Efficacy and safety of EGFR inhibitor gefitinib in recurrent or metastatic cervical cancer: a preliminary report

Sep 24, 2026

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The study evaluates gefitinib monotherapy for efficacy and safety in patients with recurrent or metastatic cervical cancer, including locoregional recurrence or distant metastases after presentation or following definitive chemoradiotherapy or postoperative radiotherapy. Patients received oral gefitinib 250 mg/day and treatment continued until progression, unacceptable adverse events, or withdrawal. Disease response used clinical and radiological assessments, while toxicity was graded using NCI CTCAE v5.0. Thirty patients were analyzed; median follow-up was 6 months, with manageable toxicities and no grade 3 or higher events.

LanguageEnglish

CategoryHealthcare

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Pages6

Reading Time15 min

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Abstract

Background

Rationale for EGFR inhibition

Gefitinib mechanism and prior evidence

Medical Oncology (2023) 40:203 [https://doi.org/10.1007/s12032-023-02070-1](https://doi.org/10.1007/s12032-023-02070-1) Efficacy and safety of EGFR inhibitor gefitinib in recurrent or metastatic cervical cancer: a preliminary report Abhishek Krishna1 · M. Sathya2 · S. Mukesh2 · M. S. Athiyamaan1 · Sourjya Banerjee1 · Johan Sunny1 · Challapalli Srinivas1 · Dilson Lobo1 · Bharat Sai Makkapatti1 · Vaishak Jawahar1 Received: 29 April 2023 / Accepted: 30 May 2023 / Published online: 13 June 2023 © The Author(s) 2023 Abstract There has been growing interest in the use of epidermal growth factor receptor inhibitors in various cancers. The study was conducted to evaluate the efficacy and safety of gefitinib as a monotherapy in patients with recurrent or metastatic cervical cancer. Patients with cervical carcinoma who experienced locoregional recurrence or distant metastases either at presentation or after definitive combined chemoradiotherapy or postoperative radiotherapy were enrolled. Gefitinib was administered orally at a dose of 250 mg/d to eligible patients. Treatment with Gefitinib was continued until disease progression, intolerable adverse effects were developed, or consent was withdrawn. Clinical and radiological investigations were used to verify the disease response. Toxicity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The study enrolled 32 patients who met the eligibility criteria. Thirty patients were available for the analysis. The majority of the patients included in the analysis had FIGO stage IIIB disease at their initial presentation. The median follow-up time was 6 months (3–15 months) . Two patients (7%) had a complete clinical response, 7 patients (23%) had a partial response, 5 patients (17%) showed a stable disease and 16 patients had progressive disease (53%) . The disease control rate was 47% . The median PFS was noted to be 4.5 months and the 1-year PFS was 20% . None of the individuals experienced toxicity of grade 3 or higher. All toxicities were managed conservatively. The study suggests that gefitinib maybe a promising therapeutic option for patients with advanced cervical cancer who have limited treatment alternatives. Keywords Gefitinib · Cervical cancer · EGFR · Metastatic Background Cervical cancer is an important health concern across the globe, with an estimated 6 lakh new cases and 3,41,000 deaths in 2020 alone [1] . According to the latest data from Globocan 2020, India accounted for 106,208 new cases and 57,778 deaths in 2020, contributing to 5.5% of all new cancer cases and 6.7% of cancer-related deaths in the country [1 , 2] . Cervical cancer is the second most common cancer among women in India and is one the leading cause of death in Indian women aged 15–49 years [1] . The high incidence of cervical cancer in India is attributed to the lack of * Abhishek Krishna [abhishek.krishna@manipal.edu](abhishek.krishna@manipal.edu) 1 Department of Radiation Oncology, Kasturba Medical College, Mangalore, India 2 Department of Radiation Oncology, Mysore Medical College and Research Institute, Mysore, India awareness and access to screening programmes, constrained healthcare infrastructure, and a relatively high prevalence of risk factors such as human papillomavirus (HPV) infection, poor menstrual hygiene, and limited access to advanced healthcare services [3] . The treatment of choice for locally advanced cervical cancer is concurrent chemoradiation with platinum complexes [4]. Despite receiving chemoradiation, 30 to 50% of patients with locally advanced tumours are at risk of recurrence or metastasis [5–7] . The overall prognosis for recurrent and metastatic cervical cancer patients is grim, presenting a considerable clinical challenge to oncologists [6 , 7] . Moreover, treatment options for this subset of patients are limited, and typically, palliative in nature. To address this, several chemotherapy regi

FAQs

What patient population was enrolled in the gefitinib study?

Patients with cervical carcinoma with locoregional recurrence or distant metastases, either at presentation or after definitive combined chemoradiotherapy or postoperative radiotherapy, were enrolled.

How was gefitinib administered and how long were patients treated?

Gefitinib was given orally at 250 mg/day, with treatment continued until disease progression, intolerable adverse effects, or withdrawal of consent.

What did the study report about safety and severe toxicity?

No individuals experienced toxicity of grade 3 or higher; all toxicities were managed conservatively.

Sep 24, 2026

Uploaded by Mia