Assessment of Adverse Drug Reactions Among Cancer Patients in A Tertiary Care Hospital: A Prospective Observational Study

Abstract

Adverse drug reactions (ADRs) remain a major challenge in cancer therapy due to the narrow therapeutic index of anticancer drugs, polypharmacy, and patient-related factors. This review consolidates clinical data on ADRs reported in cancer patients receiving anticancer and supportive pharmacotherapy in a tertiary care setting. Demographic characteristics, cancer types, drugs implicated, patterns of ADRs, affected organ systems, routes of administration, management strategies, and outcomes were critically analyzed along with causality, severity, and preventability assessments using standard pharmacovigilance scales. The review indicates a higher incidence of ADRs among pediatric and adolescent patients, with males being more frequently affected. Hematological malignancies constituted the majority of cases. Gastrointestinal and whole-body reactions were the most commonly reported ADRs, with vomiting being the predominant manifestation. The intravenous route of administration was most frequently associated with ADR occurrence. Causality assessment classified most reactions as probable or possible, while severity assessment revealed that the majority of ADRs were mild, with very few severe cases. Preventability analysis showed that a significant proportion of ADRs were either definitely or probably preventable. Most patients recovered completely or continued therapy with appropriate management, highlighting favorable clinical outcomes.This review emphasizes the considerable burden of ADRs in oncology practice and underscores the importance of continuous pharmacovigilance, early detection, and multidisciplinary intervention. Strengthening ADR monitoring and reporting systems can significantly enhance patient safety, reduce preventable reactions, and improve therapeutic outcomes in cancer care.

Keywords

Introduction

CANCER STATISTICS:

Cancer as an ailment marked by the aberrant proliferation and progression of regular cells, extending beyond their typical confines[1]. Cancer ranks among the foremost contributors to mortality globally, spanning nations across varying income brackets. Compounding this challenge, the incidence and mortality rates of cancer are anticipated to escalate swiftly due to population expansion, aging demographics, and the adoption of lifestyle practices that heighten cancer susceptibility. In 2012, approximately 14.1 million new cancer cases were recorded globally, resulting in 8.2 million cancer-related deaths1ha. The incidence rates vary widely among the 50 selected registries, ranging from more than 400 per 100,000 males and 300 per 100,000 females to below 100 per 100,000 for both genders. The mortality rates across the 50 selected countries vary, with figures exceeding 200 deaths per 100,000 males and over 100 deaths per 100,000 females, while some regions experience less than 50 deaths per 100,000 for both genders[2]. The global impact of cancer has intensified due to factors such as population aging and the rising prevalence of cancer-related behaviours, notably smoking. Additionally, exposure to various triggering elements such as chemicals, radiation, poor dietary choices, and sedentary lifestyles has contributed to this burden[3]. The 20-year prevalence proportions increase almost exponentially until approximately the age of 70, reaching a peak between ages 75 and 95, and then gradually decline there after. Numerous cancers exhibit incidence and mortality peaks at young ages that may not be visually apparent in our data, yet they remain statistically significant. SEER data indicate that cancer incidence and mortality rates are elevated in men compared to women, higher among Black Americans than White Americans, and lower among Asian. However, despite this, many of the most prevalent cancer incidence rates reach a peak and then decrease in both men and women, as well as in both White and Black populations.[4]

TREATMENT OF CANCER AND ITS INDUCED ADVERSE REACTIONS:

Treatment of cancer can be done by various means like chemotherapy, immunotherapy, radiotherapy, stem cell transplant, hormonal therapy. Chemical-based treatments for cancer have a history spanning several centuries, yet it wasn't until the 1940s that the initial instance of effective and well-documented systemic chemotherapy emerged. Chemotherapy for cancer involves the delivery of cytotoxic chemicals, which possess cell-killing capabilities, aiming to either eradicate the tumour or, in certain cases, diminish its size to alleviate tumour-related symptoms and potentially extend lifespan. Typically, cytotoxic drugs are administered intravenously, as it is the safest method  to limit tumour exposure to these drugs. Cytotoxic drugs are predominantly administered in specified combinations comprising two or more drugs. The objective is to enhance the likelihood of overcoming tumour cell resistance, enhance the regimen's effectiveness against various tumour cell variants, and minimize the risk of significant toxicity to normal tissues[5]. Patients undergoing chemotherapy often experience a variety of negative effects, nausea, impaired taste, diarrhoea, general tiredness, constipation, and insomnia with fatigue being a prevalent complaint encountered frequently among them[6]. Cancer immunotherapy aims to utilize the remarkable potency and precision of the immune system to combat malignancies. Despite cancer cells being less immunogenic compared to pathogens, the immune system demonstrates its capacity to identify and eradicate tumour cells[7]. The challenge of identifying human cancer antigens and quantifying immune responses against human cancers relegated studies of tumour immunology to the margins of immunology research[8]. Approximately 80% of patients undergoing immunotherapy may encounter adverse events, typically within the initial 3–4 months of treatment, although they can also manifest later. Constitutional symptoms like fatigue and skin issues are frequently observed as the most prevalent immune-related adverse events (irAEs) and tend to emerge early. However, more subtle adverse events such as endocrinopathies or pneumonitis can develop gradually[9].   Radiotherapy is a crucial form of cancer treatment, playing a significant role in either curing or alleviating symptoms for numerous cancer patients. Operating radiotherapy facilities requires substantial initial investment, and their ongoing operation demands a considerable staffing commitment[10]. Radiation therapy stands out as the most potent cytotoxic treatment option for localized solid cancers. Its effectiveness is underscored by the ongoing use of curative radiation therapy by approximately 60% of cancer patients in the USA, even a century after its invention, despite advancements in various other treatment methods[11]. Late adverse effects resulting from radiotherapy for cancer treatment encompass gastrointestinal complications, neurological issues, dysfunction related to the anal, rectal, urinary, and sexual systems, pelvic or hip fractures, thromboembolic disorders, and the development of secondary cancers[12]. A stem cell transplant involves transferring hematopoietic stem cells following the administration of high-dose chemotherapy, sometimes coupled with radiotherapy. This treatment aims to eliminate malignant cells while also eradicating the patient's bone marrow in the process[13].adverse effects seen in stem cell transplantation are pulmonary complications, vascular complications, cardiovascular complications[14]. Hormone therapy proves to be a successful and safe treatment option for breast cancer and prostate cancer that are positive for estrogen and progesterone  receptors[15]. Adverse effects of hormonal therapy are sexual dysfunctions, hot flashes, feeling of tiredness, bone loss and bone fractures , metabolic disorders, cardiovascular complications, metabolic disorders, Anaemia.[16]

METHODOLOGY:

STUDY SITE :The proposed study was conducted   among the cancer patients in a tertiary care hospital

STUDY DESIGN :The proposed study was prospective and observational

STUDY DURATION:

• The duration of the study was 6 Months.
• Protocol writing, Forming Questionaries: 1 Month
• Conducting and executing the survey: 2-3 Months
• Data Analysis and Submission: 1-2 Month

SAMPLE SIZE : Convenient sampling

MATERIALS:

• Inform Consent Form (English, Hindi, Marathi, Kannada).
• Patient Information Sheet (English, Hindi, Marathi, Kannada).
• Causality assessment scale
• Severity assessment scale
• Preventability assessment scale

STUDY  PROCEDURE :

DISTRIBUTION OF DEMOGRAPHIC DETAILS AMONG CANCER PATIENTS:

Table no.1: DISTRIBUTION OF AGE AMONG CANCER PATIENTS:

Sr no	Category	Frequency	Percentage(%)
1	0-10	22	24.71
2	11-20	32	25.84
3	21-30	2	2.24
4	31-40	1	1.12
5	41-50	10	11.23
6	51-60	12	23.59
7	61-70	5	5.61
8	71-80	4	4.49
9	81-90	1	1.12

Figure 1 : Among 89 cancer patients 32 patients were found between the age group of 11-20 and only one patient was found between the age group of 81-90 (Table no.1 and fig 1)

Table no.2: DISTRIBUTION OF GENDER AMONG CANCER PATIENTS

SN	Characteristics	Frequency	Percentage(%)
1.	Male	50	56.17
2.	Female	39	43.82

Figure 2 : Among 89 cancer patients 50 patients were found to be male and 39 patients were found to be female (Table no.2 and fig 2)

Table no.3: DISTRIBUTION OF DIAGNOSIS AMONG CANCER PATIENTS:

Sr no	Category	Frequency	Percentage(%)
1.	CA Tongue	2	2.24
2.	PRE B ALL	32	35.95
3.	Rhabdomyosarcoma	4	4.49
4.	T. Cell All	4	4.49
5.	CML in lymphoid blast crisis	3	3.37
6.	Breast cancer	7	7.86
7.	Iron Deficiency anaemia	1	1.12
8	Adenocarcinoma of gastroesophageal just post chemo	1	1.12
9.	APML	5	5.61
10.	Acute Promyelocytic Leukaemia	1	1.12
11.	AML	2	2.24
12.	Neuroendocrine tumour  of oesophagus	1	1.12
13.	Yolk sac  tumour	1	1.12
14.	Hodgkin’s Lymphoma	3	3.37
15.	Neuroblastoma	1	1.12
16.	Extra renal Rhabdoid tumour	1	1.12
17.	A S AMK	1	1.12
18.	CA. pancreas	1	1.12
19.	Cancer oesophagus	2	2.24
20.	C A Cervix	3	3.37
21.	Leukemoid reaction	3	3.37
22.	CA Rectum	2	2.24
23.	CA Ovary	2	2.24
24.	GCT	1	1.12
25.	CA Stomach	1	1.12
26.	NHL	1	1.12
27.	Multiple myeloma	3	3.37

Table no.7:  CLASSIFICATION OF REACTIONS ACCORDING TO ORGAN SYSTEM IN CANCER PATIENTS :

SN	ORGAN SYSTEM	FREQUENCY	PERCENTAGE(%)
1.	GIT	28	31.46
2.	Skin	13	14.60
3.	Respiratory	5	5.61
4.	Blood	4	4.49
5.	Mouth	5	5.61
6.	Whole body	34	38.20

FIGURE 3 : Among 89 cancer patients 34 patients had whole body related reactions and five patients had mouth and respiratory related reactions (Table no.7 ) (fig 3)

Table no.8: DISTRIBUTION OF ROUTE OF ADMINISTRATION

SN	ROA	Frequency	Percentage (%)
1.	IV	67	75.28
2.	Oral	14	15.73
3.	SC	7	7.86
4.	Intranasal	1	1.12

Figure 4 :Among 89 cancer patients 67 patients drug was administered with IV route and only one patient drug was administered with intranasal route (Table no.8) (fig 4)

DISTRIBUTION OF ADR PATTERN AMONG CANCER PATIENTS

Table no.9: MANAGEMENT OF ADR AMONG CANCER PATIENTS

SN	Category	Frequency	Percentage (%)
1.	Drug Withdrawn	22	23.40
2.	No change	66	67.0
3.	Dose altered	1	1.06

Figure 5 : Among 89 cancer patients managing of ADR among 66 patients was done by not changing drug regimen and among 22 patients the ADR was managed by withdrawing the drug and in one patient it was managed by altering the dose ( Table no.9)  ( fig 5)

Table no.10 : TREATMENT GIVEN AGAINST THE ADR AMONG CANCER PATIENTS:

SN	Category	Frequency	Percentage(%)
1	Symptomatic	32	34.04
2	Specific	40	43.61
3	Nil	15	22.34

Figure 6 : Among 89 cancer patients 40 patients were given specific treatment and 15 patients were not given any treatment and 32 patients were given symptomatic treatment.(Table no 10) (fig.6)

Table no.11 : DISTRIBUTION OF OUTCOMES AMONG CANCER PATIENTS:

SN	Category	Frequency	Percentage(%)
1	Recovering	10	11.23
2	Continuing	27	30.33
3	Unknown	3	3.37
4	Recovered	36	40.44
5	others	12	13.48
6	Fatal	1	1.12

Figure 7 : Among 89 cancer patients  distribution of outcomes among cancer patients 36 were recovered ,10 are recovering and one patient was fatal(Table no 11) (fig.7)

Table no.12 : DISTRIBUTION OF DECHALLENGE AMONG CANCER  PATIENTS:

SN	Category	Frequency	Percentage(%)
1	Yes	30	33.70
2	No	59	66.29

Figure 8 :Among 89 cancer patients 30 patients were under dechallenge category and 59 patients were not under dechallenge category (Table no.12) (fig 8)

Table no.13 : DISTRIBUTION OF RECHALLENGE AMONG CANCER PATIENTS:

SN	Category	Frequency	Percentage(%)
1	Yes	32	35.95
2	No	57	64.04

Table no.14 :  NARANJO SCALE: Causality assessment of ADR among Cancer  patients:

SN	Category	Frequency	Percentage(%)
1	Probable	56	62.92
2	Possible	29	32.58
3	Unlikely	1	1.12
4	Definite	3	3.37

Figure 10 : Among 89 cancer patients according to Naranjo scale 56 patients were under the category of probable and one patient was under the category of unlikely (Table no.14) (fig 10)

Table no 15 : WHO PROBABILITY SCALE

SN	Category	Frequency	Percentage(%)
1.	Probable	51	57.30
2.	Possible	30	33.70
3.	Certain	8	8.98

Figure 11 :Among 89 cancer patients 51 patients were under the category WHO probable scale and 8 patients were under category of certain (Table no.15) ( fig.11)

Table no 16:  HARTWIG SEVERITY SCALE

Sr No	Category	Frequency	Percentage(%)
1.	Mild	68	76.40
2.	Moderate	20	22.47
3.	Severe	2	2.24

Figure 12 :Among 89 cancer patients according to Hartwig Severity scale 68 patients were under the category of mild and two patients were under the category of severe( Table no.16) (fig.12)

Table no.17 :  SCHUMOCK PREVENTABILITY SCALE

SN	Category	Frequency	Percentage(%)
1.	Definitely preventable	34	38.20
2.	Probably preventable	53	59.55
3.	Not preventable	2	2.24

Figure 13:  Among 89 cancer patients 53 ADRs  were probably preventable 34 were definitely preventable and two ADRs were not preventable (table no.17) (fig 13)

Table no 18:  PREDISPOSING FACTOR

SN	Category	Frequency	Percentage(%)
1.	Others	70	78.65
2.	Due to disease condition	1	1.12
3.	Intercurrent Disease	10	11.23
4.	Intercurrent Disease & Multiple dry therapy	2	2.24
5.	Intercurrent Disease & Gender	2	2.24
6.	Age, Intercurrent Disease & Gender	1	1.12
7.	Age & Intercurrent Disease	1	1.12
8.	Age & Gender	1	1.12
9.	Gender & intercurrent Disease	1	1.12

Figure 14 : Among 89 cancer patients 70 patients were having predisposing factors in the category of others ( Table no.18) (Fig 14)

DATA COLLECTION FORM :

RESULTS AND DISCUSSION

In our comprehensive study conducted at a multispecialty tertiary care hospital, we meticulously analysed adverse drug reactions (ADRs) associated with anticancer drugs over a six-month period. Our findings provided valuable insights into the demographic patterns and characteristics of these ADRs, shedding light on their prevalence, severity, and preventability.

Firstly, we observed a striking trend wherein the incidence of ADRs was highest among patients in the 11-20 age group, contrasting sharply with the lowest occurrence observed in patients aged 81-90. This disparity underscores the need for age-specific considerations in cancer treatment protocols and highlights potential vulnerabilities in certain age demographics. This observation aligns closely with previous research conducted by Novy Gupte et.al[17]., reinforcing the consistency of our findings within the broader literature.

Furthermore, our analysis revealed a notable gender discrepancy in ADR occurrence, with males exhibiting a higher susceptibility compared to females. This finding echoes similar observations made by Pai Sunil Bellare et.al[18]., suggesting a potential gender-related predisposition to certain types of ADRs or variations in drug metabolism and response between sexes.

The identification of B-cell acute lymphoblastic leukaemia (ALL) patients as the cohort most affected by ADRs provides valuable clinical insights, indicating specific vulnerabilities within this population that warrant closer monitoring and intervention. This aligns with prior research by Gashaw Workalemahu et.al[19]further corroborating the significance of our findings within the context of existing literature on ADRs in cancer patients.

In terms of the specific types of ADRs observed, nausea and vomiting emerged as the predominant adverse events, highlighting the significant impact of gastrointestinal side effects on patients undergoing anticancer therapy. This mirrors findings reported by Sewunet Admasu Belachew et. al[20]and underscores the importance of effective supportive care measures to alleviate treatment-related symptoms and enhance patient comfort and adherence.

Moreover, our analysis of the anatomical distribution of ADRs revealed that the whole body, gastrointestinal tract (GIT), and skin were the most affected systems. This contrasts with previous studies, such as that conducted by Sapan Kumar Bahera et .al[21]where blood-related disorders were more prevalent due to differences in treatment modalities.

In terms of management strategies, our findings indicate a propensity for maintaining the current drug regimen rather than altering treatment plans in response to ADRs, reflecting the cautious approach adopted by healthcare providers to minimize treatment disruptions while addressing patient safety concerns. This concurs with observations made by Anekha Antony et al [22], highlighting the consistency of clinical practices across different healthcare settings.

Utilizing established assessment scales such as the Naranjo scale and WHO causality assessment scale allowed us to categorize ADRs based on their probability and severity, providing a standardized framework for evaluating and managing these adverse events. The predominance of probable ADRs and their high preventability further emphasizes the importance of proactive pharmacovigilance measures in mitigating risks and optimizing patient outcomes.

Finally, our assessment of ADR severity using Hartwig's severity scale revealed that the majority of adverse events were mild, suggesting a favourable safety profile for the anticancer drugs examined in our study. This aligns with previous research by Julie Birdie Wahlang et al [23]., reaffirming the tolerability of these medications within the context of cancer therapy.

In summary, our study contributes valuable insights into the epidemiology, clinical characteristics, and management of ADRs in cancer patients undergoing anticancer treatment, corroborating and extending existing knowledge in the field. By elucidating demographic trends, anatomical distributions, and management practices associated with ADRs, our findings inform the development of targeted interventions aimed at optimizing patient safety and treatment efficacy in oncological care settings.

CONCLUSION

In summary, current study highlights the prevalence and characteristics of adverse drug reactions (ADRs) in cancer patients undergoing anti-cancer treatments at our tertiary care hospital. Through comprehensive assessment using various scales, we identified patterns, causality, severity, and preventability factors 

associated with these ADRs. These findings underscore the importance of robust pharmacovigilance in oncological care to optimize patient safety and treatment efficacy.    However, acknowledging study limitations, including sample size and patient heterogeneity, future research should explore longitudinal designs and larger cohorts for validation and expansion of these findings.

ACKNOWLEDGEMENT

The authors acknowledge the contributions of previous researchers whose work provided the basid for this review. We also thank our mentors and  institution for their guidance and support during the preparatin of this article.

CONFLICT OF INTEREST

The authors declare that they have no Conflict of Interest related to the publication of this article.

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