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Pemetrexed plus cisplatin active in advanced, recurrent cervical carcinoma
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The combination of pemetrexed and cisplatin appeared safe and effective in women with advanced, persistent or recurrent carcinoma of the cervix, according to results of a phase 2 trial.
“This combination should be further developed in the treatment of cervical cancer,” David Scott Miller, MD, professor of obstetrics and gynecology at UT Southwestern Medical Center, and colleagues wrote. “Given that it may be less toxic than and as active as cisplatin plus paclitaxel, and that it can be combined with bevacizumab (Avastin, Genentech), comparison of cisplatin–pemetrexed plus bevacizumab with cisplatin–paclitaxel plus bevacizumab would be appropriate.”
David Scott Miller
Miller and colleagues sought to estimate the antitumor activity of pemetrexed (Alimta, Lilly) in combination with cisplatin in 54 patients (median age, 46 years; 54% white) with advanced, persistent or recurrent carcinoma of the cervix. The majority of patients (80%; n=43) had squamous histology.
Patients received no prior chemotherapy, unless it was administered in addition to primary radiation therapy.
All patients received 500 mg/m2 pemetrexed and 50 mg/m2 cisplatin intravenously every 21 days until disease progression or treatment cessation due to adverse events.
Tumor response by RECIST criteria served as the primary outcome measure.
Median PFS was 5.7 months (range, 0.3-38.6) and median OS was 12.3 months (range, 0.3-38.6).
One patient (1.9%) achieved complete response and 16 (29.5%) achieved partial response, equating to an overall response rate of 31.4%. The median duration of response was 7.6 months.
Twenty-four patients (44.5%) achieved stable disease (median duration, 5.1 months). Eight patients (14.8%) demonstrated increasing disease. Five patients (9.3%) were inevaluable for response.
All 17 patients who demonstrated response had measurable tumor in nonradiated disease sites. The response rate for nonradiated disease sites was 38% (95% CI, 23.8-53.5). No responses were observed in the nine patients with measurable tumor in irradiated disease sites.
Researchers observed responses in 33% (n=14) of patients with squamous histology and 27% (n=3) of those with adenocarcinoma. They reported responses in 26% (n=7) of patients who had received cisplatin with radiotherapy and 37% (n=10) of those who had not received cisplatin.
The pemetrexed–cisplatin combination also appeared tolerable, as 26% of patients received more than nine treatment cycles.
Common grade ≥2 adverse events included neutropenia (35%), leukopenia (28%) and metabolic toxicities (28%).
Disclosure: The researchers report no relevant financial disclosures.
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