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- Title
Phase I/II Study of Cisplatin plus Nab‐Paclitaxel with Concurrent Thoracic Radiotherapy for Patients with Locally Advanced Non‐Small Cell Lung Cancer.
- Authors
Hayashi, Hidetoshi; Ogura, Masakazu; Niwa, Takashi; Yokoyama, Toshihide; Tanizaki, Junko; Ozaki, Tomohiro; Yoshioka, Hiroshige; Kurata, Takayasu; Tamura, Yosuke; Fujisaka, Yasuhito; Tanaka, Kaoru; Hasegawa, Yoshikazu; Kudo, Keita; Chiba, Yasutaka; Nakagawa, Kazuhiko
- 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. Background: We 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. Methods: In 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. Results: In 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. Conclusion: Concurrent 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.
- Subjects
ANTINEOPLASTIC agents; CANCER invasiveness; CISPLATIN; CLINICAL trials; CONFIDENCE intervals; DRUG dosage; DRUG toxicity; LUNG cancer; PACLITAXEL; PATIENT safety; RADIOTHERAPY; TREATMENT effectiveness; CHEMORADIOTHERAPY
- Publication
Oncologist, 2021, Vol 26, Issue 1, p19
- ISSN
1083-7159
- Publication type
Article
- DOI
10.1002/ONCO.13524