A Randomized Phase III Study Comparing Carboplatin With Nab-Paclitaxel Versus Docetaxel for Elderly Patients With Squamous-Cell Lung Cancer: Study Protocol |
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| Authors: | Yoshihito Kogure Hideo Saka Yuichi Takiguchi Shinji Atagi Takayasu Kurata Noriyuki Ebi Akira Inoue Kaoru Kubota Mitsuhiro Takenoyama Takashi Seto Akiko Kada Takeharu Yamanaka Masahiko Ando Nobuyuki Yamamoto Akihiko Gemma Yukito Ichinose |
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| Affiliation: | 1. Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Aichi, Japan;2. Department of Medical Oncology, Chiba University Hospital, Chiba, Japan;3. Department of Internal Medicine, National Hospital Organization Kinki-chuo Chest Medical Center, Osaka, Japan;4. Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan;5. Department of Respiratory Oncology, Iizuka Hospital, Fukuoka, Japan;6. Department of Palliative Medicine, Tohoku University School of Medicine, Miyagi, Japan;7. Cancer Center and Department of Pulmonary Medicine and Oncology, Nippon Medical School Hospital, Tokyo, Japan;8. Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan;9. Clinical Research Center, National Hospital Organization Nagoya Medical Center, Aichi, Japan;10. Department of Biostatistics, Yokohama City University, Kanagawa, Japan;11. Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Aichi, Japan;12. Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan;13. Department of Respiratory Medicine, Nippon Medical School Hospital, Tokyo, Japan |
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| Abstract: | BackgroundTreatment with carboplatin (CBDCA) with weekly paclitaxel (PTX) has shown survival benefits compared with vinorelbine or gemcitabine in elderly patients with non-small-cell carcinoma (NSCLC). Docetaxel (DOC), however, remains a standard treatment in NSCLC. The 130-nm albumin-bound formulation of PTX (nab-PTX) has shown activity in NSCLC. Treatment with CBDCA with weekly nab-PTX showed significantly higher efficacy than CBDCA with PTX in patients with squamous histology and significantly increased overall survival (OS) in patients aged 70 years and older.Patients and MethodsThis randomized, multicenter, phase III trial (UMIN000019843) was designed to compare the efficacy and safety of CBDCA with nab-PTX with DOC in patients aged 70 years and older with advanced squamous NSCLC. Elderly patients who have received no previous chemotherapy for advanced/metastatic squamous NSCLC with Eastern Cooperative Oncology Group performance status of 0 or 1 will be randomized 1:1 to DOC (60 mg/m2 intravenous [I.V.] on day 1) or CBDCA (area under the blood concentration time curve 6 on day 1) with nab-PTX (100 mg/m2 I.V. on days 1, 8, and 15) of each 21-day cycle. The primary end point is OS. Recruitment began in December 2015 and planned enrollment is 250 patients.ConclusionIf OS is greater in patients treated with CBDCA with nab-PTX than with DOC, this study will provide a new standard of care for elderly patients with squamous NSCLC. |
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| Keywords: | Chemotherapy Combination therapy NSCLC Overall survival Single agent |
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