Open AccessPhase I/ II Study of Cisplatin plus Nab‐Paclitaxel with Concurrent Thoracic Radiotherapy for Patients with Locally Advanced Non‐Small Cell Lung Cancer
Author(s) -
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
Publication year - 2021
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1002/onco.13524
Subject(s) - medicine , paclitaxel , lung cancer , leukopenia , radiation therapy , cisplatin , pneumonitis , chemoradiotherapy , regimen , oncology , esophagitis , phases of clinical research , neutropenia , chemotherapy , gastroenterology , lung , disease , reflux
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/m 2 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/m 2 , one of six patients experienced DLT (esophagitis of grade 3) at 70 mg/m 2 , 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/m 2 and cisplatin at 75 mg/m 2 every 3 weeks showed encouraging feasibility and activity for locally advanced NSCLC.