new treatment, and antiemetic therapy. Semin Oncol 29:119-124, 2002[Medline] 25. Herrstedt J: Risk-benefit of antiemetics in the prevention and treatment of chemotherapy-induced nausea and vomiting. Expert Opin Drug Saf 3:231-248, 2004[Medline] 26. Pater JL, Osoba D, Zee B, et al: Effects of altering the time of administration and the time frame of quality of life assessment in clinical trials: An example using the EORTC QLQ-C30 in a large anti-emetic trial. Qual Life Res 7:273-278, 1998[Medline] 27. Warr DG, Hesketh PJ, Gralla RJ, et al: Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol 23:2822-2830, 2005 28. Kris MG, Hesketh PJ, Herrstedt J, et al: Consensus proposals for the prevention of acute and delayed vomiting and nausea following high-emetic-risk chemotherapy. Support Care Cancer 13:85-96, 2005[CrossRef][Medline] 29. Herrstedt J, Aapro MS, Roila F, Kataja VV: ESMO minimum clinical recommendations for prophylaxis of chemotherapy-induced nausea and vomiting (NV). Ann Oncol 16:i77-i79, 2005 (suppl 1) 30. De Wit R, Herrstedt J, Rapoport B, Carides, et al: The oral NK1 antagonist, aprepitant, given with standard antiemetics provides protection against nausea and vomiting over multiple cycles of cisplatin-based chemotherapy: A combined analysis of two randomized, placebo controlled phase III clinical trials. Eur J Cancer 40:403-410, 2004[Medline] 31. Sigsgaard T, Herrstedt J, Handberg J, et al: Ondansetron plus metopimazine compared with ondansetron plus metopimazine plus prednisolone as antiemetic prophylaxis in patients receiving multiple cycles of moderately emetogenic chemotherapy. J Clin Oncol 19:2091-2097, 2001 32. Kris GM, Hesketh PJ, Somerfield MR, et al: American Society of Clinical Oncology guideline for antiemetics in oncology: Update 2006. J Clin Oncol 24:2932-2947, 2006 Submitted January 8, 2006; accepted July 19, 2006.
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Copyright © 2006 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
5mm) or at least one episode of vomiting was reported during the first 24 hours after start of chemotherapy. Any episodes of nausea and/or vomiting thereafter up to 5 days after chemotherapy was considered delayed.
2 tests (Fisher's exact test). 
