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Phase I/II trial of biweekly docetaxel and cisplatin with concurrent thoracic radiation for stage III non-small-cell lung cancer

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Abstract

Objectives: We conducted phase I and II studies of biweekly docetaxel and cisplatin with concurrent radiotherapy, followed by consolidation chemotherapy with the same drugs in patients with locally advanced, unresectable non-small-cell lung cancer (NSCLC). Our objectives were to define the maximum-tolerated dose and dose-limiting toxicity (DLT) in the phase I study, and to determine the response rate, toxicity, and survival rate at the recommended dose (RD) in the phase II study. Methods: Patients with unresectable stage IIIA and IIIB NSCLC were studied. Six to eight cycles of docetaxel and cisplatin were administered at 2-week intervals. In the phase I study, patients received four dose levels: level 1, docetaxel/cisplatin=30/40 mg/m2; level 2, 35/40; level 3, 40/40; and level 4, 45/40. Radiotherapy was delivered at a rate of 2 Gy per fraction/day up to a total dose of 60 Gy over the course of 6 weeks, during the first three cycles of chemotherapy. Results: DLT comprised neutropenia at level 4 in the phase I study (n=15), and level 3 was considered the RD. In the phase II study (n=46), two patients had a complete response (4.3%) and 34 had a partial response (73.9%), for an overall response rate of 78.2% [95% CI (66.3–90.2%)]. The survival rate was 69.1% at 1 year and 39.6% at 2 years, with a median survival time of 19.1 months. Leukopenia, neutropenia, anemia, and radiation esophagitis were the most common toxic reactions, with Grade ≥3 reactions occurring at rates of 77, 70, 17, and 8%, respectively. Conclusion: Biweekly docetaxel and cisplatin with concurrent RT was active and well tolerated in patients with unresectable stage III NSCLC.

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Authors and Affiliations

  1. Division of Pulmonary Medicine, Department of Medicine, Kyoto Prefectural University of Medicine, 465 Kawaramachi Hirokoji, Kamigyo-ku, 602, Kyoto, Japan

    Yoshinobu Iwasaki, Shuji Ohsugi, Atsushi Natsuhara, Taichiro Arimoto, Tadaaki Yamada, Toshiyuki Takesako, Kenji Kohno, Shigekuni Hosogi, Masaki Nakanishi & Yoshinori Marunaka

  2. Department of Radiology, Kyoto Prefectural University of Medicine, 465 Kawaramachi Hirokoji, Kamigyo-ku, 602, Kyoto, Japan

    Takuji Tsubokura & Tsunehiko Nishimura

  3. Department of Pulmonary Medicine, Kyoto 2nd Red Cross Hospital, 602, Kyoto, Japan

    Hidehiko Harada & Hiroshi Hara

  4. Department of Pulmonary Medicine, Shiga National Hospital, 527, Higashi-ohmi, Japan

    Mikio Ueda

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  1. Yoshinobu Iwasaki
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  2. Shuji Ohsugi
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Correspondence to Yoshinobu Iwasaki.

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Iwasaki, Y., Ohsugi, S., Natsuhara, A. et al. Phase I/II trial of biweekly docetaxel and cisplatin with concurrent thoracic radiation for stage III non-small-cell lung cancer. Cancer Chemother Pharmacol 58, 735–741 (2006). https://doi.org/10.1007/s00280-006-0220-y

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  • DOI: https://doi.org/10.1007/s00280-006-0220-y

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