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Table of Contents
ORIGINAL ARTICLE
Year : 2018  |  Volume : 1  |  Issue : 2  |  Page : 92-95

Health-related quality of life in patients with multiple myeloma on novel agents: Report from a tertiary cancer center in rural India


1 Department of Clinical Hematology and Medical Oncology, Malabar Cancer Centre, Thalassery, Kerala, India
2 Department of Psychiatry, Kannur Medical College, Anjarakkandy, Kannur, Kerala, India
3 Department of Psychiatry, KMCT Medical College, Kozhikode, Kerala, India

Date of Web Publication17-May-2019

Correspondence Address:
Avaronnan Manuprasad
Department of Clinical Hematology and Medical Oncology, Malabar Cancer Centre, Thalassery - 670 103, Kerala
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/CRST.CRST_11_19

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  Abstract 


Background: Multiple myeloma is a disease where health-related quality of life (HRQoL) is an important treatment end point. There are limited quality of life data of patients on novel antimyeloma agents, especially from developing countries.
Methods: All adult patients diagnosed with multiple myeloma who were on novel agents for a period of at least one year and attended our clinic between July 15, 2015 and July 30, 2015 were included in the study. They were asked to fill local language versions of European Organization for Research and Treatment of Cancer Questionnaire Core 30 (EORTC QLQ-C30), supplemented by the myeloma-specific module, and the outcomes were analyzed. Mean scores of the study population were compared with EORTC reference values. A higher score for a functional domain indicates a higher level of functioning, whereas a higher symptom score indicates a higher symptomatic burden.
Results: Of the total 64 patients, median age was 60 years and 60% (n = 38) were females. Median duration from diagnosis was 23 months (12–92 months). Mean QoL score for global quality of life was 55.3 and was comparable to the reference score. Our patients had significantly lower physical function score and higher financial strain compared to the reference population. The most common symptom was pain (60%), and the most common adverse effect was peripheral neuropathy (60%). Sixty-five percent of the patients were worried about future health and 42% about dying.
Conclusion: Our patients with multiple myeloma have lower HRQoL compared to the reference population in many domains, despite being on novel agents.

Keywords: India, multiple myeloma, novel agents, quality of life


How to cite this article:
Raghavan V, Manuprasad A, Sajeev Kumar P B, Raj Z, Shenoy PK, Nair CK. Health-related quality of life in patients with multiple myeloma on novel agents: Report from a tertiary cancer center in rural India. Cancer Res Stat Treat 2018;1:92-5

How to cite this URL:
Raghavan V, Manuprasad A, Sajeev Kumar P B, Raj Z, Shenoy PK, Nair CK. Health-related quality of life in patients with multiple myeloma on novel agents: Report from a tertiary cancer center in rural India. Cancer Res Stat Treat [serial online] 2018 [cited 2019 Jun 16];1:92-5. Available from: http://www.crstonline.com/text.asp?2018/1/2/92/258530




  Introduction Top


Multiple myeloma is a disease where the use of novel agents results in significant improvement in overall survival.[1] Being an incurable disease with high symptom burden, ensuring good health-related quality of life (HRQoL) is an important aim of myeloma treatment. Furthermore, with improvement in survival, treatment-related cumulative side effects become another concern, although this aspect is less well studied compared to other endpoints. In developing countries, clinicians face the dual challenges of organizing access to the novel agents as well as improving quality of life through better supportive measures. Though there are some published data on various aspects of multiple myeloma from India, those addressing HRQoL issues are scant. Usually, HRQoL assessment relies on the use of self-reported questionnaires validated for the purpose. The European Organization for Research and Treatment of Cancer (EORTC) has developed a set of questionnaires to evaluate the HRQoL in patients with different cancers enrolled in clinical trials, and it is the most commonly used tool in myeloma.[2],[3] The same questionnaire has been used in Indian patients with different solid tumors like breast and lung but not in myeloma.[4],[5] Here, we report a cross-sectional study on quality of life issues of multiple myeloma patients treated at a tertiary cancer center located in rural South India.


  Methods Top


This is a cross-sectional study done at a tertiary cancer center in South India located in a rural area. All adult patients diagnosed with multiple myeloma who were on disease-modifying agents for a period of at least 1 year and attending the outpatient department from July 15, 2015 to July 30, 2015 were included in the study. Institutional Review Board approval was obtained. Informed consent was taken from all the patients, and they were asked to fill 2 questionnaires: The Malayalam (local language) versions of the EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), supplemented by the myeloma-specific module (EORTC QLQ-MY20). In addition, demographic and disease characteristics were also recorded.

Tools

  1. Sociodemographic proforma
  2. EORTC QLQ-C30 Malayalam Version. The QLQ-C30 is a validated 30-item questionnaire consisting of 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social functioning), 3 symptom scales (fatigue, pain, and nausea/vomiting), and a Global Health Status/QoL scale. It also includes 6 single item scales (dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial difficulties)
  3. EORTC QLQ Multiple myeloma module(EORTC QLQ MY 20) Malayalam version which is a supplemental multiple myeloma specific 20 item module. It includes 2 functional domains (future perspective and body image) and 2 symptom domains (disease symptoms and side effects of treatment).[6]


Based on the EORTC scoring manual, a “raw score” was calculated which was standardized to a value ranging from 0 to 100 using linear transformation (Transformed score).[7] A higher score for a functional domain indicates a higher level of functioning, whereas a higher symptom score indicates a higher symptomatic burden. The mean score was compared with that of EORTC reference values for myeloma patients (all stages).[8] This was done by calculating the minimum important difference (MID) for each score in the EORTC QLQ-C30 reference manual. MID is the smallest change in a quality of life score that is important to the patient.[5],[9] MID values were taken as 0.2 of the standard deviation (SD) by distribution method, as recommended by Samsa et al.[10] Functional and symptom scales of the supplementary module were also calculated as per the same manual.


  Results Top


Baseline and treatment characteristics

A total of 64 patients were included in the study. The median age was 60 years (range 30–80). Most (n = 53, 85%) were married, and the majority belonged to the rural population. Thirty-eight patients (60%) were females. Regarding education, 90% of the patients (n = 57) had at least a primary school certificate. Occupations of the patients were reported as per modified Kuppuswamy scale. Twenty-two patients (34%) were unemployed and 18 (28%) were unskilled workers. Semiskilled and skilled workers constituted 30% (n = 20). Only four patients were semiprofessional or professional by occupation.[11] The most common treatment regime was melphalan/prednisolone/thalidomide (MPT), in 25 patients (40%). Twenty patients (30%) received lenalidomide/dexamethasone and 10 patients (15%) received cyclophosphamide/bortezomib/dexamethasone. Thalidomide/dexamethasone combination was used in 9 patients (15%). Three patients (5%) underwent autologous stem cell transplantation (ASCT). Upfront International Staging System (ISS) staging information was not available in 11 patients who were already started on treatment from outside hospitals. Among the remaining patients, the most common stage at presentation was ISS 3 (45%). Median time from diagnosis was 23 months (12–92 months). At the time of study, 70% of the patients (n = 44) had at least very good partial response (VGPR) and 25% (n = 16) had partial remission (PR). Other parameters are described in [Table 1].
Table 1: Patient characteristics

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Global quality of life

Mean QOL score (transformed score) for the entire cohort was 55.3 ± 21. It was similar to the reported EORTC reference value of 55.7 (SD 22.8) for myeloma (all stages) but was lower than that the reference values for all cancer patients (mean score – 61.3) and for advanced cancer patients (mean score – 56.3).

Functions

Mean functional scores ranged from 61 (physical and role function) to 88 (cognitive function). Difference more than MID was observed in case of physical function (lower than the reference value) and in case of cognitive function (higher than the reference value). Differences for other scores were within MID [Table 2].
Table 2: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 functional scores

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Symptoms

Mean scores of fatigue, pain, appetite loss, constipation, and diarrhea were lower than the reference values, and the difference was greater than MID. Dyspnea, insomnia, and loss of appetite scores were higher in the study population, but difference was less than MID. Our patients had significantly higher financial strain with mean score being almost double that of the reference value [Table 3].
Table 3: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 symptom scores

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European Organization for Research and Treatment of Cancer Quality of Life Questionnaire my20 questionnaire

Sixty percent of the patients had experienced pain. The most common site was back, which was reported in 60% of those with pain. Other sites of pain were hip (47%) followed by shoulder girdle (43%) and chest (15%). Most common adverse event was peripheral neuropathy (“tingling sensation”) which was seen in 60% of patients and was very severe (“very much”) in 11%. Among the symptom scales, mean score was 20.75 ± 18.3 for disease symptoms and was 20 ± 16.2 for side effects. Eleven patients (17%) felt they were “less attractive” because of the illness or treatment. Sixty-five percent of the patients were worried about their future health and 42% were worried about dying. The mean score was 93.3 ± 16 for myeloma-related body image and was 81 ± 23 for myeloma-related future perspective.


  Discussion Top


Multiple myeloma is an incurable hematological malignancy where prolongation of survival as well as HRQoL has become an increasingly important goal of treatment. Published literature on HRQoL in myeloma patients in the era of novel agents is relatively rare.[12] Furthermore, to the best of our knowledge, there is no proper study examining the quality of life in Indian patients with multiple myeloma. Our study highlights the important quality of life issues in a developing country which are different from that of the developed countries.

Our study population was majority female (60%) and the median age was 60 years. Being a tertiary cancer center in rural India, most of the patients belonged to the rural population (>90%). Although all of our patients received novel agents, only 5% could undergo ASCT due to resource constraints.

We used a version of EORTC QLQ-C30 in the local language, which had already been validated. The mean score of global quality of life of our patients was similar to that for EORTC reference values for all stages of myeloma. It was about 10 points higher than reported for Indian patients with metastatic lung cancer but about 20 points lower compared to young breast cancer patients.[4],[5] Among the functional domains, mean score for physical function was significantly lower in the current study compared to the reference value despite median duration of treatment being about 2 years. However, cognitive function score was higher and was comparable to that of general population (86.1 ± 20). Higher functional score in some of the domains may be a result of treatment with novel agents. QOL in myeloma can have complex patterns and may depend on demographic factors, as shown in previous studies.[13]

Among the symptom scores, most of the means were lower than the reference values, indicating the reduction in symptom burden related to treatment. Diarrhea was the symptom with the lowest score, as in the reference population. The most striking observation was the significantly higher financial strain in our patients, with 55% of patients having financial issues, despite being treated in a government institution. Another publication from a public sector institute in North India has raised questions about the out-of-pocket expenses during myeloma treatment despite the cost being much lower than in private institutions.[14]

Pain was the most common symptom, and peripheral neuropathy was the most common adverse effect, which was similar to other reports.[15] Only 17% of our patients felt “less attractive” which was much lower than in western literature, where it was around 35%–60%. This may be related to differences in cultural practices and demographic patterns.[15],[16] High mean score for myeloma related future perspective also indicates that it was less of a concern for our population. However, a significant proportion of patients reported being worried about their future health and about dying.


  Conclusion Top


Though limited by small sample size and cross-sectional design, this study throws light on the HRQoL issues in Indian patients with multiple myeloma on novel agents. Our patients had lower HRQoL in many of the studied domains, compared to western populations, even after having favorable response to treatment. Higher rates of financial constraints, pain, and worries about dying indicate the need to incorporate a holistic approach in the management of multiple myeloma. Larger studies are needed to address this specific question considering the unique socioeconomic scenario in the developing world.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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Kumar SK, Rajkumar SV, Dispenzieri A, Lacy MQ, Hayman SR, Buadi FK, et al. Improved survival in multiple myeloma and the impact of novel therapies. Blood 2008;111:2516-20.  Back to cited text no. 1
    
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Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365-76.  Back to cited text no. 2
    
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Sonneveld P, Verelst SG, Lewis P, Gray-Schopfer V, Hutchings A, Nixon A, et al. Review of health-related quality of life data in multiple myeloma patients treated with novel agents. Leukemia 2013;27:1959-69.  Back to cited text no. 3
    
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Dubashi B, Vidhubala E, Cyriac S, Sagar TG. Quality of life among younger women with breast cancer: Study from a tertiary cancer institute in South India. Indian J Cancer 2010;47:142-7.  Back to cited text no. 4
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Stead ML, Brown JM, Velikova G, Kaasa S, Wisløff F, Child JA, et al. Development of an EORTC questionnaire module to be used in health- related quality-of-life assessment for patients with multiple myeloma. Br J Haematol 1999:104. p. 605-11.  Back to cited text no. 6
    
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Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A; on Behalf of the EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring Manual. 3rd ed. Brussels: European Organization for Research and Treatment of Cancer; 2001.  Back to cited text no. 7
    
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Scott NW, Fayers PM, Aaronson NK, Bottomley A, de Graeff A, Groenvold M, et al. EORTC QLQ-C30 Reference Values. Brussels: EORTC Quality of Life Group; 2008.  Back to cited text no. 8
    
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Musoro ZJ, Hamel JF, Ediebah DE, Cocks K, King MT, Groenvold M, et al. Establishing anchor-based minimally important differences (MID) with the EORTC quality-of-life measures: A meta-analysis protocol. BMJ Open 2018;8:e019117.  Back to cited text no. 9
    
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Samsa G, Edelman D, Rothman ML, Williams GR, Lipscomb J, Matchar D. Determining clinically important differences in health status measures: A general approach with illustration to the health utilities index mark II. Pharmacoeconomics 1999;15:141-55.  Back to cited text no. 10
    
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Kvam AK, Waage A. Health-related quality of life in patients with multiple myeloma – Does it matter? Haematologica 2015;100:704-5.  Back to cited text no. 12
    
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Robinson D Jr., Esseltine DL, Regnault A, Meunier J, Liu K, van de Velde H. The influence of baseline characteristics and disease stage on health-related quality of life in multiple myeloma: Findings from six randomized controlled trials. Br J Haematol 2016;174:368-81.  Back to cited text no. 13
    
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Kaur G, Prinja S, Malhotra P, Lad DP, Prakash G, Khadwal A, et al. Cost of treatment of multiple myeloma in a public sector tertiary care hospital of North India. Indian J Hematol Blood Transfus 2018;34:25-31.  Back to cited text no. 14
    
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Kiely F, Cran A, Finnerty D, O'Brien T. Self-reported quality of life and symptom burden in ambulatory patients with multiple myeloma on disease-modifying treatment. Am J Hosp Palliat Care 2017;34:671-6.  Back to cited text no. 15
    
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Mols F, Oerlemans S, Vos AH, Koster A, Verelst S, Sonneveld P, et al. Health-related quality of life and disease-specific complaints among multiple myeloma patients up to 10 yr after diagnosis: Results from a population-based study using the PROFILES registry. Eur J Haematol 2012;89:311-9.  Back to cited text no. 16
    



 
 
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  [Table 1], [Table 2], [Table 3]



 

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