Phase I/II Study of Cisplatin plus Nab‐Paclitaxel with Concurrent Thoracic Radiotherapy for Patients with Locally Advanced Non‐Small Cell Lung Cancer |
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| Authors: | Hidetoshi Hayashi Masakazu Ogura Takashi Niwa Toshihide Yokoyama Junko Tanizaki Tomohiro Ozaki Hiroshige Yoshioka Takayasu Kurata Yosuke Tamura Yasuhito Fujisaka Kaoru Tanaka Yoshikazu Hasegawa Keita Kudo Yasutaka Chiba Kazuhiko Nakagawa |
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| Affiliation: | 1. Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka-Sayama, Japan;2. Department of Radiation Oncology, Kishiwada City Hospital, Kishiwada, Japan;3. Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan;4. Department of Medical Oncology, Kishiwada City Hospital, Kishiwada, Japan;5. Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata, Japan;6. Department of Respiratory Medicine and Thoracic Oncology, Osaka Medical College Hospital, Takatsuki, Japan;7. Clinical Research Center, Osaka Medical College Hospital, Takatsuki, Japan;8. Department of Medical Oncology, Izumi City General Hospital, Izumi, Japan;9. Department of Thoracic Medical Oncology, National Hospital Organization Osaka Minami Medical Center, Kawachinagano, Japan;10. Clinical Research Center, Kindai University Hospital, Higashiosaka, Japan |
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| Abstract: | ![]()
Lessons Learned - The combination of cisplatin plus nab‐paclitaxel with concurrent thoracic radiotherapy in unresectable stage III non‐small cell lung cancer is a promising therapeutic strategy.
- Further investigation is warranted.
BackgroundWe conducted a phase I/II trial of cisplatin plus nab‐paclitaxel with concurrent thoracic radiotherapy for locally advanced non‐small cell lung cancer (NSCLC) to determine the recommended dose (RD) of nab‐paclitaxel and to evaluate the safety and efficacy of this regimen.MethodsIn the phase I study, escalating doses of weekly nab‐paclitaxel were administered together with cisplatin at 75 mg/m2 every 3 weeks and concurrent radiotherapy. In the phase II study, nab‐paclitaxel was administered at the RD.ResultsIn the phase I study, whereas no dose‐limiting toxicity (DLT) was observed with nab‐paclitaxel at 50 or 60 mg/m2, one of six patients experienced DLT (esophagitis of grade 3) at 70 mg/m2, determined as the RD. Twenty‐four patients at RD were evaluable for safety and efficacy in phase II. Common toxicities included esophagitis (87.5%) and leukopenia (79.2%). Pneumonitis and treatment‐related deaths were not observed, but 20 patients (83.3%) experienced radiation pneumonitis, with one case of grade 3 and four of grade 2, after completion of concurrent chemoradiotherapy. The 2‐year overall survival and progression‐free survival rates were 73.9% and 56.5% (95% confidence interval [CI], 34.3%–74.7%), respectively.ConclusionConcurrent chemoradiation with nab‐paclitaxel at 70 mg/m2 and cisplatin at 75 mg/m2 every 3 weeks showed encouraging feasibility and activity for locally advanced NSCLC. |
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| Keywords: | Cisplatin, Dose‐ limiting toxicity, nab‐ Paclitaxel, Radiotherapy, Non‐ small cell lung cancer |
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