A prospective study of adverse drug reactions associated with chemotherapy in patients of carcinoma head and neck in Government Cancer Hospital Indore, India

Sameer Pandit, Manish Verma, Pooja Solanki Mishra


Background: Adverse drug reactions (ADRs) has become one of the major health issues due to wide use of medications worldwide. Chemotherapy is one of the treatment lines in which multiple drugs are commonly used for long term in cancer patients, are more prone to cause ADR.

Methods: Head and neck cancer patients admitted in government cancer hospital, Indore for chemotherapy were included in study for a period of 6 month from March to August 2019. Data from chemotherapy related ADR was obtained either from patient’s case reports or interview of patients, recorded in suspected adverse drug reaction reporting form (version 1.3) of CDSCO and analyzed.

Results: During 6 months duration total 126 patients (M:F=108:18) were enrolled in the study, among which 251 ADRs were reported. Majority of ADRs occur in 45-60 years of age group followed by 30-45 years. Paclitaxel, cisplatin, 5-florouracil (5-FU) combinations (45.2%) implicated highest number of ADRs followed by paclitaxel and carboplatin combination (38%). Most common ADR was alopecia and constipation. ADR related mostly with GIT system followed by integumentary, haematological system while CNS was least affected.

Conclusions: In this study Ca tongue was most commonly seen head and neck cancer followed by Ca buccal mucosa. Age group 45-60 years were commonly affected. Paclitaxel, cisplatin, 5-FU combination was commonly used regimen and primary cause of ADR. Alopecia and constipation were noted to be most common ADR. Other ADRs reported were mild and easily manageable.


Adverse drug reactions, Chemotherapy, Head and neck cancer

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