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Erlotinib plus cisplatin chemoradiation induced high response rate in cervical cancer
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The addition of erlotinib to cisplatin and radiotherapy demonstrated significant anticancer activity in patients with locally advanced cervical cancer, according to results of an open-label, single-site, phase 2 study.
The regimen also appeared well tolerated.
The analysis included 36 patients with International Federation of Gynecology and Obstetrics stage IIB to IIIB squamous cell carcinoma, a bi-dimensionally measurable lesion, and an ECOG performance of 0 to 2.
Patients received 150 mg oral erlotinib (Tarceva; Genentech, Astellas). Treatment began a week prior to initiation of cisplatin-based chemoradiation and continued until the final brachytherapy cycle.
Radiotherapy, administered for 9 weeks, was delivered in two phases: teletherapy at 4,500 cGy in 25 daily fractions for 5 days per week, and four subsequent cycles of brachytherapy at 1-week intervals at a dose of 600 cGy. Chemotherapy — which consisted of 40 mg/m2 IV cisplatin (maximum dose, 70 mg) — was administered on days 1, 8, 15, 22 and 29 during teletherapy.
Overall response served as the primary endpoint. PFS, OS, and safety and tolerability served as secondary endpoints.
The median therapy duration was 77 days. Median follow-up was 59.3 months.
Thirty-four patients (94.4%) demonstrated complete response. OS was 91.7% at 2 years and 80% at 3 years. PFS was 80.6% at 2 years and 73.8% at 3 years.
Pending confirmation of efficacy in randomized trials, targeted therapies such as the combination of erlotinib and cisplatin-based chemoradiation may become standard treatment for locally advanced cervical cancer, according to Angélica Nogueira-Rodrigues, MD, of the Brazilian National Cancer Institute.
“While cervical cancer is a neglected disease and very few clinical trials have been reported in the last 10 years, some groups, including ours, have reported that its biology might be prone to targeted therapy,” Nogueira-Rodrigues said in a press release. “To the best of our knowledge, this is the first study to present that a targeted agent has promising activity in the management of locally advanced cervical disease.”
Disclosure: The researchers report no relevant financial disclosures.
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