Nab-paclitaxel regimen active in locally advanced cervical cancer
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Key takeaways:
- Nab-paclitaxel with cisplatin-based concurrent chemoradiotherapy appeared effective and well tolerated.
- Further follow-up is necessary to assess long-term survival outcomes.
The addition of nab-paclitaxel to cisplatin-based concurrent chemoradiotherapy appeared effective for women with locally advanced cervical cancer, according to prospective study results.
The combination also appeared well tolerated, findings presented at Society of Gynecologic Oncology Annual Meeting on Women’s Cancer showed.
Background and methods
Women with locally advanced cervical cancer often undergo cisplatin-based concurrent chemoradiotherapy.
Results of a preclinical study suggested nab-paclitaxel (Abraxane, Bristol Myers Squibb) can act as a radiosensitizer and improve tumor radiotherapy, according to study background.
Mingyi Li, MD, researcher in the department of radiation oncology at Affiliated Cancer Hospital & Institute of Guangzhou Medical University in China, and colleagues conducted a single-arm phase 2 trial to assess the efficacy and safety of concurrent chemoradiotherapy with nab-paclitaxel and cisplatin for locally advanced cervical cancer.
Researchers enrolled women with histologically or cytologically diagnosed stage IIIB to stage IVA cervical cancer and at least one measurable lesion.
All patients received external beam radiotherapy delivered at doses 45 Gy or 50.4 Gy in 25 or 28 fractions; those with positive lymph nodes received a dose of 60 Gy in 25 or 28 fractions.
All patients also received intracavitary brachytherapy in four or five fractions of 7 Gy or 6 Gy — equating to a total dose of 28 Gy or 30 Gy — once weekly or twice weekly.
Patients received two cycles of triweekly nab-paclitaxel — dosed at 200 mg/m2 — and cisplatin 75 mg/m2 during radiation, plus two cycles of adjuvant chemotherapy.
Researchers followed a Simon two-stage design that specified 31 patients would be enrolled in the first stage and, if at least 21 responded to treatment, another 62 patients would be enrolled.
Objective response rate served as the primary endpoint. Secondary endpoints included OS, PFS, time of radiotherapy interruption and safety.
Results
Investigators enrolled 50 patients between November 2019 and April 2022. Five dropped out, leaving 45 (median age, 52 years) for the preliminary analysis. The majority had stage IIIC disease (71.1%) and squamous cell carcinoma (93.3%).
All patients completed radiotherapy (median duration, 55 days), with a median two cycles each of concurrent chemotherapy and adjuvant chemotherapy.
Nineteen patients required radiation treatment interruption (median, 6 days).
Researchers reported ORRs of 90.9% after external beam radiation therapy, 97.4% (complete response, 39.5%) at 1 month after concurrent chemoradiotherapy, and 100% (complete response, 91.2%) at 3 months after concurrent chemoradiotherapy.
The most common grade 3/grade 4 adverse events included leukopenia (55.6%), anemia (48.9%), neutropenia (40%) and thrombocytopenia (22.2%).
Nonhematologic toxicities generally were grade 1 or grade 2. Researchers reported three grade 3 nonhematologic toxicities, with two cases of diarrhea and one case of abdominal pain.
“Further follow-up is needed to assess long-term survival outcomes,” Li and colleagues wrote.
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Li M, et al. Nab-paclitaxel and cisplatin-based concurrent chemoradiotherapy for locally advanced cervical cancer: A prospective, single-arm phase II clinical trial. Presented at: Society of Gynecologic Oncology Annual Meeting on Women’s Cancer; March 25-28, 2023; Tampa, Florida.
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