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Docetaxel plus cisplatin in recurrent and/or metastatic non-squamous-cell head and neck cancer: a multicenter phase II trial

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Abstract

The clinical utility of systemic therapy and genomic profiling in non-squamous-cell head and neck cancer (NSCHNC) has not been fully elucidated. This phase II trial evaluated the efficacy and safety of docetaxel and cisplatin combination in the first-line setting. Eligibility criteria were recurrent and/or metastatic NSCHNC; progressive disease within the last 6 months; no prior systemic therapy; and ECOG performance status of 0–1. Patients received docetaxel (75 mg/m2 on day 1) and cisplatin (75 mg/m2 on day 1), repeated every 21 days for 6 cycles. The primary endpoint was confirmed objective response rate (ORR). The secondary endpoints included progression-free survival (PFS), overall survival (OS), and adverse events. Next-generation sequencing (NGS) was performed using the Ion AmpliSeq Cancer Hotspot Panel v2. Twenty-three patients were enrolled from November 2012 to October 2016, of whom 8 were male. Median age was 57 years. Ninety-six percent of cases were metastatic. Among 22 evaluable patients, confirmed ORR was 45% (95% confidential interval 24–68%). With a median follow-up period of 18.8 months, median PFS and OS were 6.7 and 20.1 months, respectively. Grade 3/4 adverse events included febrile neutropenia (39%) and anemia (22%). No treatment-related deaths were observed. NGS analysis revealed potential treatment targets, including ERBB2, KIT, and ALK. The docetaxel and cisplatin combination regimen can be considered a new treatment option in recurrent and/or metastatic NSCHNC, although primary prophylaxis for febrile neutropenia should be considered. Diverse genomic alterations may lead novel treatment options.

This trial was registered with the UMIN Clinical Trials Registry as UMIN000008333 on [September 1st, 2012].

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Acknowledgements

We thank Dr. Yutaka Fujiwara, Aichi Cancer Center Hospital, for his helpful advice on the conceptual stage of the protocol. This study was funded by a Grant-in-Aid for Scientific Research C (Grant Numbers: 26462605 and 17K11384) from the Ministry of Education, Culture, Sports, Science and Technology, Japan.

Funding

This study was funded by a Grant-in-Aid for Scientific Research C (Grant Numbers: 26462605 and 17K11384) from the Ministry of Education, Culture, Sports, Science and Technology, Japan. The funding source had no role in the study.

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Authors and Affiliations

  1. Department of Medical Oncology and Hematology, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan

    Yoshinori Imamura, Naomi Kiyota, Yoshiaki Nagatani, Masanori Toyoda & Hironobu Minami

  2. Department of Medical Oncology, Kindai University Faculty of Medicine, 377-2 Ohnohigashi, Osaka-Sayama, Osaka, 589-8511, Japan

    Kaoru Tanaka & Hidetoshi Hayashi

  3. Cancer Center, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan

    Naomi Kiyota & Hironobu Minami

  4. Department of Otolaryngology-Head and Neck Surgery, Nara Medical University, 840 Shijo-Cho, Kashihara, Nara, 634-8521, Japan

    Ichiro Ota

  5. Department of Otolaryngology, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji Kamigyo-ku, Kyoto, 602-8566, Japan

    Akihito Arai

  6. Department of Head and Neck Surgery, Hyogo Cancer Center, 13-70 Kitaoujicho, Akashi, Hyogo, 673-8588, Japan

    Shigemichi Iwae

  7. Department of Otolaryngology, National Hospital Organization Tokyo Medical Center, 2-5-1 Higashigaoka, Meguro-ku, Tokyo, 152-8902, Japan

    Shujiro Minami

  8. Department of Otolaryngology, Kindai University Nara Hospital, 1248-1 Otoda-cho, Ikoma, Nara, 630-0293, Japan

    Katsunari Yane

  9. Division of Head and Neck Medical Oncology, Miyagi Cancer Center, 47-1 Nodayama, Medeshimashiode, Natori, Miyagi, 981-1293, Japan

    Tomoko Yamazaki

  10. Department of Genome Biology, Kindai University Faculty of Medicine, 377-2 Ohnohigashi, Osaka-Sayama, Osaka, 589-8511, Japan

    Takayuki Takahama, Kazuko Sakai & Kazuto Nishio

  11. Department of Otolaryngology-Head and Neck Surgery, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan

    Naoki Otsuki & Ken-ichi Nibu

Authors
  1. Yoshinori Imamura
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  2. Kaoru Tanaka
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Contributions

All authors contributed to the study conception and design. Patient recruitment was performed by YI, KT, NK, HH, IO, AA, SI, SM, KY, YN, MT, NO, KN, and HM. Data collection and analysis was performed by YI, TT, KS, and KN. The first draft of the manuscript was written by YI and TT. All authors commented on previous versions of the manuscript. Funding acquisition was conducted by NK. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Naomi Kiyota.

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Conflict of interest

Naomi Kiyota has received honoraria for Bristol-Myers Squibb and grant support from Bristol-Myers Squibb outside the submitted work. Hidetoshi Hayashi has received honoraria for AstraZeneca, Bristol-Myers Squibb, and Ono Pharma and grant support from Boehringer Ingelheim and Ono Pharma outside the submitted work. Tomoko Yamazaki has received grant support from AstraZeneca, MSD, and Ono Pharma outside the submitted work. Ken-ichi Nibu has received honoraria for Ono Pharma outside the submitted work. Hironobu Minami has received grant support from Bristol-Myers Squib and Pfizer outside the submitted work. The other authors declare that they have no conflict of interest for this study.

Ethical approval

The study protocol was approved by the institutional review board at each participating center. The trial was conducted in accordance with the Declaration of Helsinki. This trial was registered with the UMIN Clinical Trials Registry as UMIN000008333.

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All patients provided written informed consent before study entry.

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Imamura, Y., Tanaka, K., Kiyota, N. et al. Docetaxel plus cisplatin in recurrent and/or metastatic non-squamous-cell head and neck cancer: a multicenter phase II trial. Med Oncol 38, 128 (2021). https://doi.org/10.1007/s12032-021-01581-z

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