A multicenter phase II trial of paclitaxel, carboplatin, and cetuximab followed by chemoradiotherapy in patients with unresectable locally advanced squamous cell carcinoma of the head and neck
Abstract Background Induction chemotherapy (IC) in locally advanced squamous cell carcinoma of the head and neck (LA‐SCCHN) often compromises compliance with subsequent chemoradiotherapy (CRT), which negatively affects outcomes. Here, we assessed the combination of paclitaxel (PTX), carboplatin (CBD...
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| Format: | Article |
| Language: | English |
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Wiley
2020-03-01
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| Series: | Cancer Medicine |
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| Online Access: | https://doi.org/10.1002/cam4.2852 |
| _version_ | 1797319202955067392 |
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| author | Tomohiro Enokida Takenori Ogawa Akihiro Homma Kenji Okami Shujiro Minami Ayako Nakanome Yasushi Shimizu Daisuke Maki Yuri Ueda Takao Fujisawa Atsushi Motegi Akira Ohkoshi Jun Taguchi Koji Ebisumoto Shogo Nomura Susumu Okano Makoto Tahara |
| author_facet | Tomohiro Enokida Takenori Ogawa Akihiro Homma Kenji Okami Shujiro Minami Ayako Nakanome Yasushi Shimizu Daisuke Maki Yuri Ueda Takao Fujisawa Atsushi Motegi Akira Ohkoshi Jun Taguchi Koji Ebisumoto Shogo Nomura Susumu Okano Makoto Tahara |
| author_sort | Tomohiro Enokida |
| collection | DOAJ |
| description | Abstract Background Induction chemotherapy (IC) in locally advanced squamous cell carcinoma of the head and neck (LA‐SCCHN) often compromises compliance with subsequent chemoradiotherapy (CRT), which negatively affects outcomes. Here, we assessed the combination of paclitaxel (PTX), carboplatin (CBDCA), and cetuximab (Cmab) as IC for unresectable LA‐SCCHN. Methods Induction chemotherapy consisted of weekly CBDCA area under the plasma concentration‐time curve = 1.5, PTX 80 mg/m2 and Cmab with an initial dose of 400 mg/m2 followed by 250 mg/m2 for 8 weeks. Following IC, CDDP (20 mg/m2, 4 days × 3 cycles) and concurrent radiotherapy (70 Gy/35 fr) were started. Primary endpoint was the proportion of CRT completion (%CRT completion). PCE was planned to be deemed effective if the Bayesian posterior probability (PP), defined as the probability that %CRT completion was larger than the threshold value of 65%, exceeded 84%. Results Thirty‐five patients were enrolled. Cases were hypopharynx/oropharynx/larynx in 17/17/1 patients, all at Stage IV. Of 35 patients, 34 (97%) completed IC and 32 received CRT and met the criteria of full analysis set (FAS). In FAS, the %CRT completion was 96.9%, and PP was 99.9%, exceeding the prespecified boundary of 84%. Mean cumulative dose and relative to dose intensity of CDDP in CRT was 232.5 mg/m2 and 100%, respectively. Response rate was 88.6% by IC and 93.8% in the CRT phase. Three year overall survival was 83.5%. Main grade 3 toxicities included neutropenia (11.4%) and skin rash (5.7%) during IC; and oral mucositis (31.3%) and neutropenia (12.5%) during CRT. No grade 4 toxicity or treatment‐related death was seen. Conclusions PCE as IC was feasible, with promising efficacy and no effect on compliance with subsequent CRT in unresectable LA‐SCCHN. |
| first_indexed | 2024-03-08T04:03:27Z |
| format | Article |
| id | doaj.art-4167ef393f2548d2b02a6ccd8d374368 |
| institution | Directory Open Access Journal |
| issn | 2045-7634 |
| language | English |
| last_indexed | 2024-03-08T04:03:27Z |
| publishDate | 2020-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Medicine |
| spelling | doaj.art-4167ef393f2548d2b02a6ccd8d3743682024-02-09T09:26:02ZengWileyCancer Medicine2045-76342020-03-01951671168210.1002/cam4.2852A multicenter phase II trial of paclitaxel, carboplatin, and cetuximab followed by chemoradiotherapy in patients with unresectable locally advanced squamous cell carcinoma of the head and neckTomohiro Enokida0Takenori Ogawa1Akihiro Homma2Kenji Okami3Shujiro Minami4Ayako Nakanome5Yasushi Shimizu6Daisuke Maki7Yuri Ueda8Takao Fujisawa9Atsushi Motegi10Akira Ohkoshi11Jun Taguchi12Koji Ebisumoto13Shogo Nomura14Susumu Okano15Makoto Tahara16Department of Head and Neck Medical Oncology National Cancer Center Hospital East Chiba JapanDepartment of Otolaryngology – Head and Neck Surgery Tohoku University School of Medicine Miyagi JapanDepartment of Otolaryngology, Head & Neck Surgery Hokkaido University Graduate School of Medicine Sapporo JapanDepartment of Otolaryngology – Head Neck Surgery Tokai University Kanagawa JapanDepartment of Otorhinolaryngology National Hospital Organization Tokyo Medical Center Tokyo JapanDepartment of Otolaryngology – Head and Neck Surgery Tohoku University School of Medicine Miyagi JapanDepartment of Medical Oncology Hokkaido University Hospital Sapporo JapanDepartment of Otolaryngology – Head Neck Surgery Tokai University Kanagawa JapanDepartment of Head and Neck Medical Oncology National Cancer Center Hospital East Chiba JapanDepartment of Head and Neck Medical Oncology National Cancer Center Hospital East Chiba JapanDivision of Radiation Oncology and Particle Therapy National Cancer Center Hospital East Chiba JapanDepartment of Otolaryngology – Head and Neck Surgery Tohoku University School of Medicine Miyagi JapanDepartment of Medical Oncology Hokkaido University Hospital Sapporo JapanDepartment of Otolaryngology – Head Neck Surgery Tokai University Kanagawa JapanBiostatistics Division Center for Research Administration and Support National Cancer Center Chiba JapanDepartment of Head and Neck Medical Oncology National Cancer Center Hospital East Chiba JapanDepartment of Head and Neck Medical Oncology National Cancer Center Hospital East Chiba JapanAbstract Background Induction chemotherapy (IC) in locally advanced squamous cell carcinoma of the head and neck (LA‐SCCHN) often compromises compliance with subsequent chemoradiotherapy (CRT), which negatively affects outcomes. Here, we assessed the combination of paclitaxel (PTX), carboplatin (CBDCA), and cetuximab (Cmab) as IC for unresectable LA‐SCCHN. Methods Induction chemotherapy consisted of weekly CBDCA area under the plasma concentration‐time curve = 1.5, PTX 80 mg/m2 and Cmab with an initial dose of 400 mg/m2 followed by 250 mg/m2 for 8 weeks. Following IC, CDDP (20 mg/m2, 4 days × 3 cycles) and concurrent radiotherapy (70 Gy/35 fr) were started. Primary endpoint was the proportion of CRT completion (%CRT completion). PCE was planned to be deemed effective if the Bayesian posterior probability (PP), defined as the probability that %CRT completion was larger than the threshold value of 65%, exceeded 84%. Results Thirty‐five patients were enrolled. Cases were hypopharynx/oropharynx/larynx in 17/17/1 patients, all at Stage IV. Of 35 patients, 34 (97%) completed IC and 32 received CRT and met the criteria of full analysis set (FAS). In FAS, the %CRT completion was 96.9%, and PP was 99.9%, exceeding the prespecified boundary of 84%. Mean cumulative dose and relative to dose intensity of CDDP in CRT was 232.5 mg/m2 and 100%, respectively. Response rate was 88.6% by IC and 93.8% in the CRT phase. Three year overall survival was 83.5%. Main grade 3 toxicities included neutropenia (11.4%) and skin rash (5.7%) during IC; and oral mucositis (31.3%) and neutropenia (12.5%) during CRT. No grade 4 toxicity or treatment‐related death was seen. Conclusions PCE as IC was feasible, with promising efficacy and no effect on compliance with subsequent CRT in unresectable LA‐SCCHN.https://doi.org/10.1002/cam4.2852carboplatincetuximabchemoradiotherapyinduction chemotherapypaclitaxelunresectable locally advanced squamous cell carcinoma of the head and neck |
| spellingShingle | Tomohiro Enokida Takenori Ogawa Akihiro Homma Kenji Okami Shujiro Minami Ayako Nakanome Yasushi Shimizu Daisuke Maki Yuri Ueda Takao Fujisawa Atsushi Motegi Akira Ohkoshi Jun Taguchi Koji Ebisumoto Shogo Nomura Susumu Okano Makoto Tahara A multicenter phase II trial of paclitaxel, carboplatin, and cetuximab followed by chemoradiotherapy in patients with unresectable locally advanced squamous cell carcinoma of the head and neck Cancer Medicine carboplatin cetuximab chemoradiotherapy induction chemotherapy paclitaxel unresectable locally advanced squamous cell carcinoma of the head and neck |
| title | A multicenter phase II trial of paclitaxel, carboplatin, and cetuximab followed by chemoradiotherapy in patients with unresectable locally advanced squamous cell carcinoma of the head and neck |
| title_full | A multicenter phase II trial of paclitaxel, carboplatin, and cetuximab followed by chemoradiotherapy in patients with unresectable locally advanced squamous cell carcinoma of the head and neck |
| title_fullStr | A multicenter phase II trial of paclitaxel, carboplatin, and cetuximab followed by chemoradiotherapy in patients with unresectable locally advanced squamous cell carcinoma of the head and neck |
| title_full_unstemmed | A multicenter phase II trial of paclitaxel, carboplatin, and cetuximab followed by chemoradiotherapy in patients with unresectable locally advanced squamous cell carcinoma of the head and neck |
| title_short | A multicenter phase II trial of paclitaxel, carboplatin, and cetuximab followed by chemoradiotherapy in patients with unresectable locally advanced squamous cell carcinoma of the head and neck |
| title_sort | multicenter phase ii trial of paclitaxel carboplatin and cetuximab followed by chemoradiotherapy in patients with unresectable locally advanced squamous cell carcinoma of the head and neck |
| topic | carboplatin cetuximab chemoradiotherapy induction chemotherapy paclitaxel unresectable locally advanced squamous cell carcinoma of the head and neck |
| url | https://doi.org/10.1002/cam4.2852 |
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