The term “cancer” refers to a group of diseases with various types that can develop anywhere in the body. Normal cell growth and division is disrupted and cells continue to multiply uncontrollably. At the same time, old cells cluster together to form a mass of tissue known as a “tumor” in which old cells don’t die as they should (Harsh Mohan, 2010). Normal cells undergo controlled division, death programme and they remain intact in place whereas cancerous cell divide unmanageable, disregard apoptosis and continue to relocate. Alteration of one or more gene produce malignant cells and an array of them result in cancer. The American Cancer Society (ACS) indicates that 1 in 2 males and individuals Assigned Male at Birth (AMAB), as well as 1 in 3 females and individuals Assigned Female at Birth (AFAB), will develop cancer (American Cancer Society, 2022). Although cancer can affect anyone, it is influenced based on sex and ethnicity. The 2022 annual report on cancer stats that it affects more men and AMAB compared to female and are concerned to black men more frequently (Sathishet al., 2025). Early signs are weight loss, chronic tiredness, fever at night etc and warning signs are persistent lumps or bumps, difficult breathing and swallowing. Cancer is most often caused due to acquired genetic mutation. Smoking, diet, environmental toxins, hormone therapy augment the incidence of cancer. Adopting lifestyle changes such as quitting smoking, exercising, following diet programs can reduce cancer potential (Katzung, 2018). The primary types of cancer are: carcinoma, sarcoma, lymphoma and leukaemia (Bruntonet al., 2017). The four phases of malignancy based on size and location are stage I,II,III,IV which are cancer confined to small area, cancer not yet spread, might have spread to adjacent area, further even spread to organ respectively (Brierleyet al.,2016). The elements of cancer management play a crucial role in shaping the patient’s treatment objectives and, in turn, aid in identifying the patient’s prognostic factors that includes kind of cancer, treatment variable, and patient factors. Chemotherapy utilizes drugs to destroy cancer cells. These targeted anticancer medications stop cancerous cells from multiplying, reproducing, and generating new cells. Its goals are to eradicate cancer, its recurrence, to reduce tumor before surgery, to alleviate pain etc. In addition to chemotherapy, other drug therapies such as hormone treatment, immunotherapy, and targeted therapies are used to treat cancer (National Cancer Institute, 2007). Medications are often given in combination to prevent the development of drug resistance (Amjadet al.,2023). Though healthcare professionals try to balance out treatment with minimum negative impact, adverse effects are a part of all cancer therapy. So chemotherapy-induced toxicities can be categorized according to their pathophysiological or anatomical characteristics. Alopecia, nausea and vomiting, myelosuppression, cardiac toxicity, haemorrhagic cystitis, mucositis, hot flashes, electrolyte imbalance, Deep Vein Thrombosis (DVT) are toxicities connected to anti-cancer drugs. Delaying chemotherapy in oncology can jeopardize an individual’s health and hinder the road to recovery. Chemotherapy is a cornerstone in the treatment of many cancers, and any delay in treatment can negatively affect outcomes. The risk of death increases significantly with the length of time cancer treatment is delayed, rising from 6% to 13% for individuals whose treatment is postponed by just 30 days (Talenset al., 2021). In some instance, chemotherapy is indicated as not just efficient but also rehabilitative. Optimizing anticancer therapy for better efficacy and minimal toxicity involves evaluating and comparing current practices with established standards. As a result, drug utilization studies can aid in prioritizing the efficient allocation of healthcare resources (Patilet al.,2023). Hence this study aims to conduct the analysis of chemotherapy induced toxicity in cancer patients with the objectives to scrutinize patterns, frequency, causality and severity of chemotherapy induced toxicities along with examining the prescribing pattern in delayed chemotherapy.

The research was a prospective observational study on chemotherapy induced toxicities. It was initiated after the approval from Institutional Ethical Committee of Omega Speciality Hospital, Hyderabad having ethical approval No. OH/ECBHR/Pharm.D/01/2022-01. The hospital provides chemotherapy, radiotherapy, brachytherapy and palliative care which was the study site. Study duration was 6 months from September 2022 to February 2023. The study standards were set up with an inclusion criteria of in-patients from the oncology ward, patients above 16 years of age, patients possessing co-morbidities. Patients of both genders were considered. Exclusion criteria included out-patients, patients below 16 years, pregnant women, nursing mothers and patients who were near to death. Demographics and clinical data was collected from patient case sheets. Necessary details of the suspected chemotherapy toxicities were recorded. Study was monitored effectively for data updation on regular basis and tracked which equipped the study to show patient advancement to chemotherapy induced toxicities. Statistical package for social science (SPSS®statistics) program IBM SPSS Statistics 24 was used for data analysis for obtaining graphs and results. Confidence interval 95% and p value <0.05 was considered significant. Data analysis consisted of examining the frequency and severity of combined hematological toxicity, combined Gastro-Intestinal (GI) toxicity and specific toxicities which were described based on demographic traits and medical variables. Chi-square testing was used to compare differences between subgroups for categorical data. Chi square tests was utilized to assess the associations between socio-demographic and clinical variables and chemotherapy induced toxicities, including combined GI and hematological toxicity. After discussing the intent of the study, all patients gave their full informed consent. The study followed the Declaration of Helsinki.

A sample size of 221 cases collected out of which 349 chemotherapy induced toxicities identified. Table 1 illustrates patients with (50-59) years have the highest incidence of chemotherapy induced toxicities with severity as mild (9%), moderate (18%) and high (6%). However, the association between age and toxicity was not found statistically significant as p=0.867. The severity was classified based on Hartwig and Siegel (Adverse Drug Reactions) ADRs causality assessment scale. Out of 221 cases moderate severity was seen majorly in 52% followed by 30% mild cases. In accordance with the gender distribution, females seen to experience chemotherapy induced toxicities in increased amount comprising of mild (23%), moderate (33%) and high (12%) comparative to male counterparts of mild (7%), moderate (19%) and high (6%). However, the association between gender and toxicity was not statistically significant as p=0.2057 was observed. During diagnosis of cancer types it was observed that patients enduring any type of cancer have their incidence of chemotherapy induced toxicities with varying frequency. Patients with blood cancer, bone cancer, brain cancer, skin cancer, kidney cancer, liver cancer had the least frequency of induced toxicities whereas reproductive cancer (23%) and breast cancer (22%) had highest frequency of chemotherapy induced toxicities. With reference to the chemotherapy regimen (Table 2), patients were prescribed more with (Paclitaxel+carboplatin) as dual therapy in 17% cases, which was observed to exhibit highest number of cases with toxicity. This was followed by mono-therapy prescription with only Paclitaxel in majorly 7% cases. Patients who have taken the course of 2 cycle (C) were highly inclined to have chemotherapy induced toxicities followed by 1C and 4C. Patients with the course of 7C, 16C, 21C, and 26C were least susceptible to toxicities and 3C, 5C, 8C, 9C were moderately susceptible. From Table 3, chemotherapy induced toxicities majorly observed with respect to combined haematological toxicities of anaemia (26%), leukopenia (34%), thrombocytopenia (24%) and leucocytosis (1%). Next commonly observed gastro-intestinal toxicities were 9% nausea and vomiting, 6% diarrhoea and 6% constipation cases. Duration of hospital stay report that there had been delay in chemotherapy initiation where, most of the 54% patients experienced a delay of 24 hr followed by 48 hr delay in 46% patients and the longest delay observed was 14 days in 2% patients. On examining the prescription pattern in delayed chemotherapy it was observed that drugs utilized commonly were 91% blood products followed by 76% granulocyte colony stimulating factor. The commonly prescribed drugs for supportive care were Packed cell volume 30%, Inj. Filgrastim 32% and Inj. Romiplostin 16% given for management of symptoms listed in Table 4.

Our study, had chemotherapy-induced toxicities in the age group of (50-59) years which was comparable to a study done by (Tamang et al., 2012). This maybe because older individuals may experience more toxicities (ADRs) due to decreased metabolic and excretory functions, which lead to the accumulation of the drug in the body and result in more adverse reactions (Shresthaet al., 2019). So older patients must be taken care of with great vigilance. In the research at hand, toxicities were more frequently observed in females which aligns with finding in a study done in India by (Surendiranet al., 2010). This maybe due to the pharmacokinetic and pharmacodynamic characteristic difference of the medications involved (Khanal et al., 2014). In the present research most prevalent type pf cancer were reproductive cancer and breast cancer whereas a study conducted by (Pai Sunilet al.,2016) reported that oropharyngeal cancer and cervical cancer remained the most common individual cancer type. In this research patients receiving dual therapy and mono-therapy were more susceptible to develop toxicities which could be due to various treatment modalities employed that are influenced by several variables including cancer staging, treatment costs, and patient-doctor-related factors. Hence, in this study ADRs specifically induced by chemotherapy were considered which for which a study done by (Sharmaet al., 2015) was taken as a reference. In current study, greater chemotherapy induced toxicities were observed in the patients who have taken the course of 2^nd cycle and the risk factors attributing to the toxicity include poly-chemotherapy and aging. As per a study done by (Belachewet al.,2016) it is said that age-related declines in bone marrow reserve increased the likelihood of chemotherapy-induced myelo-suppression. It was noticed that most of the toxicities occurred after change of one plan to other chemotherapy hence most of the toxicities were found in 2^nd cycle. Chemotherapy induced toxicities observed in this study was related to bone marrow suppression leading to various blood disorders which has been associated with potentially fatal consequences, treatment delays, poorer outcomes, and an excessive utilization of supportive care resources as explained in a study done by (Eltinget al., 2001). A 24 hr chemotherapy initiation delay was seen in most patients which was considered due to social stigma, financial issues, comorbidities, care plan differences, missed orders, unrecorded order revisions, unsigned doctor orders and lab test procedures described in a study done by (Bunnellet al., 2013). The causality assessment of ADRs in our study of moderate severity was high and was in contrary to a study done by (Surendiranet al., 2010; Uchiyamaet al., 2021). In this current study for the management of chemotherapy induced toxicity a total number of 369 drugs were given to the patient. Blood products were commonly prescribed and for supportive care packed cell volume, Filgrastim and Romiplostin were given which is comparable to a study done by (Ganseret al.,1996). One of the most frequent adverse effects of cancer chemotherapy was nausea and vomiting, the use of newer anti-emetics has been seen to greatly reduced its incidence (Jenns K, 1994; Malliket al., 2007). In our study, the antiemetic dosage was generally increased to manage side effects.

The prescription regimens of various single and combined therapies were examined, with combined drug regimens often linked to chemotherapy-induced toxicity, leading to delays or cancellations. Many cases with reproductive cancer followed by breast cancer had paclitaxel+carboplatin treatment endured haematological and gastrointestinal toxicities most often observed in older patients. Most toxicity causalities were moderate to mild, observed more in female than male patients. Switching off chemotherapy regimen to one another paved the way to toxicities. This study highlights the importance of active patient monitoring to promptly detect and manage toxicities, ensuring patient safety, toxicities, duration of hospital stay, economic burden were constrained via early detection. Our study also calls for further investigation into the variables influencing chemotherapy-induced toxicities and the factors contributing to inter individual variability, as these insights could enable personalized treatment approaches and improve patient outcomes. Additionally, understanding the factors influencing these toxicities, including patient demographics, treatment regimens, and comorbidities, is essential for optimizing treatment protocols. Hence, it is suggestive that future research should focus on identifying personalized approaches to minimize toxicity, ensuring more effective and safer chemotherapy regimens for diverse patient groups.

The authors are grateful to the Management of Omega Super Speciality Hospitals and Sultan- Ul-Uloom College of Pharmacy, Hyderabad for permitting to do the research work and guiding through the process of data collection.