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Nishimura, Y. et al.

Yasumasa Nishimura, Kazuhiko Nakagawa, Koji Takeda, Masahiro Tanaka, Yoshihiko Segawa, Kayoko Tsujino, Shunichi Negoro, Nobukazu Fuwa, Toyoaki Hida, Masaaki Kawahara, Nobuyuki Katakami, Keiko Hirokawa, Nobuyuki Yamamoto, Masahiro Fukuoka, Yutaka Ariyoshi,

Phase I/II trial of sequential chemoradiotherapy using a novel hypoxic cell radiosensitizer, doranidazole (PR-350), in patients with locally advanced non-small-cell lung Cancer (WJTOG-0002).

PURPOSE: This Phase I/II trial was conducted to assess the efficacy and safety of PR-350, a novel hypoxic cell radiosensitizer, when administered with thoracic radiation therapy (RT) after induction chemotherapy (CT) for locally advanced non-small-cell lung cancer (NSCLC). METHODS AND MATERIALS: Two cycles of cisplatin (80 mg/m(2)) and paclitaxel (180 mg/m(2)), or carboplatin (AUC = 6) and paclitaxel (200 mg/m(2)) were given before RT of 60 Gy in 30 fractions. In the Phase I portion, the starting dosage of PR-350 was 10 daily administrations (2000 mg/m(2)) in combination with RT, and this number was increased in increments of 10 for successive groups to 30 doses. RESULTS: In total, 37 patients were enrolled. In Phase I (n = 20), PR-350 could be administered 30 times with concurrent thoracic RT. Thus, in Phase II (n = 17), PR-350 was administered 30 times. The major toxicity was radiation pneumonitis, with Grade 3 or more pneumonitis noted in 6 patients (16%) including 2 with treatment-related deaths. However, no Grade 3 or more esophageal toxicity was noted, and only Grade 1 peripheral neuropathy was noted in 9 patients (24%). For all 37 patients, the median survival time (MST) and the 2-year survival rate were 15.9 months and 24%, respectively. For 18 patients receiving 21 to 30 doses of PR-350, the MST and 2-year survival rate were 20.9 months and 33%, respectively. CONCLUSIONS: Thoracic RT combined with 30 daily administrations of PR-350 after induction CT was well tolerated and promising for locally advanced NSCLC.[1]

References

Phase I/II trial of sequential chemoradiotherapy using a novel hypoxic cell radiosensitizer, doranidazole (PR-350), in patients with locally advanced non-small-cell lung Cancer (WJTOG-0002). Nishimura, Y., Nakagawa, K., Takeda, K., Tanaka, M., Segawa, Y., Tsujino, K., Negoro, S., Fuwa, N., Hida, T., Kawahara, M., Katakami, N., Hirokawa, K., Yamamoto, N., Fukuoka, M., Ariyoshi, Y. Int. J. Radiat. Oncol. Biol. Phys. (2007) [Pubmed]

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