A phase II study of adaptive two-step intensity-modulated radiation therapy (IMRT) with chemotherapy for loco-regionally advanced nasopharyngeal cancer (JCOG1015).,International Journal of Clinical Oncology

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A phase II study of adaptive two-step intensity-modulated radiation therapy (IMRT) with chemotherapy for loco-regionally advanced nasopharyngeal cancer (JCOG1015).
International Journal of Clinical Oncology ( IF 2.4 ) Pub Date : 2020-03-27 , DOI: 10.1007/s10147-020-01665-2
Yasumasa Nishimura ₁ , Satoshi Ishikura ₂ , Taro Shibata ₃ , Takeshi Kodaira ₄ , Yoshinori Ito ₅ , Kazuhiko Tsuchiya ₆ , Yuji Murakami ₇ , Jun-Ichi Saitoh ₈ , Tetsuo Akimoto ₉ , Kensei Nakata ₁₀ , Michio Yoshimura ₁₁ , Teruki Teshima ₁₂ , Takashi Toshiyasu ₁₃ , Yosuke Ota ₁₄ , Kazuki Ishikawa ₁ , Hidetoshi Shimizu ₄ , Toshiyuki Minemura ₁₅ , Kenichi Nakamura ₃ , Masahiro Hiraoka ₁₆

Affiliation

Department of Radiation Oncology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan.
Department of Radiology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan.
JCOG Data Center/Operations Office, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Department of Radiation Oncology, Aichi Cancer Center Hospital, 1-1 Kanoko-den, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.
Department of Radiation Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Department of Radiation Oncology, Hokkaido University Hospital, Kita14 Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan.
Department of Radiation Oncology, Hiroshima University Hospital, 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, Japan.
Department of Radiation Oncology, Gunma University, 3-39-22, Showa-machi, Maebashi, Gunma, 371-8511, Japan.
Department of Radiation Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Department of Radiology, Sapporo Medical University, S1W17, Chuo-ku, Sapporo, Hokkaido, 060-8556, Japan.
Department of Radiation Oncology and Image-Applied Therapy, Kyoto University, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.
Department of Radiation Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan.
Department of Radiation Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.
Department of Radiation Oncology, Hyogo Cancer Center, 13-70 Kitaouji, , Akashi, Hyogo, 673-8558, Japan.
Center for Cancer Control and Information Services, National Cancer Center, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Department of Radiation Oncology, Japanese Red Cross Wakayama Medical Center, 4-20 Komatsubara-Dori, Wakayama, 640-8558, Japan.

Background

A phase II study of adaptive two-step intensity-modulated radiotherapy (IMRT) with chemotherapy for nasopharyngeal cancer (NPC) (JCOG1015) was conducted to evaluate the efficacy and safety.

Methods

Patients aged 20–75 years with stages II–IVB NPC were enrolled. As adaptive two-step IMRT, computed tomography planning was performed twice before IMRT for the initial plan of 46 Gy/23 fractions and during treatment for the boost plan of 24 Gy/12 fractions with a total dose of 70 Gy. Chemotherapy (cisplatin 80 mg/m²/3-weeks × 3 courses) was administered concurrently with IMRT, followed by adjuvant chemotherapy (cisplatin at 70 mg/m² with 5-FU 700 at mg/m² for 5 days/4 weeks × 3 courses).

Results

Between 2011 and 2014, 75 patients were enrolled from 12 institutions. The 3-year overall survival (OS) for the 75 patients was 88%, and the upper and lower limits of the 95% CI of 78%–94% were higher than the expected 3-year OS of 75% for the target population adjusted by the actual proportion of stage II:III:IV = 21%:44%:35%. The 3-year progression-free survival (PFS) and loco-regional PFS were 71% [59–80%] and 77% [66–85%], respectively. Although no grade 4–5 late toxicities were observed, 15 patients (20%) developed grade 3 late toxicities. Grade 2 xerostomia was noted in 26%, 12%, and 9% at 1, 2, and 3 years after starting IMRT, respectively.

Conclusions

Adaptive two-step IMRT for NPC demonstrated an excellent 3-year OS with acceptable toxicities. This method may be one treatment option for locally advanced NPC.

中文翻译：

局部局部晚期鼻咽癌（JCOG1015）的化学疗法适应性两步式调强放射治疗（IMRT）的II期研究。

背景

进行了一项针对鼻咽癌（NPC）（JCOG1015）的化学疗法两步式调强放射治疗（IMRT）的适应性II期研究，以评估疗效和安全性。

方法

纳入年龄为20-75岁的II-IVB期NPC患者。作为自适应两步IMRT，在IMRT之前针对46 Gy / 23馏分的初始计划和在治疗期间针对24 Gy / 12馏分的增强计划进行两次断层扫描计划，总剂量为70 Gy。在IMRT的同时进行化学疗法（顺铂80 mg / m ^2/3周×3个疗程），然后进行辅助化疗（70 mg / m ²顺铂与5-FU 700 mg / m ²进行5天/ 4周×3门课程）。

结果

在2011年至2014年之间，共有12家机构的75名患者入选。75名患者的3年总生存（OS）为88％，而95％CI的上限和下限为78％–94％，高于目标人群的预期3年总生存率75％根据阶段II：III：IV的实际比例进行调整后= 21％：44％：35％。3年无进展生存期（PFS）和局部区域PFS分别为71％[59-80％]和77％[66-85％]。尽管未观察到4-5级晚期毒性，但15例患者（20％）出现3级晚期毒性。开始IMRT后的1年，2年和3年，发现2级口腔干燥症分别占26％，12％和9％。